Journal articles: 'Cohorts Treatment'

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Chang, Lawrence, Peter S. Hall, Luciana Preger, Nikoleta Sjekloca, Estevan Bergamaco, Anne Broe, Plamena Petrova, et al. "Real-world treatment patterns and outcomes among patients (pts) with second-line (2L) and third-line (3L) metastatic triple-negative breast cancer (mTNBC) in England using the Cancer Analysis System (CAS)." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): 1075. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.1075.

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1075 Background: TNBC is the most aggressive type of breast cancer due to rapid growth, metastasis, and recurrence post-treatment. This study aimed to assess real-world treatment patterns and survival of pts with mTNBC who received 2L and 3L therapy in England and report OS and PFS of pts receiving 2L therapies stratified by treatment-free interval from the curative setting. Methods: This retrospective study using the CAS database, included pts with mTNBC who received at least three systemic treatments (at least two in metastatic setting) for TNBC during the years 2012 to 2020. Cohort2L included pts with initial early-stage BC diagnosis and treatment (at least two systemic treatments prior to 2L). Cohort3L included pts initially diagnosed with either early-stage TNBC, or de novo advanced TNBC (at least two systemic treatments prior to 3L). The two cohorts are not mutually exclusive. The study outcomes were stratified by cohort (Cohort2L and Cohort3L) and treatment-free interval (<12 m versus ≥12 m from end of curative treatment to start of 1L treatment, Cohort2L only). Kaplan-Meier methods estimated progression-free survival (PFS) and overall survival (OS). PFS was proxied by ‘Time to treatment discontinuation or death’ (TTDD). Log-rank tests compared the distribution of OS and PFS for 2L stratified by treatment-free interval (<12 m versus ≥12 m). Results: Cohort2L included 606 pts and Cohort3L included 374 pts. Tumor morphology was similar across Cohorts. Pts at 3L had worse ECOG performance score compared to 2L, and more pts with de novo advanced TNBC had brain metastasis at any point after diagnosis than pts diagnosed with early-stage TNBC. Regimens at 2L for Cohort2L included capecitabine (32%), eribulin (16%), carboplatin and gemcitabine in combination (12%), and paclitaxel (10%). A similar distribution was seen for Cohort3L. Regimens at 3L (Cohort3L only), included eribulin (38%), capecitabine (16%), and paclitaxel (13%). Stratifying Cohort2L by treatment-free interval did not exhibit significant differences in PFS nor OS by log rank tests (Table). Conclusions: This nationwide study, in England, accentuates the significant unmet need in 2L and 3L therapy for mTNBC highlighted by the poor prognosis. The stratification by prior treatment-free interval from curative setting did not show a difference in OS or PFS for patients receiving 2L treatment. [Table: see text]

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Sidiqi, M. Hasib, Mohammed A. Aljama, Francis K. Buadi, Rahma M. Warsame, Martha Q. Lacy, Angela Dispenzieri, David Dingli, et al. "Stem Cell Transplantation for Light Chain Amyloidosis: Decreased Early Mortality Over Time." Journal of Clinical Oncology 36, no. 13 (May 1, 2018): 1323–29. http://dx.doi.org/10.1200/jco.2017.76.9554.

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Purpose Autologous stem-cell transplantation (ASCT) has been used in patients with immunoglobulin light chain (AL) amyloidosis for more than two decades. Early experience raised concerns regarding safety with high early-mortality rates. Patients and Methods We report 20 years of experience with ASCT for AL amyloidosis at the Mayo Clinic Rochester. In all, 672 consecutive patients receiving ASCT for AL amyloidosis were divided into three cohorts on the basis of date of transplantation (cohort 1, 1996-2002 [n = 124]; cohort 2, 2003-2009 [n = 302]; and cohort 3, 2010-2016 [n = 246]). Results The median age for the entire cohort was 59 years, with patients in cohort 3 being slightly older than those in the other two cohorts (60 v 58 v 54 years for cohorts 3, 2, and 1, respectively; P < .001). Fewer patients in cohort 3 had more than two organs involved (9% v 18% v 19% for cohorts 3, 2, and 1, respectively; P < .001). More patients received pretransplantation therapy in cohort 3 compared with earlier time periods (49% v 38% v 42% for cohorts 3, 2, and 1, respectively; P = .02). Hematologic response was higher in cohort 3 (84% v 79% v 69% for cohorts 3, 2, and 1, respectively; P = .002). Median overall survival for the entire cohort was 122 months and improved over time (not reached v 120 months v 75 months for cohorts 3, 2, and 1, respectively; P < .001). Treatment-related mortality declined over time (2.4% v 8.6% v 14.5% for cohorts 3, 2, and 1, respectively; P < .001). On multivariable analysis, conditioning dose, Mayo stage 2012, and hematologic response were independent predictors of survival. Conclusion ASCT is a highly effective therapy for AL amyloidosis. The improved survival and markedly reduced treatment-related mortality in eligible patients indicate that this will remain an important first-line option even in the era of treatment approaches that use novel agents.

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Sun, Jenny W., Rui Wang, Dongdong Li, and Sengwee Toh. "Use of Linked Databases for Improved Confounding Control: Considerations for Potential Selection Bias." American Journal of Epidemiology 191, no. 4 (January 6, 2022): 711–23. http://dx.doi.org/10.1093/aje/kwab299.

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Abstract Pharmacoepidemiologic studies are increasingly conducted within linked databases, often to obtain richer confounder data. However, the potential for selection bias is frequently overlooked when linked data is available only for a subset of patients. We highlight the importance of accounting for potential selection bias by evaluating the association between antipsychotics and type 2 diabetes in youths within a claims database linked to a smaller laboratory database. We used inverse probability of treatment weights (IPTW) to control for confounding. In analyses restricted to the linked cohorts, we applied inverse probability of selection weights (IPSW) to create a population representative of the full cohort. We used pooled logistic regression weighted by IPTW only or IPTW and IPSW to estimate treatment effects. Metabolic conditions were more prevalent in linked cohorts compared with the full cohort. Within the full cohort, the confounding-adjusted hazard ratio was 2.26 (95% CI: 2.07, 2.49) comparing initiation of antipsychotics with initiation of control medications. Within the linked cohorts, a different magnitude of association was obtained without adjustment for selection, whereas applying IPSW resulted in point estimates similar to the full cohort’s (e.g., an adjusted hazard ratio of 1.63 became 2.12). Linked database studies may generate biased estimates without proper adjustment for potential selection bias.

