Journal articles on the topic 'Commonwealth Advisory Committee on Advanced Education'

This report of NATO's Advanced Educational Technology (AET) advisory committee is written to provide a summary as well as a vision of the role of technology in education. Over fifty ARW's (Advanced Research Workshops) and ASI's (Advanced Study Institutes) have provided a forum for hundreds of AET professionals to interact and collaborate. The published books and reports have had an impact on thousands of educational designers and planners. The summary of position and thematic papers that were presented at the final capstone workshop provide a framework for future research, development, and effective implementation of AET systems.

Introduction: Advanced systemic mastocytosis (AdvSM) comprises a heterogeneous group of clonal mast cell neoplasms, primarily driven by KIT D816V. Measures of AdvSM response, including the International Working-Group for Myeloproliferative Neoplasms Research and Treatment and European Competence Network on Mastocytosis (IWG-MRT-ECNM) criteria, are based on improvements in mast cell-related organ damage (C-findings), and further sub-classified by the extent of reduction in measures of mast cell disease (e.g. serum tryptase level, bone marrow mast cell burden). However, assessment of some C-findings lacks precision (such as splenomegaly and its resolution). Normalization of C-findings may not be an adequate surrogate for important clinical outcomes such as overall survival (OS). We evaluated whether pure pathologic response (PPR) criteria based on changes in bone marrow mast cells, serum tryptase, and complete blood count was more closely correlated with OS compared to the modified IWG-MRT-ECNM (mIWG-MRT-ECNM) criteria. Methods: As an exploratory post-hoc analysis of the phase 1 EXPLORER study of avapritinib in AdvSM, we evaluated responses lasting ≥12 weeks by both mIWG-MRT-ECNM and PPR criteria. At baseline, evaluability for mIWG-MRT-ECNM response required ≥1 evaluable C-findings; PPR required presence of bone marrow mast cell aggregates and/or serum tryptase ≥20 ng/mL. Per PPR, morphologic complete remission (mCR) is absence of bone marrow mast cell aggregates, serum tryptase <20 ng/mL and full (or partial [mCRh]) hematologic recovery; morphologic partial remission (mPR) is ≥50% reduction in bone marrow mast cells and serum tryptase level. OS was analyzed by Kaplan-Meier method and was time from first dose to death. OS comparisons were by log-rank test, performed for best response and landmark analyses at various cycles. Results: As of the data cut-off of August 30, 2019, 80 patients enrolled including 62 with AdvSM (7 with aggressive SM [ASM], 44 SM with an associated hematologic neoplasm [SM-AHN] and 11 with mast cell leukemia [MCL]). Ten (16%) AdvSM patients (7 ASM, 3 SM-AHN) were not response evaluable (RE) per mIWG-MRT-ECNM criteria, due to a lack of an evaluable C-finding at baseline, and 4 additional AdvSM patients were recently enrolled and were not yet response evaluable. Of the 48 RE patients (3 ASM, 35 SM-AHN and 10 MCL) the best overall response rate (ORR) per mIWG-MRT-ECNM was 77% (8% CR, 19% CRh, 42% partial response [PR], and 8% clinical improvement [CI]). Non-responders had stable disease (SD; 21%) or were not evaluable (NE) due to insufficient (<13 weeks) follow-up (2%). Responders (CR/CRh/PR/CI) had 18-month OS of 85% (CR/CRh, 100%; PR, 77%; CI, 75%; Figure 1A); non-responders had 18-month OS of 48% (SD, 53%; NE, 0%) (P=0.042). Per PPR criteria, the best ORR was similar at 79%; however, a greater proportion of patients were assessed as being in a complete remission (15% mCR, 27% mCRh and 38% mPR). Non-responders by PPR all had SD (21%). This demonstrates that elimination of measurable mast cell burden can be discordant with complete C-finding resolution. Responders (mCR/mCRh/mPR) by PPR had 18-month OS of 88% (mCR/mCRh: 100%; mPR: 72%; Figure 1B); non-responders (all SD) had 18-month OS of 21% (P=0.0001). Eventually, all 62 AdvSM patients will be evaluable by PPR criteria, including those 10 patients without mIWG evaluable C-findings at baseline; however, 5 patients had insufficient follow-up at the time of analysis. For the 57 AdvSM patients with sufficient follow up, the best ORR per PPR criteria was similar at 77% (14% mCR, 26% mCRh and 37% mPR). Overall, no patients had a best response of progressive disease based on mIWG or PPR criteria. Landmark analyses of PPR at the end of 6 cycles showed a trend in 18-month OS of mCR/mCRh>mPR>SD in patients with similar starting avapritinib doses of ≥200 mg daily (n=48 of 57 PPR-evaluable patients). Conclusions : In the phase I EXPLORER study, response assessment in AdvSM using PPR criteria increases the evaluable population, significantly correlates with OS, and should be explored as a potential primary endpoint for future trials. Disclosures Gotlib: Blueprint Medicines Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Chair of the Response Adjudication Committee and Research Funding, Research Funding; Deciphera: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: co-chair of the Study Steering Committee and Research Funding. Radia:Blueprint Medicines Corporation: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees, Other: Education events. George:Blueprint Medicines Corporation: Consultancy, Other: I have received no funding for this research. ARUP Laboratories, owned by the University of Utah, has received funding; Allakos: Consultancy; Deciphera: Other: consultancy, but has received no financial compensation for the past 12 months; Celgene: Consultancy. Robinson:Blueprint Medicines Corporation: Research Funding. Drummond:Jazz: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Pfizer: Consultancy, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Takeda: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Blueprint Medicine Corporation: Research Funding. Bose:Incyte Corporation: Consultancy, Honoraria, Research Funding, Speakers Bureau; Kartos Therapeutics: Honoraria, Research Funding; Astellas Pharmaceuticals: Research Funding; NS Pharma: Research Funding; Pfizer, Inc.: Research Funding; Promedior, Inc.: Research Funding; Constellation Pharmaceuticals: Research Funding; Celgene Corporation: Honoraria, Research Funding; CTI BioPharma: Honoraria, Research Funding; Blueprint Medicines Corporation: Honoraria, Research Funding. Hexner:Samus Therapeutics: Research Funding; Novartis: Research Funding; American Board of Internal Medicine: Other: member of the hematology exam committee; Blueprint Medicines Corporation: Other: serves on a data safety monitoring committee, Research Funding. Winton:Blueprint Medicines Corporation: Research Funding; Samus Therapeutics: Research Funding; Incyte Corporation: Research Funding. Horny:Novartis: Consultancy; Blueprint Medicines Corporation: Consultancy. Tugnait:Blueprint Medicines Corporation: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Schmidt-Kittler:Blueprint Medicines Corporation: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Evans:Blueprint Medicines Corporation: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Lin:Blueprint Medicines Corporation: Current Employment, Current equity holder in publicly-traded company. Mar:Blueprint Medicines Corporation: Current Employment, Current equity holder in publicly-traded company. Deininger:Leukemia & Lymphoma Society: Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Other, Research Funding; Ariad: Consultancy, Honoraria, Other; Incyte: Consultancy, Honoraria, Other, Research Funding; Novartis: Consultancy, Other, Research Funding; Medscape: Consultancy; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Fusion Pharma: Consultancy; Blueprint Medicines Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: part of a study management committee, Research Funding; DisperSol: Consultancy; Galena: Consultancy, Honoraria, Other; Celgene: Research Funding; Gilead Sciences: Research Funding; SPARC: Research Funding; Sangamo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Other, Research Funding. DeAngelo:Incyte Corporation: Consultancy; Glycomimetics: Research Funding; Forty-Seven: Consultancy; Amgen: Consultancy; Novartis: Consultancy, Research Funding; Pfizer: Consultancy; Abbvie: Research Funding; Jazz: Consultancy; Autolos: Consultancy; Shire: Consultancy; Takeda: Consultancy; Blueprint Medicines Corporation: Consultancy, Research Funding; Agios: Consultancy.

V ancomycin-resistant enterococci (VRE) are increasingly recognised nosocomial pathogens in clinical areas with high antibiotic usage. Patients with chronic renal failure, including those requiring haemodialysis, are at particular risk. Investigation and control of an outbreak of VRE in two renal wards, highlighting mattresses as reservoirs and environmental measures to control VRE are reported in this paper. Outbreak control measures included standard isolation in accordance with the Recommendations of the Hospital Infection Control Practices Advisory Committee (HICPAC). Patients were screened on admission and weekly using a rectal swab. The inanimate environment including mattresses was also screened. Enhanced environmental decontamination was performed on a daily basis. The outbreak continued over a 20-week period with most cases occurring in the first 6 weeks. The results of screening indicated that 59 (13%) of 451 patients and 54 (8.3%) of 647 environmental samples were positive for VRE. VRE was isolated from 35 (8%) of 433 mattresses, 12 (8.1%) of 148 environmental ledges, 4 (8%) of 50 toilets, and 3 (18.8%) of 16 items of cleaning equipment. Molecular typing indicated that a predominant strain was also implicated in mattress contamination, thus highlighting a potential and important reservoir for transmission of VRE. Difficulty with eradication of VRE from the environment was encountered despite enhanced cleaning regimens and a doubling of use of disinfectant was necessary. Restriction of antibiotics, hand hygiene, hygiene and education are the cornerstone of VRE prevention and control. Lessons from this outbreak highlight the role of the environment in VRE transmission and the need for attention to the environment, especially mattress decontamination.

Scientific advances in genetics and genomics are rapidly redefining our understanding of health and illness and creating a significant shift in practice for all health care disciplines. Nurses educated at the graduate level are well-prepared to assume clinical and leadership roles in health care systems and must also be prepared to assume similar roles related to genetic/genomic health care. This chapter describes the processes used to create a consensus document identifying the genetic/genomic competencies essential for nurses prepared at the graduate level. Three groups were involved in the competency development; a steering committee provided leadership and used qualitative methods to review and analyze pertinent source documents and create an initial competency draft; an advisory board evaluated and revised the draft, and a consensus panel refined and validated the final set of competencies. The concensus process resulted in 38 competencies organized under the following categories: Risk Assessment and Interpretation; Genetic Education, Counseling, Testing and Results Interpretation; Clinical Management; Ethical, Legal, and Social Implications; Professional Role; Leadership, and Research. These competencies apply to all individuals functioning at the graduate level in nursing, including but not limited to advanced practice registered nurses, clinical nurse leaders, nurse educators, nurse administrators, and nurse scientists and are intended to inform and guide their practice.

Introduction: The utility of amyloidosis staging systems has been validated for newly diagnosed patients, but their role in restaging after starting treatment has not been explored. Given the high early mortality in this disease, restaging remote from the diagnosis may have clinical value. We designed this study to evaluate whether the currently used staging systems are prognostic when applied at 3 and 6 months from starting first-line treatment, and whether stage migration impacts survival. Methods: This is a retrospective study including patients with systemic light chain amyloidosis diagnosed between January, 1st 2006 and June, 30th 2019 and were seen in Mayo Clinic, Rochester, MN within 90 days of diagnosis; the analysis included 535 and 301 patients who had restaging data available for at least one of the staging systems at 3 and 6 months, respectively. Patients were grouped into 4 stages using the 2015 European modification of the Mayo 2004 staging system based on values of cardiac biomarkers (cardiac troponin T and NTproBNP), and using the Mayo 2012 staging system based on cardiac biomarkers and the difference in serum free light chain concentration (dFLC). Overall survival (OS) was calculated from the time of re-staging until death or last follow up. Results: Using the modified Mayo 2004 staging system at 3 months from starting first-line treatment, median OS was 11.8 [95%CI: 11.4-not reached (NR)], 10.8 (95%CI: 9.4-NR), 4.6 (95%CI: 2.8-6.7), and 1.1 (95%CI: 0.7-2.6) years in patients with stage I, II, IIIa, and IIIb, respectively. Using Mayo 2012 staging at 3 months, OS was 11.8 (95%CI: 10.9-NR), 9.0 (95%CI: 6.2-NR), 5.2 (95%CI: 3.3-6.1), and 0.8 (95%CI: 0.7-1.1) years in patients with stage I, II, III, and IV, respectively (Figure 1a &b). Using the modified Mayo 2004 staging system at 6 months from starting first-line treatment, median OS was NR (95%CI: NR-NR), 9.8 (95%CI: 6.2-NR), 5.4 (95%CI: 3.2-9.0) and 0.9 (95%CI: 0.6-3.7) years in patients with stage I, II, IIIa, and IIIb, respectively. Using Mayo 2012 staging at 6 months, OS was NR (95%CI: 8.4-NR), NR (95%CI: 7.9-NR), 4.6 (95%CI: 3.0-6.5), and 0.9 (95%CI: 0.2-1.8) years in patients with stage I, II, III, and IV, respectively (Figure 1c &d). On multivariate analysis, advanced (stage > 2) modified Mayo 2004 stage (HR: 1.6, P=0.004) and advanced (stage > 2) Mayo 2012 stage (HR: 2.4, P<0.001) at 3 months were associated with decreased survival independent of cardiac response, hematologic response, and transplantation status. Although advanced Mayo 2004 stage at 6 months was associated with decreased survival, it was not statistically significant (HR: 1.5, P=0.09). In contrast, advanced Mayo 2012 stage at 6 months was independently associated with decreased survival (HR: 2.1, P=0.02). For both systems, worsening stage at 3 months or at 6 months was associated with a worse survival than retaining the original stage. In contrast, improving stage as compared to remaining in same stage was not associated with better survival at 3 or 6 months (Table 1). When the analysis was restricted to patients who had an advanced stage at diagnosis, improving stage at 3 months was associated with longer survival compared to retaining the original stage, with both modified Mayo 2004 (10.8 vs. 3.3 years, P<0.001) and Mayo 2012 (8.1 vs. 2.6 years, P<0.001) staging systems. At 6 months, stage improvement was associated with longer survival than retaining the original stage when the modified Mayo 2004 staging system was used (NR vs. 5.0 years, P=0.02), but it was not statistically significant when the Mayo 2012 staging system was used (5.9 vs. 3.7 years, P=0.12). Conclusion: The modified Mayo 2004 and the Mayo 2012 staging systems have independent prognostic value when used for restaging after 3 and 6 months from initiation of first-line treatment. Migration to a higher stage from diagnosis predicts decreased survival, compared to retaining the same stage. Stage improvement is associated with a better OS in patients with advanced stage at diagnosis. Disclosures Dispenzieri: Alnylam, Intellia, Janssen, Takeda, Pfizer, Prothena, Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding. Kapoor:GlaxoSmithKline: Research Funding; Sanofi: Consultancy, Research Funding; Janssen: Research Funding; Celgene: Honoraria; Amgen: Research Funding; Takeda: Honoraria, Research Funding; Cellectar: Consultancy. Dingli:Rigel: Consultancy; Millenium: Consultancy; Sanofi-Genzyme: Consultancy; Bristol Myers Squibb: Research Funding; Karyopharm Therapeutics: Research Funding; Janssen: Consultancy; Alexion: Consultancy; Apellis: Consultancy. Lin:Novartis: Consultancy; Celgene: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gamida Cells: Consultancy; Takeda: Research Funding; Merck: Research Funding; Legend BioTech: Consultancy; Juno: Consultancy; Janssen: Consultancy, Research Funding; Vineti: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding. Gertz:Alnylam: Consultancy; NCI SPORE MM: Research Funding; Ionis/Akcea: Consultancy; Amyloidosis Foundation: Research Funding; Celgene: Consultancy; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Advisory Board for Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Advisory Board for Proclara: Membership on an entity's Board of Directors or advisory committees; i3Health: Consultancy; Springer Publishing: Patents & Royalties; Prothena: Consultancy; Sanofi: Consultancy; Janssen: Consultancy; Spectrum: Consultancy, Research Funding; Annexon: Consultancy; Appellis: Consultancy; Amgen: Consultancy; Medscape: Consultancy, Speakers Bureau; Physicians Education Resource: Consultancy; Data Safety Monitoring board from Abbvie: Membership on an entity's Board of Directors or advisory committees; International Waldenstrom Foundation: Research Funding. Kumar:Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Genecentrix: Consultancy; Cellectar: Other; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Kite Pharma: Consultancy, Research Funding; MedImmune: Research Funding; Carsgen: Other, Research Funding; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Merck: Consultancy, Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Karyopharm: Consultancy; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; BMS: Consultancy, Research Funding; Novartis: Research Funding; Adaptive Biotechnologies: Consultancy; Tenebio: Other, Research Funding; Dr. Reddy's Laboratories: Honoraria; Sanofi: Research Funding.

Although there are a number of quality frameworks available for evaluating palliative services, it is necessary to adapt these frameworks to models of care designed for the rural context. The purpose of this paper was to describe the development of a program assessment framework for evaluating a rural palliative supportive service as part of a community-based research project designed to enhance the quality of care for patients and families living with life-limiting chronic illness. A review of key documents from electronic databases and grey literature resulted in the identification of general principles for high-quality palliative care in rural contexts. These principles were then adapted to provide an assessment framework for the evaluation of the rural palliative supportive service. This framework was evaluated and refined using a community-based advisory committee guiding the development of the service. The resulting program assessment framework includes 48 criteria organized under seven themes: embedded within community; palliative care is timely, comprehensive, and continuous; access to palliative care education and experts; effective teamwork and communication; family partnerships; policies and services that support rural capacity and values; and systematic approach for measuring and improving outcomes of care. It is important to identify essential elements for assessing the quality of services designed to improve rural palliative care, taking into account the strengths of rural communities and addressing common challenges. The program assessment framework has potential to increase the likelihood of desired outcomes in palliative care provisions in rural settings and requires further validation.

Objective: A needs assessment was undertaken for faculty development needs of nurse educators teaching in baccalaureate nursing education programs across Pakistan.Methodology: The survey instrument was developed by the researcher in consultation with an advisory committee. It contained 25 items that reflected the demographic profile of the participants and another 98 statements on a 5 point Likert type scale to assess faculty development. Data collection was done across twenty schools of nursing.Results: The major findings of the study indicated a critical shortage of academically prepared nursing faculty with advanced degrees and teaching experience to perform their role effectively. Female faculty outnumbered male faculty. Five factors were identified that could both promote or obstruct faculty development and included awareness and convenience, institutional support, prevailing leadership, politics and personal factors. Additionally, four factors were extracted for challenges for undertaking faculty development; technology and curriculum, students and resources, academic leadership and professional role. Lastly, four factors were identified as areas of interests for faculty development; learning and instruction, support for scholars, support for teaching and national curriculum.Conclusion: This is the first national needs assessment that has been undertaken for faculty development for baccalaureate nursing programs in Pakistan. Although, the data may not hold international significance it would add to the existing international data base on needs assessment for faculty development.

CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Apply new information about MS to a comprehensive individualized treatment plan for patients with MS Integrate the team approach into long-term planning in order to optimize rehabilitation care of patients with MS Accreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group. The CMSC is accredited by the ACCME to provide continuing medical education for physicians. The CMSC designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Practitioner Alternatives (NPA) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. NPA designates this enduring material for 1.0 Continuing Nursing Education credit. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has received royalties from Springer Publishing and has received intellectual property rights from Biogen. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Scott D. Newsome, DO, MSCS (author), has served on scientific advisory boards for Biogen, Genentech, Novartis, and Genzyme, and has performed contracted research (institution received funds) for Biogen, Genentech, and Novartis. Philip J. Aliotta, MD, MSHA, CHCQM, FACS (author), has served on speakers' bureaus for Astellas Pharma, Actavis, Augmenix, and Allergan and has performed contracted research for Allergan. Jacquelyn Bainbridge, PharmD (author), has disclosed no relevant financial relationships. Susan E. Bennett, PT, DPT, EdD, NCS, MSCS (author), has served on speakers' bureaus for Acorda Therapeutics, Biogen, and Medtronic; has received consulting fees from and performed contracted research for Acorda Therapeutics; and is chair of the Clinical Events Committee at Innovative Technologies. Gary Cutter, PhD (author), has participated on Data and Safety Monitoring Committees for AMO Pharma, Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Neuren, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceuticals, NHLBI (Protocol Review Committee), and NICHD (OPRU Oversight Committee); has received consulting fees from and/or served on speakers' bureaus and scientific advisory boards for Cerespir, Genzyme, Genentech, Innate Therapeutics, Janssen Pharmaceuticals, Klein-Buendel Incorporated, MedImmune, Medday, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara, Somahlution, Teva Pharmaceuticals, Transparency Life Sciences, and TG Therapeutics; and is President of Pythagoras, Inc., a private consulting company located in Birmingham, AL. Kaylan Fenton, CRNP, APNP, MSCN (author), has disclosed no relevant financial relationships. Fred Lublin, MD (author), has received consulting fees/fees for non-CME/CE activities from Bayer HealthCare Pharmaceuticals, Biogen, EMD Serono, Novartis, Teva Neuroscience, Actelion, Sanofi/Genzyme, Acorda, Questcor/Mallinckrodt, Roche/Genentech, MedImmune, Osmotica, Xenoport, Receptos/Celgene, Forward Pharma, Akros, TG Therapeutics, AbbVie, Toyama, Amgen, Medday, Atara Biotherapeutics, Polypharma, Pfizer, Johnson & Johnson, Revalesio, Coronado Bioscience, and Bristol-Myers Squibb; has served on speakers' bureaus for Genentech/Roche and Genzyme/Sanofi; has performed contracted research for Acorda, Biogen, Novartis, Teva Neuroscience, Genzyme, Xenoport, and Receptos; is the co–chief editor of Multiple Sclerosis and Related Disorders; and has an ownership interest in Cognition Pharmaceuticals. Dorothy Northrop, MSW, ACSW (author), has disclosed no relevant financial relationships. David Rintell, EdD (author), has received consulting fees from Novartis and has served as a patient education speaker for Teva Neuroscience. He started as a salaried employee of Sanofi Genzyme in November 2015. Dr. Rintell's work on this project was completed before he became a salaried employee of Sanofi Genzyme. Bryan D. Walker, MHS, PA-C (author), has served on scientific advisory boards for EMD Serono and Sanofi Genzyme and owns stock in Biogen. Megan Weigel, DNP, ARNP-C, MSCN (author), has received consulting fees from Mallinckrodt, Genzyme, and Genentech, and has served on speakers' bureaus for Bayer Corp, Acorda Therapeutics, Teva Neuroscience, Biogen, Mallinckrodt, Genzyme, Novartis, and Pfizer. Kathleen Zackowski, PhD, OTR, MSCS (author), has performed contracted research for Acorda Therapeutics. David E. Jones, MD (author), has received consulting fees from Biogen and Novartis, and has performed contracted research for Biogen. One anonymous peer reviewer for the IJMSC has performed contracted research (institution received funds) for Novartis, Chugai, and Biogen. Another reviewer has received consulting fees and served on speakers' bureaus for Biogen, Sanofi Genzyme, Genentech, EMD Serono, and Novartis. The third reviewer has disclosed no relevant financial relationships. Lori Saslow, MS (medical writer), has disclosed no relevant financial relationships. The staff at the IJMSC, CMSC, NPA, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Disclosures listed for authors are those applicable at the time of their work on this project and within 12 months previously. Financial relationships for some authors may have changed in the interval between the time of their work on this project and publication of the article. Funding/Support: Funding for the Framework of Care consensus conference was provided by the Consortium of Multiple Sclerosis Centers, Mallinckrodt Pharmaceuticals, and Mylan Pharmaceuticals. Method of Participation: Release Date: December 1, 2016 Valid for Credit Through: December 1, 2017 In order to receive CME/CNE credit, participants must:Review the CME/CNE information, including learning objectives and author disclosures.Study the educational content.Complete the post-test and evaluation, which are available at http://www.cmscscholar.org. Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This CME/CNE activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC, NPA, and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC, NPA, or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

CME/CNE Information Activity Available Online: To access the article, post-test, and evaluation online, go to http://www.cmscscholar.org. Target Audience: The target audience for this activity is physicians, physician assistants, nursing professionals, and other health-care providers involved in the management of patients with multiple sclerosis (MS). Learning Objectives: Apply new information about MS to a comprehensive individualized treatment plan for patients with MS Adjust rehabilitative interventions to accommodate for fluctuating or ongoing MS symptoms Accreditation Statement: This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the Consortium of Multiple Sclerosis Centers (CMSC), Nurse Practitioner Alternatives (NPA), and Delaware Media Group. The CMSC is accredited by the ACCME to provide continuing medical education for physicians. The CMSC designates this journal-based CME activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Nurse Practitioner Alternatives (NPA) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. NPA designates this enduring material for 1.0 Continuing Nursing Education credit. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Disclosures: Francois Bethoux, MD, Editor in Chief of the International Journal of MS Care (IJMSC), has served as Physician Planner for this activity. He has received royalties from Springer Publishing; has received intellectual property rights from Biogen; has received consulting fees from Acorda Therapeutics, Ipsen, and Merz Pharma; and has performed contracted research for Acorda Therapeutics. Laurie Scudder, DNP, NP, has served as Nurse Planner for this activity. She has disclosed no relevant financial relationships. Scott D. Newsome, DO, MSCS (author), has served on scientific advisory boards for Biogen, Genentech, Novartis, and Genzyme and has performed contracted research (institution received funds) for Biogen, Genentech, and Novartis. Philip J. Aliotta, MD, MSHA, CHCQM, FACS (author), has served on speakers' bureaus for Astellas Pharma, Actavis, Augmenix, and Allergan and has performed contracted research for Allergan. Jacquelyn Bainbridge, PharmD (author), has disclosed no relevant financial relationships. Susan E. Bennett, PT, DPT, EdD, NCS, MSCS (author), has served on speakers' bureaus for Acorda Therapeutics, Biogen, and Medtronic; has received consulting fees from and performed contracted research for Acorda Therapeutics; and is chair of the Clinical Events Committee at Innovative Technologies. Gary Cutter, PhD (author), has participated on Data and Safety Monitoring Committees for AMO Pharma, Apotek, Gilead Pharmaceuticals, Horizon Pharmaceuticals, Modigenetech/Prolor, Merck, Merck/Pfizer, Opko Biologics, Neuren, Sanofi-Aventis, Reata Pharmaceuticals, Receptos/Celgene, Teva Pharmaceuticals, NHLBI (Protocol Review Committee), and NICHD (OPRU Oversight Committee); has received consulting fees from and/or served on speakers' bureaus and scientific advisory boards for Cerespir, Genzyme, Genentech, Innate Therapeutics, Janssen Pharmaceuticals, Klein-Buendel Incorporated, MedImmune, Medday, Nivalis, Novartis, Opexa Therapeutics, Roche, Savara, Somahlution, Teva Pharmaceuticals, Transparency Life Sciences, and TG Therapeutics; and is President of Pythagoras, Inc., a private consulting company located in Birmingham, AL. Kaylan Fenton, CRNP, APNP, MSCN (author), has disclosed no relevant financial relationships. Fred Lublin, MD (author), has received consulting fees/fees for non-CME/CE activities from Bayer HealthCare Pharmaceuticals, Biogen, EMD Serono, Novartis, Teva Neuroscience, Actelion, Sanofi/Genzyme, Acorda, Questcor/Mallinckrodt, Roche/Genentech, MedImmune, Osmotica, Xenoport, Receptos/Celgene, Forward Pharma, Akros, TG Therapeutics, AbbVie, Toyama, Amgen, Medday, Atara Biotherapeutics, Polypharma, Pfizer, Johnson & Johnson, Revalesio, Coronado Bioscience, and Bristol-Myers Squibb; has served on speakers' bureaus for Genentech/Roche and Genzyme/Sanofi; has performed contracted research for Acorda, Biogen, Novartis, Teva Neuroscience, Genzyme, Xenoport, and Receptos; is the co–chief editor of Multiple Sclerosis and Related Disorders; and has an ownership interest in Cognition Pharmaceuticals. Dorothy Northrop, MSW, ACSW (author), has disclosed no relevant financial relationships. David Rintell, EdD (author), has received consulting fees from Novartis and has served as a patient education speaker for Teva Neuroscience. He started as a salaried employee of Sanofi Genzyme in November 2015. Dr. Rintell's work on this project was completed before he became a salaried employee of Sanofi Genzyme. Bryan D. Walker, MHS, PA-C (author), has served on scientific advisory boards for EMD Serono and Sanofi Genzyme and owns stock in Biogen. Megan Weigel, DNP, ARNP-C, MSCN (author), has received consulting fees from Mallinckrodt, Genzyme, and Genentech, and has served on speakers' bureaus for Bayer Corp, Acorda Therapeutics, Teva Neuroscience, Biogen, Mallinckrodt, Genzyme, Novartis, and Pfizer. Kathleen Zackowski, PhD, OTR, MSCS (author), has performed contracted research for Acorda Therapeutics. David E. Jones, MD (author), has received consulting fees from Biogen, Novartis, and Genzyme and has performed contracted research for Biogen (institution received funds). One anonymous peer reviewer for the IJMSC has performed contracted research (institution received funds) for Novartis, Chugai, and Biogen. Another reviewer has received consulting fees and served on speakers' bureaus for Biogen, Sanofi Genzyme, Genentech, EMD Serono, and Novartis. The third reviewer has disclosed no relevant financial relationships. Lori Saslow, MS (medical writer), has disclosed no relevant financial relationships. The staff at the IJMSC, CMSC, NPA, and Delaware Media Group who are in a position to influence content have disclosed no relevant financial relationships. Note: Disclosures listed for authors are those applicable at the time of their work on this project and within 12 months previously. Financial relationships for some authors may have changed in the interval between the time of their work on this project and publication of the article. Funding/Support: Funding for the Framework of Care consensus conference was provided by the Consortium of Multiple Sclerosis Centers, Mallinckrodt Pharmaceuticals, and Mylan Pharmaceuticals. Method of Participation: Release Date: February 1, 2017 Valid for Credit Through: February 1, 2018 In order to receive CME/CNE credit, participants must:Review the CME/CNE information, including learning objectives and author disclosures.Study the educational content.Complete the post-test and evaluation, which are available at http://www.cmscscholar.org. Statements of Credit are awarded upon successful completion of the post-test with a passing score of >70% and the evaluation. There is no fee to participate in this activity. Disclosure of Unlabeled Use: This CME/CNE activity may contain discussion of published and/or investigational uses of agents that are not approved by the FDA. CMSC, NPA, and Delaware Media Group do not recommend the use of any agent outside of the labeled indications. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of CMSC, NPA, or Delaware Media Group. Disclaimer: Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any medications, diagnostic procedures, or treatments discussed in this publication should not be used by clinicians or other health-care professionals without first evaluating their patients' conditions, considering possible contraindications or risks, reviewing any applicable manufacturer's product information, and comparing any therapeutic approach with the recommendations of other authorities.

Background: Newly diagnosed patients with AL Amyloidosis are a heterogeneous population, ranging from incidentally found nephrotic syndrome to delayed advanced cardiac disease. For the purposes of trials, patients with the highest-risk disease are often excluded from trial participation. An NT-proBNP of 8500 or higher is the criterion most often used for exclusion from clinical trials due to high rates of early death. It is well documented that overall survival is improving over time, in part due to earlier diagnosis and in part due to more effective therapies. It is our aim to describe outcomes of patients with very high (NT-proBNP >=8500) and advanced stage amyloidosis excluding very high (VH) NT-proBNP. Methods: To address this need, we examined the outcomes of AL patients diagnosed between 1/2012 and 7/2020 and seen at our institution within 90 days of diagnosis. Of the 1290 patients, 291 were seen beyond the 90 day threshold and were thus excluded. Another 170 patients were excluded due to missing biomarkers to calculate stage, leaving 829 patients for our analysis. Thresholds for troponins and BNPs were used according to Muchtar Blood 133(7):2019 to correct for assay used. The vast majority of patients had troponin T measured, and for them the 0.025 mcg/L and the 0.035 mcg/L cut-points were used for the 2012 and 2004 staging systems. A minority of patients did not have troponin T, but rather high sensitivity troponin T (n=129) or troponin I (n=23). For patients with high sensitivity troponin T, cut-points of 41 and 50 ng/L were used, respectively, for the 2012 and 2004 systems, and for patients with troponin I only, a cut-point of 0.1 mcg/L was used for both systems. In the 3 patients with no NT-proBNP but with BNP, 400 and 81 ng/L were used respectively for the 2012 and 2004 systems; otherwise, the 1800 ng/L and 332 ng/L cut-offs were used. A BNP of > 700 ng/L was considered equivalent to NT-proBNP greater than or equal to 8500 ng/L. For the 2012 system, the dFLC of 18 mg/dL was used as a cut-off. Survival estimates were done using the method of Kaplan-Meier, and differences in survival were by determined by Log-Rank. Results: The median age of patients was 65 (range 29, 89), and 65% were male. 148 (17%) of these newly diagnosed patients had a VH (>=8500) NT-proBNP. Patients with VH NT-proBNP were older (67 versus 64 years, p=0.004). Only 4% of the VH NT-proBNP patients received an ASCT in contrast to 34% without VH NT-proBNP. With a median follow-up of 30 months for surviving patients, median OS for VH NT-proBNP patients was 3.3 months in contrast to patients without VH NT-proBNP at 68.4 months (Figure). Breakdown of early death for patients with VH NT-proBNP by stage is shown in Table. Of Mayo 2012 patients staged I, II, III, and IV, the percent of patients with VH NT-proBNP was 0, 3, 20, and 45%. In contrast, for the European modification of the Mayo 2004 system, the percent with VH NT-proBNP by stage was 0, 6, 0, 100 for stages I, II, IIIa, and IIIb, respectively. Among the VH NT-proBNP patients, there was stage discrimination using the Mayo 2012 system (6-month death rates were 17, 45, and 66% for patients with stages II, III, and IV, respectively, p=0.02). In contrast, using the Mayo 2004 system in the patients with VH NT-proBNP, 6-month death rates were 45 and 60% for stage II and IIIb patients, respectively (p= 0.12). Among patients without VH NT-proBNP, rates of death in the first year were 21% including stage I patients whose death rates were well under 10%. Patients without VH NT-proBNP but Mayo 2012 Stage III and IV had 1-year mortalities of 28 and 43% respectively. Using the modified Mayo 2004 system, excluding the VH NT-proBNP 1-year mortality was 19 and 37% for patients with stage II and IIIa, respectively. Discussion: Establishing expected outcomes for the sickest AL amyloidosis patients is a means by which trials can be designed for these patients with an unmet need. Patients with VH NT-proBNP should be considered for specially designed trials, and patients without VH NT-proBNP and advanced stage should be included in trials for newly diagnosed patients regardless of stage as long as there is appropriate stratification. Disclosures Dispenzieri: Janssen: Research Funding; Pfizer: Research Funding; Intellia: Research Funding; Alnylam: Research Funding; Celgene: Research Funding; Takeda: Research Funding. Kumar:AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Tenebio: Other, Research Funding; BMS: Consultancy, Research Funding; Sanofi: Research Funding; Carsgen: Other, Research Funding; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Adaptive Biotechnologies: Consultancy; Dr. Reddy's Laboratories: Honoraria; Novartis: Research Funding; MedImmune: Research Funding; Genecentrix: Consultancy; Kite Pharma: Consultancy, Research Funding; Cellectar: Other; Karyopharm: Consultancy; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments. Dingli:Karyopharm Therapeutics: Research Funding; Bristol Myers Squibb: Research Funding; Millenium: Consultancy; Janssen: Consultancy; Alexion: Consultancy; Rigel: Consultancy; Apellis: Consultancy; Sanofi-Genzyme: Consultancy. Kapoor:Celgene: Honoraria; Cellectar: Consultancy; Janssen: Research Funding; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding. Lin:Janssen: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Novartis: Consultancy; Celgene: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Juno: Consultancy; Legend BioTech: Consultancy; Merck: Research Funding; Takeda: Research Funding; Gamida Cells: Consultancy; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Vineti: Consultancy. Gertz:Springer Publishing: Patents & Royalties; Amyloidosis Foundation: Research Funding; International Waldenstrom Foundation: Research Funding; NCI SPORE MM: Research Funding; Ionis/Akcea: Consultancy; Alnylam: Consultancy; Prothena: Consultancy; Sanofi: Consultancy; Janssen: Consultancy; Spectrum: Consultancy, Research Funding; Annexon: Consultancy; Appellis: Consultancy; Amgen: Consultancy; Medscape: Consultancy, Speakers Bureau; Physicians Education Resource: Consultancy; Data Safety Monitoring board from Abbvie: Membership on an entity's Board of Directors or advisory committees; Celgene: Consultancy; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Advisory Board for Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Advisory Board for Proclara: Membership on an entity's Board of Directors or advisory committees; i3Health: Consultancy.

Abstract Background As treatments, management strategies, and the role of advanced practice providers (APPs) have evolved in recent years, the Crohn’s & Colitis Foundation sought to understand the educational and resource needs of clinicians caring for patients with inflammatory bowel diseases (IBDs). The aim of this study was to describe the self-identified IBD knowledge and resource gaps of clinicians to inform the development of future programming. Methods A survey containing 19 questions created by the foundation’s Professional Education Committee, a subset of its National Scientific Advisory Committee, was conducted from September 7, 2018 to October 15, 2018. Responses were included from providers if they were currently seeing any IBD patients in a clinical setting. The foundation distributed the survey by email and various social media channels to encourage a diverse response. The survey included questions on comfort levels around diagnosis, treatment, and management of patients with IBD, in addition to preferences and utilization of educational resources. The × 2 test was used to evaluate significant differences among respondents in the various domains surveyed. Results There were 197 eligible responses, of which 75% were from MD/Dos, followed by 25% APN/PA/RN/MSN/PhD/other; and 70% of respondents provide care for adult patients. The amount of time in practice was divided evenly among respondents. Fifty-seven percent of respondents practice in an academic/university setting, and approximately 75% indicated that ≥21% of their practice consisted of patients with IBD. Forty-four percent and 46% of respondents reported access to IBD based mental health providers and social workers in their practice, respectively. Seventy-two percent reported access to radiologists, 69% had access to dietitians, and 62% had access to advance practice providers. The areas of greatest educational need were prescribing medical cannabis (if approved locally) for pain management (62%); caring for patients with prior malignancy (35%); caring for pregnant patients and family planning (33%); caring for elderly patients (30%); and therapy decisions, including use of JAK inhibitors (29%), drug holidays (25%), and use of biosimilars (24%). More than 50% of respondents stated they do not participate in shared decision-making, citing time as the most common limiting factor. The majority of providers cited live education as their preferred learning format, and they wish to earn continuing medical education (CME) hours. Conclusion This survey helped identify current IBD educational needs in our professional community. With a rapidly changing treatment landscape and an increase in the diversity of providers delivering care, additional opportunities to keep abreast of practice changes are critical to providing comprehensive, quality care in IBD. Our survey demonstrated that shared decision-making is underutilized in practice due to a need for resources that aid in its efficient integration into practice. Based on our results, a focus on creating live learning opportunities that offer CME are needed in the areas of therapeutic decision-making and treating IBD in special subsets (eg, prior malignancy, pregnancy, elderly).

