Journal articles: '621.311.1.003 + 621.314'

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Anashkin, S., A. Bovkun, L. Bindi, V. Garanin, and Y. Litvin. "Kudryavtsevaite, Na3MgFe3+Ti4O12, a new kimberlitic mineral." Mineralogical Magazine 77, no. 3 (April 2013): 327–34. http://dx.doi.org/10.1180/minmag.2013.077.3.06.

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AbstractKudryavtsevaite, ideally Na3MgFe3+Ti4O12, is a new mineral from kimberlitic rocks of the Orapa area, Botswana. It occurs as rare prismatic crystals, up to 100 μm m across, associated with Mg-rich ilmenite, freudenbergite and ulvöspinel. Kudryavtsevaite is opaque with a vitreous lustre and shows a black streak. It is brittle; the Vickers hardness (VHN100) is 901 kg mm−2 (range: 876–925) (Mohs hardness ∼6). In reflected light, kudryavtsevaite is moderately bireflectant and very weakly pleochroic from dark grey to a slightly bluish grey. Under crossed polars, it is very weakly anisotropic with greyish-bluish rotation tints. Internal reflections are absent. Reflectance values (%), Rmin and Rmax, are: 21.3, 25.4 (471.1 nm), 20.6, 24.1 (548.3 nm), 20.0, 23.5 (586.6 nm) and 19.1, 22.4 (652.3 nm).Kudryavtsevaite is orthorhombic, space group Pnma, with a = 27.714(1), b = 2.9881(3), c = 11.3564(6) Å, V = 940.5(1) Å3, and Z = 4. The crystal structure [R1 = 0.0168 for 819 reflections with I > 2σ(I)] consists of edge-sharing and corner-sharing chains composed of Mg, Fe3+ and Ti atoms coordinated by six atoms of oxygen and running along the b axis, with Na filling the tunnels formed by the chains. The eight strongest powder-diffraction lines [d in Å (I/I0) (hkl)] are: 7.17 (100) (301), 4.84 (70) (302), 2.973 (35) (901), 2.841 (50) (004), 2.706 (50) (902), 2.541 (50) (312), 2.450 (70) (611), and 2.296 (45) (612). The average results of 12 electron microprobe analyses gave (wt.%): Na2O 16.46(15), CaO 1.01(3), MgO 5.31(5), Fe2O3 22.24(32), Cr2O3 1.05(6), Al2O3 0.03(2), TiO2 53.81(50), total 99.91, corresponding to the empirical formula (Na2.89Ca0.10)Σ2.99(Ti3.67Fe1.523+Mg0.72Cr0.08)Σ5.99O12, or ideally Na3MgFe3+Ti4O12.The new mineral has been approved by the IMA-CNMNC and named for Galina Kudryavtseva (1947–2006), a well known Russian mineralogist and founder of the Diamond Mineralogy Laboratory and scientific school for investigation of diamond mineralogy and geochemistry at the Lomonosov State University in Moscow, Russia.

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Nakamura, Masato, Tae Won Kim, Rui-hua Xu, Young Suk Park, Yong Sang Hong, Tao Zhang, Takeshi Kato, et al. "A multinational, randomized, phase III trial of XELIRI with or without bevacizumab versus FOLFIRI with or without bevacizumab as second-line therapy for metastatic colorectal cancer: Safety analysis of Asian XELIRI project (AXEPT)." Journal of Clinical Oncology 35, no. 4_suppl (February 1, 2017): 681. http://dx.doi.org/10.1200/jco.2017.35.4_suppl.681.

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681 Background: Several studies have shown that capecitabine plus irinotecan (XELIRI) has promising efficacy and safety in patients with metastatic colorectal cancer. AXEPT is a non-inferiority, phase III comparison of XELIRI with or without bevacizumab vs 5-fluorouracil/folinic acid plus irinotecan (FOLFIRI) with or without bevacizumab as second-line therapy in patients with metastatic colorectal cancer. Methods: We undertook an open-label, non-inferiority, randomized phase III trial in South Korea, China and Japan. Patients were randomized 1:1 to XELIRI (irinotecan 200 mg/m2 on day 1 plus capecitabine 800 mg/m2 twice daily for 2 weeks in a 3-week cycle) with or without bevacizumab 7.5 mg/kg or FOLFIRI with or without bevacizumab. The primary endpoint was overall survival. Results: From December 2013 to August 2015, 650 patients were enrolled and 625 (311 in FOLFIRI and 314 in XELIRI) were included to safety analysis at the cutoff dates on August 31, 2016. Patient baseline characteristics including KRAS status and UGT1A1 gene polymorphism were similar between the two treatment arms. Prior chemotherapy with oxaliplatin was given to 97.4% in both arms. The overall incidence of grade 3-4 toxicity was 73% in FOLFIRI arm and 53.2% in XELIRI arm. Whereas FOLFIRI was associated with more grade 3-4 neutropenia (43.7% vs 16.2%), leucopenia (13.5% vs 7.3%) and all grades anemia (80.4% vs 69.4%) than XELIRI, XELIRI was associated with more all grades hand-foot syndrome (34.1% vs 14.8%) and grade 3-4 diarrhea (7.0% vs 3.2%). There was no significant difference in febrile neutropenia (4.2% in FOLFIRI and 2.9% in XELIRI). The addition of bevacizumab did not alter safety profiles between XELIRI and FOLFIRI. There was a treatment-related death in FOLFIRI arm (0.3%). Conclusions: Both FOLFIRI and XELIRI were safe and well tolerated, though there were differences in the rates and toxicity profiles at which adverse events occur. Clinical trial information: NCT01996306. UMIN000012263.

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Sawattep, Jeeranut, Thad A. Howard, Noppawan P. Morales, Yupin Sanvarinda, Pranee Fucharoen, Suthat Fucharoen, and Russell E. Ware. "Single Nucleotide Polymorphism (SNP) Discovery within the UGT1A Gene Complex: Allelic Frequencies and Ethnic Differences." Blood 104, no. 11 (November 16, 2004): 3780. http://dx.doi.org/10.1182/blood.v104.11.3780.3780.

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Abstract The UDP-glycosyltransferase (UGT1A) gene complex plays an important role in the hepatic metabolism of many chemicals, toxins, and drugs including bilirubin and acetaminophen. In this large gene complex that spans over 200kb, there are at least 13 different coding regions that can serve as exon 1, followed by a common sequence that contains exons 2–5. These variable exon 1 sequences confer different chemical specificities for binding compounds, while exons 2–5 provide glycosyltransferase function (glucuronidation) that enhances water solubility and excretion. Mutations and polymorphisms within the UGT1A complex may help explain the phenotypic variability that is observed in drug metabolism for patients with hematological diseases. To date, several important polymorphisms have been identified in the coding regions of the UGT1A1 and UGT1A6 exon 1 sequences, but formal single nucleotide polymorphism (SNP) discovery has not been reported. Using genomic DNA obtained from a cohort of Thai patients with beta-thalassemia/HbE (n=37) and African-American patients with sickle cell anemia (n=12), flanking and coding sequences for UGT1A1 exon 1 (1.5kb), UGT1A6 exon 1 (1.5kb), and UGT1A common exons 2–5 (2.5kb) were fully sequenced in both directions. Polymorphisms that occurred more than once were compared to wildtype sequences obtained from NCBI, Accession Number AF297093. Single Nucleotide Polymorphisms in the UGT1A gene complex SNP NCBI nucleotide Location African-American Thai * indicates a SNP previously identified in NCBI g/c 109183 5′ 1A6 Exon 1 .875/.125 .676/.324 c/g 109301 5′ 1A6 Exon 1 .833/.167 1.000/.000 g/t 109628 1A6 Exon 1 .458/.542 .662/.338 c/t 109713 1A6 Exon 1 1.000/.000 .905/.095 a/g * 109924 1A6 Exon 1 .542/.458 .689/.311 a/g * 110150 1A6 Exon 1 .708/.292 .689/.311 a/c * 110161 1A6 Exon 1 .625/.375 .662/.338 t/g 110236 1A6 Exon 1 .750/.250 .973/.027 c/t 174679 5′ 1A1 Exon 1 .500/.500 .770/.230 g/c 174979 5′ 1A1 Exon 1 1.000/.000 .946/.054 g/a * 175253 1A1 Exon 1 1.000/.000 .932/.068 a/g 182226 Intron 2 .955/.045 .689/.311 t/c 182521 Intron 2 .850/.150 .905/.095 c/t 187524 3′ Exon 5 .417/.583 .865/.135 c/g * 187652 3′ Exon 5 .625/.375 .851/.149 c/g * 187753 3′ Exon 5 .587/.417 .838/.162 In addition to the well-described UGT1A1 (TA)n promoter polymorphism, a total of 16 SNPs were identified in these regions, including 10 that have not been previously reported. Four novel promoter SNPs were identified, along with three new UGT1A6 exon 1 coding SNPs and three non-coding SNPs within the common exon 2–5 region. The alellic frequencies for these SNPs can only be estimated from this small sample size, but indicate substantial differences between Thai and African-American patients. A larger sample size will be used to determine a more accurate allelic frequency for each SNP, and to identify haplotype associations. These novel SNPs within the UGT1A gene complex may have important effects on drug metabolism and may explain some of the phenotypic variability observed in these patient populations.

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Blasius, Jörg. "Nishisato, S. (2007). Multidimensional nonlinear descriptive analysis. Boca Raton, FL: Chapman & Hall/CRC. 312 + xiii pp. US$89.95. ISBN 1-58488-612-9." Psychometrika 72, no. 4 (July 3, 2007): 647–48. http://dx.doi.org/10.1007/s11336-007-9017-0.

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Gehrcke, Martielo Ivan, Helena Mondardo Cardoso, Doughlas Regalin, Gizelli da Silva, Vanessa Sasso Padilha, Aury Nunes de Moraes, and Nilson Oleskovicz. "Cardiac index by thermodilution or transthoracic echocardiography in dogs at different hemodynamic states." Ciência Rural 46, no. 11 (August 15, 2016): 2049–54. http://dx.doi.org/10.1590/0103-8478cr20150352.

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ABSTRACT: Proper monitoring of cardiac index (CI) in critically ill patients requires accurate and minimally invasive methods. The aim of this study was to compare the CI values obtained by thermodilution or echocardiography using different methods in dogs in different hemodynamic states. Nine dogs weighing 19.6±1.3kg were anesthetized with isoflurane at 1.4V% (Baseline) and subjected to mechanical ventilation (MV),a hypodynamic state (Hypo) with isoflurane at 3.5V% and hyperdynamic state (hyper) with dobutamine infusion at 5μgkg-1min-1. CI analysis was performed by thermodilution (TD) and using the modified Simpson's method, aortic velocity-time integral (A-VTI) method and pulmonary VTI (P-VTI) method. We performed Pearson's correlation and Bland-Altman analysis. The CI values (Lm-2min-1) of the animals in the Baseline, MV, Hypo and Hyper states were 4.3±1, 3.6±0.7, 2.9±0.66 and 6.1±2, for TD; 2.8±0.7, 2.4±0.3, 1.7±0.7 and 4.4±1.2, for Simpson's method; 3.4±0.9, 3.1±0.7, 2.6±3.4, 6.1±1.8 for A-VTI; and 3.6±0.8, 3.6±0.8, 2.7±0.6 and 6.2±1.5, for P-VTI. The CI values using Simpson's method were lower than those obtained by TD in all states, and it was observed a significant correlation in the Hypo (r=0.89) and Hyper (r=0.76) groups. In addition,the percent error in the Hypo group using Simpson's method was 26% relative to TD, which allowed for the identification of the different hemodynamic states. With respect to the other methods and states, there was no agreement or correlation between the methods and TD. We concluded that none of the tested echocardiography methods exhibited acceptable agreement with thermodilution at different hemodynamic states.

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Van Dyk, S., L. M. Gerritsma- Van der Vijver, and D. G. Van der Nest. "Die toksisiteit van Gladiolus dalenii van Geel." Suid-Afrikaanse Tydskrif vir Natuurwetenskap en Tegnologie 13, no. 4 (July 10, 1994): 125–28. http://dx.doi.org/10.4102/satnt.v13i4.594.

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The biological activity of Gladiolus dalenii van Geel (Iridaceae) corms (used in ethnomedicine) and leaves were evaluated in a few systems. A profile of acute toxicity in rats was compiled and it was found that both corms and leaves contained cytotoxic substances affecting mitotic active tissue. Acute deaths resulted from congestive heart failure. The toxicity of a fraction (coded as GDI) isolated from corms was qualitatively similar to that of corms and leaves. Estimated minimum lethal doses, given in mg/kg body weight, lie in the range 10-31 (i.p.) and 3 160 - 5 620 (p.o.) for corms, 100-316 (i.p.) and > 1 780 (p.o.) for leaves and 1-3 (i.p.) and > 1 000 (p.o.) for fraction GDI. Intact plant material showed no activity against a series of microbes. Fraction GDI was active against Candida albicans. Phototoxicity was not detected.

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Mayorova, Yana, Viktor Glebov, Viktoriya Erofeeva, Sergey Yablochnikov, and Bogdan Laver. "Physiological Evaluation of the Cardiology System of Nonresident Students at Different Training Periods." E3S Web of Conferences 169 (2020): 04004. http://dx.doi.org/10.1051/e3sconf/202016904004.

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The article provides a physiological assessment of the state of the cardiovascular system of students in different periods of the academic year. The study was conducted on a sample of 311 nonresident and Moscow students. An analysis of the spectral characteristics of HRV showed that during the examination session the total power of the spectrum decreased compared with the indicators during the training session. During the intercessional period, the total spectrum power in the studied group of students amounted to 4856.34 ± 645 ms2, and during the examination session this indicator decreased by 35.8% and amounted to 3119.41 ± 522 ms2. A comparative analysis of the HRV activity wave spectrum of the studied student sample showed significant changes (p <0.05) of students’ functional state indicators (SDNN, LF, HF, LF / HF; SI, ARS). According to the studied indicators, a growth trend was noted: (SDNN: from 43.89 ± 8.12 to 78.03 ± 3.86; LF: 27.78 ± 7.33 42.56 ± 4.51; LF / HF: 0.67 ± 0.03 1.72 ± 0.02; SI: 102.95 ± 11.3 467.77 ± 6.1; ARS: 1-2 ± 0.12 5-7 ± 0.01 ) and a decrease in HF (41.74 ± 5.3 to 24.67 ± 2.94).

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Politi, Mary C., Renata W. Yen, Glyn Elwyn, Natasha Kurien, Sophie G. Czerwinski, Danielle Schubbe, Catherine H. Saunders, and Marie-Anne Durand. "Encounter Decision Aids Can Prompt Breast Cancer Surgery Cost Discussions: Analysis of Recorded Consultations." Medical Decision Making 40, no. 1 (December 12, 2019): 62–71. http://dx.doi.org/10.1177/0272989x19893308.

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Background. Patients frequently worry about care costs, but clinicians seldom address the topic. Cost information is not typically included in patient decision aids (DAs). We examined whether including cost information in an encounter DA, with clinician training, influenced cost conversations. Method. As part of a larger trial, 14 surgeons from 4 cancer centers were randomized to 1 of 3 interventions: (1) Picture Option Grid DA that included a prompt to discuss relative treatment costs, hereafter called “cost prompt group”; (2) a text-only Option Grid DA that did not include cost information; (3) usual care. Groups 2 and 3 hereafter are referred to as “non-cost prompt groups.” Adult (18+) female patients, with stages I-IIIA breast cancer, eligible for both breast-conserving surgery and mastectomy were included. We gave surgeons feedback about adherence to the study protocol at 3, 6, and 12-months. We adapted a checklist to code the content of the audio-recorded clinical encounters. Results. 424/622 (68%) patients consented; 311 (73%) were eligible and successfully recorded (143 in the cost prompt group, 168 in the non-cost prompt groups). Costs were discussed in 132/311 (42.4%) encounters, and occurred more often in the cost prompt versus non-cost prompt groups (66.7% versus 33.3%; p<.001). Surgeons initiated the cost discussion in 86.4% of encounters in the cost prompt group vs. 34.1% in the non-cost prompt groups (p<0.001). In the non-cost prompt groups, insurance or employment questions led patients to ask about costs. Cost discussions lasted about 34 seconds when present and had sparse comparative details. Conclusions. Encounter DAs containing cost information trigger cost discussions. Additional support should help clinicians improve the quality of cost discussions and address financial distress.

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Lawson, Lovett, Mohammed A. Yassin, Alex N. Onuoha, Andrew Ramsay, Rachel R. M. Anderson de Cuevas, Sally Theobald, Peter D. O. Davies, and Luis E. Cuevas. "Yield of Smear Microscopy and Radiological Findings of Male and Female Patients with Tuberculosis in Abuja, Nigeria." Tuberculosis Research and Treatment 2010 (2010): 1–5. http://dx.doi.org/10.1155/2010/241659.

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Objective. To describe the yield of smear-microscopy and radiological findings by male and female patients with symptoms of tuberculosis in Abuja, Nigeria.Methods. Patients ≥15 years old with cough for >3 weeks submitted 3 sputum samples for smear microscopy. One specimen was cultured using MGIT-960. All patients had lung X-rays and screened for HIV.Results. were more likely to be smear-positive than females (262/774 [34%] and 137/547 [25%],P<.01), but similar proportions of males and females were culture-positive (437/691 [63%] and 294/495 [59%],P=.09). 317/626 (50.6%) males and 249/419 (59.4%) females were HIV-positive (P<.005). Among culture-positives patients, HIV-infected males were less likely to have positive smears than HIV-negative males (49.2% versus 66%,P=.001). Among females, smear positivity did not vary with HIV (46.4% for HIV-positive and 52.9% for HIV-negative,P=.38). Of 274 culture-confirmed TB cases, 226 (82.5%) had cavities, and 271 (99%) had ≥1 lung areas affected. HIV-positive males were more likely to have lung cavities than HIV-positive females (85% versus 69%,P<.04) and to have ≥3 lung areas affected (P=.03).Conclusion. Differences in the yield of smear-microscopy, culture and X-rays on presentation are due to several factors including HIV coinfection and gender.

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Powles, J., J. Wiseman, D. J. A. Cole, and B. Hardy. "Effect of chemical structure of fats upon their apparent digestible energy value when given to growing/finishing pigs." Animal Science 57, no. 1 (August 1993): 137–46. http://dx.doi.org/10.1017/s000335610000670x.

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AbstractFour metabolism trials were conducted. Trials 1 and 2 (Tl, T2) investigated degree of saturation of fats (ratio of unsaturated to saturated fatty acids, U/S) on digestible energy (DE) content. Fats evaluated were rape oil (RO) and tallow (T) for Tl (U/S 15·67 and 0·97 respectively) and RO and palm oil (PO) for T2 (U/S 15·33 and 0·85 respectively). Three fats of intermediary U/S for each trial were produced by blending the two fats in proportions to give U/S of 3·18,2·08 and 1·49 in both trials. Trials 3 and 4 (T3, T4) investigated the effect of free fatty acid (FFA) content of fats on DE value. Fats were soya-bean oil (SO) and soya-bean acid oil (SAO) for T3 (FFA 6·2 and 626·0 g/kg respectively) and T and tallow acid oil (TAO) for T4 (FFA 44·3 and 818·2 g/kg fat respectively). Three fats of intermediary FFA for each trial were formed by blending the two fats in the ratios of 72:25, 50: 50 and 25: 75 in both trials. The FFA content of the blends were 161·2, 316·1 and 471·1 g/kg fat for T3 and 237·8, 431·3 and 624·7 g/kg fat for T4. All trials evaluated five fats by substitution, at 40, 80 and 120 g/kg into a basal diet, in a cross-over design, with 16 gilts of 25 kg initial live weight evaluating 16 diets over four time periods. Diets were offered for 10 days followed by a 5-day collection period using the marker to marker technique. Fat content of food and faeces, with methodology based on acid hydrolysis, allowed calculation of apparent digestible fat (AFD) of experimental diets. Analysis of variance gave effects of fats (P < 0·001 for Tl, T3 and T4 and P = 0·014 for T2), rates of inclusion (P < 0·001 for all trials), and fats × rates (P > 0·05, P > 0·05, P < 0·001, P < 0·01 for T1, T2, T3 and T4 respectively). Extrapolation of the function obtained by regressing AFD of diets (y) on rate of inclusion of fat (x) to × = 1000 generated values for the fats. The product of the coefficient of apparent fat digestibility of fats and their respective gross energies gave DE values for fats which were MJ/kg: T1 RO = 35·8 and T = 31·2; T2 RO = 36·7 and PO = 33·1; T3 SO = 374 and SAO = 32·8 and T4 T = 33·8 and TAO = 28·9. Data for fat blends intermediary between the two fats showed that DE improved exponentially as a function of U/S and that DE declined linearly with increasing FFA content.

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Cho, Sung-Hyun, Hyo-Jin Lee, Osama R. Aldhafian, and Yang-Soo Kim. "Comparison of Lateralized Versus Medialized Reverse Total Shoulder Arthroplasty: A Systematic Review and Meta-analysis." Orthopaedic Journal of Sports Medicine 10, no. 1 (January 1, 2022): 232596712110639. http://dx.doi.org/10.1177/23259671211063922.