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Qin, Shukui, Jiafu Ji, Rui-hua Xu, Wei Wang, Yong Tang, Feng Bi, Jin Li, et al. "Treatment patterns and outcomes in Chinese gastric cancer by HER2 status: A non-interventional registry study (EVIDENCE)." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): 4025. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.4025.

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4025 Background: Gastric cancer (GC) is the second leading cause of cancer-related deaths in China. Trastuzumab (TRA) has been used to treat HER2+ metastatic gastric cancer (mGC) in China since 2012. However, real-world data on effectiveness and safety in Chinese patients are limited. Methods: This prospective, multicenter (85 hospitals), real-world noninterventional registry study evaluated the effectiveness and safety of TRA in five cohorts of Chinese GC patients with different HER2 statuses from April 2013 to June 2018. Effectiveness analysis was conducted in three cohorts: Cohort I (HER2+ mGC with TRA), Cohort II (HER2+ mGC untreated with TRA) and Cohort IV (HER2− mGC untreated with TRA). Safety outcomes of TRA-related adverse events (AEs) were analyzed in Cohort I. Results: Cohorts I, II and IV included 709 patients (174, 113 and 422, respectively; mean age 57.8 years; 72% male); 64.9% of patients were ECOG 0–1, 93.7% had a primary GC tumor and 42.3% were at stage T4. Progressive disease was the cause of death in 32.8%, 27.4% and 29.9% in Cohorts I, II and IV, respectively. Respective mean duration of follow-up was 422.5, 287.5 and 277.5 days. Median overall survival (OS) was 22.3, 17.2 and 17.4 months, respectively. After excluding patients who had surgery, the respective median OS was 19.9, 15.3, and 12.6 months. For the first-line treatment, the median OS in Cohort I was 22.1 months, and the median progression free survival (PFS) was 8.2, 6.9 and 6.2 months in Cohorts I, II and IV, respectively. Response rates (RR) for first-line treatment in Cohorts I, II and IV were 51.7%, 18.4% and 32.8%, respectively. After propensity score matching, OS, PFS and RR were all significantly better in Cohort I versus II (all P<0.05). The most common regimen, TRA+XELOX (capecitabine+oxaliplatin), was estimated to have the longest median OS at 34.6 months. Grade ≥3 AEs were reported in 33.9% (59/174) of patients in Cohort I; anemia was the most common AE (12.1%). Conclusions: TRA improved OS and PFS in Chinese HER2+ mGC patients compared with chemotherapy alone and was well tolerated and effective when combined with a range of other therapies in a real-world setting. Clinical trial information: NCT01839500.

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Lamy, Francois-Xavier, Daniel C. Beachler, Leo J. Russo, Stephan Lanes, Jade Dinh, Devon H. Taylor, Ruihua Yin, Aziza Jamal-Allial, and Patrice Verpillat. "Characteristics, treatment patterns, and survival from three cohorts of advanced or metastatic cancer patients using healthcare claims data in the United States." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): e13082-e13082. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.e13082.

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e13082 Background: Our main objective was to identify, in healthcare claims data, patients with advanced or metastatic: urothelial carcinoma (amUC), gastric cancer (amGC) and non-small cell lung cancer (amNSCLC) and to report on their characteristics, treatments, and survival rates using contemporaneous real-world data. Methods: This cohort study was conducted in the HealthCore Integrated Research Database (HIRD), from January 2010 to January 2018, which contains healthcare claims data from commercial health plans across the US (60 million lives). We applied algorithms, previously validated on registry data, to the HIRD to define 3 cohorts of advanced stage cancer. Cohort characteristics and treatment patterns were described. Patient vital status was captured through probabilistic linkage with the National Death Index (NDI) and survival was assessed using the Kaplan-Meier method. Results: Algorithms to predict advanced stage cancer resulted in the following cohorts: 1,501 amUC, 6,253 amGC and 38,451 amNSCLC cases. Most patients in each cohort were de novo advanced or metastatic, but subsets were diagnosed at early stage and progressed to advanced stage (ranging from 15.1% for amNSCLC to 23.1% for amUC). Patient characteristics, treatments and survival outcomes are described in Table. Not all received systemic treatment; Immune Checkpoint inhibitors (ICI) were used in 5.3%, 2.2% and 10.8% of treated amUC, amGC and amNSCLC patients, respectively. Conclusions: In these cohorts of advanced or metastatic cancer patients, median survival time was limited despite most receiving treatment: radiation, systemic therapy or surgery. Treatment with ICI was low despite recent data in amUC and amNSCLC. Characteristics, treatments, and survival from estimated advanced stage date. [Table: see text]

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Joshi, Vandana, Christine E. Grella, and Yih-Ing Hser. "Drug Use and Treatment Initiation Patterns: Differences by Birth-Cohorts." Journal of Drug Issues 31, no. 4 (October 2001): 1039–62. http://dx.doi.org/10.1177/002204260103100412.

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Data from Drug Abuse Treatment Outcome Studies (DATOS) were used to examine differences in correlates of early stages of drug use patterns by birth-cohorts and gender. Males showed a steady increase in family problems in each birth cohort, compared to females who showed a higher mean number of family problems in each birth cohort. The findings suggest different correlates of the early stages of drug-use pattern namely; experimentation with drugs before the onset of weekly drug use and early age of escalated or weekly drug use. Experimentation was associated with delayed onset of escalated drug use. “Experimenters” were associated with illegal activities and mental health problems, whereas “early escalators” were associated with childhood and school problems. The positive association of onset of illegal activities and psychological symptoms before the onset of weekly drug use with experimentation and delayed onset of escalated drug use was consistent across gender and birth-cohorts. Similarly, the association of family and school problems with early age of onset of escalated drug use was also consistent across gender and birth cohorts. Treatment providers can benefit from a better understanding of clients' pathways and progression of addiction careers in order to assess their treatment needs.