Introduction:Treatment options for R/R MCL, MZL and WM are limited. New combinations are in development. A previous Phase Ib study evaluating atezolizumab (A) in combination with obinutuzumab (O) in patients (pts) with R/R NHL reported no new safety signals and overall response rates of 57% and 16% in follicular lymphoma and diffuse large B-cell lymphoma pts, respectively (Palomba, et al. ICML 2017). The Phase II TEGAR study (EudraCT: 2016-003579-22) evaluated the safety and efficacy of A in combination with O or rituximab (R) in pts with R/R MCL, MZL or WM. Methods:R/R MCL or WM pts received eight 21-day (D) cycles (C) of A 1200mg in combination with O 1000mg as induction. O was given by IV infusion on D1 of each C and optionally as a split dose on D1 (100mg) and D2 (900mg) of C1. O 1000mg was also given on D8 and D15 of C1. A was given after O on D1 of each C unless split dosing was pursued, in which case A was initiated on D2 C1 after the D2 O dose. R/R MZL pts received A 1200mg in combination with R 375mg/m2 by IV infusion on D1 C1 and A 1200mg by IV infusion and R 1400mg by SC injection on D1 C2-8 as induction. A was always given after R. In all pts, A 1200mg was continued from C9 for 10 Cs. Anti-CD20 premedication was given per protocol. The primary endpoint in the MCL and MZL cohorts was end of induction (EOI) response; in the WM cohort it was best overall response (BOR). Data cut-off was December 17, 2019, and the primary analysis presents results at EOI. Results:A total of 30 MCL, 21 MZL (3 nodal [N], 10 extra nodal [including 7 non-gastric (EN) and 3 gastric (G)] and 8 splenic [S]) and 4 WM pts were enrolled (median age: 67 years [range: 47-87]; 56.4% male). The majority of MCL (80%) and MZL (67%) pts had Ann Arbor stage IV disease. Refractory disease was present in 36.7% of MCL, 23.8% of MZL and 25.0% (1/4) of WM pts. Median prior systemic treatments was 2 in the MCL (range: 1-8) and MZL (1-7) groups and 3.5 (1-4) in the WM group; 14/30 pts (46.7%) in the MCL group had received prior ibrutinib. In the MCL, MZL and WM groups, respectively, 50.0%, 71.4% and 75.0% (3/4) of pts completed O or R treatment, 23.3%, 38.1% and 25.0% (1/4) completed A induction, and 10.0%, 9.5% and 0% had ongoing treatment at cut-off. Median numbers of O/A infusions were 9.5/8 (range: 2-10/1-18) (MCL group) and 10/9.5 (2-10/1-18) (WM group); in MZL, median numbers of R/A administrations were 8/15 (2-8/2-18). Median observation times were 9.99 (range: 0.9-23.4), 15.77 (2.7-22.3) and 8.43 (1.3-15.3) months in MCL, MZL and WM pts, respectively. Treatment-emergent adverse events (TEAEs) occurred in 93.3% of MCL, 95.2% of MZL and 100% (4/4) of WM pts. Overall, the most frequent TEAEs were anemia, neutropenia and thrombocytopenia (18.2% each), and the most frequent serious TEAEs were pneumonia (5.5%) and sepsis (3.6%). The most frequent Grade (Gr) 3-4 AEs were neutropenia (16.4%), thrombocytopenia (9.1%) and pneumonia (9.1%), and Gr 3-4 AEs occurred in 53.3%, 47.6% and 100% (4/4) of MCL, MZL and WM pts, respectively. Serious AEs occurred in 30.0%, 23.8% and 0% of MCL, MZL and WM pts, respectively. AEs of special interest occurred in 33.3% of MCL, 33.3% of MZL and 50.0% (2/4) of WM pts, with the most frequent being peripheral edema (10.0% MCL, 4.8% MZL). TEAEs leading to discontinuation occurred in 10.0%, 19.0% and 0% of MCL, MZL and WM pts, respectively. One fatal TEAE (pneumonia) occurred in each of the MCL and MZL groups. Objective response rates (ORR) at EOI were 16.7%, 42.9% and 0% (complete response in 3.3%, 14.3% and 0%) and BOR rates were 33.3%, 52.4% and 0% in MCL, MZL and WM pts, respectively. For MZL subtypes, ORRs were 66.7% N, 57.1% EN, 66.7% G and 12.5% S; BOR rates were 66.7%, 71.4%, 66.7% and 25.0%, respectively. Three MCL pts, 1 MZL patient and 1 WM patient discontinued before the first post-baseline assessment and were considered non-responders. Median duration of response was 6.8 (range: 0.0-14.2) months for MCL and not reached (NR) for MZL. Median progression free survival was 10.1 months (95% CI: 3.4, 14.0) for MCL, NR for MZL and 6.7 months (95% CI: 6.2, 7.2) for WM. Median overall survival was 23.4 months (95% CI: 12.3, 23.4) for MCL and NR for MZL or WM. Median time to next treatment was 10.5 months (95% CI: 6.7, 23.4) for MCL, 22.3 months (95% CI: 14.3, 22.3) for MZL and NR for WM. Conclusions:A in combination with O or R has an acceptable safety profile in R/R MCL and MZL pts and no new safety signals were identified. A promising response rate was observed in MZL pts. WM data were inconclusive due to the small sample size. Disclosures Panayiotidis: AbbVie:Honoraria, Research Funding;Roche:Honoraria, Research Funding;Novartis:Honoraria, Research Funding;Genesis:Honoraria, Research Funding;Janssen:Honoraria;Gilead:Honoraria;Takeda:Honoraria;Phizer:Honoraria;ASH:Honoraria.Thieblemont:Novartis:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Hospira:Research Funding;Kyte:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Gilead:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Roche:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding;Cellectis:Speakers Bureau;BMS:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees;Janssen:Honoraria;University Employement:Current Employment;Celgene:Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees.Ptushkin:Alexion Pharmaceuticals Inc.:Honoraria.Marin Niebla:Janssen:Membership on an entity's Board of Directors or advisory committees, Other: Participation in advisory committees, continuing Medical Education for companies' staff members, Speakers Bureau;Takeda:Membership on an entity's Board of Directors or advisory committees, Speakers Bureau;Roche:Other: Continuing Medical Education for companies' staff members, Speakers Bureau;Celgene:Speakers Bureau;Abbvie:Speakers Bureau;Gilead:Membership on an entity's Board of Directors or advisory committees, Other: Participation in advisory committees, continuing Medical Education for companies' staff members;Kiowa Kirin:Membership on an entity's Board of Directors or advisory committees, Other: Participation in advisory committees, continuing Medical Education for companies' staff members;BeiGene:Membership on an entity's Board of Directors or advisory committees.Garcia-Sanz:Novartis:Honoraria;Janssen:Honoraria, Research Funding;Incyte:Research Funding;Gilead:Honoraria, Research Funding;BMS:Honoraria;Amgen:Membership on an entity's Board of Directors or advisory committees;Pharmacyclics:Honoraria;Takeda:Consultancy, Research Funding.Zaritskey:Janssen:Research Funding;Celgene:Research Funding;Almazov centre:Current Employment.Le Gouill:Roche Genentech, Janssen-Cilag and Abbvie, Celgene, Jazz pharmaceutical, Gilead-kite, Loxo, Daiichi-Sankyo and Servier:Honoraria;Loxo Oncology at Lilly:Consultancy.Buske:Morphosys:Membership on an entity's Board of Directors or advisory committees;Roche, Janssen, Bayer, MSD:Research Funding;Roche, Janssen, AbbVie, Pfizer, Celltrion:Honoraria, Speakers Bureau.Van Hoef:Lipomed AG:Ended employment in the past 24 months;Roche AG:Current Employment.Perretti:F. Hoffmann-La Roche Ltd:Current Employment.Tomiczek:F. Hoffmann-La Roche Ltd, Basel, Switzerland:Current Employment.Stathis:ADC Therapeutcis:Other, Research Funding;Merck:Other, Research Funding;Pfizer:Other, Research Funding;Loxo:Honoraria, Other, Research Funding;PharmaMar:Other: Travel Grant;Bayer:Other, Research Funding;MEI Pharma:Other, Research Funding;Novartis:Other, Research Funding;Cellestia:Research Funding;Roche:Other, Research Funding;Member of the steering committee of the trial of this abstract:Other;Abbvie:Other: Travel Grant. OffLabel Disclosure: GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody indicated: in combination with chlorambucil, for the treatment of pts with previously untreated CLL; in combination with bendamustine followed by GAZYVA monotherapy, for the treatment of pts with FL who relapsed after, or are refractory to, a rituximab-containing regimen; in combination with chemo followed by GAZYVA monotherapy in pts achieving at least a partial remission, for the treatment of adult pts with previously untreated stage II bulky, III or IV FL. RITUXAN (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of adult pts with: R/R, low grade or follicular, CD20-positive, B-cell NHL as a single agent; previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemo and, in pts achieving a CR or PR to a rituximab product in combination with chemo, as single-agent maintenance therapy; non-progressing (including SD), low-grade, CD20 positive, B-cell NHL as a single agent after first-line CVP chemo; previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP or other anthracycline-based chemo regimens; previously untreated and previously treated CD20-positive CLL in combination with FC. RITUXAN HYCELA is a combination of rituximab, a CD20-directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult pts with: R/R FL as a single agent; previously untreated FL in combination with first line chemo and, in pts achieving a CR or PR to rituximab in combination with chemo, as single agent maintenance therapy; non-progressing (including SD), FL as a single agent after first-line CVP chemotherapy; previously untreated DLBCL in combination with CHOP or other anthracycline-based chemo regimens; previously untreated and previously treated CLL. TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: for the treatment of adult pts with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemo and whose tumors express PD-L1* or are not eligible for any platinum-containing chemo regardless of PD-L1 status, or have PD during or following any platinum-containing chemo, or within 12 months of neoadjuvant or adjuvant chemo; for the first-line treatment of adult pts with metastatic NSCLC whose tumors have high PD-L1 expression* with no EGFR or ALK genomic tumor aberrations; in combination with bevacizumab (bev), paclitaxel, and carboplatin, for the first-line treatment of adult pts with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult pts with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations; for the treatment of adult pts with metastatic NSCLC who have PD during or following platinum-containing chemo; in combination with paclitaxel protein-bound for the treatment of adult pts with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1*; in combination with carboplatin and etoposide, for the first-line treatment of adult pts with ES-SCLC; in combination with bev for the treatment of pts with unresectable or metastatic HCC who have not received prior systemic therapy. *As determined by an FDA-approved test

Abstract Abstract 1952 Background: Initial clinical response rates have improved significantly with current treatments for multiple myeloma (MM). However, most patients eventually relapse or become refractory to approved agents, prompting the development of additional targeted agents and combination regimens. Vorinostat is a first-in-class oral histone deacetylase inhibitor that regulates the expression of genes and proteins involved in tumor growth and survival, and is approved in the United States for the treatment of patients with advanced cutaneous T-cell lymphoma in whom prior therapies have failed. Bortezomib, a reversible proteasome inhibitor, is approved for the treatment of patients with MM who have received at least 1 prior therapy. The synergistic effects of vorinostat and bortezomib have been shown in preclinical studies and confirmed in Phase I trials in patients with relapsed/refractory (RR) MM, producing objective response rates (ORRs; partial response or better) of up to 42% in all patients (including those with bortezomib-refractory disease) and overall clinical benefit of up to 90%. Methods: Vantage 088 is a global, Phase III, randomized, double-blind study to investigate the safety and efficacy of vorinostat vs placebo in combination with bortezomib in patients with relapsed MM and progressive disease after 1–3 prior antimyeloma regimens. The primary objective is to determine the duration of progression-free survival, with a planned enrollment of 742 patients. Overall survival, time to progression, ORR, tolerability, and patient-reported outcomes (PROs) will be included as secondary and exploratory outcomes. A distinctive aspect of this study design involves the evaluation of PROs using validated instruments, including quality-of-life (QoL) questionnaires for cancer patients (EORTC QLQ-C30) and myeloma patients (EORTC QLQ-MY20) and the EuroQoL-5D, presenting an opportunity to correlate PROs with efficacy and safety data. Interim analysis will take place when at least 126 events have occurred. Vantage 095 is a Phase IIB open-label study to investigate the efficacy and tolerability of vorinostat combined with bortezomib in patients with RR MM who had received ≥2 prior antimyeloma regimens; were refractory to bortezomib; and were relapsed, refractory to, intolerant of, or ineligible for other MM therapies, including immunomodulatory drugs (IMiDs). The primary objective is to determine the ORR, with a planned enrollment of 142 patients. In both studies, patients receive 21-day cycles of intravenous bortezomib (1.3 mg/m2; days 1, 4, 8, and 11) combined with oral vorinostat 400 mg (or matching placebo in Vantage 088) once daily on days 1–14. Efficacy is assessed using European Bone and Marrow Transplantation Group criteria. Adverse events (AEs; including clinical and laboratory events) are assessed and recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0). Results: Vantage 088: As of June 11, 2010, 349 patients (range, 1–17 cycles) were randomized. Patients received a median of 2 prior regimens (range, 1–3 regimens; 25% prior bortezomib, 48% prior thalidomide, and 12% prior lenalidomide). Vantage 095: As of June 11, 2010, 108 patients were enrolled. Patients (median age, 62 y; 57% men; 67% with Eastern Cooperative Oncology Group performance status 1) were heavily pretreated (median prior regimens, 5 [range, 2–17]). Interim efficacy data were reviewed in January 2010 by an independent data monitoring committee (DMC) for the first 43 patients enrolled; the futility threshold was passed, and final results are expected to be available 2Q2011. Conclusion: 2 ongoing global, multicenter, investigational trials are evaluating the efficacy and safety of combined vorinostat and bortezomib in patients with RR MM and are rapidly accruing patients. The Vantage 088 trial has passed the initial safety evaluations by the DMC, while interim results from Vantage 095 suggest that combined vorinostat and bortezomib may have clinical activity in patients with RR MM who are refractory to bortezomib and IMiDs and ineligible for other regimens. Disclosures: Siegel: Celgene and Millennium: Advisory Board, Speakers Bureau; Merck: Advisory Board, Consultancy. Off Label Use: Vorinostat Combined with Bortezomib for treatment in Multiple Myeloma. Jagannath:Celgene: Honoraria; Millenium: Honoraria; Ortho Biotech: Honoraria; Onyx Pharma: Honoraria; Merck: Honoraria; Proteolix: Honoraria; Imedex: Speakers Bureau; Medicom World Wide: Speakers Bureau; Optum Health Education: Speakers Bureau; PER Group: Speakers Bureau. Hajek:Janssen-Cilag: Honoraria; Celgene: Honoraria; Merck, Sharp, and Dohme: Honoraria. Dimopoulos:MSD: Honoraria, Membership on an entity's Board of Directors or advisory committees; Millenium: Honoraria, Membership on an entity's Board of Directors or advisory committees; Ortho Biotech: Honoraria, Membership on an entity's Board of Directors or advisory committees. Lonial:Millennium: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; Onyx: Consultancy, Research Funding. Graef:Merck Research Laboratories: Employment. Pietrangelo:Merck Research Laboratories: Employment. Lupinacci:Merck Research Laboratories: Employment. Reiser:Merck Research Laboratories: Employment. Anderson:Millennium Pharmaceuticals: Consultancy; Celgene: Consultancy; Novartis: Consultancy; Onyx: Consultancy; Merck: Consultancy; BMS: Consultancy; Acetylon: Equity Ownership, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Background: Patients with Waldenström Macroglobulinemia (WM) tend to present at an older age. Frailty, resulting from comorbidities and reduced organ function, poses unique challenges to the management of WM in the elderly. Age above 65 years, is an established unfavorable prognostic factor in WM. However, data specifically pertaining to the very elderly patient population are scant. The impact of advanced age (≥75 years at diagnosis) on the clinical features and outcomes of patients with symptomatic/active WM were studied. Methods: Patients with active WM, evaluated at Mayo Clinic, Rochester between January 1996 and December 2018 were included in the study. The characteristics and laboratory parameters at presentation of the cohort of patients with the age ≥75 years were compared to those of the younger (age <75 years) cohort. The median follow-up and overall survival (OS) were assessed from active disease to last follow-up or death using the Kaplan Meier method. Because older age is a confounding factor for deaths from unrelated causes, the cause-specific survival (CSS) was calculated. Deaths were deemed WM-related if patients died from progressive disease, transformation with antecedent WM, concomitant light chain (AL) amyloidosis, infection associated with WM or anti-WM therapy related toxicity, while patients who died from other causes were considered to have a WM-unrelated death. The patients who died from causes unrelated to WM were censored at death for CSS analysis. The OS of the cohort of the very elderly patients was compared to that of a cohort of the general US population, matched for age, sex as well as follow-up from the calendar-year of diagnosis, to assess the degree to which WM impacts survival. Results: Among 949 consecutive patients, with a median follow-up of 8.4 years [95% Confidence Interval (CI): 7.7-9.3 years] from active disease, the median age at diagnosis was 65 years (range: 31-93 years). Of 177 patients (19%) who were ≥75 years of age at the onset of active WM, 173 (98%) received anti-WM therapy. The baseline characteristics of the 2 cohorts (patients ≥75 years of age versus <75 years) are outlined in Table 1. The patients in the age ≥75 years cohort were noted to have lower IgM levels and serum albumin, and higher serum LDH and serum β-2 microglobulin compared to the age <75 years cohort. A higher proportion of patients in the age <75 years cohort had coexisting AL amyloidosis at diagnosis. The frequency of MYD88L265P mutation was similar between the 2 cohorts (p=0.2). During the 23-year period, there was an increase in the proportion of patients ≥75 years who were diagnosed with active WM (12% during the 1996-2003 period, 18% during 2004-2010, 25% during 2011-2018; P<0.0001). In the elderly WM cohort, the most frequently used frontline treatment was rituximab monotherapy (36%), followed by rituximab-alkylating agent-based regimen (31%). Of 177 patients with age ≥75 years, 89 (50%) patients were deceased at the time of last follow-up and 58% (52/89) of all deaths in age ≥75 years were attributable to WM. By contrast, 303 (39%) out of the 772 patients in the age <75 years cohort were deceased at last follow-up, with 73% (224/303) deaths attributable to WM. The CSS for patients with age ≥75 years was 10.9 years (95% CI: 7.3-11.7 years) versus 14.7 years (95% CI: 13.2-15.7 years) for age <75 years [Risk ratio 2.1(95% CI: 1.5-2.8); p<0.0001]. At the 1 and 2 year follow-up, WM-related mortality was 6.8% and 11.9%, respectively, for patients with age ≥75 years versus 2.6% and 4.9%, respectively, for the younger cohort. The median OS of patients with age ≥75 years from the diagnosis of active WM was 5.9 years (95% CI: 4.2-7.3 years) compared to the OS of 8.3 years for an age, sex and calendar-year-matched cohort, derived from the general US population (p<0.001), Figure 1. Conclusion: Patients who are ≥75 years of age at the time of diagnosis of active WM present with certain poor prognostic features, including higher serum LDH and β-2 microglobulin and lower serum albumin compared to their younger counterparts. The impact of advanced age is underscored by a poorer WM-specific survival for the subset of patients with the age ≥75 years compared to the younger cohort. Furthermore, although active/symptomatic WM is typically an indolent malignancy, it adversely affects OS of the very elderly patients as suggested by the comparison with an age, sex and calendar-year matched cohort of the general US population. Disclosures Ansell: Bristol Myers Squibb: Research Funding; Trillium: Research Funding; Affimed: Research Funding; Regeneron: Research Funding; ADC Therapeutics: Research Funding; Seattle Genetics: Research Funding; AI Therapeutics: Research Funding; Takeda: Research Funding. Gertz:Ionis/Akcea: Other: personal fee; Alnylam: Other: personal fee; Prothena: Other: personal fee; Spectrum: Other: personal fee, Research Funding; Annexon: Other: personal fee; Appellis: Other: personal fee; Amgen: Other: personal fee; Medscape: Other: personal fee, Speakers Bureau; Physicians Education Resource: Other: personal fee; Abbvie: Other; Celgene: Other; Research to Practice: Other; Sanofi: Other; Teva: Speakers Bureau; Johnson and Johnson: Speakers Bureau; DAVA oncology: Speakers Bureau; Proclara: Other; Springer Publishing: Patents & Royalties; Aurora Bio: Other; Janssen: Other: personal fee. Nowakowski:NanoString: Research Funding; Seattle Genetics: Consultancy; Curis: Consultancy; Kymera: Consultancy; Kite: Consultancy; Ryvu: Consultancy, Membership on an entity's Board of Directors or advisory committees; MorphoSys: Consultancy, Research Funding; Celgene/BMS: Consultancy, Research Funding. Witzig:Spectrum: Consultancy; Immune Design: Research Funding; Karyopharm Therapeutics: Research Funding; Acerta: Research Funding; Incyte: Consultancy; MorphSys: Consultancy; AbbVie: Consultancy; Celgene: Consultancy, Research Funding. Dispenzieri:Pfizer: Research Funding; Janssen: Research Funding; Intellia: Research Funding; Alnylam: Research Funding; Takeda: Research Funding; Celgene: Research Funding. Dingli:Sanofi-Genzyme: Consultancy; Janssen: Consultancy; Bristol Myers Squibb: Research Funding; Rigel: Consultancy; Apellis: Consultancy; Karyopharm Therapeutics: Research Funding; Alexion: Consultancy; Millenium: Consultancy. Kumar:Sanofi: Research Funding; Kite Pharma: Consultancy, Research Funding; Cellectar: Other; Genecentrix: Consultancy; Novartis: Research Funding; Karyopharm: Consultancy; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Carsgen: Other, Research Funding; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; MedImmune: Research Funding; Adaptive Biotechnologies: Consultancy; Tenebio: Other, Research Funding; Dr. Reddy's Laboratories: Honoraria; BMS: Consultancy, Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments. Kapoor:Cellectar: Consultancy; Janssen: Research Funding; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Celgene: Honoraria.