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Background: Reverse total shoulder arthroplasty (rTSA) is an established procedure for cuff tear arthropathy. More lateralized prostheses have been designed to overcome the reported adverse outcomes of Grammont-style rTSA. Purpose: To compare the clinical and radiological outcomes of medialized and lateralized center of rotation (COR) in rTSA. Study Design: Systematic review; Level of evidence, 3. Methods: This review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Included were studies with a level of evidence ≥3 that compared medialized and lateralized rTSA with a minimum follow-up of 12 months. Functional scores including the American Shoulder and Elbow Surgeons (ASES) score and Constant score (CSS), range of motion at final follow-up, gain of external rotation (ER), visual analog scale (VAS) pain score, scapular notching, and heterotopic ossification (HO) were compared. Data were analyzed using random-effects or fixed-effects models in accordance with heterogeneity. Results: Five retrospective cohort studies and 1 randomized controlled study (n = 594 patients) were included. Lateralized rTSA resulted in greater improvement in ER degree ( P < .001), a lower VAS pain score (standardized mean difference [SMD], –0.39; P = .002), and a lower rate of scapular notching (risk ratio [RR], 0.40; P < .001) and HO (RR, 0.52; P < .001). Final forward flexion (SMD, –0.14; P = .629) and ER (SMD, 0.21; P = .238) did not differ significantly between the 2 groups. Overall functional scores, including ASES score (SMD, 0.22; P = .310) and CSS (SMD, 0.37; P = .077), also did not differ significantly (SMD, 0.28; P = .062). The overall complication rate did not differ significantly between the 2 groups (RR, 0.71; P = .339). Conclusion: Compared with medialized rTSA, lateralized COR rTSA results in greater improvement in ER and the VAS pain score, decreased rates of scapular notching and HO, and no significant changes in functional outcome scores or the complication rate.

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Sharma, Om P., Michael F. Oswanski, Rusin J. Joseph, Peter Tonui, Libby Westrick Pa-C, Shekhar S. Raj, Thomas Tatchell, Phillip J. Waite, and Angela Gandaio. "Venous Thromboembolism in Trauma Patients." American Surgeon 73, no. 11 (November 2007): 1173–80. http://dx.doi.org/10.1177/000313480707301121.

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Serial venous duplex scans (VDS) were done in 507 trauma patients with at least one risk factor (RF) for venous thromboembolism (VTE) during a 2-year study period. Deep vein thrombosis (DVT) was detected in 31 (6.1%) patients. This incidence was 3.1 per cent in low (1–2 RFs), 3.4 per cent in moderate (3–5 RFs), and 7.7 per cent in high (≥6 RFs) VTE scores ( P = 0.172). Incidence was statistically different (3% vs 7.2%, P = 0.048) on reanalyzing patients in two risk categories, low-risk (1–4 RFs) and high-risk (≥5 RFs). Only 4 of 16 RFs had statistically higher incidence of DVT in patients with or without RFs: previous VTE (27.3% vs 5.6%, odds ratio (OR) 6.628, P = 0.024), spinal cord injury (22.6% vs 5%, OR 5.493, P = 0.001), pelvic fractures (11.4% vs 5.1%, OR 2.373, P = 0.042), and head injury with a greater than two Abbreviated Injury Score (10.5% vs 4.2%, OR 2.639, P = 0.014). On reanalyzing patients with ≥5 RFs vs <5RFs, obesity (14.3 vs 6.1%, P = 0.007), malignancy (5.6% vs 0.6%, P = 0.006), coagulopathy (10.8% vs 1.8%, P = 0.000), and previous VTE (3.2% vs 0%, P = 0.019) were significant on univariate analysis. Patients with DVT had 3.70 ± 1.75 RFs and a 9.61 ± 4.93 VTE score, whereas, patients without DVT had 2.66 ± 1.50 RFs and a 6.83 ± 3.91 VTE score ( P = 0.000). DVTs had a direct positive relationship with higher VTE scores, length of stay, and number of VDS (>1 r, P ≤ 0.001). Increasing age was a weak risk factor (0.03 r, P = 0.5). First two VDS diagnosed 77 per cent of DVTs. Patients with injury severity score of ≥15 and 25 had higher DVTs compared with the ones with lower injury severity score levels ( P ≤ 0.05). Pulmonary embolism was silent in 63 per cent and DVTs were asymptomatic in 68 per cent.

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Bignami, Elena, Marcello Guarnieri, Marina Pieri, Francesco De Simone, Alcira Rodriguez, Luigi Cassarà, Rosalba Lembo, Giovanni Landoni, and Alberto Zangrillo. "Volatile anaesthetics added to cardiopulmonary bypass are associated with reduced cardiac troponin." Perfusion 32, no. 7 (April 11, 2017): 547–53. http://dx.doi.org/10.1177/0267659117701562.

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Background: Every year, over 1 million cardiac surgical procedures are performed all over the world. Reducing myocardial necrosis could have strong implications in postoperative clinical outcomes. Volatile anaesthetics have cardiac protective properties in the perioperative period of cardiac surgery. However, little data exists on the administration of volatile agents during cardiopulmonary bypass. The aim of this study was to assess if volatile anaesthetics administration during cardiopulmonary bypass reduces cardiac troponin release after cardiac surgery. Materials and methods: We retrospectively analysed data from 942 patients who underwent cardiac surgery in a teaching hospital. The only difference between the groups was the management of anaesthesia during CPB. The volatile group received sevoflurane or desflurane while the control group received a combination of propofol infusion and fentanyl boluses. Patients who received volatile anaesthetics during cardiopulmonary bypass (n=314) were propensity-matched 1:2 with patients who did not receive volatile anaesthetics during CPB (n=628). Results: We found a reduction in peak postoperative troponin I, from 7.8 ng/ml (4.8-13.1) in the non-volatile group to 6.8 ng/ml (3.7-11.8) in the volatile group (p=0.013), with no differences in mortality [2 (0.6%) in the volatile group and 2 (0.3%) in the non-volatile group (p=0.6)]. Conclusions: Adding volatile anaesthetics during cardiopulmonary bypass was associated with reduced peak postoperative troponin levels. Larger studies are required to confirm our data and to assess the effect of volatile agents on survival.

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Tirupathi, Raghavendra, Ruth Freshman, Norma Montoy, and Melissa Gross. "786. Diagnostic stewardship of C difficile PCR testing with two step algorithm- A rural community hospital experience." Open Forum Infectious Diseases 7, Supplement_1 (October 1, 2020): S437—S438. http://dx.doi.org/10.1093/ofid/ofaa439.976.

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Abstract Background An estimated 15% of hospitalized patients are asymptomatic carriers of C. diff. Inappropriate testing can lead to over diagnosis, treatment, isolation & substantial financial penalties. Ours is a rural 310 bed hospital with nurse driven C. diff test ordering protocol. Due to inadvertent test ordering, we had an uptick in the HO-CDI incidence with rates as high as 0.94 per 1000 patient days in 2017. In order to streamline testing, we initiated an infection preventionist(IP) led diagnostic stewardship program which was implemented in two phases in 2017-2019 Methods The phase 1 involved daily review by IPs regarding the legitimacy of PCR order for minimum 3 loose stools in 24 hours, use of laxatives, presence of symptoms.There were concerns nationally that then CDI risk adjustment model from NHSN in 2017 does not optimally account for the impact of specific CDI testing methods used by individual hospitals on CDI SIRs. Hence, in Jan 2018 NHSN’s MDRO/CDI Protocol stated “Results of the final test that are placed in the patient’s medical record should be used to determine whether event meets the CDI LabID defn”.This led to phase 2 in mar 2019 which involved two step testing which started with C diff PCR assay with positive test reflexed to the toxin A/B assay. Results During the first phase, and a full year of the protocol in 2018, the number of completed PCR tests decreased to 626 (compared to 940 PCR tests in 2016) with an 34% decrease. In the year following implementation of the Diagnostic Stewardship, HO CDI decreased from 60 in 2017 to 43 events in 2018 with a reduction of 28%. Subsequently, HO CDI further decreased in 2019 to 28 with a reduction of 35%. Since the start of the project in 2017, HO CDI have decreased 54% in total. The reduction in 314 C diff PCR tests in the first year[2017-2018] led to a savings of $8300 in lab supplies. No readmissions with C difficile infection documented within 30 days on patients who did not meet the criterion for testing. Significant decrease in the usage of C difficile antibiotics. After the start of the two step test, we have seen a precipitous drop in our HO-CDI rates to less than 0.3 per 1000 pt days by the end of 2019. Quarterly comparison of HO CDI incidence for 2017-2020 HO CDI incidence before and following phase 1 and phase 2 interventions C. difficile antibiotic use trends during intervention period Conclusion IP run diagnostic stewardship programs with two step tests are highly successful in streamlining testing and in discriminating infection from colonization Disclosures All Authors: No reported disclosures

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McQuellon, R. P., G. B. Russell, M. T. Jesse, C. R. Thomas, and Y. Keung. "Factors associated with long-term survival following stem cell transplantation (SCT) for non-Hodgkin lymphoma." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 18504. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.18504.

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18504 Background: Psychosocial variables have been associated with survival in stem cell transplantation recipients. The purpose of this study was to examine the relationship between clinical, psychosocial, and demographic variables and long-term survival. Methods: Autologous SCT recipients with NHL (n=315) from 1/92 - 4/05 (mean age = 51.6 yrs (±12); 35% F; 7% AA; median survival/follow-up = 4.4/ 6.1 yrs) completed the Center for Epidemiologic Studies-Depression Scale, Functional Assessment of Cancer Therapy- BMT (FACT-BMT; physical well-being, PWB), Profile of Mood States, and the Medical Outcomes Study Social Support Survey (MOS-SS) prior to transplantation. Clinical and demographic data were abstracted from the patient’s record. Cox’s proportional hazards regression models were used to assess the effect of the following variables on survival: clinical - histological subtypes (HS) [anaplastic large cell (ALC), diffuse large B-cell (DLBC), mantle cell (MC), indolent, and aggressive], grade, stage, type of conditioning regimen (TC), chemosensitivity (CS), number of chemotherapy regimens (1–7) prior to SCT (NCR); demographic - age, race, gender; and psychosocial - depressed mood, general distress, quality of life, and social support. Measures with a univariate p-value <0.2 were fit in a backwards stepwise regression; remaining variables had a p-value < 0.05. Results: The included univariate model variables (p-values) were: HS (0.0004), grade (0.004), TC (0.14), CS (0.0001), NCR (0.02), PWB (0.03), FACT-BMT subscale (0.16), SS-Emotional (0.05), SS-affection (0.13). In the regression model, predictors of survival were: HS (<0.0001), median survival = ALC 1.9, DLBC 2.7, aggressive 3.3, MC 5.1, indolent 8.4 yrs; CS (0.008); NCR (0.03), and PWB(0.03). Conclusions: Clinical variables were the most predictive of survival. Psychosocial variables were not associated with survival. No significant financial relationships to disclose.

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Takeuchi, Tsutomu, Hisashi Yamanaka, Naoki Ishiguro, Nobuyuki Miyasaka, Masaya Mukai, Tsukasa Matsubara, Shoji Uchida, et al. "Adalimumab, a human anti-TNF monoclonal antibody, outcome study for the prevention of joint damage in Japanese patients with early rheumatoid arthritis: the HOPEFUL 1 study." Annals of the Rheumatic Diseases 73, no. 3 (January 11, 2013): 536–43. http://dx.doi.org/10.1136/annrheumdis-2012-202433.

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ObjectivesTo evaluate the efficacy and safety of adalimumab+methotrexate (MTX) in Japanese patients with early rheumatoid arthritis (RA) who had not previously received MTX or biologics.MethodsThis randomised, double-blind, placebo-controlled, multicentre study evaluated adalimumab 40 mg every other week+MTX 6–8 mg every week versus MTX 6–8 mg every week alone for 26 weeks in patients with RA (≤2-year duration). The primary endpoint was inhibition of radiographic progression (change (Δ) from baseline in modified total Sharp score (mTSS)) at week 26.ResultsA total of 171 patients received adalimumab+MTX (mean dose, 6.2±0.8 mg/week) and 163 patients received MTX alone (mean dose, 6.6±0.6 mg/week, p<0.001). The mean RA duration was 0.3 years and 315 (94.3%) had high disease activity (DAS28>5.1). Adalimumab+MTX significantly inhibited radiographic progression at week 26 versus MTX alone (ΔmTSS, 1.5±6.1 vs 2.4±3.2, respectively; p<0.001). Significantly more patients in the adalimumab+MTX group (62.0%) did not show radiographic progression (ΔmTSS≤0.5) versus the MTX alone group (35.4%; p<0.001). Patients treated with adalimumab+MTX were significantly more likely to achieve American College of Rheumatology responses and achieve clinical remission, using various definitions, at 26 weeks versus MTX alone. Combination therapy was well tolerated, and no new safety signals were observed.ConclusionsAdalimumab in combination with low-dose MTX was well tolerated and efficacious in suppressing radiographic progression and improving clinical outcomes in Japanese patients with early RA and high disease activity.

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Manca, Maria Elena, Maria Lucia Manunta, Antonio Spezzigu, Laura Torres-Rovira, Antonio Gonzalez-Bulnes, Valeria Pasciu, Peter Piu, et al. "Melatonin deprival modifies follicular and corpus luteal growth dynamics in a sheep model." REPRODUCTION 147, no. 6 (June 2014): 885–95. http://dx.doi.org/10.1530/rep-13-0405.

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This study assessed the effect of melatonin deprival on ovarian status and function in sheep. Experimental procedures were carried out within two consecutive breeding seasons. Animals were divided into two groups: pinealectomised (n=6) and sham-operated (n=6). The completeness of the pineal gland removal was confirmed by the plasma concentration of melatonin. Ovarian status was monitored by ovarian ultrasonography for 1 year to study reproductive seasonality. Follicular and corpus luteal growth dynamics were assessed during an induced oestrous cycle. As the effects of melatonin on the ovary may also be mediated by its antioxidant properties, plasma Trolox equivalent antioxidant capacity (TEAC) was determined monthly for 1 year. Pinealectomy significantly extended the breeding season (310±24.7 vs 217.5±24.7 days in controls;P<0.05). Both pinealectomised and sham-operated ewes showed a well-defined wave-like pattern of follicle dynamics; however, melatonin deficiency caused fewer waves during the oestrous cycle (4.3±0.2 vs 5.2±0.2;P<0.05), because waves were 1 day longer when compared with the controls (7.2±0.3 vs 6.1±0.3;P<0.05). The mean area of the corpora lutea (105.4±5.9 vs 65.4±5.9 mm2;P<0.05) and plasma progesterone levels (7.1±0.7 vs 4.9±0.6 ng/ml;P<0.05) were significantly higher in sham-operated ewes compared with pinealectomised ewes. In addition, TEAC values were significantly lower in pinealectomised ewes compared with control ones. These data suggest that melatonin, besides exerting its well-known role in the synchronisation of seasonal reproductive fluctuations, influences the growth pattern of the follicles and the steroidogenic capacity of the corpus luteum.Free Italian abstractAn Italian translation of this abstract is freely available athttp://www.reproduction-online.org/content/147/6/885/suppl/DC1.

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Liu, Lijuan, Jeremy P. Richards, Robert A. Creaser, S. Andrew DuFrane, Karlis Muehlenbachs, and Peter B. Larson. "Geology and age of the Morrison porphyry Cu–Au–Mo deposit, Babine Lake area, British Columbia." Canadian Journal of Earth Sciences 53, no. 9 (September 2016): 950–78. http://dx.doi.org/10.1139/cjes-2015-0231.

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The Morrison porphyry Cu–Au–Mo deposit is genetically and spatially related to Eocene plagioclase–hornblende–biotite porphyry intrusions. One porphyry intrusion yielded a U–Pb age of 52.54 ± 1.05 Ma. Mineralization occurs in three stages: (1) vein-type and disseminated chalcopyrite and minor bornite (associated with potassic alteration and gold mineralization); (2) vein-type molybdenite (associated with weak phyllic alteration); and (3) polymetallic sulfide–carbonate veins (dolomite ± quartz–sphalerite–galena–arsenopyrite–chalcopyrite, associated with weak sericite–carbonate alteration). Re–Os dating of molybdenite yielded ages of 52.54 ± 0.22 and 53.06 ± 0.22 Ma, similar to the age of the host porphyry intrusion. Stage 1 vein fluids were predominantly of magmatic origin: Th = 400–526 °C; salinity = 39.8–47.8 wt.% NaCl equiv.; δ18Ofluid = 3.7‰–6.3‰; disseminated chalcopyrite–pyrite δ34SCDT = 0.2‰ and −0.8‰ (CDT, Canyon Diablo Troilite). Stage 2 fluids were a mixture of magmatic and meteoric water: Th = 320–421 °C; salinity = 37.0–43.1 wt.% NaCl equiv.; δ18Ofluid values range from 0.3‰ to 3.4‰; molybdenite and pyrite δ34SCDT = −2.1‰ and −1.2‰. Stage 3 fluids were predominantly of meteoric water origin: Th = 163–218 °C; salinity = 3.1–3.9 wt.% NaCl equiv.; δ18Ofluid = −2.3‰ to 3.9‰ for early vein quartz, and 1.1‰ to 6.1‰ for late vein dolomite; sphalerite and pyrite δ34SCDT = −7.1‰ to −5.6‰. Morrison is interpreted to be a typical porphyry Cu–Au–Mo deposit related to a calc-alkaline to a high-K calc-alkaline diorite to granodiorite intrusive suite, generated in a continental arc in response to early Eocene subduction of the Kula–Farallon plate beneath North America.

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Corazza, Gino R., Giuseppe Benati, Antonio Di Sario, Carlo Tarozzi, Alessandra Strocchi, Mario Passeri, and Giovanni Gasbarrini. "Lactose intolerance and bone mass in postmenopausal Italian women." British Journal of Nutrition 73, no. 3 (March 1995): 479–87. http://dx.doi.org/10.1079/bjn19950050.

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Previous studies on the role of lactose malabsorption in the pathogenesis of postmenopausal osteoporosis have yielded conflicting results and further information is needed. To date, all studies have been carried out on populations with a low prevalence of lactose malabsorption and the lactose intestinal absorptive capacity was tested using a non-physiological dose of lactose. In fifty-eight Italian postmenopausal women (mean age 57 (SD 7) years), bone mineral density (BMD) at lumbar spine, H2breath response after ingestion of 20 g lactose, intensity of symptoms of intolerance after a lactose load and daily Ca intake were evaluated. No differences were found between women with or without a positive H2, breath test with regard to BMD (−1·2 (SD 0·9) ν −0·9 (SD 0·8)) and Ca intake (509 (SD 266) ν 511 (SD 313) mg/d). On the contrary, both BMD and Ca intake were significantly lower in women with lactose malabsorption and symptoms of intolerance (−1·5 (SD 0·7) and 378 (SD 220) mg/d) than in those with malabsorption without symptoms (−0·9 (SD 0·9) and 624 (SD 254) mg/d). Moreover, in lactose malabsorbers Ca intake was correlated inversely with symptom score (rs−0·31,P<0·05) and positively with BMD (rs0·42,P<0·005). Our results show that in Italian postmenopausal women Ca intake and BMD are not influenced directly by lactose malabsorption; the appearance of symptoms of intolerance seems to influence BMD unfavourably through a reduced Ca intake.

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Abu-Khalaf, Maysa, Fnu Nikita, Ayako Shimada, Hannah Hackbart, Dina Alnabulsi, Scott Keith, Ana Maria Lopez, and Meghan Butryn. "Abstract P4-11-32: Change in body mass index in breast cancer survivors." Cancer Research 82, no. 4_Supplement (February 15, 2022): P4–11–32—P4–11–32. http://dx.doi.org/10.1158/1538-7445.sabcs21-p4-11-32.