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Tredan, Olivier, Marie Laurent, Melina Gilberg, Rim Ghorbal, Alexandre Vainchtock, Joannie Lortet-Tieulent, Martin Prodel, and Julien Dupin. "Innovative Approach for a Typology of Treatment Sequences in Early Stage HER2 Positive Breast Cancer Patients Treated With Trastuzumab in the French National Hospital Database." Cancer Informatics 21 (January 2022): 117693512211351. http://dx.doi.org/10.1177/11769351221135134.

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Background: Our objective was to describe the hospital-based systemic treatment sequences in early stage HER2+ breast cancer patients treated with trastuzumab in France in 2016. Methods: This retrospective observational study was based on the national hospital discharge database (PMSI). Patients hospitalized for breast cancer in 2016 and administration of trastuzumab between 6 months prior and 1 year after surgery were included. The following treatments were identified: (1) trastuzumab ± chemotherapy; (2) chemotherapy alone; (3) q3w trastuzumab weekly chemotherapy. Hospital admissions for cardiac events before and after the surgery were investigated. An unsupervised machine learning technic called TAK (Time-sequence Analysis through K-clustering) was used to identify and visualize typical systemic treatment sequences. Results: Overall, 3531 patients were included: 2619 adjuvant cohort patients (74.2%) and 912 neoadjuvant cohort patients (25.8%). The mean age was 56.4 years (±12.3), 99.7% patients were female. Treatment initiation occurred within 6 weeks of the surgery in 58% and 92% of patients, and trastuzumab treatment lasted 12 months (±1 month) in 75% and 66% of patients in the adjuvant and neoadjuvant cohorts, respectively. Nevertheless, 12% and 22% of patients were treated with trastuzumab for <11 months in the adjuvant and neoadjuvant cohorts, respectively. There was not one standard sequence of treatments per cohort, but 4 and 3 typical treatment sequences in the adjuvant and the neoadjuvant cohorts, respectively, plus 2 treatment sequences with an early treatment withdrawal. The frequency of patients with ⩾1 hospital stay with a cardiac event was higher among patients with an early treatment withdrawal. Conclusions: The treatment sequences of most patients were in line with the recommendations in force. The machine learning approach provided a telling visual display of the results, thereby allowing healthcare professionals, health authorities, patients, and care givers to see the whole picture of the hospital-administered drug strategies.

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Kuykendall, Andrew, Chetasi Talati, Najla Al Ali, Eric Padron, David Sallman, Jeffrey E. Lancet, Kendra L. Sweet, Alan F. List, Kenneth S. Zuckerman, and Rami S. Komrokji. "Comparing Eras: Assessing Treatment Trends before and after Ruxolitinib Approval." Blood 128, no. 22 (December 2, 2016): 3124. http://dx.doi.org/10.1182/blood.v128.22.3124.3124.

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Abstract Background: Ruxolitinib is a JAK1/2 inhibitor that gained FDA approval for treatment of intermediate and high-risk myelofibrosis (MF) in 2011. Prior to ruxolitinib, a variety of treatments were used for myelofibrosis, with variable efficacy. Even in the ruxolitinib era, treatment decisions are primarily focused on symptom management, as no treatment, other than allogeneic hematopoietic stem-cell transplant (allo-HSCT) has shown to have a strong disease-modifying effect. Ruxolitinib significantly improves splenomegaly and constitutional symptoms associated with MF. Here, we aim to compare MF treatments before and after ruxolitinib approval to assess treatment patterns and impact on clinical outcomes. We hypothesized that an increased use of ruxolitinib after its FDA-approval would affect those with constitutional symptoms and/or splenomegaly and correlate with decreased use of other treatments aimed at these symptoms. Methods: This was a single institution, retrospective study of all patients with a diagnosis of MF who were seen at our center between 2/2001 and 6/2016. The World Health Organization 2016 definition of primary myelofibrosis (PMF) was used for confirmation of diagnosis. Initial treatment was defined as first treatment after diagnosis of MF. Specific phenotypes were assigned retrospectively based on chart review reflecting the patient's initial complaints which led to diagnosis. Results: We identified 312 eligible patients. This group was divided into two cohorts: those diagnosed prior to the ruxolitinib era (cohort PRE, n = 177) and those diagnosed in the ruxolitinib era (cohort POST, n = 135). Demographics (gender, race, age at diagnosis) and presenting features were comparable between the cohorts. In the PRE cohort, JAK2 inhibitor use occurred in the setting of a clinical trial as well as in patients who were diagnosed prior to ruxolitinib approval, but first received treatment after its approval. In this cohort, 25% of patients received a JAK2 inhibitor, with 36% of these patients receiving it as frontline therapy (see figure 1). This compared to 44% of POST patients who received a JAK-2 inhibitor, with 69% receiving it in the frontline setting. POST patients were, more likely to receive ruxolitinib overall (OR 2.28, p = 0.001) and as first-line therapy (OR 4.49, p < 0.0001). POST patients were less likely to receive an erythropoiesis-stimulating agent (ESA) overall (OR 0.40, p = 0.0003) and as first line therapy (OR 0.51, p = 0.02). Thalidomide was also less commonly used in the POST patients (OR 0.34, P = 0.003). The use of hydroxyurea was similar between cohorts. When stratified based on the presence of constitutional symptoms (CS) and/or splenomegaly (S), patients most commonly received an ESA, JAK-2 inhibitor, or hydroxyurea as frontline therapy (see figure 2). When both CS and S were present, patients more commonly received the latter two options. Patients presenting with CS and S were more likely to receive ruxolitinib as first line therapy in the POST cohort compared to the PRE (OR 5.5, p = 0.0004); however, the use of first line hydroxyurea was not significantly different between the PRE and POST cohorts (p = 0.28). In all, ten separate frontline treatments were used in the symptomatic PRE cohort while only five were utilized in POST patients. In patients presenting without constitutional symptoms or splenomegaly, there was no difference in initial treatment strategy in the PRE and POST cohorts, and ruxolitinib was rarely utilized in this patient population. No difference in overall survival (OS) was noted between the two cohorts. Conclusion:After FDA-approval, ruxolitinib has emerged as the most common first-line treatment option for MF, specifically in patients with constitutional symptoms and splenomegaly, with decreased up-front use of thalidomide, ESAs and hydroxyurea. Patients presenting without constitutional symptoms or splenomegaly were no more likely to received ruxolitinib in the post-approval era, indicating a preference for alternative treatment options in this group. Longer follow up is needed to assess survival impact of frontline ruxolitinib use in our patient population. Disclosures Sweet: Karyopharm: Honoraria, Research Funding; Ariad: Consultancy, Speakers Bureau; Pfizer: Speakers Bureau; Novartis: Consultancy, Speakers Bureau; Incyte Corporation: Research Funding. Komrokji:Novartis: Consultancy, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding.