8036^ Background: Two phase III trials (ECOG 4599 and BO17704) demonstrated that the addition of bevacizumab (Bev) to platinum-based regimens improved overall and/or progression-free survival (PFS) in patients (pts) with advanced non-squamous NSCLC (Sandler et al. NEJM 2006; Manegold et al. ESMO2008). However, no investigation with Bev has been conducted in Japanese NSCLC pts. Methods: This randomized, open-label phase II study compared a 3-weekly regimen of 15mg/kg of Bev plus carboplatin/paclitaxel (CP) versus CP alone. The primary endpoint was PFS; secondary endpoints included overall survival (OS), response rate (RR) and safety. Eligibility criteria: histologically or cytologically documented previously untreated advanced or recurrent non-squamous NSCLC; ECOG PS 0–1; no brain metastases. A size of 180 pts was planned to be randomized to: C AUC=6 and P 200mg/m2 q3 wks for up to 6 cycles plus Bev continued to progression at 15mg/kg q3 wks, or CP alone at the randomization ratio of 2:1. The study was designed to observe a 20% reduction in the risk of a PFS event in the Bev arm compared with control. Results: Between 4/07 and 3/08, 180 pts were accrued. Three pts of them were ineligible and 3 pts were not dosed at all. PFS (as assessed by investigators) and RR were significantly improved. OS is immature due to short duration of follow up. Updated PFS results as assessed by the central review committee and OS data will be provided. No new safety signals for Bev were detected. Conclusions: This is the first study of Bev in Japanese pts with NSCLC. The addition of 15mg/kg of Bev to CP significantly improved PFS and RR. The HR of PFS seemed at least as good as previous trials outside Japan. Safety of Bev was within a range already reported. This study confirms the efficacy and safety of Bev in Japanese pts with NSCLC. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

3532^ Background: AUY922, a novel isoxazole-based HSP90 inhibitor, causes the degradation of multiple cellular tumor promoting targets. Preclinical evidence suggests broad anti-tumor activity of AUY922, warranting clinical development. Methods: Single agent AUY922 was administered as IV infusion over 1h once a week to patients (pts) with advanced solid malignancies, utilizing a Bayesian design for dose-escalation. The primary endpoint was determination of the maximum tolerated dose of AUY922; secondary endpoints included safety, tolerability, preliminary activity, PK and PD. Results: Between Jul 2007 and Dec 2008, 44 pts with were treated at dose levels of 2 mg/m2 (3pts), 4 mg/m2 (4pts), 8 mg/m2 (5pts), 16 mg/m2 (7pts), 22 mg/m2 (11pts), 28 mg/m2 (7pts) and 40 mg/m2 (7pts). Median age was 56 years; 95% of pts had a WHO performance status 0 or 1. The most frequently reported adverse events were nausea in 19 patients (50.0 %), diarrhea in 18 patients (47.4 %), fatigue in 15 patients (39.5 %), and vomiting in 9 patients (23.7 %). Grade 1 and 2 diarrhea, fatigue, nausea and vomiting were suspected to be related to AUY922 at doses ≥ 8 mg/m2. Grade 3 events, including atrial flutter, 1pt, at 22 mg/m2, anorexia, fatigue and diarrhea, 2 pts, at 40 mg/m2, were reported as dose limiting toxicities. Expansion of the 40 mg/m2 cohort was initiated in Dec 2008. The median terminal half life of AUY922 at doses up to 28 mg/m2 was 56 h (24 to 108 h). Pharmacodynamic analyses show dose proportional induction of HSP70 in peripheral blood mononuclear cells by AUY922. Six pts achieved disease stabilization for at least 16 and up to 64 weeks. Conclusions: Single-agent AUY922, administered as a weekly infusion, is well tolerated at doses up to 40 mg/m2. Prolonged disease stabilization was seen in a subset of patients receiving AUY922 across dose levels. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

Background: Lytic bone lesions are one of the most common clinical characteristics of patients with multiple myeloma (MM) and identification of bone lesions help distinguish between patients with smoldering multiple MM and active MM. Given this, the most recent update of the diagnostic criteria for MM incorporates advanced imaging approaches for distinguishing between the two entities. Several small retrospective studies have compared conventional skeletal survey (SS) with whole-body low dose computed tomography (WBLDCT) scan or the CT portion of a positron emission tomography (PET) scan. Conducting prospective studies comparing these two modalities side by side is limited by the radiation exposure. We undertook this study to provide a comparison between these two imaging modalities in terms of their ability to recognize lytic bone lesions in patients with MM. Patients and methods: This was a retrospective study of consecutive patients with the diagnosis of MM treated at Mayo Cinic Hospital during 2004- 2018. Patients were included if they had a conventional skeletal survey no more than 3 months before MM diagnosis or any time after diagnosis and also had a WBLDCT or PET-CT within a 12-month period following the skeletal survey. We chose this approach since it is unlikely that a patient would have had both modalities done at the same time as part of standard of care (SOC). This approach was also facilitated by a gradual change in our SOC for skeletal imaging from conventional skeletal survey to WBLDCT. To measure the robustness of our findings, we performed a sensitivity analysis in patients who had the exam ≤6 months apart. Proportions were compared using a chi-square test and survival estimates were calculated using the Kaplan- Meier methodology and compared using log rank test. Results: The overall study cohort had 1040 patients, median age was 62 years at diagnosis (range, 24-94), 61% were male and 39% were female. The median time to the skeletal survey was 8 months from diagnosis (range, 0-160) and the median time to WBLDCT or PET-CT from SS was 2 months (0-12). A PET-CT was available in 789 (76%) of patients and WBLDCT in 251 (24%) of patients. Among the 300 patients with no lesions identified by SS, 188 (63%) had lytic lesions identified by CT, while in 60/740 (8%) patients with a positive SS did not have lytic lesions observed on the CT (p<0.0001). Overall, CT identified lytic lesions in 868 (84%) patients compared with 740 (71%) patients with lytic lesions seen on SS. Although the proportion of lytic lesions was slightly higher with PET compared to WBLDCT, the analysis did not reach statistical significance (65% vs. 56%; p = 0.17; Table 1a). After restricting the analysis to those with ≤6 months gap between low dose CT and SS (n=737), the result did not change (Table 1b). Further examination demonstrated that presence of lytic lesions by SS had no impact on OS from diagnosis, detection of lesions on the CT exam was associated with an inferior survival (112 vs. 81 months, p<0.0001). (Figure 1) Conclusion: Skeletal survey has been the screening technique of choice for evaluation of bone involvement in MM for decades. However, CT based approaches have higher sensitivity with lytic lesions identified in a higher proportion of patients. The prognostic value of lytic disease is evident with CT based detection, again suggesting that this provides a more accurate estimate of the skeletal disease burden. Low dose CT rather than conventional radiographs should be the modality of choice for monitoring disease-progression and diagnosing active multiple myeloma. Disclosures Kapoor: Cellectar: Consultancy; Janssen: Research Funding; Sanofi: Consultancy, Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Celgene: Honoraria. Gertz:Abbvie: Other; Celgene: Other; Physicians Education Resource: Other: personal fee; Medscape: Other: personal fee, Speakers Bureau; Janssen: Other: personal fee; Spectrum: Other: personal fee, Research Funding; Johnson and Johnson: Speakers Bureau; Teva: Speakers Bureau; Annexon: Other: personal fee; Research to Practice: Other; Sanofi: Other; Proclara: Other; DAVA oncology: Speakers Bureau; Springer Publishing: Patents & Royalties; Appellis: Other: personal fee; Amgen: Other: personal fee; Prothena: Other: personal fee; Aurora Bio: Other; Alnylam: Other: personal fee; Ionis/Akcea: Other: personal fee. Dispenzieri:Takeda: Research Funding; Pfizer: Research Funding; Janssen: Research Funding; Intellia: Research Funding; Alnylam: Research Funding; Celgene: Research Funding. Dingli:Alexion: Consultancy; Janssen: Consultancy; Sanofi-Genzyme: Consultancy; Millenium: Consultancy; Bristol Myers Squibb: Research Funding; Rigel: Consultancy; Apellis: Consultancy; Karyopharm Therapeutics: Research Funding. Lin:Merck: Research Funding; Takeda: Research Funding; Legend BioTech: Consultancy; Juno: Consultancy; Bluebird Bio: Consultancy, Research Funding; Celgene: Consultancy, Research Funding; Novartis: Consultancy; Vineti: Consultancy; Janssen: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Sorrento: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gamida Cells: Consultancy. Kumar:Dr. Reddy's Laboratories: Honoraria; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Sanofi: Research Funding; Novartis: Research Funding; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; Adaptive Biotechnologies: Consultancy; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Carsgen: Other, Research Funding; Cellectar: Other; MedImmune: Research Funding; Karyopharm: Consultancy; BMS: Consultancy, Research Funding; Tenebio: Other, Research Funding; Genecentrix: Consultancy; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Kite Pharma: Consultancy, Research Funding.

Abstract The field of hemophilia has advanced tremendously over the past few decades leading to significant improvements to a patient's life expectancy. However, gaps in clinician's knowledge about appropriate tailored management of hemophilia can result in suboptimal patient outcomes. A study was conducted to determine if a series of online educational interventions on hemophilia could improve the knowledge and confidence of hematologists/oncologists in treating patients with hemophilia. The Perelman School of Medicine at the University of Pennsylvania, Office of CME, the National Hemophilia Foundation and Medscape, LLC, in partnership with an expert steering committee, developed a global, accredited educational curriculum (http://www.medscape.org/sites/advances/hemophilia-management) focused on the advances in the management of hemophilia. Six activities, including text and video formats, within the curriculum were evaluated using a pre-assessment/post-assessment study design comparing participants' responses to knowledge and case-based multiple choice questions before exposure to educational content (pre-assessment measurement) with the same participants' responses after participation in the educational activity (post-assessment measurement). Outcomes assessment questions focused on current evidence-based recommendations for the management of hemophilia. For all questions combined, paired 2-tailed t-test was used to assess whether the mean pre-assessment score was different from the mean post-assessment score. The effect size (Cohen's d) was calculated by comparing pre-assessment means and post-assessment means of linked learners to show the effect of educational intervention. Effect size of >0.8 and 0.4-0.8 are considered a large and medium effect size, respectively. A total of 256 hematologist/oncologist participants who completed all pre- and post- assessment questions for each assessment were included in the evaluation across the 6 interventions. An increase in knowledge and performance was demonstrated as a result of participation in each of the 6 interventions with effect sizes of 0.25, 0.559, 0.618, 0.721, 1.26, and 2.275. Topics that demonstrated the largest statistically significant increases in correct post-assessment compared with pre-assessment answers included: mechanism of action of Fc fusion technology (63% relative increase, p<.001), patient counseling when switching to an extended half-life factor replacement (100%, P=.008), joint health in hemophilia (340% relative increase, P<.05), and incidence of inhibitors (227% relative increase, p<.05).Confidence in when to use prophylaxis increased post-educational exposure (7.3% mean confidence shift using a 7-point Likert scale) as measured in 3 of the 6 activities. Areas where knowledge gaps remained, as evidenced by >15% incorrect answers post-education, included: adherence with prophylaxis, outcomes for children and adults with severe hemophilia A receiving prophylaxis vs episodic treatment, clinical data from recent studies with new extended half-life factor products in terms of efficacy, tolerability, and risk of inhibitor development in persons of different ages and risk settings, and the potential place of extended half-life factor products in the strategy for the care of individuals with hemophilia A and B. This study demonstrates the success of a targeted online hemophilia educational curriculum using text and video formats in improving the knowledge and confidence of hematologists/oncologists who treat patients with hemophilia, while also identifying remaining educational needs for future education. Disclosures Van Laar: Medscape LLC: Employment. Pipe:CSL Behring: Consultancy; Bayer: Consultancy; American Thrombosis and Hemostasis Network: Other: Chair of the Board of Directors; National Hemophilia Foundation: Other: member of the Medical and Scientific Advisory Committee; Novo Nordisk: Consultancy; Baxter: Consultancy; Biogen Idec Inc: Consultancy.

4590^ Background: Results of the phase III, randomized, double blind, placebo-controlled AP trial demonstrated that sorafenib is effective and safe for the treatment of advanced HCC in patients from the AP region (Cheng et al, Lancet Oncol, 2009). Hepatic function influences treatment as a measure of organ damage and tumor stage. We performed subset analyses of the AP study dataset according to baseline hepatic function, as indicated by levels of ALT/AST and AFP. Methods: Patients (N=226) with advanced HCC, ECOG PS 0–2, Child-Pugh class A, and no prior systemic therapy were randomized 2:1 to receive sorafenib 400 mg BID or placebo. Endpoints included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 days from first demonstration of response), time to progression (TTP) and safety. Patients were grouped by baseline levels of ALT/AST (normal, mild, or moderate) and AFP (normal or abnormal). Results: Median TTP, OS and DCR by subset are shown in the table . The most common grade 3/4 adverse events in the sorafenib populations were hand-foot skin reaction and diarrhea. Conclusions: Sorafenib was effective and safe in patients from the AP region with advanced HCC within a broad range of baseline hepatic enzyme and AFP levels. These results suggest that sorafenib is an effective treatment for HCC, irrespective of baseline ALT/AST or AFP levels. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

Introduction: First degree relatives of patients with monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma (MM), and African Americans, have an increased risk of having MGUS and MM compared to the general population. However, current guidelines do not advocate for screening family members of MM for plasma cell disorders (PCD). Understanding the epidemiology of familial plasma cell disorders (PCDs) is essential in order to identify people at highest risk of developing PCDs who may benefit from targeted screening strategies. The aims of this study were to assess the prevalence of MM patients with a family history of PCD, and the implications of a family history of PCD on the overall survival (OS) of MM patients. Methods: We retrospectively reviewed the electronic medical records of patients with symptomatic MM followed at Mayo Clinic and diagnosed between January 1989 and June 2019. Clinical notes were reviewed for documentation pertaining to family history of PCDs. Kaplan Meier survival analysis was used to assess the OS, where OS was calculated from the date of diagnosis of symptomatic MM until death; patients were censored if they were alive at the date of last follow up. A Cox proportional hazards model was used to provide risk estimates for OS. Results: A total of 8403 patients with symptomatic MM were included in this study. Family history was documented in 1521 patients, and 291 patients (3.5% of all patients, 19% of those with any documented family history) had a documented family member with a PCD. The median age at diagnosis of symptomatic MM was significantly lower in patients with (n=291) versus without (n= 8112) a family history of PCD (60.9 versus 63.6 years, p&lt;0.0001). The median OS of MM patients with a family history of PCD was significantly longer than MM patients without a family history of PCD (8.1 versus 4.9 years, respectively, with p&lt;0.0001, see figure 1). Using a multivariable Cox proportional hazards model, MM patients with a family history of PCD had a significantly lower risk of death compared to those without a family history of PCD (HR 0.66, 95% CI 0.55-0.78, p&lt;0.0001) even after adjusting for sex, age at diagnosis (above versus below age 65), self-reported race (African American versus not African American), or date of diagnosis (before versus after 2010). When restricting the analyses to the 1521 patients with clearly documented family history, the survival benefit amongst patients with versus without a family history of PCD was similar. In probands with a PCD family history, 182 (63%) had a first degree relative with PCD, whereas 109 (37%) had a second degree relative with PCD. The most common reported PCD amongst family members was MM (figure 2). Nineteen (6.5%) probands with a family history of PCD had 2 or more relatives with a PCD (6 MM patients had 2 or more first degree relatives, 5 MM patients had at least 1 first and 1 second degree relative, and 8 MM patients had 2 or more second degree relatives with a PCD history). There was no significant difference in the median OS between MM patients with a first degree versus second degree relative with PCD (HR 1.03, 95% CI 0.74-1.46, p=0.837), or MM patients with 1 versus 2 or more relatives with PCD (HR 1.01, 95% CI 0.53-1.96, p=0.962). Conclusion: We reviewed patients with symptomatic MM seen at Mayo Clinic over the last 30 years and found that the prevalence of patients with a documented family history of PCD was 3.5%. MM patients with a family history of PCD were diagnosed with MM at a younger age and survived longer than patients without a family history of PCD. Further work is needed to understand factors underlying the survival benefit in patients with a family history of PCD, and whether they present with less aggressive or less advanced disease at diagnosis. Disclosures Dispenzieri: Intellia: Research Funding; Alnylam: Research Funding; Pfizer: Research Funding; Takeda: Research Funding; Celgene: Research Funding; Janssen: Research Funding. Kapoor:Sanofi: Consultancy, Research Funding; Cellectar: Consultancy; Janssen: Research Funding; Amgen: Research Funding; Takeda: Honoraria, Research Funding; GlaxoSmithKline: Research Funding; Celgene: Honoraria. Gertz:Spectrum: Other: personal fee, Research Funding; Janssen: Other: personal fee; Abbvie: Other; Amgen: Other: personal fee; Physicians Education Resource: Other: personal fee; Medscape: Other: personal fee, Speakers Bureau; Prothena: Other: personal fee; Teva: Speakers Bureau; Celgene: Other; Research to Practice: Other; Sanofi: Other; DAVA oncology: Speakers Bureau; Annexon: Other: personal fee; Appellis: Other: personal fee; Ionis/Akcea: Other: personal fee; Alnylam: Other: personal fee; Aurora Bio: Other; Proclara: Other; Johnson and Johnson: Speakers Bureau; Springer Publishing: Patents & Royalties. Kumar:Genentech/Roche: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Novartis: Research Funding; Amgen: Consultancy, Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments, Research Funding; Carsgen: Other, Research Funding; Cellectar: Other; Dr. Reddy's Laboratories: Honoraria; Oncopeptides: Consultancy, Other: Independent Review Committee; IRC member; Janssen Oncology: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; AbbVie: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; BMS: Consultancy, Research Funding; Karyopharm: Consultancy; MedImmune: Research Funding; Sanofi: Research Funding; Tenebio: Other, Research Funding; Kite Pharma: Consultancy, Research Funding; Adaptive Biotechnologies: Consultancy; Genecentrix: Consultancy; Takeda: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments; Merck: Consultancy, Research Funding; Celgene/BMS: Other: Research funding for clinical trials to the institution, Consulting/Advisory Board participation with no personal payments.