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Abstract Background: Obesity is associated with an increased risk of breast cancer recurrence and poor survival. Obesity rate in adults in the city of Philadelphia is high, with non-Hispanic blacks and Hispanics having the highest rates. We sought to evaluate changes in body mass index (BMI) in breast cancer survivors within the first 2 years from initial encounter for a breast cancer (BC) diagnosis (dx), and investigate factors that may correlate with a change in BMI. Methods: We identified 5,423 BC patients (pts) in our electronic medical record, (1/2015-present), using ICD-10 code C50.X. We then selected pts with BMI values at the three-time points: baseline, 1 year and 2 year intervals from baseline. The closest BMI value before the 1st encounter within 6 months prior to BC dx was considered as the baseline BMI. BMI at 1 year +/- 3 months after the BC dx was considered 1-year interval BMI. BMI at 2 years +/- 6 months after the BC dx was considered 2-year interval BMI. Subjects needed baseline BMI and at least 1 year or 2 year follow-up BMI for inclusion. After all BMI exclusions, 630 pts were included in the study cohort. We used a mixed effects model to predict BMI changes as a linear function of association with time, sex, race and ethnicity, age at BC dx, baseline BMI, treatments (i.e., chemotherapy [CT], endocrine therapy [ET], or immunotherapy [IO] and the interaction of race and ethnicity and treatment in estimating mean change of BMI. The significance level of all tests was set a priori to the 0.05 level. Results: The mean age at BC dx was 61 years; pts identified were mostly white, non-Hispanic/Caucasian (55%), or Black/African American (AA) (34%). By BMI category, we did not observe any substantial difference in the mean age at BC dx and gender distribution (p = 0.81 for age and p = 0.86 for gender). However, the distributions of race and ethnicity differed among BMI categories (p < .01) where the percentage of Black/AA pts was high in the BMI ≥ 30 category. Black/AA pts receiving IO were likely to have BMI change (decrease) compare to white non-Hispanic pts with similar conditions. Black/AA pts receiving no treatment or non IO-treatment were more likely to change BMI (increased, 95% CI: 0.22, 1.03) after BC dx compared to white, non-Hispanic pts. Interestingly, Black/AA pts receiving IO tended to change BMI (decreased) compared to Black/AA pts not receiving IO. Conclusion: We observed the interaction effect of race/ethnicity and treatment on BMI change in BC survivors within 2 years after a BC dx, with Black/AA pts more likely to have an increase in BMI. Table 1.Descriptive Statistics Summary, n = 630.VariableALL (n=630)BMI ≤ 24.9 (n=160, 25%)25 ≤ BMI ≤ 29.9 (n=180, 29%)BMI ≥ 30 (n=290, 46%)p-valueAge at 1st Encounter with BC dx, mean (SD)61.8 (11.8)62.1 (12.5)62.1 (12.1)61.5 (11.2)0.808Sex, n (%)Female625 (99.2)159 (99.4)178 (98.9)288 (99.3)0.857Male5 (0.8)1 (0.6)2 (1.1)2 (0.7)Race & Ethnicity, n (%)White/Caucasian348 (55.2)103 (64.4)106 (58.9)139 (47.9)<.001Black/AA215 (34.1)35 (21.9)48 (26.7)132 (45.5)Hispanic/Latino20 (3.2)5 (3.1)5 (2.8)10 (3.4)Asian/Pacific Islander39 (6.2)17 (10.6)18 (10.0)4 (1.4)American Indian/Alaskan Native2 (0.3)0 (0.0)0 (0.0)2 (0.7)Unknown6 (1.0)0 (0.0)3 (1.7)3 (1.0)BMI (baseline), mean (SD)29.9 (7.1)22.2 (2.0)27.1 (1.4)35.9 (5.7)<.001Treatment (Yes) , n (%)HistoricalCT2 (0.3)1 (0.6)1 (0.6)0 (0.0)0.294ET35 (5.6)7 (4.4)12 (6.7)16 (5.5)0.663IO4 (0.6)2 (1.3)1 (0.6)1 (0.3)0.487BaselineCT20 (3.2)4 (2.5)7 (3.9)9 (3.1)0.815ET54 (8.6)16 (10.0)15 (8.3)23 (7.9)0.742IO11 (1.7)5 (3.1)2 (1.1)4 (1.4)0.3111 yearCT154 (24.4)41 (25.6)42 (23.3)71 (24.5)0.886ET309 (49.0)73 (45.6)93 (51.7)143 (49.3)0.535IO29 (4.6)10 (6.3)8 (4.4)11 (3.8)0.4892 yearsCT71 (11.3)20 (12.5)15 (8.3)36 (12.4)0.337ET231 (36.7)50 (31.3)73 (40.6)108 (37.2)0.198IO32 (5.1)7 (4.4)4 (2.2)21 (7.2)0.051 Citation Format: Maysa Abu-Khalaf, Fnu Nikita, Ayako Shimada, Hannah Hackbart, Dina Alnabulsi, Scott Keith, Ana Maria Lopez, Meghan Butryn. Change in body mass index in breast cancer survivors [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-11-32.

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Smolen, J. S., T. Korotaeva, M. Nurmohamed, S. Siebert, P. Bergmans, K. De Vlam, E. Gremese, et al. "AB0530 EFFECT OF SKIN SYMPTOMS ON DISEASE IMPACT IN PATIENTS WITH PSORIATIC ARTHRITIS RECEIVING THE IL-12/23 INHIBITOR USTEKINUMAB OR TNF INHIBITORS IN THE REAL-WORLD PSABIO STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1295–96. http://dx.doi.org/10.1136/annrheumdis-2021-eular.767.

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Background:Psoriatic arthritis (PsA) is characterised by musculoskeletal symptoms, and patients (pts) with PsA usually experience psoriasis concurrently. Real-world data reflecting impact of skin symptoms on PsA disease burden are limited.Objectives:Analyse effectiveness of ustekinumab (UST) and tumour necrosis factor inhibitor (TNFi) therapy on extent of skin involvement, and the impact this has on PsA disease burden and drug persistence.Methods:PsABio (NCT02627768) is a prospective, observational study of 1st/2nd/3rd-line UST or TNFi treatment in PsA in 8 European countries. Extent of skin involvement was categorised as body surface area (BSA): clear/almost clear; <3% but not clear/almost clear; 3–10%; or >10%. Pt-reported disease impact was evaluated by PsAID-12, including assessment of two skin-related domains (D): D3 (skin problems, including itching) and D10 (embarrassment and/or shame because of appearance). Estimated persistence at 1 year was assessed across baseline (BL) BSA categories.Results:At BL, significantly more pts receiving UST than TNFi had BSA >10% (Figure 1). BL disease impact (PsAID-12) was worse in pts with BSA >10% than <3% in D3, D10 and total (non-overlapping 95% CIs suggest significance) (Table 1). BSA improved from BL to 1 year with both treatments. At 1 year, 64% of pts in both groups had clear/almost clear skin and only 3% had BSA >10% (Figure 1). At 1 year, both treatments significantly reduced disease impact (PsAID-12 total), and D3 and D10 scores, irrespective of BL BSA category, but most markedly in pts with higher BL BSA (Table 1). Worse BL psoriasis was generally associated with longer persistence for both treatments; however, at 1 year, pts with BSA >10% had significantly shorter persistence with TNFi (mean [95% CI]: 361 [336; 387] days) than with UST (410 [394; 426] days).Conclusion:In PsA, interleukin-12/23 inhibition (UST) and TNFi therapy in routine care rapidly and substantially reduced extent of skin involvement and related disease impact. Pts with highest BL skin involvement had significantly longer drug persistence with UST than with TNFi. Together, PsABio data suggest that successful treatment of skin involvement in PsA with biologics reduces disease burden and may improve persistence, especially in pts with worse BL psoriasis.Figure 1Table 1.PsAID-12 scores at BL and change from BL scores at 6 months and 1 year, by BL BSA categoryMean (95% CI)Domain 3(skin problems, including itching)Domain 10(embarrassment and/orshame because of appearance)Total PsAID-12USTTNFiUSTTNFiUSTTNFiPsAID-12 score at BL by BL BSA <3%4.2 (3.7; 4.8)3.1 (2.7; 3.6)3.9 (3.3; 4.4)3.1(2.6; 3.6)5.7(5.3; 6.0)5.0 (4.6; 5.3) 3–10%6.4 (5.9; 6.8)5.8 (5.3; 6.3)4.1 (3.5; 4.7)4.5 (3.9; 5.1)5.4 (5.1; 5.8)5.8 (5.4; 6.1) >10%7.9 (7.5; 8.3)6.7 (6.0; 7.5)6.1 (5.4; 6.8)5.8 (4.8; 6.8)6.2 (5.7; 6.6)6.1 (5.6; 6.7)Change from BL in PsAID-12 score at 6 months by BL BSA <3%-1.5 (-2.1; -0.9)-0.8 (-1.3; -0.3)-1.5 (-2.0; -0.9)-1.2 (-1.6; -0.7)-1.6 (-2.0; -1.2)-1.9 (-2.2; -1.5) 3–10%-3.2 (-3.8; -2.7)-2.4 (-3.0; -1.9)-1.9 (-2.5; -1.3)-2.0 (-2.5; -1.5)-2.0 (-2.4; -1.6)-2.4 (-2.8; -2.0) >10%-4.2 (-4.9; -3.6)-2.5 (-3.2; -1.9)-2.9 (-3.5; -2.2)-1.6 (-2.4; -0.8)-2.4 (-2.8; -2.0)-2.2 (-2.7; -1.7)Change from BL in PsAID-12 score at 1 year (LOCF) by BL BSA <3%-1.5 (-2.1; -0.9)-0.8 (-1.3; -0.3)-1.6 (-2.2; -1.1)-1.2 (-1.7; -0.7)-1.6 (-2.0; -1.2)-1.9 (-2.3; -1.5) 3–10%-3.5 (-4.0; -2.9)-3.2(-3.7; -2.7)-2.0 (-2.6; -1.4)-2.5 (-3.0; -2.0)-2.2 (-2.6; -1.7)-3.0 (-3.4; -2.6) >10%-4.9 (-5.5; -4.3)-3.1 (-4.0; -2.3)-3.5 (-4.2; -2.8)-2.7 (-3.7; -1.8)-2.9 (-3.4; -2.4)-2.9 (-3.5; -2.2)PsAID-12 total score ≤4 is considered a patient-acceptable symptom state.BL, baseline; BSA, body surface area; CI, confidence interval; LOCF, last observation carried forward; PsAID-12, 12-item Psoriatic Arthritis Impact of Disease questionnaire; TNFi, tumour necrosis factor inhibitor; UST, ustekinumabAcknowledgements:This study was funded by Janssen.Disclosure of Interests:Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis- Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Grant/research support from: AbbVie, AstraZeneca, Lilly, Novartis, Roche, Tatiana Korotaeva Speakers bureau: AbbVie, Amgen, Biocad, Janssen, Lilly, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Consultant of: AbbVie, Amgen, Biocad, Janssen, Lilly, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Grant/research support from: Pfizer, Michael Nurmohamed Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Stefan Siebert Speakers bureau: AbbVie, Amgen (previously Celgene), Biogen, Janssen, Novartis, UCB, Consultant of: AbbVie, Janssen, UCB, Grant/research support from: Amgen (previously Celgene), Boehringer Ingelheim, Bristol-Myers Squibb, GSK, Janssen, Novartis, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson & Johnson, Employee of: Janssen, Kurt de Vlam Speakers bureau: AbbVie, Amgen, Eli Lilly, Novartis, UCB, Paid instructor for: Amgen, Galapagos, UCB, Consultant of: Eli Lilly, Galapagos, Johnson & Johnson, Novartis, UCB, Grant/research support from: Celgene, Elisa Gremese: None declared., Beatriz Joven-Ibáñez Speakers bureau: AbbVie, Celgene, Janssen, Novartis, MSD, Pfizer, Wim Noel Employee of: Janssen, Petros Sfikakis Consultant of: AbbVie, Actelion, Boehringer Ingelheim, Enorasis, Farmaserv-Lilly, Genesis, Gilead, MSD, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Faran, Janssen, Pfizer, Roche, Elke Theander Employee of: Janssen, Laure Gossec Consultant of: AbbVie, Amgen, Bioepis, Biogen, Bristol-Myers Squibb, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi.

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Penna, Domenico, Maura Nicolosi, Mythri Mudireddy, Natasha Szuber, Rangit Vallapureddy, Terra L. Lasho, Christy Finke, et al. "20+ Years and Alive with Primary Myelofibrosis: Phenotypic Signature of Very Long-Lived Patients." Blood 132, Supplement 1 (November 29, 2018): 4301. http://dx.doi.org/10.1182/blood-2018-99-109718.

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Abstract Background: Current prognostication in primary myelofibrosis (PMF) utilizes MIPSS70 (mutation-enhanced international prognostic scoring system for transplant-age patients), MIPSS70+ version 2.0 (karyotype-enhanced MIPSS70) and GIPSS (genetically-inspired prognostic scoring system, which is based on mutations and karyotype) (JCO 2018;36:310; JCO doi: 10.1200/JCO.2018.78.9867; Leukemia. 2018;doi:10.1038/s41375-018-0107). These contemporary models are inter-complimentary and highly efficient in predicting overall survival. However, specific risk factors for very long survival (e.g. 20+ years) and short-term mortality (i.e. death within 5 years of diagnosis) have not been systematically looked into. Methods: Study patients were recruited from the Mayo Clinic, Rochester, MN, USA. Diagnoses were according to the 2016 World Health Organization criteria (Blood. 2016;127:2391). Logistic regression statistics was used to identify predictors of 20-year survival and 5-year mortality. Variables evaluated in the logistic model included those that are currently listed in MIPSS70, MIPSS70+ version 2.0 and GIPSS, as well as age (≤70 vs >70 years) and sex. Receiver operating characteristic (ROC) curves and area under the curve (AUC) were used to estimate predictive accuracy. The JMP® Pro 13.0.0 software from SAS Institute, Cary, NC, USA, was used for all calculations. Results: A total of 1,282 consecutive patients with PMF (median age 65 years, range 19-92; 63% males) were used to identify 26 (2%) patients (median age 51 years, range 28-71; 38% males) who survived their disease for at least 20 years (very long-lived patients) and 626 (49%) patients (median age 68 years, range 27-92; 66% males) who died within 5 years of their diagnosis. Clinically-derived information, including the clinical variables used in MIPSS70 and MIPSS70+ version 2.0, with the exception of fibrosis grade (information available in 60%), was available in 99% of the study population; cytogenetic information was available in 94%, driver mutational status in 71% and the full profile of high molecular risk (HMR) mutations, including ASXL1, SRSF2, U2AF1 Q157, EZH2, IDH1 and IDH2, in 42%. MIPSS70+ version 2.0 risk distribution for the entire study population (n=1,282) was 4% very low risk, 16% low risk, 19% intermediate risk, 40% high risk and 21% very high risk; the corresponding percentages for the 26 very long-lived patients were 14%, 29%, 14%, 43% and 0% and for the 626 short-term survivors were 0%, 4%, 10%, 47% and 39% (p<0.001). Cytogenetic, driver mutation and HMR mutation information was available in 100%, 58% and 27% of the 26 long-term survivors, respectively, and 98%, 63% and 39% of the 626 short-term survivors. Multivariable logistic regression analysis of 20-year survival identified the following seven variables as being favorable: age ≤70 years (p=0.002); female sex (p=0.03); hemoglobin level ≥10 g/dl for women and ≥11 g/dl for men (p=0.03), leukocyte count ≤25 x 109/l (p=0.009), platelet count ≥100 x 109/l (p=0.002), circulating blasts ≤1% (p=0.03) and absence of constitutional symptoms (p=0.04). The particular phenotypic profile exhibited a high degree of predictive accuracy with an estimated AUC of 0.90 (Figure 1a); karyotype and mutations did not retain significance in this particular analysis; in fact, 5 (71%) of the 7 long-term survivors who were informative harbored at least one HMR mutation. A similar analysis for 5-year mortality identified the following risk factors: high molecular risk mutations (p<0.001); unfavorable or very high risk karyotype (p<0.001); absence of type 1/like CALR mutations (p<0.001); age >70 years (p<0.001); constitutional symptoms (p<0.001); hemoglobin level <10 g/dl for women and <11 g/dl for men (p<0.001); leukocyte count >25 x 109/l (p=0.004); and circulating blasts >1% (p=0.001); predictive accuracy was estimated at AUC 0.87 (Figure 1b). Conclusions: The phenotypic profile of long-lived patients in PMF includes young age (≤70 years old), female sex, asymptomatic disease (i.e. no constitutional symptoms) and absence of moderate to severe anemia, thrombocytopenia or leukocytosis and ≤1% circulating blasts; each one of these parameters, with the exception of female sex, were present in ≥80% of long-term survivors. Karyotype and mutations were more relevant in predicting short-term mortality. Disclosures No relevant conflicts of interest to declare.

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Sidana, Surbhi, Nidhi Tandon, Angela Dispenzieri, Morie A. Gertz, Francis Buadi, Martha Lacy, David Dingli, et al. "Factors predicting organ response in light chain amyloidosis (AL)." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 8048. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.8048.

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8048 Background: Organ response (OR) in AL is often delayed and difficult to predict early. Methods: We retrospectively analyzed 1308 patients (pts) with newly diagnosed AL from 2006 – 2015 to determine factors which could predict for OR. Results: Median age was 64 years (yr) and Mayo Stage was: 1 (22%); 2 (23%); 3 (25%); 4 (31%). Organ involvement was: cardiac (74%, n=932); renal (59%, n=738), liver (16%, n=205); gut (24%, n=310) and autonomic (12%, n=152). 59% (n=765) had > 1 organ involved, including 43% (n=567) with > 1 critical organ (heart, kidney, liver) involved. Treatment was: ASCT based (28%, n=330, N=1186), bortezomib based (24%, n=281), alkylator based (33%, n=392), others (5%, n=54) and none (10%). In evaluable pts, VGPR or better rates were: 53% at 6 months (m) (N=625), 72% at 12 m (N=465) and 57% overall (N=688). Table 1 lists OR at various time points. Complete OR in all involved critical organs was seen in: 51% (n=308, N=600), partial response (at least 1 OR when >1 organ involved) in 12% (n=73) and none in 37% (n=219). Complete OR was associated with better overall survival (OS) than partial or no OR (median OS: not reached vs 42 m vs 29 m; P <0.0001). In multivariate model the following variables at baseline or 1 yr mark were predictive of complete OR: lower Mayo Stage (p=0.01), fewer critical organs involved (p=0.007), higher baseline GFR (p=0.03), female sex (Complete OR 60% vs 47%; p=0.04) and VGPR at 1 yr (Complete OR 70% vs. 36%; p <0.0001). Other factors included in the model were age (p=0.9), bilirubin (p=0.1) and transplant (p=0.2). All aforementioned factors were significant in univariate analysis. Conclusions: Achievement of response in all involved critical organs is associated with better survival in AL pts than partial or no OR. Various baseline factors and VGPR at 1 yr can predict for achieving complete OR, with 70% pts who achieve VGPR at 1 yr having a complete OR. [Table: see text]

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Eisingerné Balassa, Boglárka, Tímea Csákvári, and István Ágoston. "Az egészségbiztosítási gyógyszerkiadások alakulása Magyarországon." Orvosi Hetilap 160, Supplement 1 (February 2019): 49–54. http://dx.doi.org/10.1556/650.2019.31394.

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Introduction: In Hungary, health expenditures – especially the question of health insurance subsidies for medicinal products – are becoming increasingly important. Aim: The aim of our analysis is to reveal the state’s health insurance expenditure between 2010 and 2016 as well as the amount of health insurance subsidies for medicinal products. Data and methods: Data were derived from the database of the National Health Insurance Fund of Hungary and of the Hungarian Central Statistical Office. During the analysis we examined the period between 2010 and 2016. We analysed the health expenditures in proportion to the gross domestic product (GDP) as well as the changes of drug traffic based on gross consumer prices and those of health insurance subsidies, and also our regional inequalities. When writing the present study, we used descriptive statistical methods. Results: The expenditures of the National Health Insurance Fund of Hungary significantly increased as proportions of the GDP from 5.5% in 2010 to 6.1% in 2016. The health insurance subsidies for medicinal products increased since 2013. The highest health insurance subsidies per 10 000 inhabitants could be seen in Baranya (405 788 HUF/inhabitant) and Csongrád (384 724 HUF/inhabitant) counties and in Budapest (377 316 HUF/inhabitant). The lowest health insurance subsidies were found in Nógrád (289 168 HUF/inhabitant) and Szabolcs-Szatmár-Bereg (271 104 HUF/inhabitant) counties. Conclusion: The trends of health and drug expenditure show a growing tendency. We can find significant regional inequalities in case of both the drug traffic based on gross consumer prices and the health insurance subsidies. It would be needed to strengthen the elements of prevention, and to popularize health-conscious lifestyle and doing sports. Orv Hetil. 2019; 160(Suppl 1): 49–54.

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MELLOR, GLEN E., NARELLE FEGAN, LESLEY L. DUFFY, KATE E. McMILLAN, DAVID JORDAN, and ROBERT S. BARLOW. "National Survey of Shiga Toxin–Producing Escherichia coli Serotypes O26, O45, O103, O111, O121, O145, and O157 in Australian Beef Cattle Feces." Journal of Food Protection 79, no. 11 (November 1, 2016): 1868–74. http://dx.doi.org/10.4315/0362-028x.jfp-15-507.

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ABSTRACT Escherichia coli O157 and six non-O157 Shiga toxin–producing E. coli (STEC) serotypes (O26, O45, O103, O111, O121, and O145, colloquially referred to as the “big 6”) have been classified as adulterants of raw nonintact beef products in the United States. While beef cattle are a known reservoir for the prototype STEC serotype, E. coli O157, less is known about the dissemination of non-O157 STEC serotypes in Australian cattle. In the present study, 1,500 fecal samples were collected at slaughter from adult (n =628) and young (n =286) beef cattle, adult (n =128) and young (n =143) dairy cattle, and veal calves (n = 315) across 31 Australian export-registered processing establishments. Fecal samples were enriched and tested for E. coli O157 and the big 6 STEC serotypes using BAX System PCR and immunomagnetic separation methods. Pathogenic STEC (pSTEC; isolates that possess stx, eae, and an O antigen marker for O157 or a big 6 serotype) were isolated from 115 samples (7.7%), of which 100 (6.7%) contained E. coli O157 and 19 (1.3%) contained a big 6 serotype. Four of the 115 samples contained multiple pSTEC serotypes. Among samples confirmed for big 6 pSTEC, 15 (1%) contained E. coli O26 and 4 (0.3%) contained E. coli O111. pSTEC of serotypes O45, O103, O121, and O145 were not isolated from any sample, even though genes indicative of E. coli belonging to these serotypes were detected by PCR. Analysis of animal classes revealed a higher pSTEC prevalence in younger animals, including veal (12.7%), young beef (9.8%), and young dairy (7.0%), than in adult animals, including adult beef (5.1%) and adult dairy (3.9%). This study is the largest of its kind undertaken in Australia. In contrast to E. coli O157 and consistent with previous findings, this study reports a relatively low prevalence of big 6 pSTEC serotypes in Australian cattle populations.

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Foti, R., G. Cardinale, L. Costa, F. Franceschini, F. Ciccia, A. Marchesoni, G. Guggino, et al. "AB0488 SPONDYLOARTHRITIS DISEASE BURDEN AS PERCEIVED BY PATIENTS: BASELINE PATIENT-REPORTED OUTCOME DATA FROM THE ITALIAN PROSPECTIVE SIRENA STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1271–72. http://dx.doi.org/10.1136/annrheumdis-2021-eular.624.