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Goetz, Michal, Chin-Bin Yeh, Igor Ondrejka, Aynur Akay, Ilona Herczeg, Iuliana Dobrescu, Boong Nyun Kim, et al. "A 12-Month Prospective, Observational Study of Treatment Regimen and Quality of Life Associated With ADHD in Central and Eastern Europe and Eastern Asia." Journal of Attention Disorders 16, no. 1 (September 21, 2010): 44–59. http://dx.doi.org/10.1177/1087054710381480.

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Objectives: This prospective, observational, non-randomized study aimed to describe the relationship between treatment regimen prescribed and the quality of life (QoL) of ADHD patients in countries of Central and Eastern Europe (CEE) and Eastern Asia over 12 months. Methods: 977 Male and female patients aged 6-17 years seeking treatment for symptoms of ADHD were assessed using the Child and Adolescent Symptom Inventory-4 Parent Checklists, and the Clinical Global Impressions-ADHD-Severity scale. QoL was assessed using the Child Health and Illness Profile-Child Edition parent report form. Patients were grouped according to whether they were prescribed psycho- and/or pharmacotherapy (treatment) or not (no/‘other’ treatment). Results: No statistically significant differences were observed between cohorts (treatment vs. no/‘other’ treatment) in terms of change in QoL, although there was improvement over 12 months, with a greater improvement experienced by patients in the treatment cohort in both study regions (CEE and Eastern Asia). Psychoeducation/counselling and methylphenidate were the predominant ADHD treatments prescribed. Conclusions: Although both treatment and no/‘other’ treatment cohorts showed improvements in mean QoL over 12 months, the difference was small and not statistically significant. A major limitation was the higher than anticipated number of patients switching treatments, predominantly from the no/‘other’ treatment cohort.

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Beachler, Daniel C., Francois-Xavier Lamy, Leo J. Russo, Stephan Lanes, Jade Dinh, Devon H. Taylor, Ruihua Yin, Aziza Jamal-Allial, and Patrice Verpillat. "Characteristics, treatment patterns, and survival from three cohorts of advanced or metastatic cancer patients using health care claims data in the United States." Journal of Clinical Oncology 37, no. 27_suppl (September 20, 2019): 129. http://dx.doi.org/10.1200/jco.2019.37.27_suppl.129.

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129 Background: Our main objective was to identify, in healthcare claims data, patients with advanced or metastatic: urothelial carcinoma (amUC), gastric cancer (amGC) and non-small cell lung cancer (amNSCLC) and to report on their characteristics, treatments, and survival rates using contemporaneous real-world data. Methods: This cohort study was conducted in the HealthCore Integrated Research Database (HIRD), from January 2010 to January 2018, which contains healthcare claims data from commercial health plans across the US (60 million lives). We applied algorithms, previously validated on registry data, to the HIRD to define 3 cohorts of advanced stage cancer. Cohort characteristics and treatment patterns were described. Patient vital status was captured through probabilistic linkage with the National Death Index (NDI) and survival was assessed using the Kaplan-Meier method. Results: Algorithms to predict advanced stage cancer resulted in the following cohorts: 1,501 amUC, 6,253 amGC and 38,451 amNSCLC cases. Most patients in each cohort were de novo advanced or metastatic, but subsets were diagnosed at early stage and progressed to advanced stage (ranging from 15.1% for amNSCLC to 23.1% for amUC). Patient characteristics, treatments and survival outcomes are described in Table 1. Not all received systemic treatment; Immune Checkpoint inhibitors (ICI) were used in 5.3%, 2.2% and 10.8% of treated amUC, amGC and amNSCLC patients, respectively. Conclusions: In these cohorts of advanced or metastatic cancer patients, median survival time was limited despite most receiving treatment: radiation, systemic therapy or surgery. Treatment with ICI was low despite recent data in amUC and amNSCLC.[Table: see text]

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Joshi, Shreyas, Elizabeth A. Handorf, Abhishek Srivastava, Selma Masic, David B. Cahn, Brian T. Kadow, Matthew R. Zibelman, et al. "Treatment facility volume and survival in patients with advanced prostate cancer." Journal of Clinical Oncology 37, no. 7_suppl (March 1, 2019): 274. http://dx.doi.org/10.1200/jco.2019.37.7_suppl.274.

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274 Background: Despite improvements in the medical management of advanced prostate cancer (aPC), it continues to be the 2nd leading cause of cancer death in American men. The contemporary management of men with aPC is increasingly complex and can vary based on access to up-to-date treatments, which is often found at busier treatment centers. We thus evaluated the relationship between facility volume and survival outcomes in aPC. Methods: The National Cancer Database (NCDB) was queried from 2004-2014 for aPC, defined as T4, N+, or M+ disease. Six pre-defined patient cohorts were evaluated. Cohort A = patients with aPC (N = 64,815); cohort B = M0 patients (N = 27,155); cohort C = M0 patients undergoing active treatment (N = 21,755); cohort = all M1 patients (N = 37,660); cohort E = M0 patients undergoing active treatment (N = 30,643); and cohort F = M1 patients who underwent active treatment and who had known metastatic sites (N = 12,452). Treatment facilities were divided into quartiles based on median treatment volume: <1.8 patients/year, 1.8-3.3 patients/year, 3.4-5.6 patients/year, and >5.6 patients/year. Regression models were adjusted along a set of covariates available in the NCDB. The primary outcome was overall survival (OS). Results: OS improved with each increase in volume quartile. The top quartile (>5.6 pts/yr) demonstrated significantly greater OS compared to the bottom quartile (<1.8 pts/yr) [HR 0.82, 95% CI 0.77-0.88, p<0.001]. The improved OS in the top volume quartile remained consistent when analyzed across the six pre-defined patient cohorts. Sensitivity analyses were conducted on Cohort A, adjusting for Gleason score and facility type, which did not change the effect of volume on survival. Conclusions: In this retrospective analysis of nearly 65K men who presented with aPC, we demonstrate that management at a high-volume facility (top quartile, >5.6 pts/yr) confers a significant OS advantage when compared to management at a facility in the lowest quartile (<1.8 pts/yr). This OS advantage persisted with similar magnitudes of effect after narrowing the cohorts by disease and treatment characteristics. These findings may have implications on the optimal management of men with advanced PC.