4580^ Background: The landmark phase III SHARP trial (Llovet et al, N Engl J Med, 2008) showed that sorafenib is effective and safe for the treatment of advanced HCC. These results were confirmed in an Asian population in the phase III Asia-Pacific (AP) study (Cheng et al, Lancet Oncol, 2009). We compared outcomes of sorafenib treatment in patients enrolled in the SHARP and AP trials with known baseline predictors of poor prognosis. Methods: Patients with advanced, unresectable, measurable HCC, ECOG PS 0–2, Child-Pugh A, and no prior systemic therapy for HCC were randomized to sorafenib 400 mg BID or placebo (SHARP: N=602; AP: N=226). Patients in the AP study had more evolved disease and a predominance of hepatitis B infection. Endpoints included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 days from first demonstration of response), and safety. Results: Efficacy results are shown in the table . The incidence of grade 3/4 drug-related adverse events (AEs) across subgroups in each study was consistent with the overall population for each study. The most common grade 3/4 AEs in all sorafenib populations were hand-foot skin reaction and diarrhea. Conclusions: Sorafenib is effective and safe for the treatment of advanced HCC in patients globally, irrespective of baseline ECOG PS and presence or absence of MVI and/or EHS. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

e15518^ Background: The multinational, phase III, randomized, double-blind, placebo-controlled AP study demonstrated that sorafenib is effective and safe for the treatment of advanced HCC in patients from the AP region (Cheng, et al. Lancet Oncol, 2009). Surgical resection with curative intent is a commonly used procedure for the treatment of HCC; however, tumor recurrence occurs in the majority of patients. Hence, it is of interest to analyze the efficacy and safety of sorafenib in patients who had undergone prior partial hepatectomy. Methods: Patients (N=226) with advanced HCC, ECOG PS 0–2, Child-Pugh class A, and no prior systemic therapy were randomized 2:1 to receive either sorafenib 400 mg BID or placebo. End points included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 d from first demonstration of response), time-to-progression (TTP), and safety. Results: Of 226 patients enrolled, 70 had previously undergone partial hepatectomy. Median TTP, OS, and DCR by subset are shown in the table. The safety profile of sorafenib in patients with and without prior hepatectomy was similar to that reported for the total study population. The most common grade 3/4 adverse events in the sorafenib groups were hand-foot skin reaction and diarrhea. Conclusions: Sorafenib was safe for the treatment of advanced HCC in patients from the AP region, whether or not they had undergone prior surgical resection. Sorafenib treatment resulted in similar TTP in patients with and without a history of prior partial hepatectomy, and the magnitude of TTP was similar in both groups to that in the overall population. Due to small sample size, further study is warranted. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

The 4th International Conference of the Chemical Societies of the South-Eastern European Countries (ICOSECS-4) was held in Belgrade, Serbia and Montenegro, from 18-21 July 2004, at the Faculty of Technology and Metallurgy, University of Belgrade. These conferences have become a biennial event: the first two were held in Halkidiki, Greece (1998 and 2000), and the third in Bucharest, Romania (2002).ICOSECS-4 was organized by the Serbian Chemical Society on behalf of the Society of Albanian Chemists, Union of Chemists of Bulgaria, Pancyprian Union of Chemists, Association of Greek Chemists, Society of Chemists and Technologists of Macedonia, Chemical Society of Montenegro, and Romanian Chemical Society.The title of the conference was Chemical Sciences in Changing Times: Visions, Challenges and Solutions. Within this broad title, there were contributions from all areas of chemistry. However, the main focus of the conference was reflected in three symposia:- Advanced materials: From fundamentals to application- The greening of chemistry: Pursuit of a healthy environment and safe food- Teaching and understanding chemistry: New concepts and strategies for changing times (dedicated to 150 years of teaching chemistry in Serbia)The meeting was organized under the auspices of the International Union of Pure and Applied Chemistry (IUPAC), the Federation of European Chemical Societies (FECS), the Ministry of Science and Environmental Protection of Serbia, and the Organization for the Prohibition of Chemical Weapons (OPCW). The president of IUPAC, Leiv Sydnes, and the president of FECS, Gabor Naray-Szabo, attended the conference and addressed the participants.Some 600 researchers from 26 countries took part in the conference. One of the reasons for this large attendance lies in the fact that the organizers of these conferences (the chemical societies of South-East Europe) have declared a commitment to keep the registration fee as low as possible. In comparison with prevailing fees at similar meetings, the ICOSECS-4 registration fee of 80 euros can be considered really modest; it included the book of abstracts, the welcome reception, a city sightseeing tour, and the conference dinner!The scientific program featured five plenary lectures:- John Fenn, Virginia Commonwealth University, Richmond, USA, the 2002 Nobel Laureate: "Electrospray wings for molecular elephants"- Peter Atkins, Oxford University, Oxford, UK: "Modern trends in chemical education"- C. N. R. Rao, Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore, India: "New directions in the chemical design of materials"- Egon Matijevic, Clarkson University, Potsdam, USA: "Mechanisms of formation of uniform fine particles and their applications"- Ivano Bertini, University of Florence, Florence, Italy: "From genomes to cellular mechanisms and drug design"In addition to the plenary lectures, the program included 38 invited lectures and 25 oral and 437 poster presentations. Brief summaries of all contributions were published in a two-volume book of abstracts.As already mentioned, the organizers put together a rich social program, which included a welcome reception in the historic City Hall (featuring a recital of the Simonuti Trio), a boat sightseeing tour of Belgrade, and a conference dinner with live music and dancing.The next conference, ICOSECS-5, will be organized by the Society of Chemists and Technologists of Macedonia in 2006.Teodor AstConference Editor and Chairman of the International Scientific Committee

9025^ Background: ILI with melphalan dosing corrected for ideal body weight (IBW) is a well tolerated treatment for patients with in-transit extremity melanoma with an approximate 30% CR and 44% overall response rate. ADH-1 is a cyclic pentapeptide that disrupts N-cadherin adhesion complexes. ADH-1 when given systemically in a preclinical model with regional melphalan demonstrated synergistic antitumor activity and had minimal toxicity in a Phase I trial with M-ILI. Methods:AJCC stage IIIB or IIIC extremity melanoma patients were treated with 4000mg of ADH-1 administered systemically on Day 1 and 8 in addition to standard dose M-ILI corrected for IBW on Day 1. Drug pK, and N-cadherin IHC staining were performed on pretreatment tumor from all patients. The primary endpoint was response at 12 weeks determined by modified RECIST. Results: 46 patients were enrolled over 15 months at 4 institutions. Thirty-four patients are presently evaluable for 12 week response. In field responses include 14 CRs (41.2%%), 9 PRs (26.5%), 5 SDs (14.7%), and 6 PDs (17.6%). The OR rate was 67.7% and at a median follow-up of 30 weeks, 8 patients have sustained CRs over 6 months. Of 34 patients, 9 have developed disease outside the region of infusion (median time to progression 12 weeks) at median follow-up 36 weeks. N-cadherin was detected in 20 of 25 (80%) pretreatment tumor samples. Grade IV toxicities included CPK elevation (4), neutropenia (1), acute respiratory distress syndrome (1), pneumonitis (1), and pulmonary infiltrate (1). There were no limb losses or compartment syndromes. Conclusions:This study is not only the first prospective multi-center ILI trial but also the first ILI study to incorporate a targeted agent in an attempt to augment anti-tumor responses. The treatment was well tolerated with CR and OR rates that appear to be significantly improved from standard M-ILI alone. Targeting N-cadherin may represent a novel strategy for improving melanoma sensitivity to chemotherapeutic agents and warrants further investigation in a large randomized multi-center trial. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

3560^ Background: BAY 73–4506 is a potent inhibitor of the receptor tyrosine kinases (VEGFR, KIT, RET, FGFR and PDGFR) and serine/threonine kinases (RAF and p38MAPK). In in-vivo models, BAY 73–4506 has demonstrated a broad spectrum of antitumor activity. Methods: This phase I study investigated the safety and pharmacokinetic (PK)/pharmacodynamic (PD) profiles of BAY 73–4506, given orally in repeating cycles of 21 days on/7 days off, in patients with refractory CRC. PK assessments were performed on days 1 and 21 of cycle 1. PD markers - including DCE-MRI and plasma levels of VEGF/soluble VEGFR-2 - were assessed at each cycle. Tumor response was evaluated per RECIST. Results: 38 patients with actively progressing CRC were treated with BAY 73–4506 at doses of 60 mg (n = 1), 120 mg (n = 4), 160 mg (n = 26), and 220 mg (n = 7) once daily. Median treatment duration was 56.5 days (range, 7–219 days). Drug-related adverse events (AEs) of all grades reported in >20% of patients were hand-foot skin reaction (HFSR) (61%; CTC 3–4, 32%), fatigue (45%; CTC 3, 11%), hoarseness (24%; CTC 3, 3%), mucositis (24%), diarrhea (24%; CTC 3, 3%), anorexia (24%), and hypertension (21%; CTC 3, 13%). Treatment-related AEs leading to dose reduction, interruption, or discontinuation (in ≥2 of patients) were HFSR (26%), fatigue (18%), thrombopenia (8%), and hypertension (5%). BAY 73–4506 showed a dose-dependent increase in exposure up to 160 mg, at which point a plateau was reached. One of 27 evaluable patients achieved a partial response (4%), 15 had stable disease (SD) at least 7 weeks after the start of treatment (55%), and 6 had SD for more than 23 weeks (22%). Patients had extensive previous antitumor treatment, including bevacizumab (44%) and cetuximab (59%). Decreases in soluble VEGFR-2 levels and iAUC60s of Gd-DTPA by DCE-MRI demonstrated that BAY 73–4506 was active on biologically relevant markers. Conclusions: BAY 73–4506 dosing at 160 mg daily, using a treatment schedule of 21 days on/7 days off was feasible in patients with advanced refractory CRC. Promising clinical activity was shown, with a disease control rate (PR+SD) of 59% in evaluable patients. Mutational analysis of selected genes (KRAS, BRAF) is ongoing. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

5021^ Background: Pazopanib, an oral multikinase angiogenesis inhibitor, has shown clinical efficacy in patients (pts) with advanced RCC. In this study (VEG105192), the efficacy and safety of pazopanib was compared with placebo in advanced RCC. Methods: Pts (N = 400 planned) with clear cell advanced RCC and measurable disease with no prior treatment or 1 prior cytokine-based treatment, were stratified and randomized (2:1) to pazopanib 800 mg QD or placebo. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), response rate (RR), and safety. The study had ≥ 90% power to detect an 80% improvement in PFS and a 50% improvement in OS, by stratified log-rank tests with α = 0.025 one-sided. Pts received continuous treatment until disease progression (PD), death or unacceptable toxicity. Upon PD, placebo pts could receive pazopanib via an extension study. Final PFS, RR and safety results are reported here. Results: A total of 233 treatment-naïve and 202 cytokine-pretreated pts were enrolled (290 pazopanib; 145 placebo). Pt characteristics were balanced between the 2 arms. ECOG 0/1 was 42%/58% and 41%/59% for pazopanib and placebo pts, respectively. PFS was significantly prolonged with pazopanib in the overall study population (9.2 vs 4.2 mos; HR: 0.46; 95% CI: 0.34, 0.62; p < 0.0000001), in treatment naïve pts (11.1 vs 2.8 mos; HR: 0.40; 95% CI: 0.27, 0.60; p < 0.0000001), and in cytokine-pretreated pts (7.4 vs 4.2 mos; HR: 0.54; 95% CI: 0.35, 0.84; p < 0.001). RR was 30% with pazopanib (vs 3% with placebo) and median duration of response was 58.7 wks. Median duration of exposure was 7.4 mos (pazopanib) and 3.8 mos (placebo). The majority of adverse events (AEs) were grade 1 or 2. Most common AEs in pazopanib-treated pts were diarrhea (52%; 4% Gr 3/4), hypertension (40%; 4% Gr 3/4), hair color change (38%; <1% Gr 3/4), nausea (26%; <1% Gr 3/4), anorexia (22%; 2% Gr 3/4), and vomiting (21%; 2% Gr 3/4). The most common laboratory abnormality was ALT elevation (53%; 10% Gr 3; 2% Gr 4). Conclusions: Pazopanib monotherapy was well tolerated and demonstrated a significant improvement in PFS and RR compared to placebo. Final OS results are awaited. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

8006^ Background: IPASS demonstrated overall superiority of first-line G vs C/P for progression-free survival (PFS) in never/light ex-smokers with stage IIIB/IV adenocarcinoma NSCLC in Asia. PFS favored CP initially and then G. Outcome was correlated with biomarkers (preplanned exploratory objective). Methods: 683 patients provided tissue samples. Analyses included primary endpoint PFS (Cox proportional hazards) and secondary endpoint objective response rate (ORR; logistic regression) by biomarker status. Results: EGFR mutation (M) status was evaluable in 437 pts by Amplification Refractory Mutation System (ARMS; 60% M+). M+ pts had significantly longer PFS and higher ORR and M- pts significantly shorter PFS and lower ORR with G than C/P. In M unknown pts PFS and ORR were similar to overall population. Post hoc analysis of overall survival favored G in M+ pts (31% maturity; HR 0.78; 95% CI 0.50–1.20) and C/P in M- pts (53% maturity; HR 1.38; 95% CI 0.92–2.90); differences were not statistically significant and follow-up is ongoing. EGFR gene-copy number was evaluable in 406 pts by fluorescence in situ hybridization (FISH; 61% FISH +). Similar PFS and ORR results to analyses by M status were observed, driven by the overlap in EGFR FISH and M status. EGFR protein expression (PE) was evaluable in 365 pts by immunohistochemistry (73% PE+). PFS outcomes did not differ statistically between PE+ and PE-. ORR favored G in both PE+ and - pts. Conclusions: EGFR M status was a strong predictive biomarker for the efficacy of G vs C/P in this clinically selected first-line setting. [Table: see text] No significant financial relationships to disclose. ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

8041^ Background: The IRESSA Pan Asia Study (IPASS) demonstrated superiority of G vs C/P for progression-free survival (PFS) in 1,217 chemonaïve, never/light ex-smokers with WHO PS 0–2, adenocarcinoma histology and stage IIIB/IV NSCLC. PFS favored C/P initially then G, likely driven by different outcomes according to EGFR mutation (M) status. Planned analyses of pts recruited in China are reported. Methods: 372 pts in China (31% of overall population) were randomized to G 250 mg/day (n=184) or C (AUC 5 or 6)/P (200 mg/m2) (n=188). Primary objective was to assess PFS in ITT population; a treatment by country interaction test (China vs other) was performed. Secondary endpoints were overall survival (OS), objective response rate (ORR, RECIST), QoL (FACT-L, TOI), symptom improvement (LCS) and tolerability. Results: PFS results for pts in China did not significantly differ from other pts (interaction test p=0.4265). G demonstrated numerically longer PFS vs C/P; effect was not constant over time, favoring C/P initially then G. Preliminary OS (28% maturity; follow-up ongoing) was similar for G and C/P. ORR was significantly higher with G (45%) than C/P (30%). QoL improvement rates were higher with G than C/P (FACT-L 44 vs 34%; TOI 45 vs 25%); symptom improvement rates were similar (LCS 48 vs 42%). G had a more favorable tolerability profile than C/P. Conclusions: For pts in China, efficacy and tolerability data were generally consistent with the overall population. G demonstrated improved efficacy (PFS and ORR), similar OS, higher QoL and similar symptom improvement rates and more favorable tolerability profile compared with C/P in chemonaïve, never/light ex-smokers with advanced NSCLC and adenocarcinoma histology. In IPASS, EGFR mutation status appeared to be a strong predictive biomarker for G efficacy compared with C/P. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

8044^ Background: The IRESSA Pan Asia Study (IPASS) demonstrated superiority of G vs C/P in 1,217 clinically selected chemonaïve pts in Asia with advanced NSCLC. PFS favored C/P initially then G, likely driven by different outcomes according to EGFR mutation (M) status. We report the planned analyses of 233 recruits in Japan (19% of overall population). Methods: From Mar 06 to Oct 07, chemonaïve, never/light ex-smokers with stage IIIB/IV NSCLC and adenocarcinoma histology were randomized to G 250 mg/day (n=114) or C (AUC 5 or 6)/P (200 mg/m2) (n=119). Primary objective was PFS in ITT population; a treatment by country interaction test (Japan vs other) was performed. Secondary endpoints were overall survival (OS), objective response rate (ORR, RECIST), QoL (FACT-L, TOI), symptom improvement (LCS subscale of FACT-L), and tolerability. Results: PFS results in pts in Japan did not significantly differ from other pts (interaction test p=0.4736). G demonstrated superior PFS compared with C/P (HR 0.69; 95% CI 0.51–0.94; p=0.0191); effect was not constant over time, favoring C/P initially then G. Preliminary OS (25% maturity; follow-up ongoing) was similar for G and C/P (HR 0.89; 95% CI 0.53–1.48). ORR for G was 41% vs 35% for C/P;odds ratio [OR] 1.34; 95% CI 0.78–2.30; p=0.2967. QoL improvement rate (TOI) was 43% for G and 28% for C/P (OR 1.92; 95% CI 1.11–3.34; p=0.0200); QoL (FACT-L 41 vs 43%; OR 0.94; 95% CI 0.56–1.60; p=0.8263) and symptom (LCS 42 vs 46%; OR 0.85; 95% CI 0.50–1.43; p=0.5340) improvement rates were similar for G and C/P. Tolerability profile was more favorable with G than C/P. There were no deaths due to ILD-type events (frequency 1.8% [G] vs 0% [C/P]). Conclusions: Efficacy and safety data for pts in Japan were generally consistent with overall population. G demonstrated improved PFS and ORR, similar OS, higher QoL (TOI) and similar symptom improvement rates, and a more favorable tolerability profile compared with C/P in chemonaïve, never/light ex-smokers with advanced NSCLC and adenocarcinoma histology. In IPASS, EGFR M status appeared to be a strong predictive biomarker for G efficacy compared with C/P. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