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Background:Previous studies have compared Patient-Reported Outcomes (PROs) in Spondyloarthritis (SpA); a recent one has found similarity in Psoriatic Arthritis (PsA) and axial patients1.Objectives:To describe PROs at SpA diagnosis (new or confirmed), by type of SpA and by gender.Methods:SIRENA is an Italian, prospective Registry of SpA patients diagnosed according to ASAS criteria and naïve to any DMARDs. At inclusion, patients were classified as predominant axial (AxSpA) or mainly peripheral (pSpA). PROs showed in the Table 1 were collected and analysed descriptively.Table 1.PhGA and PROs at diagnosis*AxSpA*pSpAAll(n=123)Women(n=64)Men(n=58)All(n=227)Women(n=109)Men(n=118)PhGA, n1156054222105117mean (SD)50.2 (28.6)54.8 (26.7)45.0 (30.1)45.4 (25.9)49.9 (25.6)41.3 (25.6)median (min, max)52.0 (0-100)62.0 (0-100)43.5 (0-100)48.5 (0-100)50.0 (1.0-100)40.0 (0-95.0)PtGA, n1125952209102107mean (SD)56.4 (27.8)61.5 (25.8)50.3 (29.2)50.3 (26.2)56.4 (23.1)44.5 (27.7)median (min, max)63.0 (0-100)70.0 (2.0-100)50.0 (0-100)50.0 (0-100)58.5 (7.0-100)47.0 (0-100)Pain VAS score, n1136052207101106mean (SD)56.7 (28.3)61.1 (26.6)50.6 (29.1)51.9 (26.8)57.4 (25.3)46.8 (27.3)median (min, max)60.0 (0-100)69.5 (2.0-100)50.0 (0-100)53.0 (0-100)61.0 (0-100)48.5 (0-100)Sleep VAS score, n1136052211103108mean (SD)55.3 (29.3)57.4 (29.5)52.3 (29.2)44.0 (30.1)50.4 (29.8)37.9 (29.2)median (min, max)59.0 (0-100)61.5 (0-100)53.0 (0-100)44.0 (0-100)53.0 (0-100)34.0 (0-100)BASFI, n11058511336568mean (SD)4.6 (2.8)5.2 (2.6)3.9 (2.8)3.5 (2.6)4.0 (2.6)3.1 (2.4)median (min, max)5.1 (0-9.7)5.8 (0-9.4)3.6 (0-9.6)2.9 (0-10.0)3.9 (0-10.0)2.45 (0-8.9)BASDAI, n11259521397069mean (SD)5.2 (2.4)5.8 (2.3)4.5 (2.3)5.2 (2.3)5.8 (2.1)4.6 (2.3)median (min, max)5.5 (0-9.3)6.2 (0-9.3)4.5 (0.3-9.2)5.5 (0.2-10.0)6.1 (1.0-10.0)4.8 (0.2-9.2)HAQ-DI score, n109585020399104mean (SD)0.9 (0.7)1.1 (0.7)0.6 (0.6)0.7 (0.7)0.9 (0.7)0.6 (0.6)median (min, max)0.8 (0.0-2.5)1.1 (0-2.5)0.5 (0-2.3)0.6 (0.0-2.8)0.8 (0-2.8)0.4 (0-2.6)WPAI% work time missed, n4919301074562mean (SD)7.3 (21.4)4.2 (9.5)9.2 (26.3)8.8 (24.7)8.6 (25.6)8.9 (24.3)median (min, max)0 (0-100)0 (0-35.1)0 (0-100)0 (0-100)0 (0-100)0 (0-100)% impairment at work, n6733341346173mean (SD)48.2 (31.9)58.5 (26.6)38.2 (33.7)39.7 (31.4)45.4 (30.9)34.9 (31.2)median (min, max)50.0 (0-100)60.0 (0-100)25.0 (0-100)40.0 (0-100)50.0 (0-100)30.0 (0-100)% overall work impairment, n4819291064561mean (SD)44.1 (33.0)52.4 (27.9)38.7 (35.3)40.1 (33.0)45.1 (33.1)36.4 (32.7)median (min, max)45.0 (0-100)60.0 (0-100)20.0 (0-100)40.0 (0-100)50.0 (0-100)30.0 (0-100)% activity impairment, n10053461839390mean (SD)56.7 (28.6)63.4 (23.9)48.0 (31.0)48.5 (30.3)55.3 (28.7)41.4 (30.4)median (min, max)60.0 (0-100)70.0 (0-100)50.0 (0-100)50.0 (0-100)60.0 (0-100)40.0 (0-100)* The sum does not add up to the total because of some missing values.Results:From 23 sites, 123 AxSpA and 227 pSpA patients were analysed. Diagnosis was new in 58% of AxSpA and 77% of pSpA. 85.5% of the pSpA had PsA, while in AxSpA the most frequent type was Ankylosing Spondylitis (48.8%). Time from symptom onset to diagnosis was higher in AxSpA than in pSpA (median 36 vs 24 months, respectively). At inclusion, composite disease activity measures showed high disease activity for AxSpA (mean ASDAS-CRP 3.1) and moderate disease activity for pSpA (mean DAS28 3.6; mean DAPSA 22.5). AxSpA patients had numerically worse values than pSpA in all the PROs collected, except for BASDAI score that was similar (mean 5.2). For both AxSpA and pSpA, all PROs were worse in women than men, except for the % of work time missed. PtGA scores were higher than PhGA, in each group and gender.Conclusion:At diagnosis, SpA patients perceive a slightly higher disease burden than assessed by Physicians. For PROs other than BASDAI, AxSpA reported a worse impact than pSpA. Overall, women showed a higher disease impact than men.References:[1]Michelsen B. et al. PLoS ONE 2015; 10(4): e0123582.Disclosure of Interests:Rosario Foti Speakers bureau: Speaker bureau honoraria from Eli Lilly, Sanofi, MSD, Janssen, AbbVie, Bristol-Myers Squibb, Celgene, Roche, Consultant of: Consultancy fees from Eli Lilly, Sanofi, MSD, Janssen, AbbVie, BMS, Celgene, Roche, Gabriella Cardinale: None declared., Luisa Costa: None declared., Franco Franceschini: None declared., Francesco Ciccia Speakers bureau: Speaker bureau honoraria from AbbVie, Abiogen, Bristol-Myers Squibb, Celgene, Janssen, Eli Lilly, Pfizer, Novartis, Roche, Consultant of: Consultancy fees from Novartis, Pfizer, Janssen, Eli Lilly, Roche, Celgene, Grant/research support from: Grant/research support from Pfizer, Novartis, Celgene, Janssen, Roche, Antonio Marchesoni: None declared., Giuliana Guggino Speakers bureau: Speaker bureau honoraria from Celgene, Sandoz, Pfizer, Grant/research support from: Grant/research support from Pfizer, Celgene, Maurizio Rossini: None declared., Ennio Lubrano Di Scorpaniello: None declared., Bruno Frediani: None declared., Maria Sole Chimenti: None declared., Gerolamo Bianchi: None declared., Giuseppe Galfo: None declared., Silvia Marelli Employee of: Employee of Janssen-Cilag SpA Italy, Ennio Favalli Speakers bureau: Consulting fees and/or speaking engagements from AbbVie, Bristol-Myers Squibb, Lilly, Merck Sharp & Dohme, Pfizer, Galapagos, Sanofi-Genzyme, and UCB.

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Appleman, Daniel E., Howard T. Evans, Gordon L. Nord, Edward J. Dwornik, and Charles Milton. "Delindeite titanosilicates and lourenswalsite, two new from the Magnet Cove region, Arkansas." Mineralogical Magazine 51, no. 361 (September 1987): 417–25. http://dx.doi.org/10.1180/minmag.1987.051.361.08.

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AbstractDelindeite and lourenswalsite are two new barium titanosilicate minerals found as microscopic crystals in miarolitic cavities in nepheline syenite in the Diamond Jo quarry, Hot Spring County, Arkansas. Delindeite is found as aggregates of flake-like crystallites in compact spherules, light pinkish grey in colour, with a resinous, pearly lustre. The flakes are biaxial positive with average n ∼ 1.813; the measured density is 3.3 g/cm3. Electron diffraction revealed a monoclinic unit cell in space group C2/m or subgroup, with a = 21.617(13), b = 6.816(5), c = 5.383(3) Å, β = 94.03(5)° (refined from X-ray powder data). The strongest X-ray lines are (hkl, dobs, Irel): (200, 10.80, 100); (311, 3.54, 24); (6̄01, 3.083, 28); (601, 2.888, 31); (2̄21, 2.806, 20); (910, 2.262,18). The crystals are submicroscopically twinned on (100) and also produce additional continuous diffraction streaks parallel to a*, which double the b and c axes. The formula derived from electron and ion probe analyses (H2O by difference), as constrained by density and molar volume data, is approximately (Na,K)2.7(Ba,Ca)4(Ti,Fe,Al)6Si8O26(OH)14, with Na > K, Ba ≫ Ca, Ti ≫ Fe,Al; Z = 1. Lourenswalsite occurs as very thin hexagonal plates in rosettes, silver grey to light brownish grey in colour. The crystals are biaxial negative with very low 2V angle. Indices of refraction are nα = 1.815, nβ ≈ nγ = 1.840; the measured density is 3.17 g/cm = 1.840; the measured density is 3.17 g/cm3. X-ray and electron diffraction show a sharp pseudohexagonal lattice with a = 5.244 Å, but extremely diffuse diffraction streaks normal to the hk0 plane. In these streaks a period of 20.5 Å can be discerned. A hexagonal unit cell with a = 5.244(2) Å, c = 20.49(3) Å can be refined from the powder diffraction data but does not account for some lines, probably because of extreme layer disorder as shown by precession single-crystal patterns. The strong X-ray powder lines are (002, 10.22, 20); (-, 3.93, 20); (111, 2.608, 100); (300, 1.5145, 80); (220, 1.3111, 25). The formula given by microprobe analyses, constrained by density and molar volume data, is approximately (K,Ba)2(Ti,Mg,Ca,Fe)4(Si,Al,Fe)6O14(OH)12 with K > Ba, Ti ≫ (Mg,Ca,Fe), Si > Al > Fe; Z = 1. These minerals are formed under oxidizing weathering conditions, and iron is assumed to be in the Fe3+ state.

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Lam, Siu W., Steffen M. de Groot, Aafke H. Honkoop, Nienke M. Nota, A. Jager, Ankie M. T. van der Velden, Monique M. E. M. Bos, et al. "Plasma VEGF-a, angiopoietin-2 (ANG2) and soluble(s)TIE2 in patients (pts) with HER2-negative locally recurrent or metastatic breast cancer (LR/MBC) treated with first-line bevacizumab (A) and paclitaxel (T) without or with capecitabine (X)." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): 1072. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.1072.

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1072 Background: In the randomized phase II ATX trial, pts with HER2-negative LR/MBC were treated with first-line AT or ATX. We determined the prognostic value for outcome of VEGF-A, ANG2 and sTIE2 measured at baseline on cycle 1 day 1 (C1D1) and after cycle 1 (C2D1). Methods: 312 pts were randomized in 1:1 ratio to AT (T 90 mg/m2 on d1, 8, 15 and A 10 mg/kg on d1, 15 q4w x 6 cycles, followed by A 15 mg/kg on d1 q3w for next cycles) or ATX (T 90 mg/m2 on d1, 8, A 15 mg/kg on d1 and X 825 mg/m2bid on d1–14 q3w x 8 cycles, followed by the same dose of A and X q3w for next cycles). The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR), response duration (RD), overall survival (OS) and safety. Plasma proteins on C1D1 (N = 173) and on C2D1 (N = 142) were measured by ELISA. The association of protein levels (continuous variable) with PFS and OS was evaluated by Cox proportional hazards model and Martingale residual plot. Results: At a median follow-up of 39 months (mo), there were 292 PFS events and 242 deaths. ATX significantly improved PFS as compared to AT (median 11 vs. 8.4 mo, stratified HR = 0.52; 95% CI, 0.41 – 0.67; P < .001). The confirmed ORR in measurable disease (N = 268) was 67% in ATX vs. 50% in AT. Median RD was 6.4 mo (95% CI, 6.1 – 8.3) in ATX v 5.4 mo (95% CI, 5.1 – 6.0) in AT. Median OS was 24.1 mo in ATX vs. 23.1 mo in AT (P= .44). The aselected ‘biomarker’ cohort (N = 173) and overall trial cohort had similar baseline characteristics. ANG2 on C1D1 moderately correlated with sTIE2 on C1D1 (Pearson’s r = .44, P < .001). High ANG2 on C1D1 was significantly associated with poor OS (HR = 1.6; 95% CI, 1.1 – 2.3; P = .01), but not with poor PFS (HR = 1.3; 95% CI, 1.0 – 1.3; P = .07). ANG2 on C2D1 was not significantly associated with OS (HR = 1.55; 95% CI, 0.99 – 2.4; P = .057) or with PFS (P= .6). sTIE2 and VEGF-A were not associated with outcome. All pts had very low levels of free VEGF-A on C2D1 (median 8 pg/ml). Conclusions: In HER2-negative LR/MBC, ATX is more effective (PFS, ORR and RD) than AT. A very high plasma level of ANG2 at baseline indicates a high risk for poor survival. Clinical trial information: NTR1348.

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De Miguel, E., J. Gratacos-Masmitja, A. P. Cacheda, J. M. Rodríguez-Heredia, A. Gallego, E. Beltrán, B. Font Ramos, C. Sastré, and C. Sanabra. "POS0978 DISEASE CONTROL IN PSORIATIC ARTHRITIS PATIENTS WITH OR WITHOUT AXIAL MANIFESTATIONS IN REAL CLINICAL PRACTICE IN SPAIN: RESULTS FROM THE MIDAS STUDY." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 755.2–756. http://dx.doi.org/10.1136/annrheumdis-2021-eular.2041.

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Background:MIDAS study assessed the disease activity in psoriatic arthritis (PsA) patients treated in clinical practice in Spain.Objectives:This sub-analysis compared disease activity between PsA patients with or without axial manifestations.Methods:MIDAS is an observational, non-interventional, cross-sectional, multicenter study conducted in Spain. Patients included were ≥18 years old with ≥6 months since diagnosis, were classified by CASPAR criteria and had initiated treatment ≥3 months. Disease activity was measured by Disease Activity in Psoriatic Arthritis (DAPSA) and Minimal Disease Activity (MDA). Axial involvement was defined according to the presence of inflammatory back pain assessed by rheumatologist.Results:312 evaluable PsA patients were included in this analysis, 12.2% of which presented with axial involvement. PsA patients with axial manifestations reported longer time from onset of symptoms to diagnosis and disease duration, higher presence of concomitant diseases, HLA-B*27+ status, C-reactive protein (CRP) levels, perception of uncontrolled disease and presence of swollen and tender joints compared to patients without axial involvement. A higher proportion of PsA patients with axial manifestations were treated with a biologic compared with those without axial involvement 68.4% vs 57.3% (Table 1). Patients with axial involvement showed a higher impairment of their quality of life compared to those without axial manifestations by a worse higher mean (SD) Psoriatic Arthritis Impact of Disease 12-item questionnaire (PSAID12) score (5.0 [2.4] vs 2.7 [2.2], respectively). In terms of disease control more patients with axial manifestations presented with moderate to high disease activity (DAPSA>14: 65.7% vs 36.8%, respectively) and did not meet the MDA criteria for remission (89.5% vs 42.7%, respectively) (Figure 1).Conclusion:PsA patients with axial manifestations presented with a higher burden of disease and showed a worse disease control compared to those without axial involvement.Table 1.Baseline demographic and clinical characteristicsWith axial manifestations(n=38)Without axial manifestations (n=274)PsA(n=312)Age (years), mean (SD)53.1 (10.4)54.1 (12.4)54.0 (12.2)Sex (male), n (%)17 (44.7%)153 (55.8%)170 (54.5%)Time since diagnosis (years), mean (SD)13.6 (10.1)10.1 (8.8)10.5 (9.0)Time from onset of symptoms to diagnosis (years), mean (SD)4.3 (6.1)2.8 (4.8)3.0 (5.0)Presence of concomitant diseases, mean (SD)26 (68.4%)166 (60.6%)192 (61.5%)Anemia, n (%)3 (7.9%)7 (2.6%)7 (2.2%)Anxiety, n (%)6 (15.8%)9 (3.3%)1 (0.3%)Asthma, n (%)2 (5.3%)7 (2.6%)1 (0.3%)Depression, n (%)6 (15.8%)1 (0.4%)1 (0.3%)Dyslipidemia, n (%)3 (7.9%)8 (2.9%)9 (2.9%)Hypertension, n (%)3 (7.9%)7 (2.6%)9 (2.9%)Others (excluding skin psoriasis, uveitis, or IBD), n (%)3 (7.9%)17 (6.2%)19 (6.1%)Presence of HLA-B*27+, n (%)6 (15.8%)28 (10.2%)34 (10.9%)CRP levels (mg/l), mean (SD)7.3 (11.3)4.6 (6.5)4.9 (7.3)Patient perceived disease control (PASS), n (%)30 (78.9%)228 (83.5%)258 (83.0%)Presence of swollen (SJC≥1), n (%)22 (57.9%)117 (42.7%)139 (44.6%)Presence of tender joints (TJC≥1), n (%)14 (36.8%)74 (27.0%)88 (28.2%)Patients treated with biological26 (68.4%)157 (57.3%)183 (58.7%)COPD, chronic obstructive pulmonary disease; CRP, C-reactive protein; HLA-B*27, human leukocyte antigen B27; IBD, inflammatory bowel disease; PASS, patient acceptable symptom state; PsA, psoriatic arthritis; SD, standard deviation; SJC, swollen joint counts; TJC, tender joint counts.Figure 1.Disease status according to clinical phenotype of PSA A) Disease activity according to DAPSA B) Disease activity according to MDA DAPSA, Disease Activity in Psoriatic Arthritis; MDA, Minimal Disease Activity; PsA, psoriatic arthritis.Acknowledgements:We thank to MIDAS group investigators and patients included in the study.Disclosure of Interests:Eugenio de Miguel Speakers bureau: AbbVie, Novartis, Pfizer, MSD, BMS, UCB, Roche, Grunental, Janssen, Sanofi., Paid instructor for: Janssen, Novartis, Roche, Consultant of: AbbVie, Novartis, Pfizer, Galapagos, Grant/research support from: Abbvie, Novartis, Pfizer, Jordi Gratacos-Masmitja Speakers bureau: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Lilly and Amgen., Consultant of: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen Cilag, Novartis, Lilly and Amgen., Grant/research support from: During the course of the year I have received a private grand from Pfizer.I have not received any private influence in the elaboration of the contents of this talk., Ana Paula Cacheda: None declared, José M. Rodríguez-Heredia Speakers bureau: Amgen, Novartis, Sanofi, Consultant of: Amgen, Biogen, Fresenius, MSD, Janssen, Roche, Novartis, Pfizer, Sanofi, Adela Gallego Speakers bureau: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen, Novartis, Lilly, Amgen and Sanofi.I have not received any private influence in the elaboration of the contents of this talk., Grant/research support from: During the course of the year I have received funding in relation to courses and / or conferences, and / or have participated as a speaker or in advisory boards from: MSD, Pfizer, AbbVie, Janssen, Novartis, Lilly, Amgen and Sanofi.I have not received any private influence in the elaboration of the contents of this talk., Emma Beltrán Speakers bureau: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Consultant of: Abbvie, Bristol, Celgene, Janssen, Lilly, MSD, Novartis, Pfizer, Roche and UCB, Beatriz Font Ramos Employee of: Novartis employee, Carlos Sastré Employee of: Novartis employee, Cristina Sanabra Employee of: Novartis employee.

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Shin, SeongHoon, Eduardo Bruera, David Hui, Jung Hye Kwon, Gary B. Chisholm, Maria Teresa San-Miguel, Julio Allo, Sriram Yennurajalingam, and Susan Frisbee-Hume. "Characteristics and outcomes of patients admitted to the acute palliative care unit (APUC) from the emergency center (EC) versus inpatient transfers (IP)." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e20581-e20581. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e20581.

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e20581 Background: Most patients admitted to APCU are transferred from inpatient oncology units. We hypothesized that EC admissions have different symptom burden and outcomes compared to IP patients. In this retrospective cohort study, we compared the symptom burden and survival between the EC and IP groups. Methods: Among all 2,568 patients admitted to our APCU between September 1, 2003 and August 31, 2008, 312 (12%) were EC patients. We randomly selected 298 IP patients as controls. We retrieved the patient demographics, cancer diagnosis, Edmonton Symptom Assessment Scale (ESAS), discharge outcomes, and overall survival from time of admission. Results: EC patients were more like to be black (22% v 11%, p=0.0006) and less likely to have hematologic cancer (5% v 14%, p=0.0003). EC patients had higher pain (5.4 v 4.6, p=0.0004), fatigue (6.7 v 6.1, p=0.0049), nausea (2.7 v 1.6, p<0.0001), insomnia (4.8 v 4.2, p=0.03) and were less likely to be delirious (41% v 55%, p=0.001). EC patients had more public insurance (44% v 38%, p=0.0142), more home discharge (29% v 11%, p=0.0001), longer admission (8 v 7 days, p=0.0002), and were 2.3x as likely to be discharged alive as compared to IP patients (p<0.0001, Wald Chi-square test). Kaplan-Meier plots and log-rank test for survival from admission of APCU for EC and IP groups were not statistically significant (Median survival after admission were 34 v 31 days, p=0.08). In multivariate analysis, EC admission (OR= 1.9, 1.2-3.0), wellbeing (OR=1.12, 1.02-1.23), dyspnea (OR=0.85, 0.79-0.92) and delirium (OR=0.39, 0.24-0.64) were independently significant for being discharge alive. The c-statistic value was 0.71. Conclusions: EC patients have higher acute symptom burden, but more likely to be discharged alive as compared to IP transfer patients. The APCU is successful at managing symptoms and facilitating discharge to the community for EC patients. [Table: see text]

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Plasse, Richard A., Stephen W. Olson, Christina M. Yuan, Lawrence Y. Agodoa, Kevin C. Abbott, and Robert Nee. "Prophylactic or Early Use of Eculizumab and Graft Survival in Kidney Transplant Recipients With Atypical Hemolytic Uremic Syndrome in the United States: Research Letter." Canadian Journal of Kidney Health and Disease 8 (January 2021): 205435812110037. http://dx.doi.org/10.1177/20543581211003763.