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Javle, Milind M., Robin Kate Kelley, Christoph Springfeld, Ghassan K. Abou-Alfa, Teresa Macarulla, Suebpong Tanasanvimon, Lipika Goyal, et al. "A phase II study of infigratinib in previously treated advanced/metastatic cholangiocarcinoma with FGFR gene fusions/alterations." Journal of Clinical Oncology 39, no. 3_suppl (January 20, 2021): TPS356. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.tps356.

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TPS356 Background: The FGFR family plays an important role in cholangiocarcinoma, with FGFR2 gene fusions detected in about 15% of patients with cholangiocarcinoma. Infigratinib is an FGFR1–3-selective oral tyrosine kinase inhibitor under evaluation in multiple indications including front-line and pre-treated cholangiocarcinoma. CBGJ398X2204 is an ongoing phase II study evaluating the efficacy of single-agent infigratinib in patients with advanced or metastatic cholangiocarcinoma with FGFR genetic alterations who have received prior gemcitabine. Methods: Study CBGJ398X2204 consists of 3 cohorts and patients in all cohorts receive oral infigratinib once daily for 21 days of a 28-day treatment cycle. Treatment will continue until progressive disease, intolerance, withdrawal of consent, or death. Cohort 1 includes patients with FGFR2 gene fusions or translocations. Cohort 2 includes patients with FGFR genetic alterations other than FGFR2 gene fusions (patients in both Cohorts 1 and 2 must not have received any prior FGFR inhibitors). Cohort 3 includes patients with FGFR2 gene fusions who have received prior treatment with a selective FGFR inhibitor other than infigratinib. The primary endpoint is objective response rate (ORR, RECIST v1.1 per central review). Secondary endpoints include overall survival and overall response rate (per investigator). Safety, pharmacokinetics, and exploratory genetic alterations/biomarkers will also be measured. The study was initiated in 2014 and has a planned enrollment of up to 160 patients across all 3 cohorts (120 in Cohort 1, 20 in Cohort 2, and 20 in Cohort 3). Cohort 1 has completed enrollment and findings from this Cohort are the focus of a separate abstract submitted to the meeting. Results are not currently available from Cohorts 2 and 3 (trial in progress). Clinical trial information: NCT02150967.

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Johnson, Blaine, Brad White, Phillip Lancaster, and Robert Larson. "An Evaluation of Temporal Distributions of High, Low, and Zero Cohort Morbidity of Cumulative First Treatment Bovine Respiratory Disease and Their Associations with Demographic, Health, and Performance Outcomes in US Feedlot Cattle." Veterinary Sciences 10, no. 2 (January 24, 2023): 89. http://dx.doi.org/10.3390/vetsci10020089.

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Timing and magnitude of bovine respiratory disease (BRD) can impact intervention and overall economics of cattle on feed. Furthermore, there is a need to better describe when cattle are being treated for BRD. The first objective was to perform a cluster analysis on the temporal distributions of cumulative first treatment BRD from HIGH (≥15% of cattle received treated for BRD) and LOW cohorts (>0 and <15% of cattle received treated for BRD) to assess cohort-level timing (days on feed) of BRD first treatments. The second objective was to determine associations among cluster groups (temporal patterns) and demographic risk factors, health outcomes, and performance. Cluster analysis determined that optimal number of clustering groups for the HIGH morbidity cohort was six clusters and LOW morbidity cohort was seven clusters. Cohorts with zero BRD treatment records were added for statistical comparisons. Total death loss, BRD morbidity, average daily gain (ADG), railing rate, days to 50% BRD, cattle received, shrink, arrival weight, and sex were associated with temporal groups (p < 0.05). These data could be used as a tool for earlier identification and potential interventions for cohorts based on the BRD temporal pattern.

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Antonarakis, Emmanuel S., Josep M. Piulats, Marine Gross-Goupil, Jeffrey Goh, Kristiina Ojamaa, Christopher J. Hoimes, Ulka Vaishampayan, et al. "Pembrolizumab for Treatment-Refractory Metastatic Castration-Resistant Prostate Cancer: Multicohort, Open-Label Phase II KEYNOTE-199 Study." Journal of Clinical Oncology 38, no. 5 (February 10, 2020): 395–405. http://dx.doi.org/10.1200/jco.19.01638.