The 18th IUPAC International Conference on Chemical Thermodynamics (ICCT-2004), concurrent with the 12th National Conference on Chemical Thermodynamics and Thermal Analysis, was held 17-21 August 2004 at the Fragrant Hill Hotel, Beijing, China. Professor Haike Yan was Conference Chair, Prof. Zhiwu Yu was Conference Co-chair, and Prof. Xibai Qiu was Secretary. The 395 participants came from 40 countries.During the official opening ceremony, there was a presentation of the first Doctorate Awards to be given by the International Association of Chemical Thermodynamics, with sponsorship from Elsevier. The three recipients were Dr. Lin Chen, Tsinghua University, Beijing; Mr. Dirk Wandschneider, University of Rostock, Germany; and Mr. Weiguo Xu, Liaoning University, China. They each received a certificate plus a cash prize of USD 500.The conference began with the Rossini lecture, presented by Prof. Jean-Pierre E. Grolier on "Advanced experimental techniques in polymer thermodynamics". The conference program consisted of eight symposia and three workshops. In Symposium 1, Electrolyte and Nonelectrolyte Solution Thermodynamics, Prof. Emmerich Wilhelm gave the plenary lecture "The fascinating world of pure and mixed nonelectrolytes". There were invited lectures by Profs. Eckhard Vogel, Fumio Hirata, and Takayoshi Kimura. In Symposium 2, New Materials, Prof. C. Richard Catlow presented the plenary lecture "Computational approaches to the catalytic activation of carbon-hydrogen bonds", and invited lectures were given by Profs. Mary Anne White and Vladimir Durov. The plenary lecture in Symposium 3, Phase Equilibrium, Supercritical Fluids, and Separation Technologies, was given by Prof. Pablo Debenedetti on "Thermodynamics of supercooled and glassy water", with invited lectures from Profs. Cornelis Peters and Ding-Yu Peng. Symposium 4, Biological, Medical, Pharmaceutical, Agricultural, and Food Thermodynamics, had as its plenary lecturer Prof. Stephan Grzesiek, who spoke on "Biomolecular interactions in solutions". Professors Lee Hansen and Ichiro Hatta were the invited lecturers.Symposium 5 was on Colloid and Interface Science. Professor Bernard Cabane presented the plenary lecture "Solid-liquid separation", and there were invited lectures from Dr. Gerd Olofsson and Profs. Watson Loh and Xueqin An. The title of Symposium 6 was Non-equilibrium Thermodynamics, Statistical Thermodynamics, and Molecular Simulation. The plenary lecture "Non-equilibrium pattern formation" was presented by Prof. Qi Ouyang, with an invited lecture by Prof. Zhen-Gang Wang. Symposium 7 considered Thermochemistry and Molecular Energetics, with Prof. Michio Sorai, the plenary lecturer, speaking on "Entropy diagnosis for phase transitions occurring in functional materials". Professor Juliana Boerio-Goates gave the invited lecture. Symposium 8 was on Industrial Thermodynamics and Data Bases. Dr. Michael Fenkel gave the plenary lecture on "Global communications and expert systems in thermodynamics: Connecting property measurement and chemical process design". Invited lectures were given by Profs. Pertti Koukkari and Zhoulan Yin.There were three workshops. Prof. Kazuya Saito was invited lecturer for the Workshop on Thermodynamic Frontiers and Education. Professors Joan Brennecke and Andreas Heintz were invited lecturers for the Ionic Liquids Workshop. Professors Joon Won Park and Junko Morikawa gave invited lectures at the Workshop on New Experimental Techniques, including Nanotechnology.In addition, there were over 180 oral presentations, spread over the symposia and workshops, and about 280 poster presentations.The Rossini lecture and plenary lectures, with the exception of the paper by Prof. P. Debenetti where the field was recently reviewed [1,2], are published in this issue, together with the invited paper by Prof. Lee Hansen entitled "A thermodynamic law of adaptation of plants to environmental temperatures". Selected papers from individual symposia will be published in the Journal of Molecular Liquids (Symposium 1), Fluid Phase Equilibria (Symposia 3 and 6), the Journal of Chemical Thermodynamics (Symposia 1, 2, and 7), Thermochimica Acta (Symposium 4), or in the Journal of Chemical and Engineering Data (Workshop on Ionic Liquids).After the previous weeks when it had been very hot and humid, the temperature dropped and the weather was most pleasant for the conference. This change in weather, together with the attractive setting of the hotel, the excellent hospitality, which included a welcome reception, an evening of acrobatics entertainment, a conference banquet in the Summer Palace, and the high standard of the presentations, made this conference memorable. In addition, there was a full program of tours for accompanying persons. Our thanks are extended to the Conference Chair and Co-chair, and to all members of the local Organizing Committee, the International Advisory Committee, and the International Scientific Committee. We are most grateful to IUPAC, the International Association of Chemical Thermodynamics, the China Association for Science and Technology, the National Natural Science Foundation of China, and the Chinese Academy of Sciences for sponsoring the conference.Thermodynamics will continue to be an important area of research for many years to come, with a wide range of applications from chemical engineering to the biosciences. We look forward to the presentation and discussion of the results of further advances in chemical thermodynamics at the next ICCT, which will take place in Boulder, Colorado in 2006.1. P. G. Debenedetti. J. Phys.: Condens. Mater. 45, R1669-1726 (2003).2. P. G. Debenedetti and H. E. Stanley. Phys. Today 56, 40-46 (2003).J. H. DymondConference Editor

1094^ Background: In the AVADO study, BV + D confirmed the clinical benefit of combining BV with taxane-based first-line chemotherapy. This analysis evaluated the safety and efficacy of BV + D in pts aged ≥65 years. Methods: Pts with HER2-negative, inoperable, LR or mBC received BV 7.5 or 15mg/kg + D 100mg/m2 or placebo (PL) + D. Pts had no prior chemotherapy for advanced disease, no CNS metastases, ECOG PS 0–1, adequate LVEF. D was administered q3w up to nine cycles, BV/PL q3w until disease progression/unacceptable toxicity. Results: BV + D significantly increased PFS compared with PL + D (BV 7.5: HR = 0.69, p=0.004; BV 15: HR = 0.61, p=0.0001) (Table) (median follow-up 10.2 months). BV significantly increased overall response rate (ORR) compared with PL. In the 127 (17.3%) pts aged ≥65 years, pts had a similar treatment benefit compared to the entire study population. Generally, BV had limited additional impact on the known side effects of D. No grade ≥3 GI perforation, wound-healing complications, CHF or proteinuria were reported. Conclusions: In this retrospective analysis of the AVADO study, addition of BV to D was generally well tolerated in elderly pts with mBC. The magnitude of the benefit in pts aged ≥65 years was similar to that in the overall study population but failed to reach statistical significance, probably due to the small sample size. [Table: see text] [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

e15541^ Background: We previously reported results of a phase I study of oxaliplatin, docetaxel, and capecitabine for advanced esophagogastric cancer (Evans et al, Am J C Onc 2007). In this phase II component we describe response rates, toxicity, and survival data. Methods: Patients with histologically confirmed metastatic esophagogastric squamous or adenocarcinoma were eligible. Patients received oxaliplatin 50mg/m2 and docetaxel 35mg/m2 on days 1 and 8 as well as capecitabine 750 mg/m2 twice daily on days 1–10 in each 21 day cycle. Results: 21 patients were enrolled and were evaluable. Median age was 65, range 46–83. All had adenocarcinoma histology. Three patients received prior adjuvant or neoadjuvant therapy. A total of 91 cycles were delivered, median of 4, range of 1–11. Median follow-up was 2 years; all patients have been followed for at least 1 year. Median overall survival was 11 months. The overall response rate was 43%. Three patients achieved a complete response. Two of these patients remain without evidence of disease at 38 and 12 months. Three patients experienced confirmed pulmonary emboli, and one patient expired at home with possible pulmonary embolism (exact cause unknown).Other Grade 3/4 toxicities were: nausea (3/21), fatigue (2/21), diarrhea (4/21), hand/foot (1/21), dehydration (3/21), esophagitis (2/21), infection (1/21), Electrolyte (3/21), neutropenic fever (2/21), neutropenia (4/21), anemia (1/21). Conclusions: DOC is an active and easily administered regimen for metastatic esophagogastric cancer. Consideration should be given for prophylactic anticoagulation for patients with metastatic esophagogastric cancer. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

Abstract. The purpose of the article is to highlight the problems of providing regional labor markets with qualified personnel and identify ways of effective interaction between educational institutions and enterprises. The theoretical significance of the article is that it, based on an experimental study conducted in the Donetsk region, analyzed the reasons for dissatisfaction of enterprises with the quality of professional training; the existing experience of cooperation between educational institutions and enterprises of the region is analyzed; barriers have been identified that prevent the establishment of an effective partnership between educational institutions and enterprises aimed at meeting the existing and future needs of the labor market in qualified personnel; the level of readiness of enterprises of the region to cooperate with institutions in the direction of modernization of material and technical base, internship of teachers, joint preparation of educational programs, advanced training of personnel is analyzed; on the basis of the analysis of results of survey it was identified professions for which it is advisable to start professional traininin in vocational institutions in Donetsk region; the model of competencies of the future skilled worker elaborated by employers is presented (on the example of the profession «Locksmith for repair of wheeled vehicles. Driver of motor vehicles (category «C»). Machinist of a truck crane»). The practical significance of the article is that based on the opinion of employers of Donetsk region, the authors offer recommendations to improve the interaction between educational institutions and enterprises of Donetsk region to solve the problem of professional training for current and future needs of the region’s economy. The presented recommendations and research model can be extrapolated to the effective development of labor markets in other regions of the country. It was revealed that the modern labor market in particular in Donetsk region is characterized by significant disparities between demand and supply of personnel (almost all vacancies in terms of occupations have a deficit, i.e. supply (number of unemployed) exceeds demand). There is a great lack of vacancies in the professions of auxiliary worker, driver of vehicles, seller of food products, seller of non-food products, cook. Instead, the scarce professions that are in demand in the labor market are a machinist bypassing turbine equipment, a locksmith repairing steam and gas turbine equipment, a machinist bypassing boiler equipment, an electrician servicing electrical installations, a kneading machine operator, a plumber, a nanny, an electrician for repair and installation of cable lines, a pipe and billet cutter, an extruder of refractory products. It is determined that the system of training of future skilled workers in educational institutions of the region needs significant modernization, as there are currently significant discrepancies between the level of preparation of graduates for professional activities and the requirements of employers. The difficulty of adaptation of graduates in the workplace is associated with the lack of certain professional competencies and personal qualities, the development of which should be paid attention to in the process of initial professional training in educational institutions — practical training, experience, practical knowlwdge), motivation to work. Deficits are also responsibility, independence, purposefulness, level of qualification. It was found that cooperation between educational institutions and employers is still carried out in traditional forms — the internships of students of educational institutions on the basis of enterprises, the participation of employees in assessing the quality of training. The prevalence of formal interaction significantly determines the quality of training for the needs of regional labor markets. The directions of personnel professional training for actual and perspective needs of the region labour market are singled out: excavator driver, car mechanic, electric gas welder, locksmith-repairman, electrician, turner, crane driver, confectioner cooker. The structure of the competency model of future skilled workers was identified — basic and professional competencies — that will ensure rapid adaptation and effective work of graduates at enterprises of the region. It is determined that for the effective development of regional labor markets and effective training for them the key is to implement the idea of public-private partnership of educational institutions and employers, the most effective forms of which should be cooperation in curricula development, advising on their content, methods and technologies of the educational process, providing recommendations for updating equipment, providing teaching materials, assistance in updating the library fund, databases, to ensure the educational process in the institution (invitation of so-called guest speakers), professional development of teachers and masters of industrial training, joint project activities, implementation of career guidance activities, organization of excursions of students and entrants to enterprises, informing about employment opportunities at enterprises, lobbying the interests of the institution at the level of local governments, participation in determining the development strategy of the institution, assistance in the process of attraction of additional sources of financing, creation of advisory bodies of the educational institution (advisory committee in the specialty, supervisory boards, etc.). Keywords: regional labor markets, professional training, educational institutions, institutions of professional (vocational) education, efficiency, professional training. JEL Classification I21, L33 Formulas: 0; fig.: 0; tabl.: 0; bibl.: 9

8046^ Background: Cet, a monoclonal antibody (mAb) that specifically targets epidermal growth factor receptor (EGFR) and Bev (anti-VEGF mAb) combined with chemotherapy has resulted in superior survival compared to chemotherapy alone in some stage IV NSCLC trials. Combining both mAb's with chemotherapy might increase survival in stage IV NSCLC pts. Methods: Chemotherapy naïve advanced NSCLC patients with ECOG status <1, adequate hematologic, hepatic, and renal function received Cet (400 mg/m2 on Day 1 as initial dose and weekly thereafter at 250 mg/m2) plus Bev (15 mg/kg on Day 8 of each 3-week cycle) for 6 cycles in combination with either 6 cycles (Arm A) or 3 cycles (Arm B) of P (200 m/kg) and C (AUC=6) on Day 1 of each 3-week cycle. Patients without progressive disease (PD) after 6 cycles continued Cet until PD or other withdrawal criteria were met. Comparison of progression-free survival (PFS) for arm A vs B is the primary objective. Results: Accrual is completed. Data are available for 85 pts: 47% women, median age 65 yrs, and 88% Caucasian. Median PFS for arm A was 6.0 vs 4.2 months for arm B, hazard ratio of 0.57 for arm A relative to arm B. Objective response was Arm A=31% and B=30%. Most frequent AEs ≥Grade 3 in pts were neutropenia [9 (10.6%), A=8, B=1], fatigue [8 (9.4%), A=4, B=4], dermatitis acneiform [6 (7.1%), A=3, B=3].13 pts withdrew due to AEs (A=4, B=9), 4 were related to Cet (2 per arm). Two pts discontinued due to death (A=2, B=0) unrelated to Cet. Conclusions: Adding both mAb's to PC resulted in acceptable toxicity. The trend for superior PFS with 6 courses of PC suggests that 3 courses of PC are not optimal. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

CRA1004^ Background: Eribulin mesylate (E7389; E) is a nontaxane microtubule dynamics inhibitor with a novel mode of action. This study is the first to compare overall survival (OS) with this new chemotherapeutic (CT) agent to real-life choices in heavily pretreated patients (pts) with metastatic breast cancer (MBC). Methods: Women with locally recurrent or MBC were enrolled in this phase III open-label, randomized, multicenter study. Pts had received 2-5 prior CT (≥2 for advanced disease), including an anthracycline and a taxane, unless contraindicated. Pts were randomized 2:1 to E 1.4 mg/m2 2-5 min IV bolus on days 1 and 8 of a 21-day cycle or treatment of physician's choice (TPC). TPC was any monotherapy (cytotoxic, hormonal, biologic) or supportive care only. The primary endpoint was OS; secondary endpoints were objective response rate (ORR), and progression-free survival (PFS) by independent review, and duration of response (DOR). Safety and tolerability were assessed. Data are from the final analysis after 422 deaths. Results: 762 pts were treated (508 E, 254 TPC). Median age was 55.2 (range 27-85), 16% were HER2-positive, 19% triple-negative, 73% received prior capecitabine, median no. of prior CT was 4. Median OS was 13.1 months (mo) for E vs. 10.7 mo for TPC, p=0.04 (primary analysis, stratified log rank test; HR 0.81; 95% CI 0.66, 0.99). Median PFS was 3.7 mo for E and 2.3 mo for TPC p=0.09 (HR 0.85; 95% CI 0.70, 1.03). ORR was 12% (0.4% complete response [CR], 11.5% partial response [PR]) for E and 5% (0 CR; 5% PR) for TPC, p=0.005. Median DOR was 4.1 mo for E (56 responders) vs. 6.7 mo for TPC (11 responders). Grade [G] 3/4 treatment-related adverse events (AEs) of interest for E were asthenia/fatigue (7.6%), neutropenia (44%), peripheral neuropathy (8.4%). 10% of pts experienced treatment-related serious AEs (12% E, 7% TPC). Conclusions: The study met its primary endpoint with a significant improvement in OS by a median of 2.5 mo with E vs. TPC. E demonstrated a manageable tolerability profile, acceptable for a CT agent used as monotherapy in this late-line setting. [Table: see text] In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519-521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2010 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

e11519^ Background: The GeparQuinto trial is investigating the incorporation of bevacizumab (B), RAD001 (everolimus) for HER2-negative, and lapatinib for HER2-positive patients (pts) into neoadjuvant treatment regimens. As these targeted agents have not yet been adequately tested in combination with epirubicin (E), cyclophosphamide (C), and docetaxel (T) chemotherapy, a run-in phase of the trial was conducted for safety reasons. Methods: Starting in 11/2007, 62 pts received 4 cycles of E: 90 mg/m2 and C: 600 mg/m2, both on day 1 q day 21 followed by 4 cycles of T: 100 mg/m2, day 1 q day 21. Pts were randomized to receive this chemotherapy alone (EC-T, n=32) or concomitantly with B: 15 mg/kg i.v., day 1 q day 21 (ECB-TB, n=30). Main eligibility criteria for this part of the study were: histologically confirmed, HER2-negative, locally advanced breast cancer (cT3 cN+ and cT4), female, and ≥18 years of age with normal cardiac function (LVEF >55%). This interim toxicity analysis was a prerequisite for opening the main phase of the HER2-negative trial part to also include pts with cT2 tumors. Results: 61 pts received all cycles of EC (n=31 EC-T, n=30 ECB-TB), 1 pt discontinued on investigator's decision, 1 pt discontinued after EC due to disease progression. 18 pts received all cycles of T in each of the EC-T and ECB-TB groups. Reasons for discontinuation of T were adverse events (n=2 EC-T, n=1 ECB-TB) or investigator's decision (n=1 EC-T). 17 pts completed all cycles of B. Statistically significant differences in toxicities were only observed for grade 3–4 leucopenia during EC (40.6%) and ECB (70.0%; p=0.024) and for grade 1–4 [grade 3–4] mucositis during T (52.4% [9.5%]) and TB (100% [36.8%]; p<0.001 [p=0.060]). No statistically significantly different levels of other hematological or non-hematological toxicities were reported between the two arms. Conclusions: Addition of B to EC followed by T is feasible with the only increase in toxicity due to leucopenia and mucositis. Based on these data, the main phase of the trial was opened and has included over 450 pts to date. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .

The social injustices of past schooling practices can no longer be tolerated. Current statistics indicate that those who study advanced mathematics are most often white males. Women and most minorities study less mathematics and are seriously under-represented in careers using science and technology. Creating a just society in which women and various ethnic groups enjoy equal opportunities and equitable treatment is no longer an issue. Mathematics has become a critical filter for employment and full participation in our society. We cannot afford to have the majority of our population mathematically illiterate: Equity has become an economic necessity.

The 2020 American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care is based on the extensive evidence evaluation performed in conjunction with the International Liaison Committee on Resuscitation. The Adult Basic and Advanced Life Support, Pediatric Basic and Advanced Life Support, Neonatal Life Support, Resuscitation Education Science, and Systems of Care Writing Groups drafted, reviewed, and approved recommendations, assigning to each recommendation a Class of Recommendation (ie, strength) and Level of Evidence (ie, quality). The 2020 Guidelines are organized in knowledge chunks that are grouped into discrete modules of information on specific topics or management issues. The 2020 Guidelines underwent blinded peer review by subject matter experts and were also reviewed and approved for publication by the AHA Science Advisory and Coordinating Committee and the AHA Executive Committee. The AHA has rigorous conflict-of-interest policies and procedures to minimize the risk of bias or improper influence during development of the guidelines. Anyone involved in any part of the guideline development process disclosed all commercial relationships and other potential conflicts of interest.

Background: The Technology Team at the Ruth Lilly Medical Library, Indiana University (IU), first started exploring virtual reality (VR) in 2016. In 2017, we began offering weekly sessions dubbed VRidays (“VR Fridays”) to give students an opportunity to experience the technology. We also purchased a portable VR setup that allowed us to demonstrate VR at our regional campuses.Description: To lower the entry barrier to VR, the Technology Team collaborated with the IU Advanced Visualization Lab to establish a reality lab in our collaborative learning space. The lab opened in the fall of 2018 and consists of four high-end VR stations that are accessible to students at any time, but they can also make an appointment for a more guided experience. Information and instructions are available on a LibGuide.Conclusion: We are currently collecting data on the number of unique users and evaluating application usage. We are working on a feedback mechanism and looking to develop collaborative partnerships across the university.Virtual Projects are published on an annual basis in the Journal of the Medical Library Association (JMLA) following an annual call for virtual projects in MLAConnect and announcements to encourage submissions from all types of libraries. An advisory committee of recognized technology experts selects project entries based on their currency, innovation, and contribution to health sciences librarianship.

Background and Purpose: In 2009, the 7 th largest populated city in the United States, had no certified Primary Stroke Centers, or organized approach to care for stroke patients. The purpose is to describe how in one year, a large geographic region progressed from no system of stroke care to an organized system of 10 Certified Primary Stroke Centers and numerous EMS agencies. Methods: Hospital leaders were compelled to create stroke programs in their facilities in response to intense community pressure following a patient who had a poor outcome secondary to no access to a stroke center in San Antonio. The Southwest Texas Regional Advisory Council (STRAC) Stroke Committee, comprised of hospital, physician and EMS leaders developed a Stroke Letter of Attestation signed by participating hospitals and EMS agencies. This letter defined an interim process for performance and pre-hospital stroke alert criteria while hospitals developed programs and became certified as stroke centers. The agreement established a commitment to maintain rapid response teams, a central one-call transfer process, and process improvement. Transfer tracking sheets were developed to monitor hospital responses to transfer requests and patient acceptance. Despite a competitive environment, Stroke Coordinators met monthly to discuss data and develop regional reports for review in the Stroke Committee. In addition, stroke algorithms were distributed to rural facilities to assist with care prior to transfer to a stroke center. Results: By coordinating a system of care with first responders, no longer diverting patients out of the service area, and data sharing, a large region progressed from having no stroke system to an organized system of 10 Certified Primary Stroke Centers, which provide the region access to quality care. The STRAC Stroke/Performance Improvement Committee and Coordinator Committee continue monthly meetings. Conclusions: This process successfully closed the gap in stroke care. The STRAC Stroke Committee continues to improve data collection, provide feedback to EMS, set goals for public education, and engage hospitals and EMS agencies in the commitment to quality stroke care. [BW1]Should this sentence move up to follow after 1 st paragraph in methods?