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Introduction: Among kidney transplant recipients (KTRs) with end-stage kidney disease (ESKD) due to atypical hemolytic uremic syndrome (aHUS), recurrence is associated with poor allograft outcomes. We compared graft and patient survival of aHUS KTRs with and without prophylactic/early use of eculizumab, a monoclonal antibody that binds complement protein C5, at the time of transplantation. Methods: We conducted a retrospective cohort study using the United States Renal Data System. Out of 123 624 ESKD patients transplanted between January 1, 2008, and June 1, 2016, we identified 348 (0.28%) patients who had “hemolytic uremic syndrome” as the primary cause of ESKD. We then linked these patients to datasets containing the Healthcare Common Procedure Coding System (HCPCS) code for eculizumab infusion. Patients who received eculizumab prior to or within 30 days of transplant represented the exposure group. We calculated crude incidence rates and conducted exact logistic regression, adjusted for recipient age and sex, for the study outcomes of graft loss, death-censored graft loss, and mortality. We also estimated the average treatment effect (ATE) by propensity-score matching, to reduce the bias in the estimated treatment effect on graft loss. Results: Our final study cohort included 335 aHUS KTRs (23 received eculizumab, 312 did not), with a mean duration of follow-up of 5.8 ± 2.7 years. There were no significant differences in baseline demographic and clinical characteristics between the eculizumab versus non-eculizumab group. Patients who received prophylactic/early eculizumab were less likely to experience graft loss compared with those who did not receive eculizumab (0% vs 20%, P = .02), with an adjusted odds ratio of 0.13 ( P = .02). In the propensity-score-matched sample, the ATE (eculizumab vs non-eculizumab) was −0.20 (95% confidence interval [CI] = −0.25 to −0.15, P < .001); thus, treatment was associated with an average of 20% reduction in graft loss. There was no significant difference in the risk of death between the 2 groups. Conclusions: Although there was no significant difference in the risk of death, prophylactic/early use of eculizumab was significantly associated with improved graft survival among aHUS KTRs. Given the high cost of eculizumab, randomized controlled trials are much needed to guide prophylactic strategies to prevent graft loss.

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Gogate, Anagha, Amanda Crosbie, Trong Kim Le, Ying Zhang, Rolee Das, and Catherine Davis. "Abstract P3-12-15: Clinical characteristics, treatment patterns, and survival outcomes in women with early triple-negative (TN) or hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2−) breast cancer (BC) in the real-world (RW) setting." Cancer Research 82, no. 4_Supplement (February 15, 2022): P3–12–15—P3–12–15. http://dx.doi.org/10.1158/1538-7445.sabcs21-p3-12-15.

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Abstract Background: BC remains the most commonly diagnosed cancer for women. TNBC is an aggressive form with a poorer prognosis compared with other subtypes. Neoadjuvant therapy (NAT) is the standard-of-care approach to shrink tumors in the breast and axilla and to improve patient outcomes. Few RW studies exist of US patients with early BC (eBC); this study aimed to describe clinical parameters by receipt of systemic therapy and to assess overall survival (OS) and progression-free survival (PFS) after NAT and adjuvant therapy (AT) in women with early HR+/HER2− or TNBC using RW evidence in the US. Methods: This retrospective observational study used the Flatiron Health nationwide electronic health record-derived de-identified database, including women ([pts], age ≥18 years) diagnosed with early HR+/HER2− BC or TNBC between 01/01/2011 and 05/31/2018. The primary outcome was to describe pt demographics, clinical characteristics, and treatment patterns. Secondary outcomes included OS and PFS. Results: Of the pts identified for inclusion (N = 5,299), 13.3% (n = 707) were diagnosed with early TNBC and 86.7% (n = 4,592) with HR+/HER2− eBC, of whom 34.7% (n = 245) and 10.9% (n = 502), respectively, did not receive systemic therapy (Table). Systemically treated pts with TNBC vs HR+/HER2− tended to be younger (59.0 years vs 64.0 years); were represented by a higher proportion of Black women (18.0% vs 7.2%); had a greater proportion presenting with invasive ductal carcinoma (IDC) (91.6% vs 78.2%); had a higher proportion with progression to metastasis (19.0% vs 5.7%) and presented with a more aggressive disease (Grade 3) at diagnosis (79.0% vs 18.4%). Most pts (98.4%) received surgery, predominantly breast-conserving surgery (BCS; unilateral lumpectomy: 62.8%); however, 17.8% received bilateral mastectomies. Overall, 9.1% of pts received NAT. More pts with TNBC vs HR+/HER2− received NAT (34.0% vs 7.9%) and achieved a pathologic complete response (pCR; 36.3% vs 6.2%). Consistent with treatment guidelines, pts with TNBC were treated with chemotherapy (CT)-doublet or single-agent regimens and pts with HR+/HER2− received hormone and CT-based regimens. Duration of NAT was similar for both subtypes (3.3 months) but was shorter for AT in pts with TNBC vs HR+/HER2− (3.4 vs 38.2 months). From initial diagnosis, the 36-month survival probability [standard error] was lower for systemically treated pts with TNBC vs HR+/HER2− (85.7% [1.8%] vs 95.6% [0.3%]) and from start of therapy by line setting (NAT: 80.6% [3.5%] vs 91.9% [1.7%]; AT: 84.7% [2.2%] vs 95.8% [0.4%]). Similarly, the 36-month PFS probability was lower for pts with TNBC vs HR+/HER2− from diagnosis (77.9% [2.1%] vs 93.3% [0.4%]) and from start of therapy by line setting (NAT: 68.7% [4.1%] vs 85.2% [2.1%]; AT: 79.5% [2.5%] vs 93.5% [0.4%]). Conclusion: This analysis of US RWE further confirms early TNBC to be a particularly aggressive form of BC, with poorer survival compared with pts with HR+/HER2− eBC. While these RW data indicate BCS is becoming more routine, almost one-fifth of pts still receive bilateral mastectomies. Overall, these data confirm there remains a high unmet need to reduce the need for aggressive treatments while further improving outcomes in pts with early TNBC and HR+/HER2− BC. Table: Patient demographics, clinical characteristics, OS and PFSPatient selection criteriaNumber of patients, n (%)SubgroupsEarly HR+/HER2− BC4,592 (86.7)Patients who received systemic therapy4,090 (89.1)Early TNBC707 (13.3)Patients who received systemic therapy462 (65.3)All patients [1] (N = 5,299), n (%)Systemically treated patients with early HR+/HER2− BC (n = 4,090), n (%)Systemically treated patients with early TNBC (n = 462), n (%)Patient demographicsMedian age (years)64.064.059.0RaceBlack or African American449 (8.5)294 (7.2)83 (18.0)White3,602 (68.0)2,835 (69.3)283 (61.3)Asian139 (2.6)111 (2.7)9 (1.9)Hispanic or Latino15 (0.3)12 (0.3)1 (0.2)Clinical characteristicsHistology at initial diagnosisIDC4,222 (79.7)3,197 (78.2)423 (91.6)ILC684 (12.9)612 (15.0)7 (1.5)Infiltrating ductal mixed and infiltrating lobular mixed132 (2.5)108 (2.6)3 (0.6)Mucinous adenocarcinoma97 (1.8)88 (2.2)0 (0.0)Other [2]122 (2.3)63 (1.5)26 (5.6)Unknown/ND42 (0.8)22 (0.5)3 (0.6)Tumor grade at initial diagnosisGrade 11,350 (25.5)1,161 (28.4)5 (1.1)Grade 22,462 (46.5)2,098 (51.3)88 (19.0)Grade 31,374 (25.9)752 (18.4)365 (79.0)Unknown/ND113 (2.1)79 (1.9)4 (0.9)Surgery at initial diagnosisYes5,215 (98.4)4,032 (98.6)450 (97.4)Surgery type [3]Unilateral lumpectomy3,277 (62.8)2,568 (63.7)241 (53.6)Unilateral mastectomy1,168 (22.4)883 (21.9)128 (28.4)Bilateral lumpectomy75 (1.4)61 (1.5)5 (1.1)Bilateral mastectomy927 (17.8)713 (17.7)89 (19.8)Treatment line settingNumber of patients who received NAT481 (9.1)324 (7.9)157 (34.0)Number of patients who received AT4,263 (80.4)3,949 (96.6)314 (68.0)pCR to NATAchieved pCR77 (16.0)20 (6.2)57 (36.3)OSFrom initial diagnosis: survival probability at Month 36, % (SE)94.0 (0.4)95.6 (0.3)85.7 (1.8)From NAT: survival probability at Month 36, % (SE)88.3 (1.6)91.9 (1.7)80.6 (3.5)From AT: survival probability at Month 36, % (SE)94.9 (0.4)95.8 (0.4)84.7 (2.2)PFSFrom initial diagnosis: progression-free probability at Month 36, % (SE)91.3 (0.4)93.3 (0.4)77.9 (2.1)From NAT: progression-free probability at Month 36, % (SE)79.9 (2.0)85.2 (2.1)68.7 (4.1)From AT: progression-free probability at Month 36, % (SE)92.5 (0.4)93.5 (0.4)79.5 (2.5)Duration of treatment, Months (n)Median duration of NAT3.3 (481)3.3 (324)3.3 (157)Median duration of AT35.3 (4263)38.2 (3,949)3.4 (314)[1] All patients includes both patients systemically treated and systemically untreated. [2] Other includes Inflammatory, Papillary, Metaplastic, Medullary and Tubular histologies. [3] Patient may have received more than one surgery. AT, adjuvant therapy; IDC, invasive ductal carcinoma; NAT, neoadjuvant therapy; ND, not documented; SE, standard error. Citation Format: Anagha Gogate, Amanda Crosbie, Trong Kim Le, Ying Zhang, Rolee Das, Catherine Davis. Clinical characteristics, treatment patterns, and survival outcomes in women with early triple-negative (TN) or hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2−) breast cancer (BC) in the real-world (RW) setting [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-12-15.

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Vyas, Kartavya J. "846. Trend Analysis of Cause-Specific Mortality among HIV-Infected Veterans: A 35-Year Study." Open Forum Infectious Diseases 8, Supplement_1 (November 1, 2021): S513. http://dx.doi.org/10.1093/ofid/ofab466.1041.

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Abstract Background The aims are to estimate the rates for, and examine the trends of, all-cause and cause-specific mortality since the beginning of the epidemic, in an effort to better forecast future mortality patterns and potentially prevent premature death. Methods All patients in the HIV Atlanta VA Cohort Study (HAVACS), an ongoing, open cohort of all HIV-infected veterans who ever sought or are seeking care at the Atlanta VA Medical Center, with a documented HIV diagnosis between January 1982 and December 2016 are included. All-cause and cause-specific mortality rates are calculated annually and for the study period, and age-adjusted to the 2000 U.S. standard population. Join-point regression analyses are performed to calculate annual percent changes (APC) and 95% CIs during periods of time when significant changes in trends are observed. Results The analytic sample consisted of 4,674 patients; of whom 1,752 (36.8%) died. The age-adjusted all-cause mortality rate per 100 PY (95% CI) is 19.0 (9.9, 28.2); this rate decreased 45.2% annually from 1983 to 1987, and thereafter became relatively stable. The age-adjusted mortality rates for AIDS–opportunistic infection (aIR=19.0, 95% CI=17.0, 21.0), cardiovascular (aIR=16.2, 95% CI=9.2, 23.1; APC=-2.0), infection (aIR=20.7, 95% CI=10.3, 31.1), liver (aIR=13.8, 95% CI=9.7, 18.0; APC=-0.6), pulmonary (aIR=24.6, 95% CI=3.4, 45.8; APC=-0.3), renal (aIR=17.6, 95% CI=11.1, 24.1; APC=-1.3), and violence (aIR=14.7, 95% CI=9.2, 20.2; APC=-2.8) have all decreased since the beginning of the epidemic, most markedly for AIDS–opportunistic infection (APC=-18.0; 95% CI=-31.9, -1.4) and infection (APC=-3.4; 95% CI=-6.5, -0.3). In contrast, the age-adjusted mortality rates for AIDS–opportunistic malignancy (aIR=32.4, 95% CI=15.9, 48.9; APC=1.5), malignancy (aIR=13.2, 95% CI=6.2, 20.2; APC=1.1), and sudden death (aIR=9.6, 95% CI=6.1, 13.1; APC=32.2) have increased since the beginning of the epidemic. Figure 1. Joinpoint regression analysis of age-adjusted mortality rates in the HAVACS cohort, 1982-2016 (n=4,674). AIDS, acquired immune deficiency syndrome; APC, annual percent change; HAVACS, HIV Atlanta VA Cohort Study; HIV, human immunodeficiency virus; PY, person-years. *Statistically significant at α=0.05. 1. 2000 U.S. standard population; excludes deaths for which the date is unknown (n=46). 2. Coding Causes of Death in HIV (CoDe) protocol adapted to classify causes of death; AIDS-related illnesses refers to an appended list of AIDS-defining illnesses (1993 definition). 3. Pulmonary infections included in pulmonary, not infection. 4. Hepatocellular carcinoma included in liver, not malignancy. Conclusion HIV-infected veterans are experiencing decreasing mortality rates due to almost all causes of death, principally infections; however, increasing mortality rates due to malignancies and sudden death are observed. Identifying risk factors for those causes on the rise may help realign resources and mitigate disease burden in this population. Disclosures All Authors: No reported disclosures

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Méndez-Calderón, C. E., C. R. Lazzarotto, L. H. Aguiar, F. L. Ongaratto, K. C. S. Tavares, M. S. Alves, S. Gaudencio-Neto, et al. "157 EFFECT OF FSH STARVATION (COASTING) FOLLOWING SUPEROVULATION ON OOCYTE COMPETENCE AND CLONING EFFICIENCY IN GOATS." Reproduction, Fertility and Development 29, no. 1 (2017): 187. http://dx.doi.org/10.1071/rdv29n1ab157.

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Oocyte competence plays a key role in the overall efficiency of reproductive biotechnologies. In cattle, FSH starvation following superovulation (coasting) improves oocyte competence, blastocyst yield and pregnancy outcome when used in ovum pickup-in vitro production programs. The aim of this study was to compare the effect of coasting after exogenous FSH stimulation on goat oocyte quality and competence to support in vitro maturation and in vivo embryo development following cloning procedures in goats. Donor and recipient preparation, cumulus-oocyte complex (COC) retrieval and selection, IVM, cloning by somatic cell nuclear transfer, embryo transfer, and pregnancy diagnosis (Days 23–26) were performed according to our established procedures [Martins et al. 2016 doi: 10.1089/cell.2015.0082]. Cumulus-oocyte complexes were obtained in vivo from 71 cycling FSH-stimulated mature Nubian-crossed goats, combined or not with FSH starvation (coasting period). Donor females were oestrous synchronized with a progesterone intravaginal insert (Day 0). On Day 10, a 0.75-mg D-cloprostenol dose was given IM, with the onset of the superovulation treatment, composed of five 20-mg FSH doses (Folltropin®, Bioniche Animal Health, Pullman, WA, USA), via IM at 12-h intervals. Donors were subjected to laparoscopic ovum pickup either 9 h (control group, n = 36) or 21 h (coasting group, n = 35) after the last FSH dose, respectively. Skin fibroblast cell cultures from a male neonate were co-transfected with a mammary gland expression vector with the human lactoferrin (hLF) coding sequence and with CRISPR/Cas9 system either for the PRNP prion gene or the Rosa26 locus. A bi-allelic hLF-PRNP and a mono-allelic hLF-Rosa26 cell colony were used for cloning. Data were compared by ANOVA or the χ2 test (P < 0.05). No differences were observed between control and coasting for number of follicles (18.7 ± 1.4 v. 21.2 ± 1.7), and retrieved (17.3 ± 1.2 v. 20.7 ± 1.9), viable (15.9 ± 1.1 v. 19.6 ± 1.8), Grade I (1.5 ± 0.3 v. 2.5 ± 0.5), and Grades III+IV (6.0 ± 0.6 v. 5.7 ± 0.7) COC, as well as for COC retrieval (92.4%, 574/621 v. 94.5%, 685/725) and fusion (62.8%, 273/435 v. 61.3%, 311/507) rates, respectively, irrespective of the cell lines. However, the coasting group rendered higher number of Grade II COC (11.3 ± 1.2 v. 8.4 ± 0.7), number and proportion of Grades I+II COC (13.9 ± 1.5 v. 9.9 ± 0.9, 70.8% v. 62.4%), and maturation rate (70.9% v. 65.4%) than the control group, respectively, for a lower proportion of Grades III+IV (29.2% v. 37.6%, respectively). A total of 213 and 233 Day-1 cloned embryos from the control and the coasting groups were transferred to 18 (96/9 hLF-PRNP and 117/9 hLF-Rosa26 cells) and 19 (128/11 hLF-PRNP and 105/8 hLF-Rosa26 cells) female recipients, respectively, resulting in 1/9 (11.1%) and 4/11 (36.4%) pregnancies from the hLF-PRNP cells, and 3/9 (33.3%) and 3/8 (37.5%) from the hLF-Rosa26 cells, for the control (4/18, 22.2%) and coasting (7/19, 36.8%) groups, respectively, for an overall pregnancy rate of 29.7% (11/37). In conclusion, the use of coasting improved oocyte quality and in vitro maturation rate, also appearing to increase pregnancy outcome after goat cloning.

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McLaughlin, Nicole, Gordon Ruan, Courtney N. Day, William S. Harmsen, Caleb J. Smith, Moritz Binder, Naseema Gangat, Ronald S. Go, Ayalew Tefferi, and Mithun Vinod Shah. "A population-based study of acute panmyelosis with myelofibrosis in the United States: 2004 to 2015." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e19003-e19003. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e19003.

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e19003 Background: Acute panmyelosis with myelofibrosis (APMF) is a rare subtype of acute myeloid leukemia characterized by acute panmyeloid proliferation with increased blasts, cytopenias with bone marrow fibrosis, and absence of splenomegaly. There is a paucity of population-based studies of APMF. Methods: We queried the United States Surveillance, Epidemiology, and End Results (SEER) database and National Cancer Database (NCDB) using the ICD-O-3 code 9931/3. The SEER 17 registries (2004-2015) were used to find data on incidence. For NCDB data, comorbid disease burden was calculated using the Charlson-Deyo Score (CDS). Hazard ratios (HR) with confidence intervals (CI) were calculated using a Cox proportional hazards model. Overall survival (OS) was estimated with the Kaplan-Meier method. Variables significant in univariable analysis were included in a multivariable analysis. Results: We identified 260 APMF patients using the SEER database. Incidence was 0.3 cases/million individuals and did not change significantly from 2004-2015. With a median follow up of 6.9 years (95% CI 6.1-7.8), the median OS was 2.3 years (95% CI 1.7-2.8). We identified 530 APMF patients using the NCDB. The median age at diagnosis was 67 years (range 22-90) and 311 (59%) were male. With a median follow up of 5.0 years (95% CI 3.0-7.6), the median OS was 2.3 years (95% CI: 0.8-6.5). OS was 69%, 31%, and 18% at 1-, 5-, and 10- years, respectively. Patients diagnosed in 2012-2015 had a significantly improved OS compared to those diagnosed in 2004-2007 (HR 0.65, 95% CI 0.49-0.85; p=0.002). 271 patients (53%) patients received chemotherapy. The OS for those that received chemotherapy was 70% at 1 year and 30% at 5 years versus 70% and 32% at 1- and 5- years for those who did not ( p=0.99). The median time to chemotherapy from time of diagnosis was 25 days (range 0-532 days). 52 patients (10%) underwent transplantation and the OS of those patients was 90% at 1 year and 45% at 5 years versus 67% and 29% at 1- and 5- years for those who did not (HR: 1.7 (95% CI: 1.2-2.6), p=0.006). In univariable analysis, factors predicting inferior OS were age ≥ 65 years old at diagnosis (HR 1.8, 95% CI 1.5-2.3; p<0.001), male sex (HR 1.5, 95% CI 1.2-1.8; p<0.001), CDS ≥ 1 (HR: 1.5 (95% CI: 1.2-2.0), p<0.001), government insurance (HR 1.8, 95% CI 1.4-2.3; p<0.001), diagnosis at a non-academic facility (HR 1.6, 95% CI 1.2-2.0, p<0.001), and not receiving a hematologic transplant (HR 1.7, 95% CI 1.2-2.6; p=0.006). Multivariable-adjusted analysis is shown in the Table. Conclusions: The overall incidence of APMF has not changed between 2004 and 2015, but OS for 2012-2015 was improved compared to 2004-2007. Age ≥ 65 years old, male sex, CDS ≥ 1, and diagnosis at a nonacademic facility predicted inferior OS. Multivariable-adjusted analysis.[Table: see text]

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Jay, Ollie, Anthony R. Bain, Tomasz M. Deren, Matthew Sacheli, and Matthew N. Cramer. "Large differences in peak oxygen uptake do not independently alter changes in core temperature and sweating during exercise." American Journal of Physiology-Regulatory, Integrative and Comparative Physiology 301, no. 3 (September 2011): R832—R841. http://dx.doi.org/10.1152/ajpregu.00257.2011.