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PURPOSE Pembrolizumab has previously shown antitumor activity against programmed death ligand 1 (PD-L1)–positive metastatic castration-resistant prostate cancer (mCRPC). Here, we assessed the antitumor activity and safety of pembrolizumab in three parallel cohorts of a larger mCRPC population. METHODS The phase II KEYNOTE-199 study included three cohorts of patients with mCRPC treated with docetaxel and one or more targeted endocrine therapies. Cohorts 1 and 2 enrolled patients with RECIST-measurable PD-L1–positive and PD-L1–negative disease, respectively. Cohort 3 enrolled patients with bone-predominant disease, regardless of PD-L1 expression. All patients received pembrolizumab 200 mg every 3 weeks for up to 35 cycles. The primary end point was objective response rate per RECIST v1.1 assessed by central review in cohorts 1 and 2. Secondary end points included disease control rate, duration of response, overall survival (OS), and safety. RESULTS Two hundred fifty-eight patients were enrolled: 133 in cohort 1, 66 in cohort 2, and 59 in cohort 3. Objective response rate was 5% (95% CI, 2% to 11%) in cohort 1 and 3% (95% CI, < 1% to 11%) in cohort 2. Median duration of response was not reached (range, 1.9 to ≥ 21.8 months) and 10.6 months (range, 4.4 to 16.8 months), respectively. Disease control rate was 10% in cohort 1, 9% in cohort 2, and 22% in cohort 3. Median OS was 9.5 months in cohort 1, 7.9 months in cohort 2, and 14.1 months in cohort 3. Treatment-related adverse events occurred in 60% of patients, were of grade 3 to 5 severity in 15%, and led to discontinuation of treatment in 5%. CONCLUSION Pembrolizumab monotherapy shows antitumor activity with an acceptable safety profile in a subset of patients with RECIST-measurable and bone-predominant mCRPC previously treated with docetaxel and targeted endocrine therapy. Observed responses seem to be durable, and OS estimates are encouraging.

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van Berge Henegouwen, Jade Maxime, Louisa Rose Hoes, Hanneke van der Wijngaart, Daphne Liselotte Van Der Velden, Alwin Huitema, Edwin P. J. G. Cuppen, Elly J. Lugtenburg, et al. "Update on the Drug Rediscovery Protocol: Expanded use of existing anticancer drugs in patients with a known molecular profile." Journal of Clinical Oncology 37, no. 15_suppl (May 20, 2019): TPS3149. http://dx.doi.org/10.1200/jco.2019.37.15_suppl.tps3149.

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TPS3149 Background: With the emergence of large-scale genetic tumor profiling and the increasing availability of approved targeted therapies, precision medicine has become crucial in cancer treatment. However, for many cancers the relative contribution of either tumor type or genetic aberration to drug sensitivity often remains unknown. Since drug access is generally limited to the on-label indication and outcome of off-label use is not systematically collected in clinical practice, innovative trials facilitating drug access, whilst systematically analyzing treatment outcomes, are urgently needed. Methods: The Drug Rediscovery Protocol (DRUP) is an ongoing, prospective, non-randomized, multi-drug, and pan-cancer trial, in which patients with advanced cancer, who have exhausted all standard of care treatment options, are treated with either targeted or immunotherapy matched to their genetic tumor profile. All submitted patients are reviewed and enrolled in multiple parallel cohorts, preceded by a baseline tumor biopsy for whole genome sequencing to confirm previously identified variants and for exploratory biomarker analyses. Each cohort is defined by a study drug, histologic tumor type, and molecular tumor profile. Efficacy is analyzed per cohort: 8 patients in stage I and 16 more in stage II if ≥ 1 response is observed in the first stage. Primary endpoints include objective response rate, stable disease at 16 weeks, and grade ≥3 adverse events. Since the start of recruitment in September 2016, 870 patients have been submitted for review and 365 patients (42%) have started treatment in one of 101 opened cohorts. Eight cohorts have graduated to the second stage, two cohorts completed accrual in either their first or second stage, and one cohort was closed due to a registered indication. Twenty-two different study treatments (i.e. immunotherapy, monoclonal antibodies, and PARP/small molecule inhibitors), provided by 11 different pharmaceutical companies, are currently available in DRUP. Data sharing with similar trials such as TAPUR and CAPTUR enables to achieve completion of slow accruing cohorts and affirm conclusions. Clinical trial information: NCT02925234.

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Meyer, Tim, Evgeny Ledin, Dong-Wan Kim, François Ghiringhelli, Piotr Serwatowski, Mark Voskoboynik, Harald Timotheus Landsteiner, Victoria Chen, Girish Jayadeva, and Teresa Macarulla. "Phase Ib study of BI 836880 (VEGF/Ang2 inhibitor) plus ezabenlimab (BI 754091; anti-PD-1 antibody) in patients (pts) with advanced hepatocellular carcinoma (HCC)." Journal of Clinical Oncology 40, no. 4_suppl (February 1, 2022): 434. http://dx.doi.org/10.1200/jco.2022.40.4_suppl.434.

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434 Background: Combination of anti-VEGF compounds and immune checkpoint inhibitors is an approved therapy across multiple solid tumors, including advanced HCC. This phase Ib study (NCT03468426) is assessing BI 836880 (bispecific VEGF/Ang2 nanobody) + ezabenlimab (anti-PD-1 antibody) in pts with advanced solid tumors. The recommended phase 2 dose (RP2D) of BI 836880 720 mg + ezabenlimab 240 mg given IV every 3 weeks was determined in Part 1. In Part 2, RP2D was assessed in 7 expansion cohorts. We report data from cohorts in HCC after prior sorafenib/lenvatinib (cohort F) and untreated unresectable HCC (cohort G). Methods: Pts with locally advanced or metastatic HCC, Child-Pugh class A, not eligible for surgical or locoregional therapies were enrolled. Cohort F enrolled pts who had progressed on or after first-line treatment with sorafenib or lenvatinib or who had discontinued due to poor tolerability after ≥2 weeks of treatment. Cohort G enrolled pts who had received no prior systemic therapy for HCC. Treatment continued until disease progression, undue toxicity or consent withdrawal. Primary endpoint is objective response rate (ORR) by RECIST 1.1. Results: As of Aug 2021, 30/31 pts have been treated in cohorts F/G: 87/77% male; median age 65/64 yrs. Follow-up is ongoing in both cohorts. 9/19 pts in cohorts F/G remain on treatment; median (range) duration of treatment is 175 (42–532)/ 169 (42–336) days in cohorts F/G. All pts were evaluable for response in cohort F: confirmed ORR to date is 40% (1 complete response; 11 partial responses [PRs]). Of 28 evaluable pts in cohort G, confirmed ORR to date is 21% (6 PRs). 12 (40%) pts in cohort F and 18 (64%) in cohort G have stable disease. In cohort F, AEs were reported in 28 (93%) pts, most frequently hypertension and proteinuria (each 30%). In cohort G, AEs occurred in 26 (84%) pts, most frequently ascites (26%) and thrombocytopenia (19%). 24 (80%) pts in cohort F and 15 (48%) in cohort G had treatment-related AEs (TRAEs). Most frequent TRAEs were proteinuria (27%), infusion-related reactions (IRRs) and hypertension (each 20%) in cohort F, and hypertension (13%), IRRs, hypothyroidism and diarrhea (each 10%) in cohort G. There were 3 pts with G5 AEs in cohort F (COVID-19 pneumonia [n = 1]; low Glasgow coma score and dyspnea [n = 1]; hepatic cirrhosis [n = 1]) and 1 G5 AE in cohort G (hepatic failure); none were considered related to treatment. AEs leading to discontinuation occurred in 2 pts in cohort F (G3 hepatic encephalopathy and G2 duodenal ulcer) and 3 in cohort G (G5 hepatic failure [n = 1]; G2 acute kidney injury and G1 decreased appetite [n = 1]; G2 diarrhea [n = 1]). Conclusions: BI 836880 + ezabenlimab had a manageable safety profile and showed promising activity in pts with untreated and second-line post-sorafenib/lenvatinib advanced HCC. Data continue to mature, particularly in cohort G. Cohort F has been expanded by a further 30 pts. Clinical trial information: NCT03468426.