Background: The Southwest Texas Regional Advisory Council (STRAC) Stroke Systems of Care Committee is comprised of hospital, physician and EMS leaders who meet monthly to discuss process improvement and system development with a commitment to improve stroke recognition, response and treatment. Over a seven- year period, this community with a population of 1.5 million people progressed from no organized approach for stroke care to an organized system which includes 12 Primary centers, 2 Comprehensive centers, and over 40 EMS agencies. Purpose: To evaluate how an organized system has impacted stroke care in Southwest Texas over the past 5 years. Methods: A retrospective review of Get With The Guidelines®-Stroke data from the STRAC service area was conducted. Specific data points reviewed include diagnosis, mode of arrival, STK 4- IV tPA measure compliance, IV tPA door to needle (D2N) times and discharge disposition. Results: A total of 20,175 patients were entered between 2010 and 2015 of which 95% (n=19,080) were discharged with stroke diagnosis. Seventy-six percent (n=14,540) of the stroke patients arrived via EMS or walk in. EMS arrivals ranged from 61% (n=1,110) in 2010 to 54% (n=2,015) in 2015. STK 4 measure compliance ranged from 62.8% (n=140) in 2011 to 88.9% (n=158) in 2013. The 2015 STK 4 measure compliance was 84.3% (n=209). IV tPA treatment rates ranged from a low of 9.6% in 2012 to >12% in 2014, 2015 and 2016. D2N < 60 minutes and the percentage of patients discharged home trended upward by over 20% during this period. Conclusions: Development of an organized system of care has impacted regional stroke treatment as demonstrated by the upward trend and stabilization of compliance of the STK 4 measure, IV tPA treatment rates, and percentage of patients discharged home. Despite improvement there is opportunity to provide community education emphasizing the importance of calling 911 when stroke is suspected. Current performance improvement initiatives include the formation of a regional public education committee and the provision of an annual regional stroke conference. The next focus is to engage area hospitals and EMS in the commitment to advance and improve stroke care.

Delivery of quality healthcare in South African is framed by the Batho Pele (“People First”) principles and the National Patients’ Rights Charter, both of which emphasise patient-centred care. However, underfunding, mismanagement, and neglect of the South African public infrastructure result in the implementation of these policy documents often not being evident in practice. The challenges of rendering patient-centred care under such circumstances spurred the development of an evidence-based best practice guideline to assist professional nurses in public hospitals. This article outlines the development of a best practice guideline for patient-centred care in public hospitals. An adapted version of the approach recommended by the Clinical Guidelines Advisory Committee of the National Institute for Health and Clinical Excellence was applied to develop the guideline. The draft guideline was submitted to experts for review. Thereafter it was modified and finalised. Nine sets of recommendations related to practice, education, organisation and policy were developed as part of the guideline. These involve (1) embracing values and beliefs foundational to patient-centred care; (2) optimal communication in all facets of care; (3) rendering of basic nursing care practices; (4) family involvement; (5) awareness of the importance of culture in patient-centred care; (6) organisational and managerial support; (7) organisational champions; (8) positive work environment; and (9) organisational structure that promotes interprofessional collaborative practice. It is anticipated that the guideline can be implemented after pilot testing and can be used by professional nurses rendering care to patients in public hospitals in South Africa.

Connecting I’ve moved house on the weekend, closer to the centre of an Australian capital city. I had recently signed up for broadband, with a major Australian Internet company (my first contact, cf. Turner). Now I am the proud owner of a larger modem than I have ever owned: a white cable modem. I gaze out into our new street: two thick black cables cosseted in silver wire. I am relieved. My new home is located in one of those streets, double-cabled by Telstra and Optus in the data-rush of the mid-1990s. Otherwise, I’d be moth-balling the cable modem, and the thrill of my data percolating down coaxial cable. And it would be off to the computer supermarket to buy an ASDL modem, then to pick a provider, to squeeze some twenty-first century connectivity out of old copper (the phone network our grandparents and great-grandparents built). If I still lived in the country, or the outskirts of the city, or anywhere else more than four kilometres from the phone exchange, and somewhere that cable pay TV will never reach, it would be a dish for me — satellite. Our digital lives are premised upon infrastructure, the networks through which we shape what we do, fashion the meanings of our customs and practices, and exchange signs with others. Infrastructure is not simply the material or the technical (Lamberton), but it is the dense, fibrous knotting together of social visions, cultural resources, individual desires, and connections. No more can one easily discern between ‘society’ and ‘technology’, ‘carriage’ and ‘content’, ‘base’ and ‘superstructure’, or ‘infrastructure’ and ‘applications’ (or ‘services’ or ‘content’). To understand telecommunications in action, or the vectors of fibre, we need to consider the long and heterogeneous list of links among different human and non-human actors — the long networks, to take Bruno Latour’s evocative concept, that confect our broadband networks (Latour). The co-ordinates of our infrastructure still build on a century-long history of telecommunications networks, on the nineteenth-century centrality of telegraphy preceding this, and on the histories of the public and private so inscribed. Yet we are in the midst of a long, slow dismantling of the posts-telegraph-telephone (PTT) model of the monopoly carrier for each nation that dominated the twentieth century, with its deep colonial foundations. Instead our New World Information and Communication Order is not the decolonising UNESCO vision of the late 1970s and early 1980s (MacBride, Maitland). Rather it is the neoliberal, free trade, market access model, its symbol the 1984 US judicial decision to require the break-up of AT&T and the UK legislation in the same year that underpinned the Thatcherite twin move to privatize British Telecom and introduce telecommunications competition. Between 1984 and 1999, 110 telecommunications companies were privatized, and the ‘acquisition of privatized PTOs [public telecommunications operators] by European and American operators does follow colonial lines’ (Winseck 396; see also Mody, Bauer & Straubhaar). The competitive market has now been uneasily installed as the paradigm for convergent communications networks, not least with the World Trade Organisation’s 1994 General Agreement on Trade in Services and Annex on Telecommunications. As the citizen is recast as consumer and customer (Goggin, ‘Citizens and Beyond’), we rethink our cultural and political axioms as well as the axes that orient our understandings in this area. Information might travel close to the speed of light, and we might fantasise about optical fibre to the home (or pillow), but our terrain, our band where the struggle lies today, is narrower than we wish. Begging for broadband, it seems, is a long way from warchalking for WiFi. Policy Circuits The dreary everyday business of getting connected plugs the individual netizen into a tangled mess of policy circuits, as much as tricky network negotiations. Broadband in mid-2003 in Australia is a curious chimera, welded together from a patchwork of technologies, old and newer communications industries, emerging economies and patterns of use. Broadband conjures up grander visions, however, of communication and cultural cornucopia. Broadband is high-speed, high-bandwidth, ‘always-on’, networked communications. People can send and receive video, engage in multimedia exchanges of all sorts, make the most of online education, realise the vision of home-based work and trading, have access to telemedicine, and entertainment. Broadband really entered the lexicon with the mass takeup of the Internet in the early to mid-1990s, and with the debates about something called the ‘information superhighway’. The rise of the Internet, the deregulation of telecommunications, and the involuted convergence of communications and media technologies saw broadband positioned at the centre of policy debates nearly a decade ago. In 1993-1994, Australia had its Broadband Services Expert Group (BSEG), established by the then Labor government. The BSEG was charged with inquiring into ‘issues relating to the delivery of broadband services to homes, schools and businesses’. Stung by criticisms of elite composition (a narrow membership, with only one woman among its twelve members, and no consumer or citizen group representation), the BSEG was prompted into wider public discussion and consultation (Goggin & Newell). The then Bureau of Transport and Communications Economics (BTCE), since transmogrified into the Communications Research Unit of the Department of Communications, Information Technology and the Arts (DCITA), conducted its large-scale Communications Futures Project (BTCE and Luck). The BSEG Final report posed the question starkly: As a society we have choices to make. If we ignore the opportunities we run the risk of being left behind as other countries introduce new services and make themselves more competitive: we will become consumers of other countries’ content, culture and technologies rather than our own. Or we could adopt new technologies at any cost…This report puts forward a different approach, one based on developing a new, user-oriented strategy for communications. The emphasis will be on communication among people... (BSEG v) The BSEG proposed a ‘National Strategy for New Communications Networks’ based on three aspects: education and community access, industry development, and the role of government (BSEG x). Ironically, while the nation, or at least its policy elites, pondered the weighty question of broadband, Australia’s two largest telcos were doing it. The commercial decision of Telstra/Foxtel and Optus Vision, and their various television partners, was to nail their colours (black) to the mast, or rather telegraph pole, and to lay cable in the major capital cities. In fact, they duplicated the infrastructure in cities such as Sydney and Melbourne, then deciding it would not be profitable to cable up even regional centres, let alone small country towns or settlements. As Terry Flew and Christina Spurgeon observe: This wasteful duplication contrasted with many other parts of the country that would never have access to this infrastructure, or to the social and economic benefits that it was perceived to deliver. (Flew & Spurgeon 72) The implications of this decision for Australia’s telecommunications and television were profound, but there was little, if any, public input into this. Then Minister Michael Lee was very proud of his anti-siphoning list of programs, such as national sporting events, that would remain on free-to-air television rather than screen on pay, but was unwilling, or unable, to develop policy on broadband and pay TV cable infrastructure (on the ironies of Australia’s television history, see Given’s masterly account). During this period also, it may be remembered, Australia’s Internet was being passed into private hands, with the tendering out of AARNET (see Spurgeon for discussion). No such national strategy on broadband really emerged in the intervening years, nor has the market provided integrated, accessible broadband services. In 1997, landmark telecommunications legislation was enacted that provided a comprehensive framework for competition in telecommunications, as well as consolidating and extending consumer protection, universal service, customer service standards, and other reforms (CLC). Carrier and reseller competition had commenced in 1991, and the 1997 legislation gave it further impetus. Effective competition is now well established in long distance telephone markets, and in mobiles. Rivalrous competition exists in the market for local-call services, though viable alternatives to Telstra’s dominance are still few (Fels). Broadband too is an area where there is symbolic rivalry rather than effective competition. This is most visible in advertised ADSL offerings in large cities, yet most of the infrastructure for these services is comprised by Telstra’s copper, fixed-line network. Facilities-based duopoly competition exists principally where Telstra/Foxtel and Optus cable networks have been laid, though there are quite a number of ventures underway by regional telcos, power companies, and, most substantial perhaps, the ACT government’s TransACT broadband network. Policymakers and industry have been greatly concerned about what they see as slow takeup of broadband, compared to other countries, and by barriers to broadband competition and access to ‘bottleneck’ facilities (such as Telstra or Optus’s networks) by potential competitors. The government has alternated between trying to talk up broadband benefits and rates of take up and recognising the real difficulties Australia faces as a large country with a relative small and dispersed population. In March 2003, Minister Alston directed the ACCC to implement new monitoring and reporting arrangements on competition in the broadband industry. A key site for discussion of these matters has been the competition policy institution, the Australian Competition and Consumer Commission, and its various inquiries, reports, and considerations (consult ACCC’s telecommunications homepage at http://www.accc.gov.au/telco/fs-telecom.htm). Another key site has been the Productivity Commission (http://www.pc.gov.au), while a third is the National Office on the Information Economy (NOIE - http://www.noie.gov.au/projects/access/access/broadband1.htm). Others have questioned whether even the most perfectly competitive market in broadband will actually provide access to citizens and consumers. A great deal of work on this issue has been undertaken by DCITA, NOIE, the regulators, and industry bodies, not to mention consumer and public interest groups. Since 1997, there have been a number of governmental inquiries undertaken or in progress concerning the takeup of broadband and networked new media (for example, a House of Representatives Wireless Broadband Inquiry), as well as important inquiries into the still most strategically important of Australia’s companies in this area, Telstra. Much of this effort on an ersatz broadband policy has been piecemeal and fragmented. There are fundamental difficulties with the large size of the Australian continent and its harsh terrain, the small size of the Australian market, the number of providers, and the dominant position effectively still held by Telstra, as well as Singtel Optus (Optus’s previous overseas investors included Cable & Wireless and Bell South), and the larger telecommunications and Internet companies (such as Ozemail). Many consumers living in metropolitan Australia still face real difficulties in realising the slogan ‘bandwidth for all’, but the situation in parts of rural Australia is far worse. Satellite ‘broadband’ solutions are available, through Telstra Countrywide or other providers, but these offer limited two-way interactivity. Data can be received at reasonable speeds (though at far lower data rates than how ‘broadband’ used to be defined), but can only be sent at far slower rates (Goggin, Rural Communities Online). The cultural implications of these digital constraints may well be considerable. Computer gamers, for instance, are frustrated by slow return paths. In this light, the final report of the January 2003 Broadband Advisory Group (BAG) is very timely. The BAG report opens with a broadband rhapsody: Broadband communications technologies can deliver substantial economic and social benefits to Australia…As well as producing productivity gains in traditional and new industries, advanced connectivity can enrich community life, particularly in rural and regional areas. It provides the basis for integration of remote communities into national economic, cultural and social life. (BAG 1, 7) Its prescriptions include: Australia will be a world leader in the availability and effective use of broadband...and to capture the economic and social benefits of broadband connectivity...Broadband should be available to all Australians at fair and reasonable prices…Market arrangements should be pro-competitive and encourage investment...The Government should adopt a National Broadband Strategy (BAG 1) And, like its predecessor nine years earlier, the BAG report does make reference to a national broadband strategy aiming to maximise “choice in work and recreation activities available to all Australians independent of location, background, age or interests” (17). However, the idea of a national broadband strategy is not something the BAG really comes to grips with. The final report is keen on encouraging broadband adoption, but not explicit on how barriers to broadband can be addressed. Perhaps this is not surprising given that the membership of the BAG, dominated by representatives of large corporations and senior bureaucrats was even less representative than its BSEG predecessor. Some months after the BAG report, the Federal government did declare a broadband strategy. It did so, intriguingly enough, under the rubric of its response to the Regional Telecommunications Inquiry report (Estens), the second inquiry responsible for reassuring citizens nervous about the full-privatisation of Telstra (the first inquiry being Besley). The government’s grand $142.8 million National Broadband Strategy focusses on the ‘broadband needs of regional Australians, in partnership with all levels of government’ (Alston, ‘National Broadband Strategy’). Among other things, the government claims that the Strategy will result in “improved outcomes in terms of services and prices for regional broadband access; [and] the development of national broadband infrastructure assets.” (Alston, ‘National Broadband Strategy’) At the same time, the government announced an overall response to the Estens Inquiry, with specific safeguards for Telstra’s role in regional communications — a preliminary to the full Telstra sale (Alston, ‘Future Proofing’). Less publicised was the government’s further initiative in indigenous telecommunications, complementing its Telecommunications Action Plan for Remote Indigenous Communities (DCITA). Indigenous people, it can be argued, were never really contemplated as citizens with the ken of the universal service policy taken to underpin the twentieth-century government monopoly PTT project. In Australia during the deregulatory and re-regulatory 1990s, there was a great reluctance on the part of Labor and Coalition Federal governments, Telstra and other industry participants, even to research issues of access to and use of telecommunications by indigenous communicators. Telstra, and to a lesser extent Optus (who had purchased AUSSAT as part of their licence arrangements), shrouded the issue of indigenous communications in mystery that policymakers were very reluctant to uncover, let alone systematically address. Then regulator, the Australian Telecommunications Authority (AUSTEL), had raised grave concerns about indigenous telecommunications access in its 1991 Rural Communications inquiry. However, there was no government consideration of, nor research upon, these issues until Alston commissioned a study in 2001 — the basis for the TAPRIC strategy (DCITA). The elision of indigenous telecommunications from mainstream industry and government policy is all the more puzzling, if one considers the extraordinarily varied and significant experiments by indigenous Australians in telecommunications and Internet (not least in the early work of the Tanami community, made famous in media and cultural studies by the writings of anthropologist Eric Michaels). While the government’s mid-2003 moves on a ‘National Broadband Strategy’ attend to some details of the broadband predicament, they fall well short of an integrated framework that grasps the shortcomings of the neoliberal communications model. The funding offered is a token amount. The view from the seat of government is a glance from the rear-view mirror: taking a snapshot of rural communications in the years 2000-2002 and projecting this tableau into a safety-net ‘future proofing’ for the inevitable turning away of a fully-privately-owned Telstra from its previously universal, ‘carrier of last resort’ responsibilities. In this aetiolated, residualist policy gaze, citizens remain constructed as consumers in a very narrow sense in this incremental, quietist version of state securing of market arrangements. What is missing is any more expansive notion of citizens, their varied needs, expectations, uses, and cultural imaginings of ‘always on’ broadband networks. Hybrid Networks “Most people on earth will eventually have access to networks that are all switched, interactive, and broadband”, wrote Frances Cairncross in 1998. ‘Eventually’ is a very appropriate word to describe the parlous state of broadband technology implementation. Broadband is in a slow state of evolution and invention. The story of broadband so far underscores the predicament for Australian access to bandwidth, when we lack any comprehensive, integrated, effective, and fair policy in communications and information technology. We have only begun to experiment with broadband technologies and understand their evolving uses, cultural forms, and the sense in which they rework us as subjects. Our communications networks are not superhighways, to invoke an enduring artefact from an older technology. Nor any longer are they a single ‘public’ switched telecommunications network, like those presided over by the post-telegraph-telephone monopolies of old. Like roads themselves, or the nascent postal system of the sixteenth century, broadband is a patchwork quilt. The ‘fibre’ of our communications networks is hybrid. To be sure, powerful corporations dominate, like the Tassis or Taxis who served as postmasters to the Habsburg emperors (Briggs & Burke 25). Activating broadband today provides a perspective on the path dependency of technology history, and how we can open up new threads of a communications fabric. Our options for transforming our multitudinous networked lives emerge as much from everyday tactics and strategies as they do from grander schemes and unifying policies. We may care to reflect on the waning potential for nation-building technology, in the wake of globalisation. We no longer gather our imagined community around a Community Telephone Plan as it was called in 1960 (Barr, Moyal, and PMG). Yet we do require national and international strategies to get and stay connected (Barr), ideas and funding that concretely address the wider dimensions of access and use. We do need to debate the respective roles of Telstra, the state, community initiatives, and industry competition in fair telecommunications futures. Networks have global reach and require global and national integration. Here vision, co-ordination, and resources are urgently required for our commonweal and moral fibre. To feel the width of the band we desire, we need to plug into and activate the policy circuits. Thanks to Grayson Cooke, Patrick Lichty, Ned Rossiter, John Pace, and an anonymous reviewer for helpful comments. Works Cited Alston, Richard. ‘ “Future Proofing” Regional Communications.’ Department of Communications, Information Technology and the Arts, Canberra, 2003. 17 July 2003 <http://www.dcita.gov.au/Article/0,,0_1-2_3-4_115485,00.php> —. ‘A National Broadband Strategy.’ Department of Communications, Information Technology and the Arts, Canberra, 2003. 17 July 2003 <http://www.dcita.gov.au/Article/0,,0_1-2_3-4_115486,00.php>. Australian Competition and Consumer Commission (ACCC). Broadband Services Report March 2003. Canberra: ACCC, 2003. 17 July 2003 <http://www.accc.gov.au/telco/fs-telecom.htm>. —. Emerging Market Structures in the Communications Sector. Canberra: ACCC, 2003. 15 July 2003 <http://www.accc.gov.au/pubs/publications/utilities/telecommu... ...nications/Emerg_mar_struc.doc>. Barr, Trevor. new media.com: The Changing Face of Australia’s Media and Telecommunications. Sydney: Allen & Unwin, 2000. Besley, Tim (Telecommunications Service Inquiry). Connecting Australia: Telecommunications Service Inquiry. Canberra: Department of Information, Communications and the Arts, 2000. 17 July 2003 <http://www.telinquiry.gov.au/final_report.php>. Briggs, Asa, and Burke, Peter. A Social History of the Internet: From Gutenberg to the Internet. Cambridge: Polity, 2002. Broadband Advisory Group. Australia’s Broadband Connectivity: The Broadband Advisory Group’s Report to Government. Melbourne: National Office on the Information Economy, 2003. 15 July 2003 <http://www.noie.gov.au/publications/NOIE/BAG/report/index.htm>. Broadband Services Expert Group. Networking Australia’s Future: Final Report. Canberra: Australian Government Publishing Service (AGPS), 1994. Bureau of Transport and Communications Economics (BTCE). Communications Futures Final Project. Canberra: AGPS, 1994. Cairncross, Frances. The Death of Distance: How the Communications Revolution Will Change Our Lives. London: Orion Business Books, 1997. Communications Law Centre (CLC). Australian Telecommunications Regulation: The Communications Law Centre Guide. 2nd edition. Sydney: Communications Law Centre, University of NSW, 2001. Department of Communications, Information Technology and the Arts (DCITA). Telecommunications Action Plan for Remote Indigenous Communities: Report on the Strategic Study for Improving Telecommunications in Remote Indigenous Communities. Canberra: DCITA, 2002. Estens, D. Connecting Regional Australia: The Report of the Regional Telecommunications Inquiry. Canberra: DCITA, 2002. <http://www.telinquiry.gov.au/rti-report.php>, accessed 17 July 2003. Fels, Alan. ‘Competition in Telecommunications’, speech to Australian Telecommunications Users Group 19th Annual Conference. 6 March, 2003, Sydney. <http://www.accc.gov.au/speeches/2003/Fels_ATUG_6March03.doc>, accessed 15 July 2003. Flew, Terry, and Spurgeon, Christina. ‘Television After Broadcasting’. In The Australian TV Book. Ed. Graeme Turner and Stuart Cunningham. Allen & Unwin, Sydney. 69-85. 2000. Given, Jock. Turning Off the Television. Sydney: UNSW Press, 2003. Goggin, Gerard. ‘Citizens and Beyond: Universal service in the Twilight of the Nation-State.’ In All Connected?: Universal Service in Telecommunications, ed. Bruce Langtry. Melbourne: University of Melbourne Press, 1998. 49-77 —. Rural Communities Online: Networking to link Consumers to Providers. Melbourne: Telstra Consumer Consultative Council, 2003. Goggin, Gerard, and Newell, Christopher. Digital Disability: The Social Construction of Disability in New Media. Lanham, MD: Rowman & Littlefield, 2003. House of Representatives Standing Committee on Communications, Information Technology and the Arts (HoR). Connecting Australia!: Wireless Broadband. Report of Inquiry into Wireless Broadband Technologies. Canberra: Parliament House, 2002. <http://www.aph.gov.au/house/committee/cita/Wbt/report.htm>, accessed 17 July 2003. Lamberton, Don. ‘A Telecommunications Infrastructure is Not an Information Infrastructure’. Prometheus: Journal of Issues in Technological Change, Innovation, Information Economics, Communication and Science Policy 14 (1996): 31-38. Latour, Bruno. Science in Action: How to Follow Scientists and Engineers Through Society. Cambridge, MA: Harvard University Press, 1987. Luck, David. ‘Revisiting the Future: Assessing the 1994 BTCE communications futures project.’ Media International Australia 96 (2000): 109-119. MacBride, Sean (Chair of International Commission for the Study of Communication Problems). Many Voices, One World: Towards a New More Just and More Efficient World Information and Communication Order. Paris: Kegan Page, London. UNESCO, 1980. Maitland Commission (Independent Commission on Worldwide Telecommunications Development). The Missing Link. Geneva: International Telecommunications Union, 1985. Michaels, Eric. Bad Aboriginal Art: Tradition, Media, and Technological Horizons. Sydney: Allen & Unwin, 1994. Mody, Bella, Bauer, Johannes M., and Straubhaar, Joseph D., eds. Telecommunications Politics: Ownership and Control of the Information Highway in Developing Countries. Mahwah, NJ: Erlbaum, 1995. Moyal, Ann. Clear Across Australia: A History of Telecommunications. Melbourne: Thomas Nelson, 1984. Post-Master General’s Department (PMG). Community Telephone Plan for Australia. Melbourne: PMG, 1960. Productivity Commission (PC). Telecommunications Competition Regulation: Inquiry Report. Report No. 16. Melbourne: Productivity Commission, 2001. <http://www.pc.gov.au/inquiry/telecommunications/finalreport/>, accessed 17 July 2003. Spurgeon, Christina. ‘National Culture, Communications and the Information Economy.’ Media International Australia 87 (1998): 23-34. Turner, Graeme. ‘First Contact: coming to terms with the cable guy.’ UTS Review 3 (1997): 109-21. Winseck, Dwayne. ‘Wired Cities and Transnational Communications: New Forms of Governance for Telecommunications and the New Media’. In The Handbook of New Media: Social Shaping and Consequences of ICTs, ed. Leah A. Lievrouw and Sonia Livingstone. London: Sage, 2002. 393-409. World Trade Organisation. General Agreement on Trade in Services: Annex on Telecommunications. Geneva: World Trade Organisation, 1994. 17 July 2003 <http://www.wto.org/english/tratop_e/serv_e/12-tel_e.htm>. —. Fourth protocol to the General Agreement on Trade in Services. Geneva: World Trade Organisation. 17 July 2003 <http://www.wto.org/english/tratop_e/serv_e/4prote_e.htm>. Links http://www.accc.gov.au/pubs/publications/utilities/telecommunications/Emerg_mar_struc.doc http://www.accc.gov.au/speeches/2003/Fels_ATUG_6March03.doc http://www.accc.gov.au/telco/fs-telecom.htm http://www.aph.gov.au/house/committee/cita/Wbt/report.htm http://www.dcita.gov.au/Article/0,,0_1-2_3-4_115485,00.html http://www.dcita.gov.au/Article/0,,0_1-2_3-4_115486,00.html http://www.noie.gov.au/projects/access/access/broadband1.htm http://www.noie.gov.au/publications/NOIE/BAG/report/index.htm http://www.pc.gov.au http://www.pc.gov.au/inquiry/telecommunications/finalreport/ http://www.telinquiry.gov.au/final_report.html http://www.telinquiry.gov.au/rti-report.html http://www.wto.org/english/tratop_e/serv_e/12-tel_e.htm http://www.wto.org/english/tratop_e/serv_e/4prote_e.htm Citation reference for this article Substitute your date of access for Dn Month Year etc... MLA Style Goggin, Gerard. "Broadband" M/C: A Journal of Media and Culture< http://www.media-culture.org.au/0308/02-featurebroadband.php>. APA Style Goggin, G. (2003, Aug 26). Broadband. M/C: A Journal of Media and Culture, 6,< http://www.media-culture.org.au/0308/02-featurebroadband.php>