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The independent influence of peak oxygen uptake (V̇o2 peak) on changes in thermoregulatory responses during exercise in a neutral climate has not been previously isolated because of complex interactions between V̇o2 peak, metabolic heat production (Hprod), body mass, and body surface area (BSA). It was hypothesized that V̇o2 peak does not independently alter changes in core temperature and sweating during exercise. Fourteen males, 7 high (HI) V̇o2 peak: 60.1 ± 4.5 ml·kg−1·min−1; 7 low (LO) V̇o2 peak: 40.3 ± 2.9 ml·kg−1·min−1 matched for body mass (HI: 78.2 ± 6.1 kg; LO: 78.7 ± 7.1 kg) and BSA (HI: 1.97 ± 0.08 m2; LO: 1.94 ± 0.08 m2), cycled for 60-min at 1) a fixed heat production (FHP trial) and 2) a relative exercise intensity of 60% V̇o2 peak (REL trial) at 24.8 ± 0.6°C, 26 ± 10% RH. In the FHP trial, Hprod was similar between the HI (542 ± 38 W, 7.0 ± 0.6 W/kg or 275 ± 25 W/m2) and LO (535 ± 39 W, 6.9 ± 0.9 W/kg or 277 ± 29 W/m2) groups, while changes in rectal (Tre: HI: 0.87 ± 0.15°C, LO: 0.87 ± 0.18°C, P = 1.00) and aural canal (Tau: HI: 0.70 ± 0.12°C, LO: 0.74 ± 0.21°C, P = 0.65) temperature, whole-body sweat loss (WBSL) (HI: 434 ± 80 ml, LO: 440 ± 41 ml; P = 0.86), and steady-state local sweating (LSRback) ( P = 0.40) were all similar despite relative exercise intensity being different (HI: 39.7 ± 4.2%, LO: 57.6 ± 8.0% V̇o2 peak; P = 0.001). At 60% V̇o2 peak, Hprod was greater in the HI (834 ± 77 W, 10.7 ± 1.3 W/kg or 423 ± 44 W/m2) compared with LO (600 ± 90 W, 7.7 ± 1.4 W/kg or 310 ± 50 W/m2) group (all P < 0.001), as were changes in Tre (HI: 1.43 ± 0.28°C, LO: 0.89 ± 0.19°C; P = 0.001) and Tau (HI: 1.11 ± 0.21°C, LO: 0.66 ± 0.14°C; P < 0.001), and WBSL between 0 and 15, 15 and 30, 30 and 45, and 45 and 60 min (all P < 0.01), and LSRback ( P = 0.02). The absolute esophageal temperature (Tes) onset for sudomotor activity was ∼0.3°C lower ( P < 0.05) in the HI group, but the change in Tes from preexercise values before sweating onset was similar between groups. Sudomotor thermosensitivity during exercise were similar in both FHP ( P = 0.22) and REL ( P = 0.77) trials. In conclusion, changes in core temperature and sweating during exercise in a neutral climate are determined by Hprod, mass, and BSA, not V̇o2 peak.

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Schanz, Julie, Heinz Tuechler, Francesc Solé, Mar Mallo, Barbara Hildebrandt, Marilyn L. Slovak, Kazuma Ohyashiki, et al. "Cytogenetic Risk Features in MDS-Update and Present State." Blood 114, no. 22 (November 20, 2009): 2772. http://dx.doi.org/10.1182/blood.v114.22.2772.2772.

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Abstract Abstract 2772 Poster Board II-748 Introduction: The IPSS-Score, published by Greenberg et al. (1997), defines the gold standard in risk stratification of patients with MDS. Since its implementation in 1997 based on 816 patients with primary MDS, the knowledge concerning the prognostic impact of distinct abnormalities increased extensively. The present study proposes a new and comprehensive cytogenetic scoring system based on an international data collection of 3803 patients, originating from the German-Austrian (GA)-, the International Risk analysis workshop (IMRAW)- and the Spanish Cytogenetics working group (GCECGH). Additionally, 53 cases of rare abnormalities were contributed by the International Cytogenetics Working Group of the MDS Foundation (ICWG), resulting in total number of 3856 pts. As compared to our previous reports, the data set was substantially enlarged by adding the GCECGH cases and data quality was improved by updating the clinical and survival data; allowing the analysis of the prognostic impact for isolated abnormalities exclusively to assure a maximum accurateness. Furthermore, multivariate analysis was refined by including peripheral cytopenias. Materials and Methods: Inclusion criteria were defined as follows: Primary MDS, age >=16, and bone marrow blasts <=30%. Regarding therapy, exclusively patients with primary MDS and supportive care, only allowing short courses of oral chemotherapy or hemopoietic growth factors were included. Based on these criteria, 958 pts. were excluded resulting in 2901 pts. available for final analysis. Univariate and multivariate analysis concerning overall survival (OS) and 25% AML-transformation (AML-t) was performed. In multivariate analysis, age, gender, bone marrow blast count and number of peripheral cytopenias were defined as co-variables. OS and AML-t in distinct cytogenetic abnormalities was only calculated when the abnormality occurred as an isolated aberration with a minimal frequency of n=10. Median observation time was 19.0 months. Clinical follow-up was performed until April 2009. Results: In total, 20 cytogenetic subgroups matching the inclusion criteria were detected. Abnormalities were grouped as normal (n=1522, 52.5% of all cases), single (1 abnormality), double (2 abnormalities) or complex (>=3 abnormalities). Single abnormalities found were: del(5q) (176, 6.1%); -7/7q- (59, 2.0%); +8 (130, 4.5%); del(20q) (48, 1.7%), -Y (46, 2.1%); der(1;7)(q10;p10)/t(1;7)(var;var) (10, 0.3%); der(3)(q21)/der(3)(q26) (10, 0.3%); del(11q) (19, 0.7%); del(12p) (17, 0.6%); i(17)(q10) (11, 0.4%); +19 (10, 0.3%), +21 (10, 0.3%) and any other single (150, 5.2%). Double abnormalities were stratified into 3 subgroups: double including del(5q) (45, 1.6%); double including -7/7q- (31; 1.1%) and any other double (98, 3.4%). As reported (Haase et al. Blood 2008), complex karyotypes were sub-divided into 2 groups: Karyotypes with 3 abnormalities (59, 2.0%) vs. >3 abnormalities (188, 6.5%). Finally, 20 pts. (0.7%) displayed cytogenetically unrelated clones. According to OS and AML-t, abnormalities were classified to 4 prognostic subgroups: good (normal, del(5q), double incl. del(5q), der(1;7)(q10;p10)/t(1;7)(var;var), del(11q), del(12p), +19, del(20q), -Y); int-1 (any other double, +8, i(17)(q10), +21, any other single, independent clones); int-2 (double incl. -7/7q-, der(3)(q21)/der(3)(q26), -7/7q-, complex 3 abnormalities) and poor (complex >3 abnormalities). Median survival was 50.6 months for good (n=1936), 25.7 months for int-1 (n=451), 16.0 months for int-2 (n=177) and 5.7 months for poor (n=188) and AML-t was 71.9 months for good (n=1681), 14.7 months for int-1 (n=384), 9.8 months for int-2 (n=148) and 3.4 months for poor (n=159). Differences in OS and AML-t were highly significant (p<0.0001). Multivariate analysis resulted in a Hazard Ratio of 1.0 for good (reference category), 1.8 for int-1, 2.1 for int-2 and 4.8 for poor concerning OS. Regarding AML-t, HR was 1.0 for good, 2.6 for int-1, 3.1 for int-2 and 5.2 for poor (all p <0.0001 for OS and AML-t). Conclusions: In summary, we were able to generate a solid database for a revised cytogenetic scoring system, which can serve as the cytogenetic model for the upcoming revision of the IPSS. Acknowledgments: The authors like to thank the MDS-Foundation for its support. Disclosures: No relevant conflicts of interest to declare.

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Corrales-Pérez, Daniel, and Francisco Martín-Romero. "Adecuaciones para mejorar la aplicación del método D3987-85 en la extracción de EPT de los antiguos residuos mineros El Fraile, Guerrero, México." Revista Mexicana de Ciencias Geológicas 35, no. 1 (March 26, 2018): 1–17. http://dx.doi.org/10.22201/cgeo.20072902e.2018.1.536.

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El método D3987-85 es uno de los procedimientos de lixiviación utilizados en el mundo para evaluar la peligrosidad de los jales de minas. El método ha sido oficializado en México en la Norma Oficial Mexicana NOM-141-SEMARNAT-2003; y durante su aplicación se han reportado inconsistencias que podrían traer graves repercusiones en la salud humana y en el ambiente. En el presente estudio se realizaron modificaciones al tiempo de agitación y relación de mezcla indicados en el método D3987-85. Adicionalmente, se implementaron técnicas eficientes de muestreo para representar más acertadamente la peligrosidad de los antiguos residuos depositados en la presa de jales El Fraile, localizada en Taxco, estado de Guerrero, México. Los jales se caracterizan por presentar concentraciones totales (mg/kg) de elementos potencialmente tóxicos (EPT) en los siguientes intervalos: As (1,719.0–3,412.1), Ag (27.8–55.7), Ba (152.1–527.3), Cd (15.6–49.7), Cu (89.7–204.5), Mn (243.6–2,195.5), Pb (3,084.9–4,930.1), Zn (449.0–5,558.7), y la presencia de las siguientes fases minerales, en orden de abundancia: cuarzo, yeso, jarosita potásica, filosilicatos, hematita, feldespatos potásicos tipo sanidina. Así mismo, de las presas de jales se colectaron tres muestras de efluentes ácidos (pH: 2.0–2.6), que registraron concentraciones (mg/L) de SO42- (3,509.3–12,249.9), Fe (459.3–1,505.0) y EPT (As: 0.7–1.3, Cd: 2.8–12.3, Cu: 6.1–23.7, Mn: 76.4–316, Zn: 334.5–1,262.5), y fueron comparadas con la composición química de las suspensiones de jales en agua (SJA) preparadas en laboratorio mediante el método D3987-85. Los efluentes ácidos son clasificados como peligrosos con base en las concentraciones de Cd disuelto (>1.0 mg/L), ya que sobrepasaron el límite máximo permisible regulado en la Norma Oficial Mexicana 141. Sin embargo, cuando se comparó la peligrosidad de las SJA preparadas mediante el método D3987-85 (18 ± 0.25 h y relación sólido-extractante de 1:20), resultó que no son peligrosos, ya que las SJA presentaron concentraciones de Cd disuelto que oscilan entre 0.2 a 0.4 mg/L. No obstante, cuando se realizaron modificaciones al método D3987-85 que consistieron en aumentar los tiempos de agitación (24 ± 0.25 h, 48 ± 0.25 h, 72 ± 0.25 h, 192 ± 0.25 h) y disminuir las relaciones de mezcla (1:10, 1:3), se obtuvieron concentraciones de Cd disuelto que oscilan entre 0.3 a 2.4 mg/L. De esta forma, se logró demostrar que las SJA obtenidas con el método modificado representan mejor la composición geoquímica de los efluentes ácidos colectados en campo, lo cual contribuye a evaluar la peligrosidad de los jales de forma más rigurosa y confiable.

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Zeng, X., D. Zhao, S. Radominski, M. Keiserman, C. K. Lee, N. Martin, S. Meerwein, Y. Sui, and W. Park. "AB0260 LONG-TERM EFFICACY AND SAFETY OF UPADACITINIB IN PATIENTS FROM CHINA, BRAZIL, AND SOUTH KOREA WITH RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE TO CONVENTIONAL SYNTHETIC DISEASE-MODIFYING ANTIRHEUMATIC DRUGS: RESULTS AT 64 WEEKS." Annals of the Rheumatic Diseases 80, Suppl 1 (May 19, 2021): 1156–57. http://dx.doi.org/10.1136/annrheumdis-2021-eular.1807.

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Background:Upadacitinib (UPA), an oral Janus kinase inhibitor, in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), showed significant improvements in clinical and functional measures compared with placebo (PBO) up to 12 weeks (wks), in patients (pts) from China, Brazil, and South Korea with rheumatoid arthritis (RA) and prior inadequate response to csDMARDs (csDMARD-IR).1Objectives:To assess the efficacy and safety of UPA up to 64 wks (long-term extension; LTE) in csDMARD-IR pts with RA from China, Brazil, and South Korea.Methods:Pts were randomized to 12 wks of blinded treatment with UPA 15 mg once daily (QD) or PBO, in combination with csDMARDs. From Wk 12 onward, pts could continue to receive open-label UPA 15 mg QD. Efficacy endpoints were analyzed by original randomized treatment group sequences over 64 wks and included American College of Rheumatology (ACR) responses, and key remission and low disease activity measures. Non-responder imputation was used to handle missing data for binary endpoints. Treatment-emergent adverse events (TEAEs) per 100 patient-years (PY) were summarized for pts receiving ≥1 dose of UPA from baseline through to Wk 64.Results:Of 338 randomized pts who received ≥1 dose of study drug, 310 (91.7%) entered the LTE and 275 (81.4%) completed 64 wks of treatment. Among those initially randomized to UPA, the proportion of pts achieving 20%/50%/70% improvement in ACR criteria, and key remission and low disease activity measures increased over 64 wks of treatment (Figure 1). Improvements from baseline in the Health Assessment Questionnaire-Disability Index and pts’ assessment of pain were observed over 64 wks of UPA treatment (data not shown). By Wk 64, efficacy results for pts who switched from PBO to UPA at Wk 12 followed a similar trajectory to those originally randomized to UPA.The observed rate of serious infections was 8.1 events/100 PY. Herpes zoster events were mostly non-serious, involving only 1 or 2 dermatomes. Most cases of hepatic disorders were Grade 1 or 2 hepatic transaminase elevations. There was 1 case of venous thromboembolic event (VTE; concurrent pulmonary embolism and deep vein thrombosis [DVT] in a patient with a history of DVT) and 3 cases of malignancy. Adjudicated major adverse cardiovascular events (Table 1) occurred in 2 pts (1 with non-fatal myocardial infarction and 1 with non-fatal stroke) who had underlying risk factors for cardiovascular disease. There were no deaths, active tuberculosis, or renal dysfunction.Conclusion:UPA 15 mg was effective in treating the signs and symptoms of RA and in improving physical function over 64 wks with no new safety signals1 in csDMARD-IR pts with RA from China, Brazil, and South Korea.References:[1]Zeng A, et al. Ann Rheum Dis 2020;79(Suppl 1):1016 [abstract SAT0160]Table 1.TEAEs at Wk 64Event (E/100 PY)UPA 15 mg(n=322; PY=334.5)Any AE421.5 (399.8–444.1) Serious AE19.1 (14.7–24.4) AE leading to discontinuation of study drug9.0 (6.1–12.8) Deathsa0AEs of special interest Serious infection8.1 (5.3–11.7) Opportunistic infection0.9 (0.2–2.6) Herpes zoster9.0 (6.1–12.8) Hepatic disorder42.2 (35.5–49.7) Gastrointestinal perforation (adjudicated)0.3 (0.0–1.7) Any malignancy (excluding NMSC)0.6 (0.1–2.2) NMSC0.3 (0.0–1.7) MACE (adjudicated)b0.6 (0.1–2.2) VTE (adjudicated)c0.3 (0.0–1.7) Anemia11.1 (7.8–15.2) Neutropenia11.7 (8.3–15.9) Lymphopenia7.8 (5.1–11.4) CPK elevation11.1 (7.8–15.2)aIncluding non-treatment-emergent deaths. bDefined as cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. cIncluding DVT and pulmonary embolism.AE, adverse event; CPK, creatine phosphokinase; E, events; MACE, major adverse cardiovascular event; NMSC, non-melanoma skin cancerAcknowledgements:AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and in the writing, review, and approval of the abstract. No honoraria or payments were made for authorship. Yanna Song, PhD, of AbbVie provided statistical support. Medical writing support was provided by Laura Chalmers, PhD, of 2 the Nth (Cheshire, UK), and was funded by AbbVie.Disclosure of Interests:Xiaofeng Zeng: None declared, Dongbao Zhao: None declared, Sebastiao Radominski: None declared, MAURO KEISERMAN: None declared, Chang-Keun Lee: None declared, Naomi Martin Employee of: AbbVie employee and may own stock or options, Sebastian Meerwein Employee of: AbbVie employee and may own stock or options, Yunxia Sui Employee of: AbbVie employee and may own stock or options, Won Park: None declared

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Yamaguchi, Kensei, Satoru Iwasa, Motohiro Hirao, Takashi Oshima, Kazuaki Harada, Yasuyoshi Sato, Akihito Kawazoe, et al. "Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the advanced gastric cancer expansion cohort." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 4025. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.4025.

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4025 Background: Eribulin has proven efficacy in previously treated metastatic breast cancer and liposarcoma. E7389-LF is a new formulation that uses liposomes to encapsulate eribulin, which is anticipated to improve eribulin concentration in tumor tissues. In the dose-expansion part of a phase 1 study of E7389-LF, the safety profile was acceptable and 2 patients (pts) out of 10 with gastric cancer (GC) had an objective response. Thus, the GC cohort was expanded for further evaluation. Here, we report efficacy and safety data from the phase 1 expansion cohort of pts with advanced GC who were treated with E7389-LF. Methods: Eligible pts were those with GC who had no alternative standard or effective therapy options after ≥2 prior chemotherapy regimens. Target total enrollment was 32 pts (10 pts in the initial GC cohort plus an additional 22 pts in the expanded cohort). E7389-LF 2.0 mg/m2 was administered intravenously once every 3 weeks. Tumor responses were assessed every 6 weeks (± 1 week) by RECIST v1.1. Results: At data cutoff (Oct 16, 2020), 34 pts with GC were enrolled (10 pts in the initial GC cohort; 24 pts in the expanded GC cohort) with a median of 5 prior therapies (range, 2–11). Previous immune checkpoint inhibitor (ICI) therapy was reported for 26 (76.5%) pts. All pts were evaluable for objective response rate (ORR) and progression-free survival (PFS), and 30 pts were evaluable for overall survival (OS). Among all pts with GC, the ORR was 17.6% (95% CI 6.8–34.5) and the disease control rate was 79.4% (95% CI 62.1–91.3). Median PFS was 3.7 months (95% CI 2.7–4.3) and median OS was 7.6 months (95% CI 6.7–15.4). The ORRs were 19.2% (95% CI 6.6–39.4) in ICI-pretreated pts and 12.5% (95% CI 0.3–52.7) in pts without prior ICI therapy. Median PFS was similar regardless of prior treatment with ICIs (3.7 months [95% CI 2.7–5.6] in ICI-pretreated pts vs 3.4 months [95% CI 1.0–4.3] in pts without prior ICI therapy); however, the PFS rate at 6 months in ICI-pretreated pts was higher vs the rate in pts without prior ICI therapy (35.9% [95% CI 17.2–55.1] vs 0%, respectively). Median OS was also longer in ICI-pretreated pts (evaluable pts, n = 23) vs pts without prior ICI therapy (evaluable pts, n = 7) (10.0 months [95% CI 6.7–not estimable] vs 6.7 months [95% CI 3.1–8.5], respectively). Common grade ≥3 adverse events included neutropenia (41.2%), leukopenia (29.4%), and anemia (26.5%). In cycle 1, there were no cases of febrile neutropenia among the 22 pts treated with prophylactic peg-GCSF; among pts who did not receive prophylactic peg-GCSF, 16.7% of pts had febrile neutropenia. Conclusions: E7389-LF had a manageable safety profile and encouraging activity in pts with heavily treated GC. In pts with GC, prior treatment with ICIs might enhance the potential efficacy of E7389-LF. These results support further development of E7389-LF for advanced GC. Clinical trial information: NCT03207672.

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Thomas, C., K. Aston, S. R. Daley, and Jacqueline Bass. "Milk production from silage 4. The effect of the composition of the supplement." Animal Science 42, no. 3 (June 1986): 315–25. http://dx.doi.org/10.1017/s0003356100018080.

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ABSTRACTPrimary growths of perennial ryegrass (Lolium perenne) were cut on 22 May and 12 June and wilted for 24 h prior to ensiling. A 40: 60 mixture of the two silages was offered ad libitum with two pelleted supplements. Supplement Ba was a mixture of (dry matter (DM) basis) 932 g rolled barley and 68 g fish meal per kg. Supplement SBP/FF consisted of 555 g unmolassed beet pulp, 314 g extracted rice bran, 56 g fat prills and 75 g soya-bean meal per kg. The factorial combination of the two supplements (Ba and SBP/FF) given at two levels, 6 kg DM (L) or 12 kg DM (H), provided the four treatments imposed over weeks 3 to 10 of lactation on 40 British Friesian cows. During weeks 12 to 20 of lactation (post-experiment period) the cows were given an equal mixture of the two concentrates at 9 kg DM per day.Supplement Ba contained less ash (31 v. 94 g/kg), acid-detergent fibre (68 v. 218 g/kg) and fat (29 v. 77 g/kg) but more starch (558 v. 89 g/kg) and digestible organic matter in the dry matter in vitro (DOMD) (781 v. 627 g/kg) than SBP/FF. The concentration of total nitrogen (N) was similar at 25·6 g/kg. Silage had a DOMD of 643 g/kg, a pH of 3·8 and proportionately 0·82 of fermentation acids as lactic acid.Apparent digestibility of gross energy was higher for Ba diets (0·748) than for SBP/FF (0·704). Cows given SBP/FF ate 0·9 kg more silage DM than those given Ba (P < 0·01) but there was no difference in digestible energy intake or in substitution rate (−0·37 kg silage DM per kg additional supplement DM). Increasing the amount of supplement increased milk yield by 3·9 kg/day (P < 0·001). Cows given SBP/FF yielded on average 1·6 kg more milk than those given Ba (P < 0·05). However, this increased output consisted almost entirely of lactose and water as a result of a high concentration of fat in the milk of cows given Ba at the low level (46·3 g/kg). Further, the concentration of protein was less with SBP/FF (28·0 g/kg) than with Ba (29·2 g/kg).The effects of SBP/FF in early lactation were translated into a positive residual effect in mid lactation equivalent to the immediate effect. In contrast, raising yield by increasing the amount of supplement did not result in increased output subsequently. The results show that a supplement of fibre and fat despite having a lower digestibility than barley can produce more milk but a similar yield of fat and protein provided silage is offered ad libitum.