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Seregin, I. V., A. A. Seregin, E. V. Filimonov, N. A. Shustitskiy, A. D. Morozov, L. A. Sinyakova, and O. B. Loran. "Ultra-Mini Percutaneous Nephrolithotripsy and Retrograde Intrarenal Surgery in Treatment of Less than 2 cm Kidney Stones: Comparative Efficacy and Safety." Creative surgery and oncology 12, no. 2 (July 15, 2022): 98–105. http://dx.doi.org/10.24060/2076-3093-2022-12-2-98-105.

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Background. Renal stones of ≤ 2cm size occur most commonly, with several treatment options currently available that include remote shockwave lithotripsy, percutaneous nephrolithotripsy (PCNL) and retrograde intrarenal surgery (RIRS). The choice of treatment for ≤ 2 cm kidney stones remains a relevant and hotly debated issue.Aim. A study of the efficacy, safety, advantages and disadvantages of ultra-mini percutaneous nephrolithotripsy (ultra-mini PCNL) and retrograde intrarenal surgery (RIRS) in treatment of ≤ 2 cm kidney stones.Materials and methods. Treatment outcomes in urology patients of the Botkin Hospital were analysed retrospectively for years 2017–2022. The patients were divided between cohorts: cohort 1 consisted of patients who underwent ultra-mini PCNL; cohort 2 included 41 patients with RIRS.Results and discussion. The incidence of complete stone absence on the day after surgery was significantly higher in cohort 1 (39; 92.8 %) vs. 2 (33; 80.4 %). Mean operation time was significantly less in cohort 1 (55 [30–80] min) vs. 2 (78 [30–125] min). Mean hospital stay did not differ significantly between the cohorts: 3 (1–5) vs. 2.8 (2–4) days in cohorts 1 and 2, respectively. Haematuria was statistically more severe in cohort 1 (7 cases; 16.6 %) vs. 2 (4 cases; 9.7 %); mean postoperative haemoglobin decrease was also significantly higher in cohort 1 (11.6) vs. 2 (6.4 g/L).Conclusion. Both ultra-mini PCNL and RIRS are effective, safe and complementary procedures in treatment for ≤2 cm renal stones. Ultra-mini PCNL is more effective over RIRS in terms of single-intervention complete stone removal and shorter operation time, whereas the overall complications rate did not significantly differ between cohorts.

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Luchesa Smith, Aphra, Christina Benetou, Hayley Bullock, Adam Kuczynski, Sarah Rudebeck, Katie Hanson, Sarah Crichton, et al. "Progress in the Management of Paediatric-Onset Multiple Sclerosis." Children 7, no. 11 (November 9, 2020): 222. http://dx.doi.org/10.3390/children7110222.

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Considerable progress has been made in the understanding and treatment of paediatric-onset multiple sclerosis (POMS); how this has translated into more effective care is less well understood. Here, we evaluate how recent advances have affected patient management and outcomes with a retrospective review of POMS patients managed at two paediatric neuroimmunology centres. Two cohorts, seen within a decade, were compared to investigate associations between management approaches and outcomes. Demographic, clinical and neurocognitive data were extracted from case notes and analysed. Of 51 patients, 24 were seen during the period 2007–2010 and 27 during the period 2015–2016. Median age at onset was 13.7 years; time from symptom onset to diagnosis was 9 months. Disease-modifying therapies were commenced in 19 earlier-cohort and 24 later-cohort patients. Median time from diagnosis to treatment was 9 months for earlier vs. 3.5 months in later patients (p = 0.013). A wider variety of treatments were used in the later cohort (four medications earlier vs. seven in the later and two clinical trials), with increased quality of life and neurocognitive monitoring (8% vs. 48% completed PedsQL quality of life inventory; 58% vs. 89% completed neurocognitive assessment). In both cohorts, patients were responsive to disease-modifying therapy (mean annualised relapse rate pre-treatment 2.7 vs. 1.7, mean post-treatment 0.74 vs. 0.37 in earlier vs. later cohorts). In conclusion, over the years, POMS patients were treated sooner with a wider variety of medications and monitored more comprehensively. However, this hugely uncontrolled cohort did not allow us to identify key determinants for the improvements observed.

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Streiff, Michael, Dejan Milentijevic, Keith McCrae, Daniel Yannicelli, Jonathan Fortier, Winnie Nelson, François Laliberté, et al. "Safety of Anticoagulant Therapies for Treatment of Venous Thromboembolism in Patients with Cancer." Blood 128, no. 22 (December 2, 2016): 1178. http://dx.doi.org/10.1182/blood.v128.22.1178.1178.