Women in Universities Women have been fighting for the right to participate in universities since 1873, when Sophia Jex Blake went to court with her fight to enrol at Edinburgh University. In rejecting her application, one of the judges stated: It is a belief, widely entertained, that there is a great difference in the mental constitution of the two sexes, just as there is in their physical conformation. The powers and susceptibilities of women are as noble as those of men; but they are thought to be different, and, in particular, it is considered that they have not the same power of intense labour as men .... (Scutt 224) In Australia, from the 1850s to the 1880s, both the University of Sydney and The University of Melbourne refused to admit women as students. In 1879, the Chancellor of the University of Sydney suggested that: The best course to be taken by advocates of advanced education for women, would be to found some sort of affiliated college for them in the vicinity of the University ... if there really be a widespread wish on the part of young women for a higher education ..." (Scutt 228). Having finally won the right to study at university in 1881, and to enter the academic workforce, women are still finding many of the old prejudices remain. Numerous studies have demonstrated that women's experiences in academe are qualitatively different from men's and that women are systematically paid lower salaries than men of equivalent academic achievement, age and length of service (Bagilhole 431-47; Loder 713-4; McElrath 269-81;). Studies have shown that differences in the experiences of male and female faculty are largely explained by gender (Booth & Burton 312-33; Everett 159-75; Over & Lancaster 309-18; Ready 7) and sex discrimination is highlighted as an ongoing contributor to the inequity (Allport 5-8; Hall & Swadener 1; Tuohy 8). A recent UNESCO-Commonwealth (http://www.unesco.org/) report states that: ... in spite of advances which women have made in many areas of public life in the past two decades, in the area of higher education management they are still a long way from participating on the same footing as men. With hardly an exception, the global picture is one of men outnumbering women at about five to one at middle management level and at about twenty to one at senior management level (Singh 4). The introduction in Australia of Sex Discrimination legislation (http://www.hreoc.gov.au/sex_discrimination/) in 1984 and more recently, Affirmative Action policies ( http://www.austlii.edu.au/) in employment and promotion rounds in some universities has not improved women's situation to the extent expected. In 1978, women held 16% of full time academic posts while gaining 25% of all higher degrees and 30% of undergraduate degrees (Commonwealth Government statistics cited by Over and McKenzie 61-71). In 1999, 54% of students were women yet women's participation in academe had only increased to 35% (DETYA) (http://www.deet.gov.au/). Women are mainly employed at the lowest academic levels. In 1999, 72% of women were employed at Levels A and B (Associate Lecturer/Lecturer) compared to 46% of men, with only 8% of women reaching Levels D and E (Associate Professor/Professor) compared to 26% of men. Women continue to be clustered in the traditionally female areas of Health, Education and Arts while few seem to have successfully broken through the barriers in the traditionally male areas of Engineering, Architecture or Agriculture (DETYA) (http://www.deet.gov.au/). Business has traditionally been viewed as a male preserve but enrolments have increased to the point where women almost equal men. However, the staff ratio of men to women remains very low at 70/30 (DETYA) (http://www.deet.gov.au/). The slow growth rate for women in academe belies the fact that more women than men are now completing university degrees. The purpose of this study was to determine how well the experiences of academic women in the male-dominated faculties of business and commerce, reflect the literature on women in universities, in general. Previous empirical studies have found inequitable treatment of women without necessarily exploring the processes of discrimination. The Study This study involved interviews with academic women who had been employed in faculties of business and commerce for at least five years. The research used the 'snowballing' technique: participants initially comprised women known to me but as these women told female colleagues of my study I was given the names of other women who were willing to participate. Participants comprised twenty-one women from three universities in Western Australia, two universities in New South Wales and one Victorian university. One woman had recently left academe and started her own business because of discriminatory practices she had encountered and another was contemplating leaving. In each university, women comprised a minority of the faculty and felt disadvantaged in some way. A semi-structured interview was used to explore with the women the issues that had been identified from previous studies of sex discrimination in the academic profession. Open-ended questions were used and the interviews conducted face to face, or, in the case of those interstate, via telephone or email. The women spoke frankly about their experiences. Findings and Discussion Promotion Each of the women in this study said that their university had established an internal promotion policy based on merit. However, they felt the greatest problem they had encountered in gaining promotion was in determining the criteria upon which they would be judged each year, and in meeting those criteria. "I have been chasing promotion for over five years. At first I was told that I would not be promoted until I got my masters degree so I worked really hard to complete it but then a male colleague was promoted without a masters. Once I got the masters I was told I needed to publish to be promoted but in the next year someone else was promoted without any publications. You go all out to meet the criteria each year but in the next year the promotions committee changes and so do the criteria for that year"(Lecturer applying for Senior Lecturer position). The promotion procedure at one university was explained by a Senior Lecturer who had served on promotion committees on two occasions. "There are about ten criteria upon which promotion can be based. When the applications are received we all get together to determine which are the criteria to be applied. In the last promotion round only four of the ten criteria were used so only people satisfying those criteria were selected." When asked whether the criteria were the same as the previous year she replied: "Last year there was more emphasis on qualifications and publications. This year community involvement and involvement in university affairs were judged as more important ... it varies from year to year". On questioning about the promotion procedures at their universities, women stated they were largely dissatisfied with the process, that they were presumed to be satisfied with their lot while the men were actively encouraged to apply. "I was told not to bother to apply (for a senior lecturer position) as I would not get it ... that there was a queue of people to be promoted before me - (named males) - and until they were promoted, I would not be considered" (Lecturer). "The position was advertised with a specific male applicant in mind and specifically excluded me by stating that the appointee must have supervisory experience. Women in my department are not given the opportunity to supervise students so I didn't even bother applying."(Lecturer aspiring to a Senior Lecturer position). One woman, upon inquiring why she was not promoted, was told that she should be grateful to have tenure and asked why she wanted to be promoted, anyway. "They would never have said that to a male, they would have expected a male to be working towards promotion" (Associate Lecturer). All women interviewed stated that they had problems keeping up with the 'goal posts' which moved from year to year. The 'moving of the goal posts' is one means by which universities are able to maintain the position of women at lower levels. Unsurprisingly, some women said they felt that promotion at their university was based on politics rather than merit. However, defining merit in universities is problematic. According to Burton (430), definitions of what is meritorious depend upon the power of particular groups to define it and, as a result, can change. The narrow view of merit is 'the best person for the job' which Burton (113) describes as an "overwhelming tendency to select in your own image". Burton (430) and Allport (5) claim universities define merit along male cultural lines with current selection, remuneration and career progression practices strongly influenced by an underlying gender bias. Burton (430) argues that there is still a tendency for work to be ranked as 'men's' or women's work with lower status attributed to the latter and an assumption that different skills and abilities are needed for each. Over and McKenzie (61-71) claim that women are disadvantaged by the fact that invalid merit criteria are applied to them which men as a group are more likely to satisfy. They state that the academic careers of most women do not fit the stereotypic male experience and it is mainly men who decide whether women should be promoted. At one university in the study, the merit criteria for senior lecturer include the requirement that aspirants have a number of overseas conference presentations. "Some of us are single working mothers and overseas conference attendance is out of the question because who's going to mind our children while we are away? The senior males were astonished when I mentioned that this was a problem for me. It had never occurred to them" (Associate Lecturer on why women at her university do not apply for promotion). Family Responsibilities The women commented on the numerous difficulties they had encountered in combining an academic career with responsibility for children. They felt that certain male faculty members perceived married women with children as lacking in career commitment, whereas married men with families were viewed as being more stable and committed to their careers. One married woman claimed that when she needed to go home to tend a sick child, her male Head of Department told her she should "get her priorities right". In 1992, Family Responsibility provisions were added to the Sex Discrimination Act (http://scaleplus.law.gov.au/html/pasteact/0/171/top.htm). However, it would appear that individual practice doesn't always follow as a result of changes in policy. Equal Pay On the subject of equal pay for equal work, the women said that they were often paid lower wages than their male colleagues despite having higher qualifications and equivalent teaching and research experience. Some women felt that the barriers between academic levels were used to artificially maintain the wage gap between men and women, regardless of qualifications and ability. This was felt to be particularly the case between the levels of Associate Lecturer (Level A) and Lecturer (Level B). "They find excuses to keep you at Associate Lecturer so that they can pay you less to do the same work that you would be doing as a lecturer ... lecturing, coordinating units and so on"(Associate Lecturer). "There are no men below Lecturer in my Department, either lecturing or with Masters degrees. As soon as they get their Masters they are promoted to Lecturer.... I'm coordinating units as an Associate Lecturer while some male lecturers have less responsibility' (Associate Lecturer with Masters degree and publications) Two women said that they had been performing higher level duties (Level B) for up to five years while working on their Masters but their university refused to pay them at the higher level until they had completed their degree. Even when they satisfied all the requirements for the Masters degree and had a letter from their supervisor saying they had satisfied all the requirements, the university refused to pay them until they had actually graduated, which was some time later. Shortly afterwards their university took on two men to perform the same duties, paying these at the higher level even though they had not completed a masters degree. One former lecturer claimed that she was employed at a time when there was a large turnover of staff in her department. A number of new staff were appointed of whom she was the only female. Although she and the other new staff were all employed at Lecturer Level B, it wasn't until later on that she discovered that the men were appointed at the top of the Lecturer salary scale while she was appointed at the bottom, with a salary differential of about10 000pa. This was despite the fact that both she and the men had similar qualifications and work experience at commencement. Teaching Loads Another complaint by women concerned inequitable teaching loads. An analysis in one Business School showed that women had higher teaching loads while men were given more time off for research. The women complained that the supervision of post-graduate students was divided up between the men, and women were excluded. Since research publication and student supervision are usually the most highly ranked criteria in academic promotion rounds, women who are not given the opportunity to participate in these areas are disadvantaged when applying for promotion. This problem is compounded since women are overwhelmingly employed at the lower levels where responsibility for the majority of teaching takes place. This leaves them with little time left to devote to research even if given the opportunity. The women also said they were often pressured into taking on higher duties than those prescribed in the Position Classification Standards for their level. They tended to acquiesce because of their need to prove they were better than men to gain promotion. One woman said that the extra administrative duties she had been given meant that she had less time for research which actually reduced her prospects for tenure and promotion. She said she didn't dare complain as the men in her department would use it as an excuse to question her commitment to her job. Conclusion An examination of women's perceptions and experiences in the workplace can help us understand the informal processes that work against women. The experiences of the women discussed in this paper provide an insight into the subtle processes that continue to operate in some higher education institutions to prevent women from reaching their full potential. Although equal opportunity legislation (http://www.hreoc.gov.au/about_the_commission/legislation/index.html) has been enacted to prevent discrimination and disadvantage to women, the implementation of policy does not always filter through to the operational levels. It is still possible to circumvent legislation in subtle ways, perhaps without even being aware that these practices are discriminative. The women in this study spoke frankly about their experiences and the difficulties they had encountered in gaining equal recognition to men, with very few satisfied that they were receiving equitable treatment. The women felt that their work was not valued as highly as that of the men they worked with and they were given less opportunities for advancement. Overall, the interviews with the women revealed interesting insights into their experiences in pursuing academic careers and in trying to gain recognition for their achievements. The collective experiences of the women provide an insight into the subtle ways in which disadvantage can be engendered. The findings of this study have serious implications for university administrators, particularly deans and heads of schools. There are many well-qualified women academics and universities cannot afford to overlook the valuable contribution these women can make to teaching, research and university governance. References Allport, Caroline. 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Tuohy, John. "Sex Discrimination Infects Med Schools: Women Say Bias Blocks Chances for Advancement". USA Today2000. 8. Links http://www.unesco.org/ http://www.deet.gov.au/ http://www.hreoc.gov.au/sex_discrimination/ http://www.hreoc.gov.au/about_the_commission/legislation/index.html http://www.austlii.edu.au/cgibin/disp.pl/au/legis/cth/consol%5fact/aaeofwa 1986634/?query=title+%28+%22affirmative+action%22+%29 http://scaleplus.law.gov.au/html/pasteact/0/171/top.htm Citation reference for this article MLA Style Ellis-Newman, Jennifer. "Women and Work" M/C: A Journal of Media and Culture 4.5 (2001). [your date of access] < http://www.media-culture.org.au/0111/Ellis-Newman.xml >. Chicago Style Ellis-Newman, Jennifer, "Women and Work" M/C: A Journal of Media and Culture 4, no. 5 (2001), < http://www.media-culture.org.au/0111/Ellis-Newman.xml > ([your date of access]). APA Style Ellis-Newman, Jennifer. (2001) Women and Work. M/C: A Journal of Media and Culture 4(5). < http://www.media-culture.org.au/0111/Ellis-Newman.xml > ([your date of access]).