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Elias, Rawad, Ilene Staff, Stephen Thompson, Christine Waszynski, Jennifer Zanchi, and Robert Dicks. "Post-operative delirium in older patients following cancer related and other high-risk surgeries." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e24024-e24024. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e24024.

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e24024 Background: Older adults are at increased risk for postoperative delirium (POD). This risk might be higher in patients with cancer as underlying malignancy and its complications predispose individuals to develop delirium. Therefore, it is important to evaluate the onset of delirium in this patient population especially as POD is associated with increased risk of rehospitalization, decline in cognitive function, morbidity and mortality. Methods: We performed a retrospective review of patients aged ≥ 70 years admitted January 2017 through July 2019 to a tertiary care referral center for a high-risk surgery, defined as associated with a mortality risk greater than 1%. Cancer related surgeries (CRS) were identified through cross matching with Cancer Registry. Patients who had delirium assessment in the postoperative setting using the Confusion Assessment Method (CAM) were included. Chi-square tests of proportion, Wilcoxon Ranked Sum and multivariate logistic regression analyses were conducted. Results: A total of 2340 patients were included in this analysis, 315 of whom had (CRS). Overall, the age (median, IQR) of patients at surgery was 76 years (72-80) and the length of stay (LOS) was 7 (4-11) days. Patients receiving CRS were younger (75, 72-79) than those with non-CRS (76, 72-81) (p = 0.022); had a shorter post-operative LOS (4, 2-7 vs. 5, 3-8; p > 0.001), and were less likely to develop POD (7.6% vs. 16.1%; p < 0.001). Among patients receiving CSR, those who developed POD were older (78 vs. 74; p = 0.008) and had longer post-operative LOS (14.0 vs. 4.0; p < 0.001). Those having experienced radiotherapy (RT) for cancer within the year before the surgery, were more likely to develop POD (40.0% vs. 6.6% p. < 0.001). Chemotherapy in the year prior to surgery did not increase the risk of POD (6.1% vs. 7.8%; p = 0.721). Among those having non-CRS, a cancer diagnosis did not affect POD. A logistic regression predicting POD indicated that the lower likelihood of POD following CRS was independent of age or gender (OR = 0.40; p < .001); RT within one year prior was independent predictor of higher POD (OR = 5.48; p = 0.003). Our data presentation will include further analysis of POD risk factors. Conclusions: Although older adults receiving CRS were significantly less likely to develop delirium than patients with other high-risk surgeries, it is still important to evaluate POD in this population due to its impact of patients’ outcomes. Further understanding of POD risk factors, such as preoperative RT, would allow the development of targeted interventions that might lessen the risk.

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Loscocco, Giuseppe Gaetano, Paola Guglielmelli, Carmela Mannarelli, Elena Rossi, Francesco Mannelli, Francesco Ramundo, Giacomo Coltro, et al. "A JAK2V617F Variant Allele Frequency Greater Than 50% Identifies Patients with Polycythemia Vera at High Risk for Venous Thrombosis." Blood 138, Supplement 1 (November 5, 2021): 237. http://dx.doi.org/10.1182/blood-2021-147869.

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Abstract Background: Thrombosis is the main cause of morbidity and mortality in pts with Polycythemia Vera (PV). Current risk stratification is based on 2 variables: age >60y and history of thrombosis. Additional thrombotic risk factors in PV are generic cardiovascular risk factors and leukocytosis. JAK2V617F (JAK2VF) variant allele frequency (VAF) at diagnosis is highly heterogeneous. A VAF>75% was associated with higher rate of all thrombosis after diagnosis (Vannucchi AM et al, Leukemia 2007), and a VAF ≥ 60% correlated with increased rate of venous thrombosis (VT) in high-risk pts (Guglielmelli P et al, ASH 2018); however, predictive role of JAK2VF VAF is still debated. Aim: To evaluate the impact of JAK2VF VAF on rate of arterial and venous thrombosis in PV pts. Patients and methods: A cohort of 576 strictly 2016 WHO-defined PV pts followed at Univ. of Florence (1981-2020) were included. All pts were annotated for JAK2VF VAF, determined <3 years from diagnosis, and thrombosis at diagnosis and follow-up (FU). Arterial thromboses (AT) included stroke, transient ischemic attacks, retinal artery occlusion, coronary artery disease, and peripheral arterial disease; VT included cerebral venous thrombosis, deep vein thrombosis, pulmonary embolism. Splanchnic vein thromboses (SVT) were excluded. Only first occurring event was considered. Cox proportional hazard regression model was used for univariate and multivariable analysis. Kaplan-Meier (KM) analysis was used for time-to-event assessment, compared by log-rank test. Results: Median age was 61.4 y (range, 16.2-91.8), 58.2% were male; 62% were high-risk based on current classification. Median JAK2VF VAF was 41.5% (range, 0.3-100). A total of 76 (13.2%) pts had an AT event before/at PV diagnosis and 49 (8.5%) pts had an AT during FU. As regards VT, 64 (11.1%) and 39 (6.8%) pts had a VT before/at or after PV diagnosis, respectively. We found that JAK2 VAF as a continue variable was correlated with the risk of VT in FU (p=0.003) but not with AT (p=0.8). ROC analysis to determine the best cut-off level for JAK2 VAF predicting VT had an AUC of 0.72 and a best cut-off value of VAF=50%. VT at FU were significantly enriched in pts with VAF >50%: 14.5% versus 2.4%, p=<0.0001. VT -free survival (VT-FS) by KM was significantly shorter in the presence of a JAK2 VAF >50% (HR 4, CI 1.9-8.6, p<0.0001) (Figure 1A), whereas no difference was found for AT (HR 0.9). In addition to JAK2VF VAF>50%, univariate analysis for VT-FS identified history of VT (HR 2.9; CI 1.4-6.1, p=0.006), leukocytosis ≥11x10 9/L (HR 1.9; CI 1.1-3.4, p=0.02) and palpable splenomegaly (HR 1.9, CI 1-3.6; p=0.04) as risk factors. Multivariable analysis confirmed VAF>50% (HR 3.8, CI 1.8-8.1, p=0.0006) and previous VT (HR 2.4, CI 1.1-5.1; p=0.02) as independent risk factors for future VT. In contrast, univariate analysis for AT-free survival (AT-FS) identified history of AT (HR 2.5; CI 1.3-4.9, p=0.007), diabetes (HR 3.3; CI 1.6-6.5, p=0.0007), hyperlipidemia (HR 3.1; CI 1.7-5.6, p=0.0003) and hypertension (HR 2, CI 1.1-3.8; p=0.03) as predictors of future AT; age >60y showed only a trend (p=0.08). Multivariable analysis for AT-FS identified diabetes (HR 2.4, CI 1.2-5; p=0.02), hyperlipidemia (HR 2.3; CI 1.2-4.3, p=0.01) and previous AT (HR 2.1, CI 1-4.2; p=0.04) as independent predictors of future AT. Validation: Our findings were validated in an independent cohort of 315 2016-WHO defined PV pts from Policlinico Gemelli, Catholic Univ., Rome. After exclusion of 26 pts with SVT, analysis was conducted on 289 pts, 38 of them with thrombosis as heralding event (21 AT and 17 VT). Multivariable analysis confirmed JAK2VF VAF >50% (HR 2.3, CI 1.03-5.0, p=0.04) and previous VT (HR 4.5, CI 2.0-10.1; p=0.0003) as independent risk factors for future VT. In pts with VAF >50%, the rate of VT at FU was 19.9% vs 7.7%, P=0.005. KM curve showed that VT-FS was significantly shorter in pts with a JAK2VF VAF >50% (HR 2.2, CI 1.2-4.2; p=0.01) (Figure 1B). Of note, impact of JAK2 VAF>50% on VT at FU was statistically significant particularly in conventionally low-risk pts, accounting for an HR of 9.4 (CI 1.2-72) and HR 3.6 (CI 1.3-10) in Florence and Rome cohorts, respectively. Conclusions: These data support JAK2VF VAF as a strong independent predictor for future venous thrombosis in PV, in association with history of prior venous events, reinforcing that AT and VT are associated with unique risk factors in pts with PV. Supported by AIRC, Project Mynerva n.21267 Figure 1 Figure 1. Disclosures Vannucchi: BMS: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees.

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Lillicrap, David, Angie Tuttle, Eric Crawford, Anne-Marie Vincent, and Georges E. Rivard. "The Prevalence of Non-Neutralizing Anti-FVIII Antibodies in the Canadian Hemophilia Population." Blood 114, no. 22 (November 20, 2009): 1291. http://dx.doi.org/10.1182/blood.v114.22.1291.1291.

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Abstract Abstract 1291 Poster Board I-313 Introduction In approximately 25% of hemophilia A patients, inhibitory anti-FVIII antibodies develop following treatment with FVIII protein infusion therapy. This is currently the most serious treatment-related complication in this population. While the presence of these antibodies has been evaluated by a functional clotting assay for the past 30 years (the Bethesda Assay), there is a growing appreciation that the anti-FVIII immune response may also include the appearance of non-neutralizing antibodies in some patients. The prevalence, natural history and clinical relevance of these antibodies are the subject of this study. Methods Plasma samples from 602 hemophilia A patients formed the study material for this project. These samples had been stored at –80C since the conversion from plasma-derived to recombinant FVIII (rFVIII) concentrates in Canada. The results of prior Bethesda assay testing were available for 392 of these samples. The ELISA-based test for non-neutralizing anti-FVIII antibodies utilized three different rFVIII products as antigens: two full-length rFVIII products and one B domain-deleted rFVIII. Each microtiter plate run included six negative and one positive control sample. All samples were tested in duplicate and samples with positive results (absorbance >mean + 3SD) were subjected to serial dilution testing. 93 of the samples were also tested by the same assay in a second laboratory. Results Anti-FVIII antibodies were documented using this ELISA-based assay in 11.5% of this population. 11.5% and 8.8% of the patients demonstrated non-neutralizing antibodies to the two full-length rFVIII concentrates Advate® and Kogenate®, respectively. In contrast, antibodies to the B domain-deleted concentrate, Xyntha®, were only found in 4.6% of patients. 2.8% of patients had antibodies to all three concentrates while 3.1% of patients had antibodies to only Advate (2.8%) or Kogenate (0.3%). Twenty four of the 392 patients (6.1%) tested with the Bethesda assay had inhibitory anti-FVIII antibodies (range 0.6 – 267 BUs). A third of these Bethesda +ve cases demonstrated positivity in this assay to all three rFVIII products, while another 30% had antibodies against one or two of the rFVIII concentrates. 48 of the 368 cases that tested negative in the Bethesda assay were positive for non-neutralizing anti-FVIII antibodies (13%). To date, 20 of the samples testing positive for non-neutralizing antibodies have been studied by serial dilution analysis and 9 of these samples were only positive at the initial dilution of 1:50. Seven cases had positive dilution titers of 1:200 (3 with inhibitory antibodies ranging from 0.6 to 98 BUs) and two samples were positive at a dilution of 1:400, both of which had positive Bethesda results of 30 and 115 BUs, respectively. To assess the inter-laboratory consistency of this testing protocol, 93 selected samples were assayed with the identical methodology in a second laboratory. These studies showed positive results for the presence of antibodies to the two full-length rFVIIIs in 32-45% of cases. In contrast, the range of positive results for the two laboratories with the B domain-deleted rFVIII was between 19 and 37%. Conclusions This study of a large Canadian hemophilia A population has demonstrated the presence of non-neutralizing anti-FVIII antibodies in 11% of the population. Antibodies to the B domain-deleted rFVIII were significantly less frequent. When evaluated, inhibitory antibodies were present in 6% of this population and in the Bethesda negative cases, non-neutralizing antibodies were found in 13% of patients. Finally, many of these non-neutralizing antibodies appear to be of low titer, and their clinical significance must await further study with clotting factor recovery and half-life analysis. Disclosures No relevant conflicts of interest to declare.

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Novella-Navarro, M., C. Plasencia, C. Tornero, K. N. Franco Gomez, I. Monjo, V. Navarro-Compán, D. Peiteado, and A. Balsa. "AB0313 CLINICAL PREDICTORS OF MULTIPLE FAILURES TO BIOLOGICAL THERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS." Annals of the Rheumatic Diseases 79, Suppl 1 (June 2020): 1455.2–1456. http://dx.doi.org/10.1136/annrheumdis-2020-eular.992.

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Background:Biological therapies have improved the clinical course and quality of life of Rheumatoid Arthritis (RA) patients. Despite the availability and effectiveness of these treatments, some patients present multiple failures to biologic disease-modifying anti-rheumatic drugs (bDMARDs), constituting a challenge to clinicians.Objectives:To determine the frequency of multiple failure to bDMARDs in RA patients and to identify baseline/early features as possible predictors of multiple failure.Methods:This case-control study involved subjects with RA1,2treated with bDMARDs from the RA-Registry at La Paz Hospital between 2000 and 2019. Patients who presented insufficient response to >3 different bDMARDs or >2 bDMARDs with different mechanism of action were considered Multi-refractory (MR-patients). Patients who achieved low disease activity or remission (by DAS-28) with the first bDMARD and maintained it in a follow-up period of at least 5 years were considered non-refractory(NR-patients).For all patients, demographic, clinical characteristics and laboratory parameters were assessed in the database at baseline visit, just prior to start bDMARD for first time and at 6-months visit.Descriptive analysis was performed, and using the “refractory status” as the dependent variable, multiple bivariate logistic regression models were performed to identify which variables should be considered in the multivariate analyses. P<0.05 was considered statistically significant. Odds Ratio (OR) and Confidence Intervals (CI) were calculated. IBM SPSS 21.0Results:In total, 402 RA patients who had ever received bDMARD treatment were identified. According to pre-established inclusion criteria, 112 patients were included: 41MR-patients(10%) and 71NR-patients(18%). No differences in gender, age or age at RA diagnosis were found between both groups. Global time on bDMARD treatment was longer inMR-patients(11.7 vs 9.7 years, p=0.01) and survival on first bDMARD was 4.1±3.4 years, which was decreasing with the successive treatments. InMR-patients, shorter disease duration between RA diagnosis and starting bDMARD (6.9 vs 10.0; p=0.04) and higher number of previous cDMARDs were observed. Also presence of erosions and extra-articular manifestations were more frequent inMR-patients (58.5% vs 25.4%, p=0.03 and 29.3% vs 12.7%, p<0.001).Results of variables included in bivariate and multivariate analyses are shown in Table 1. Finally, factors associated with multi-bDMARDs refractoriness in the multivariate analysis were presence of erosions, earlier age at bDMARD start, higher baseline DAS-28 and especially ΔDAS< 1.2 in the first 6 months of treatment (OR 11.12; 95% CI 3.34-26.82).Table 1.VARIABLEBivariateOR (95%CI)MultivariateOR (95%CI)Age at diagnosis0.99 (0.96-1.0)-Sex (Female)1.67 (0.58-4.73)5.94 (0.92-38.20)Age at bDMARD treatment0.97 (0.93-1.00)0.95 (0.90-0.99)Time between diagnosis and bDMARD0.94 (0.89-1.00)-Body mass index1.01 (0.94-1.09)-Erosions (ref yes)4.07 (1.79-9.26)3.26 (1.18-9.00)Extraarticular manifestations (ref yes)2.81 (1.0-7.52)2.14 (0.59-7.78)Metothrexate (ref yes)1.83 (0.66-5.10)-Previous cDMARDs3.54 (2.05-6.1)-CRP baseline1.02 (0.99-1.05)-DAS28 baseline1.77 (1.2-2.6)2.29 (1.39-3.76)ΔDAS-28 (ref <1.2)0.22 (0.09-0.52)11.12 (3.34-26.82)HAQ baseline1.13 (1.03-1.23)1.09 (0.92-1.29)Conclusion:In our cohort,10%of patients with RA were observed to have multi-refractoriness to bDMARDs. This study also identified baseline and early clinical characteristics of patients as predictors of multi-refractoriness, especially absence of clinical response during the first 6 months on a first bDMARD.References:[1]Arnett FC. Arthritis Rheum 1988;31:315-24.2Aletaha D. Arthritis Rheum. 2010;62:2569-81Disclosure of Interests:Marta Novella-Navarro: None declared, Chamaida Plasencia: None declared, Carolina Tornero: None declared, Karen Nathalie Franco Gomez: None declared, Irene Monjo: None declared, Victoria Navarro-Compán Consultant of: Abbvie, Lilly, Novartis, Pfizer, UCB, Speakers bureau: AbbVie, MSD, Lilly, Novartis, Pfizer, UCB, Diana Peiteado: None declared, Alejandro Balsa Grant/research support from: BMS, Roche, Consultant of: AbbVie, Gilead, Lilly, Pfizer, UCB, Sanofi, Sandoz, Speakers bureau: AbbVie, Lilly, Sanofi, Novartis, Pfizer, UCB, Roche, Nordic, Sandoz

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Oh, Bernice, Shawn Lee, Zelia Seeto, Germaine Liew, Edwynn Chiew, Zhi Wei Chen, Yiong Huak Chan, et al. "Successful Toxicity Reduction in Ma-Spore ALL 2010 in Standard/Intermediate Risk Childhood ALL: Replacing Cytarabine/Doxorubicin with More Vincristine and L-Asparaginase during Consolidation and Delayed Intensification." Blood 134, Supplement_1 (November 13, 2019): 1307. http://dx.doi.org/10.1182/blood-2019-122098.

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As ~90% children with Acute Lymphoblastic Leukemia (ALL) are now cured, the next challenge of contemporary ALL therapy is curing with less toxicity. To reduce toxicity, the Malaysia-Singapore ALL 2003 (MS2003) study lowered the intensity of induction in Standard(SR)/Intermediate Risk(IR) patients by removing Daunorubicin. However, toxicities causing prolonged delays during Consolidation and Delayed-Intensification(DI) remained major problems. To address these delays, the MS2010 study: (1) Replaced half of all cytarabine blocks with 2 doses of Vincristine(VCR) per block (2) Implemented Doxorubicin-free DI Protocol V (3) Added 1 dose of L-Asparaginase(L-Asp) to each DI block. Here, we report the significant improvements in MS2010 compared to MS2003 in terms of treatment-related toxicities. Methods MS2003 (Yeoh AEJ et al. J Clin Oncol 2012) started with a 3 drug induction for non-HR patients in a BFM ALL-IC 2002 backbone where SR consisted of 2x Protocol III and IR consisted of 3x Protocol III. In MS2010 (Yeoh AEJ et al. J Clin Oncol 2018), SR consisted of 2x Protocol V and IR consisted of 2x Protocol III + 1x Protocol V (Table 1). We performed a per-protocol analysis of 315 children with de novo SR/IR ALL, treated on MS2003 (n=183) and MS2010 (n=132) in 2 centers in Singapore, with a median follow up of 10.7 and 6.4years respectively. We analyzed clinical toxicity data, focusing on hospitalizations for fever (regardless of neutrophil count). Mean differences were adjusted for baseline characteristics including sex, race, age and Down syndrome. Results Overall decreased hospitalization stay and phase delays. In MS2010, the total duration of hospitalization for fever are fewer and shorter; this is most apparent for DI phases. For SR group, total length of stay during DI decreased from 13.7 to 6.1 days with adjusted(adj.) δ=7.0 days (95% CI 3.5-10.5, p<0.001). For IR group, this was from 19.1 to 11.5days with adj.δ=5.2 days (95% CI 0.2-10.3, p=0.042). In MS2010, overall delays in treatment are significantly reduced -- SR: From 65.9 to 16.4days, adj.δ=48.8 days(95% CI 39.8-57.8, p<0.001); IR: From 106.9 to 23.6days, adj.δ=80.9days (95% CI 68.4-93.5, p<0.001). The reduction in delays are mainly seen during Consolidation and DI. Overall, patients also completed intensive chemotherapy in a much shorter duration of time in MS2010 (see Table.1). Total ICU admissions were decreased (SR: 9.0% to 4.7% p=0.346 ; IR: 13.5% to 5.9% p=0.57). Total episodes of bacteremia were also decreased (SR: 31.2% to 18.75% p=0.708 ; IR 31.4% to 26.5% p=0.23). MS2010 Protocol III had 5 doses of L-Asp compared to 4 doses of L-Asp in MS2003 Protocol III. Although L-Asp is generally considered less myelosuppressive, there was a significant increase in the number of hospitalizations during MS2010 Protocol III blocks. This translated to longer hospitalizations per patient in MS2010 during those specific phases (III#1: adj.δ=-1.6 days 95% CI -2.8 to -0.3 p=0.017; III#2: adj.δ=-1.9 days 95% CI -3.2 to -0.6 p=0.006). These increases in hospitalizations in MS2010 Protocol IIIa were most likely due to an additional single dose of L-Asp. Equivalent survival outcomes Based on a per-protocol analysis, 5 year Event-Free survival(EFS) outcomes between the cohorts were equivalent. In the SR cohort, 5yr EFS was 93.6% (MS2003) vs. 95.5% (MS2010) p=0.685. In the IR cohorts, 5yr EFS improved from 89.4% (MS2003) to 95.6% (MS2010) p=0.151, although statistical significance was not reached. Overall, significant improvements: reduction in hospitalisation stays and reduction in treatment delays were observed in MS2010. This was achieved through a combination of (1) Replacing half of all cytarabine blocks with 2 doses of VCR per block; and (2) New DI Protocol V with no Anthracyclines. Despite the AIEOP-BFM 2000 experience of increased toxicity with Protocol III, our modifications to consolidation Ib and Protocol III have led to less phase delays, tolerable toxicities with comparable outcomes. Disclosures No relevant conflicts of interest to declare.

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Tuchman, Sascha, Chaitanya Acharya, William Mostertz, William Barry, Cristina Gasparetto, Bart Barlogie, Anil Potti, and John D. Shaughnessy. "Gene Expression Profiling Reveals 5-Azacytidine to Be a Novel, Potentially Effective Therapy for Poor-Prognosis Patients with Multiple Myeloma." Blood 114, no. 22 (November 20, 2009): 1833. http://dx.doi.org/10.1182/blood.v114.22.1833.1833.

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Abstract Abstract 1833 Poster Board I-859 Introduction Individualization of therapy for multiple myeloma (MM), based on gene expression profiling, has not yet been achieved. Methods We previously described a “metagene” genomic model that synergizes with standard clinical staging to robustly prognosticate in MM (ASCO 2009 meeting, oral abstract # 8521; submitted for publication). In the current work we queried the Connectivity Map (Lamb J et al., Science 313(5795):1929-35, 2006); http://www.broadinstitute.org/cmap) using the metagene model, to elicit novel therapies that are likely to mitigate the poor-prognosis clinical phenotype we can identify with that model. We then employed gene expression profiling, the metagene model, and probit binary regression analysis to classify 12 untreated MM cell lines as having a similar or dissimilar molecular phenotype to poor-prognosis patients. Lastly, we performed MTT tetrazolium viability assays to survey, in triplicate, the sensitivity of those cell lines to the drug identified as well as melphalan, which we used as a conventional therapeutic control. Results We used Connectivity Map to analyze the metagene model, which we had previously discovered and validated in silico using three patient cohorts with prospectively collected clinical follow-up data (n=624 total patients). In doing so, we elicited 5-azacytidine as a likely agent to reverse the poor-prognosis phenotype. Using the metagene model, we then characterized 8 untreated MM cell lines as having a “good prognosis” molecular phenotype (i.e., a gene expression profile dissimilar to poor-prognosis patients according to the metagene model), and 4 cell lines as having a “poor prognosis” molecular phenotype (i.e., similar to poor-prognosis patients based on the metagene model). “Poor-prognosis” cell lines were susceptible to viability reduction by 5-azacytidine in a dose-independent manner and, importantly, at a physiologically achievable dose in humans (5 μM), whereas ‘good-prognosis‘ cell lines were comparatively less susceptible (p=0.03 by repeated measures 2-way ANOVA). Conversely, melphalan, which we used as a clinically relevant control that was not elicited by our analysis of the metagene model as likely to be effective in poor-prognosis patients, reduced the viability of “good-prognosis” cell lines more than that of “poor-prognosis” cell lines (fig. 1; p=0.02). Conclusions Computational analysis of the extensively validated and clinically relevant metagene prognostic model indicates, and in vitro assays confirm, that 5-azacytidine is more effective in ameliorating a poor-prognosis phenotype than melphalan in a multiple myeloma pre-clinical model. This provides proof-of-concept that gene expression profiling may 1) reveal novel and effective therapeutic approaches for identifiable high-risk subgroups of patients, and 2) enable clinicians to decide prospectively which conventional agents, such as melphalan, are unlikely to be effective in certain patients' myeloma. Clinical trials are needed to study such individualized approaches to the treatment of this molecularly heterogeneous disease. Disclosures No relevant conflicts of interest to declare.

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Mukhtarova, Ziyafat. "Фазовые равновесия в системе Sm2Te3–GeTe." Kondensirovannye sredy i mezhfaznye granitsy = Condensed Matter and Interphases 21, no. 2 (June 15, 2019): 328–33. http://dx.doi.org/10.17308/kcmf.2019.21/770.

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Методами физико-химического анализа – дифференциально-термическим, высокотемпературным дифференциально-термическим, рентгенофазовым, микроструктурным, а также измерением микротвердости изучена система Sm2Te3–GeTe, которая является квазибинарным сечением тройной системы Ge–Sm–Te. При соотношении исходных теллуридов 1:1 (50 мол. %) и температуре 1100 К по перитектической реакции ж+Sm2Te3→ GeSm2Te4 образуется тройное соединение GeSm2Te4. Образцы системы, богатые GeTe, представляют собой компактные слитки блестяще-серого цвета, а сплавы, бо-гатые Sm2Te3 – спек черного цвета. Ликвидус системы Sm2Te3–GeTe состоит из трех ветвей: Sm2Te3, GeSm2Te4 и a-твердых растворов на основе GeTe. Рентгенофазовый анализ закристаллизованных образцов показал, что набор рентгеновских отражений соответствует фазам Sm2Te3, GeSm2Te4 и a-твердых растворов на основе GeTe. Установлено образование инконгруэнтно плавящегося соединения состава GeSm2Te4, которое может использоваться как термоэлектрический материал. На основе GeTe образуется узкая область твердого раствора REFERENCES Kohri H., Shiota , Kato M., Ohsugi J., Goto T. Synthesis and Thermolelectric Properties of Bi2Te3–GeTe Pseudo Binary System. Advances in Science and Technology, 2006, v. 46, pp. 168-173. https://doi.org/10.4028/www.scientifi c.net/ST.46.168 Gelbstein Y., Dado B., Ben-Yehuda O., Sadia Y., Dashevsky Z. and Dariel M. P. Highly effi cient Ge-Rich GexPb1-x Te thermoelectric alloys. Journal of Electronic Materials, 2010, v. 39(9), pp. 2049–2052. https://doi.org/10.1007/s11664-009-1012-z Gelbstein Y., Davidow J., Girard S.N., Chung D. Y. and Kanatzidis M. Controlling Metallurgical Phase Separation Reactions of the Ge0.87 Pb0.13Te Alloy for High Thermoelectric Performance. Advanced Energy Materials, 2013, v. 3, pp. 815–820. https://doi.org/10.1002/aenm.201200970 Gelbstein Y., Dashevsky Z. and Dariel M. P. Highly efficient bismuth telluride doped p-type Pb0.13Ge0.87Te for thermoelectric applications. Physical Status Solidi, 2007, v. 1(6), pp. 232–234. https://doi.org/10.1002/pssr.200701160 Gelbstein Y., Ben-Yehuda O., Dashevsky Z. and Dariel M. P. Phase transitions of p-type (Pb,Sn,Ge)Tebased alloys for thermoelectric applica tions. Journal of Crystal Growth, 2009, v. 311(18), pp. 4289–4292. https://doi.org/10.1007/s11664-008-0652-8 Gelbstein Y., Ben-Yehuda O., Pinhas E., et al. Thermoelectric properties of (Pb,Sn,Ge) Te-based alloys. Journal of Electronic Materials, 2009, v. 38(7), 1478–1482. https://doi.org/10.1007/s11664-008-0652-8 Li J., Chen Z., Zhang X., Sun Y., Yang J., Pei Y. Electronic origin of the high thermo- electric performance of GeTe among the p-type group IV monotellurides. NPG Asia Materials, 2017, v. 9, p. 353. https://doi.org/10.1038/am.2017.8 Sante D. Di., Barone P., Bertacco R., Picozzi S. Electric control of the giant rashba effect in bulk GeTe. Advanced materials, 2013, v. 25(27), pp. 3625–3626. https://doi.org/10.1002/adma.201203199 Li J., Zhang X., Lin S., Chen Z., Pei Y. Realizing the high thermoelectric performance of GeTe by Sbdoping and Se-alloying. Mater., 2017, v. 29(2), pp. 605–611. https://doi.org/10.1021/acs.chemmater.6b04066 Abrikosov N. Kh., Shelimova L. B. Poluprovodnikovye materialy na osnove soedineniy AIV BVI. [Semiconductor materials based on compounds АIV В]. Moscow, Nauka Publ., 1975, 195 p. (in Russ.) Korzhuev M. A. Vliyaniye legirovaniya na parametric of GeTe. Series 6. [Effect of doping on GeTe Series 6]. Moscow, 1983, no. 6 (179), pp. 33–36. (in Russ.) Okoye I. Electronic and optical properties of SnTe and GeTe. Journal of Physics: Condensed Matter, 2002, 14(36), pp. 8625–8637. https://doi.org/10.1088/0953-8984/14/36/318 Gelbstein Y., Rosenberg Y., Sadia Y. and Dariel M. P. Thermoelectric properties evolution of spark plasma sintered (Ge0.6Pb0.3Sn0.1)Te following a spinodal decomposition. Journal of Physical Chemistry, 2010, v. 114(30), pp. 13126–13131. https://doi.org/10.1021/jp103697s Rosenthal T., Schneider N., Stiewe C., Düblinger M., Oeckler O. Real Structure and thermoelectric properties of GeTe-rich germanium antimony tellurides. Mater., 2011, v. 23(19), pp. 4349–4356. https://doi.org/10.1021/cm201717z Li J., Chen Z., Zhang X., Yu H., Wu Z., Xie H., Chen Y., Pei Y. Simultaneous optimization of carrier concentration and alloy scattering for ultrahigh. Mater., 2017, v. 4(12), p. 341. https://doi.org/10.1002/advs.201700341 Bletskan D. I. Phase equilibrium in the system AIV-BVI-part II: systems germanium-chalcogen. Journal of Ovonic Research, 2005, v. 1(5), p. 53–60. Li S. P., Li J. Q., Wang Q. B., Wang L., Liu F. S., Ao W. Q. Synthesis and thermoelectric properties of the (GeTe)1-x(PbTe)x alloys. 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Dao, An T. T., Kohei Hosokawa, Chiharu Sugimori, Luis J. Espinoza, Kana Maruyama, Yoshitaka Zaimoku, Hiroyuki Maruyama, et al. "A Profound Decrease in FoxP3+Helios+CD4+ T Cells in a Subset of Patients with Acquired Aplastic Anemia and Pure Red Cell Aplasia: A Common Mechanism Underlying a Dependency on Cyclosporine." Blood 124, no. 21 (December 6, 2014): 4384. http://dx.doi.org/10.1182/blood.v124.21.4384.4384.

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Abstract Background: A subset of patients with acquired aplastic anemia (AA) require low-dose cyclosporine (CsA) to maintain good hematopoietic function even after achieving a remission with immunosuppressive therapy (IST). Such CsA-dependent AA offers opportunities to clarify the immune mechanisms underlying bone marrow (BM) failure, but little is known about the mechanism(s) underlying this condition except for its close association with a particular HLA-class II allele DRB1*15:01. Regulatory T cells (Tregs), defined as CD4+CD25highFoxP3+ T cells, have been shown to be decreased in patients with severe AA at diagnosis and to recover to normal levels in association with hematological recovery after successful IST. An insufficient Treg recovery may account for dependency on CsA in a particular subset of AA patients, and also in patients with idiopathic pure red cell aplasia (PRCA), another typical immune-mediated BM failure of which remission is known to depend on CsA in virtually all patients. To test this hypothesis, we determined the percentage and absolute number of Tregs, as well as Th1, Th2 and Th17 cells, in various types of immune-mediated BM failure, using an anti-FoxP3 antibody (Ab) and anti-Helios Ab that allows enumeration of the functional Tregs more precisely than conventional methods. Methods: Different CD4+ Treg subsets were enumerated using a multicolor flow cytometry assay. Peripheral blood mononuclear cells (PBMCs) were stimulated by phorbol myristate acetate (PMA) and ionomycin in the presence of monensin for four hours, then were subjected to flow cytometry to determine the percentage of CD4+ T cells positive for cytoplasmic interferon-γ (Th1), interleukin 4 (Th2) and interleukin 17 (Th17). CsA-dependent AA was defined as AA with two or more episodes of relapse of pancytopenia that occurred during more than one year of therapy, followed by a good response to CsA. All six patients with CsA-dependent AA had normal blood cell counts and HLA-DR15 (DRB1*15:01 in five and DRB1*15:02 in one). Results: The normal ranges of each T cell subset percentage and the absolute numbers determined in 47 healthy volunteers (HVs) were: FoxP3+Helios+ Tregs 6.5±1.6%/ 47.7±13.8/µl, Th1 22.3±6.6%/ 151.2± 45.5/µl, Th2 5.5±1.6%/ 38.3±170.9/µl and Th17 1.7± 0.7%/ 11.2± 4.7/µl. The expression of FoxP3 by CD4+ T cells decreased with time after sampling, and this assay therefore necessitated analyses within 16 hours after sampling using fresh PBMCs. Compared to healthy volunteers, the percentage and absolute number of FoxP3+Helios+ Treg cells were significantly lower in the five patients with severe AA at diagnosis (3.7±1.1%, 22.7±6.8/µl) and in six CsA-dependent AA patients (3.4±0.8%, 13.8±12.3/µl) (Figure). In contrast, the Treg percentages were comparable to those of the HVs in four AA patients on CsA in convalescence (5.8±1.0%) and nine patients in remission off CsA (6.3±1.1%) while the absolute numbers of FoxP3+Helios+Tregs (27.3±19.2/µl, 32.3±13.3/µl) in these groups were lower than those of the HVs. On the other hand, the percentages of all other CD4+ T cell subsets were comparable among the four different groups and HVs. The apparent decrease in FoxP3+Helios+ Tregs despite normal blood cell counts in patients with CsA-dependent AA prompted us to screen nine patients with idiopathic PRCA whose erythropoietic functions were all dependent on CsA. The FoxP3+Helios+ Tregs were decreased in both the percentage and absolute count (3.1±0.5%, 12.1±5.9/µl) in all of these patients, including two patients whose PBMCs were examined before CsA therapy. As a result, the ratios of Th1/Treg and Th17/Treg were markedly higher in newly-diagnosed AA (12.5±3.4, 0.9±0.8), CsA-dependent AA (12.6±12.1, 1.1±1.5) and PRCA (10.6±7.7, 0.7±0.3) patients than in AA patients in convalescence (6.1±4.3, 0.4±0.1) and those in remission (3.8±2.3, 0.4±0.2), which were comparable to the HVs Th1/Treg and Th17/Treg ratios (3.3±0.9, 0.3±0.2). Conclusions: Decreased percentages and absolute counts of Tregs, as well as increased Th1/Treg and Th17/Treg ratios, are common features in patients with CsA-dependent AA and PRCA. A persistent decrease in Tregs may serve as a good marker for predicting AA relapse in patients responding to CsA. Figure 1 Figure 1. Disclosures No relevant conflicts of interest to declare.

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H., Findlay R. "Geometry, kinematics and regional significance of faulting and related lamprophyric intrusion in the mineralised zone at the Pu Sam Cap complex, Northwest Vietnam." VIETNAM JOURNAL OF EARTH SCIENCES 40, no. 4 (September 18, 2018): 320–40. http://dx.doi.org/10.15625/0866-7187/40/4/13102.

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The alkali volcanics and intrusive rocks, dated at around 35-33Ma, are cut by mineralised northeast and east trending faults showing predominant evidence for strike-slip. Mineralisation includes haematite-Au-Cu and is accompanied by iron-rich alteration of the volcanic rocks. Detailed assessment of the geometry of the fault system at Pu Sam Cap suggests that the faults formed as a Riedel shear system during left-lateral slip within the Song Hong-Song Chay shear zone and the numerous contemporaneous northwest trending faults to the south; the northeast trending faults are interpreted as dextral “book-end’’ faults between major northwest trending faults enclosing the Pu Sam Cap massif. As mineralisation is hosted within these faults and is also associated with lamprohyric dykes it confirms a thermal event younger than the alkaline volcanics and syenitic intrusives at Pu Sam Cap, suggesting a hidden, young porphyry system. The age of faulting, and thus the maximum age for this young intrusive event, is attributed to the 23-21Ma period of late-stage left-lateral strike-slip motion across northwest Vietnam.ReferencesAnczkiewicz R., Viola G., Muntener O., Thrirlwall M., Quong N.Q., 2007. Structure and shearing conditions in the Day Nui Con Voi massif: implications for the evolution of the Red River Fault. Tectonics 26: TC2002.Cao Shunyun, Liu Junlai, Leis B., Zhao Chunquiang 2010. New zircon U/Pb geochronology of the post-kinematic granitic plutons in Diancang Shan Massif along the Ailao-Shan-Red River Shear Zone and its geological implications. Acta Geologica Sinica (English Edition), 84, 1474-1487.Chung S.-L., Lee T., Lo C., et al., 1997. Intraplate extension prior to continental extrusion along the Ailao Shan-Red River shear zone.Geology, 25, 311-314.Cloos H., 1928. Experimentezurinnern Tektonik. Zentralblatt fur Mineralogie und Palaeontologie, 1928, 609-621.Findlay R.H., Phan Trong Trinh 1997. The structural setting of the Song Ma region, Vietnam, and the Indochina-South China plate boundary problem. Gondwana Research, 1, 11-33.Jolivet L., Beysasac O., Goffe B., Avigad D., Leprevrier C., Maluski H., Ta Trong Thang, 2001. Oligo-Miocene midcrustal subhorizontal shear in Indochina. Tectonics, 20, 46-57.Khuong The Hung 2010. The complex tectonic events and their influence on formation of mineral deposits in northwest Vietnam. Unpublished PhD Thesis, University of Science and Technology, Cracow, 167p.Leloup P.H., N. Arnau, R. Lacassin, J.R. Kienast, T.M. Harrison, P.T. Trinh, A. Replumaz and P. Tapponnier, 2001. New constraints on the structure, thermochronology and timing of the Ailao Shan - Red river shear zone, SE Asia, J. G. R., 106, 6657-6671.Leloup PH.., R. Lacassin, P. Tapponnier, U. Scharer, Zhong Dalai, Liu Xaohan, Zhangshan, Ji Shaocheng and PT.Trinh, 1995. The Ailao Shan - Red river shear zone (Yunnan, China), Tertiary transform boundary of Indochina, Tectonophysics, 251, 3-84. Leprevier C., Maluski H., Nguyen Van Vuong, Roques D., Axente V., Rangin C., 1996. Indosinian NW-trending shear zones within the Truong Son belt, Vietnam: 40Ar-39Ar Triassic ages and Cretaceous to Cenozoic overprints. Tectonophysics, 283, 105-107.Lien-Sheng Zhang, Scharer U. 1999. Age and origin of magmatism along the Cenozoic Red River shear belt, China. Contributions to Mineralogy and Petrology, 134, 67-85.Nagy E.A., Scharer U., Minh N.T., 2000. Oligo-Miocene granitic magmatismin central Vietnam and implications for continental deformation in Indochina. Terra Nova, 12, 67-76.Nguyen Thi Bich Thuy, 2016. Isotop dating U-Pb Zircon of Syenit Formation, Pu Sam Cap. Journal of Geology, A Serie, 356, 30-36. (In Vietnamese).Pei-Long Wang, Ching-Hua Lo, Tung-Yi Lee, Sun-ling Chun, Ching-Yan Lan, Nguyen Trong Yem 1998. Thermochronological evidence for the movement of the Ailo Shan-Red River shear zone, a perspective from Vietnam. Geology, 26, 887-890.Phan Trong Trinh, Nguyen Trong Yem, Herve L.P., Tapponnier P., 1994. Late Cenozoic stress fields in North Vietnam from microtectonic measurements. Proceedings of the International Workshop on Seismotectonics and Seismic Hazard in Southeast Asia. Geological Survey of SR Vietnam, Hanoi, 182-186.Riedel W., 1929. Zur Mechanikgreologischer Brucherscheinungen. Zentralblatt fur Mineralogie und Palaeontologie, Abhandlung B, 354-368.Scharer U., Tapponnier P., Lacassin R., Leloup P.H., Dalai Z., Shaosheng J., 1990. Intraplate tectonics in Asia: a precise age for large-scale Miocene movement along the Ailao Shan-Red River shear zone, China. Earth and Planetary Science Letters, 97, 65-77.Scharer U., Zhang L.S., Tapponnier P., 1994. Duration of strike-slip movements in large shear zones: the Red River belt, China. Earth and Planetary Science Letters, 126, 379-397.Searle M.P., 2006. Role of the Red River Shear zone, Yunnan and Vietnam, in the continental extrusion of SE Asia. Journal of the Geological Society, London, 163, 1025-1036.Searle M.P., Meng-Wan Yeh, Te-Hsien Lin, Sun-Lin Chung, 2010. Structural constraints on the timing of left-lateral shear along the Red River shear zone in the Ailao Shan and Diancang Shan Ranges, Yunnan, SW China. Geosphere, 6, 316-338.Tapponnier P., Lacassin R., Leloup H., Scharer U., Zhong Dalai, Wu Hawei, Liu Ziaohan, Ji Shaocheng, Zhang Lianshang, Zong Jiayou, 1990. The Ailao Shan/ Red River metamorphic belt: Tertiary left-lateral shear between Indochina and south China. Nature, 342, 431-437.Tchalenko J.S., 1970. Similarities between shear zones of different magnitudes. Bulletin of the Geological Society of America, 81, 1625-1640.Viola G., Anczkiewicz R. 2009. Exhumation history of the Red River shear zone in northern Vietnam: new insights from zircon and apatite fission-track analysis. Journal of Asian Earth Sciences, 33, 78-90.Yang Yiseng, Hong Qun, Hu Huan-ting, Hieu Pham Trung, Nguyen Thi Bich Thuy, Chen Fu-kun, 2013. Geochemical characteristics and genesis of the Cenozoic porphyry in the Laizhou area, northwestern Vietnam. Acta Petrologica Sinica, 29(3), 899-911. (In Chinese with English abstract, full English version through Google Translate).

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