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Abstract Introduction: Anticoagulation is effective for the treatment of venous thromboembolism (VTE) in cancer patients, but it is also associated with an increased risk of bleeding. Previous clinical trials (e.g., CLOT and CATCH) of LMWH and warfarin for the treatment of VTE in cancer patients reported major bleeding in 3% to 6% of treated patients. The objective of this observational study was to compare the risk of major bleeding in cancer patients treated with anticoagulants for VTE in a real world setting. Methods: Medical and pharmacy claims from the Humana Database from 1/1/2013 to 05/31/2015 were analyzed. Newly diagnosed cancer patients with a first VTE diagnosis occurring after their first cancer diagnosis, and with ≥1 dispensing of an anticoagulant within 7 days after their VTE diagnosis, were selected. Based on the first anticoagulant received, patients were classified into one of the following cohorts: LMWH, warfarin, and rivaroxaban (other agents not included due to low utilization). Inverse probability of treatment weights based on propensity score were used to adjust for differences between treatment cohorts for the following comparisons: LMWH vs. rivaroxaban, LMWH vs. warfarin, and rivaroxaban vs. warfarin. Patients were followed up until the earliest event, either treatment non-persistence (gap > 60 days between the end of the days of supply of a dispensing and the start date of the next dispensing), or end of data availability. Major bleeding events were identified using validated criteria (Cunningham et al., 2011). Kaplan-Meier rates at 3 and 6 months and Cox proportional hazards models were used to compare the risk of bleeding between different treatment cohorts. To better understand the risk of major bleeding in cancer patients unrelated to anticoagulation, a cohort of patients with cancer who did not have VTE and did not receive an anticoagulant was added as a control cohort. Results: A total of 2,428 patients (LMWH: n=660; warfarin: n=1,061; rivaroxaban: n=707) were included. Baseline demographic and clinical characteristics were well balanced among treatment cohorts. Median duration of therapy with LMWH was shorter than rivaroxaban (1.0 vs. 3.0 months, p<.0001) and warfarin (1.0 vs. 3.5 months, p<.0001). Rates of major bleeding for LMWH and rivaroxaban were 8.3% and 8.2%, respectively at 6 months with a hazard ratio (HRs [95% CI]) of 1.03 (0.64-1.65; Figure 1A). In the comparison between LMWH and warfarin cohorts, major bleeding rates were 8.5% and 8.6%, respectively at 6 months with hazard ratio (HRs [95% CI]) of 1.04 (0.69-1.57; Figure 1B). The risk of major bleeding was also similar for rivaroxaban and warfarin cohorts, 9.0% and 8.7%, respectively at 6 months with a hazard ratio (HR [95% CI]) of 1.01 (0.71-1.43; Figure 1C). For the control cohort of cancer patients without VTE and not receiving anticoagulation median follow-up was 5.6 months. Rates of major bleeding events for the control cohort were 2.6% and 4.2 % at 3 and 6 months, respectively. Conclusion: This real world study of cancer patients treated for VTE found that the risk of major bleeding was similar for the 3 most widely prescribed anticoagulants in current clinical practice: LMWH, warfarin, and rivaroxaban. The observed rates of major bleeding were generally higher than what has been reported for LMWH and warfarin in the CLOT and CATCH trials. Patient characteristics such as older age (average age 73 years) could have contributed to the higher major bleeding rate seen in this study compared to the CLOT and CATCH trials, respectively. Figure 1 Rates of Major Bleeding Events LMWH vs. rivaroxaban cohorts Figure 1. Rates of Major Bleeding Events. / LMWH vs. rivaroxaban cohorts Figure 2 LMWH vs. warfarin cohorts Figure 2. LMWH vs. warfarin cohorts Figure 3 rivaroxaban vs. warfarin cohorts Figure 3. rivaroxaban vs. warfarin cohorts Disclosures Streiff: Portola: Research Funding; Janssen: Consultancy, Research Funding; Roche: Research Funding; CSL Behring: Consultancy, Research Funding. Milentijevic:Janssen Scientific Affairs: Employment, Equity Ownership. McCrae:Janssen: Membership on an entity's Board of Directors or advisory committees. Yannicelli:Janssen Scientific Affairs: Employment, Equity Ownership. Fortier:Janssen Pharmaceuticals: Research Funding. Nelson:Janssen Scientific Affairs: Employment, Equity Ownership. Laliberté:Janssen Scientific Affairs: Research Funding. Crivera:Janssen Scientific Affairs, LLC, Raritan, New Jersey: Employment, Equity Ownership. Lefebvre:Janssen Scientific Affairs: Research Funding. Schein:Johnson & Johnson: Employment, Equity Ownership, Other: Own in excess of $10,000 of J&J stock. Khorana:Roche: Consultancy, Honoraria; Sanofi: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria; Halozyme: Consultancy, Honoraria; Bayer: Consultancy, Honoraria; Leo: Consultancy, Honoraria, Research Funding; Amgen: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs, LLC: Consultancy, Honoraria, Research Funding.

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Poblete Ríos, Marcia, and Ricardo Vera Martínez. "DESERCIÓN EN LA CARRERA DE LICENCIATURA EN EDUCACIÓN Y PEDAGOGÍA EN INGLÉS UNIVERSIDAD DE ATACAMA, CHILE." Foro Educacional, no. 17 (May 20, 2015): 65. http://dx.doi.org/10.29344/07180772.17.642.

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RESUMEN:El presente trabajo da cuenta de aquellas variables asociadas a la deserción estudiantil en la carrera de Licenciatura en Educación y Pedagogía en Inglés, dictada por el Instituto de Idiomas de la Universidad de Atacama.Se realiza un estudio de las 16 primeras cohortes de la carrera, desde su inicio en 1991,hasta la correspondiente al año 2006. Luego de estudiar detenidamente cada cohorte, pudo determinarse que las variables asociadas más recurrentes de deserción son: cambio de carrera y retiro temporal. En un menor grado de recurrencia se ubican el mal rendimiento, el traslado de ciudad, los problemas económicos y el embarazo. Se ofrecen algunas sugerencias para seraplicadas como tratamiento remedial, para así promover la disminución de la ocurrenciade deserción en futuras cohortes.Palabras clave: cohortes, deserción, variables asociadas, tratamientos remediales.DROP-OUTS IN THE EDUCATION LICENTIATE ANDENGLISH TEACHING PROGRAM, UNIVERSITY OFATACAMA, CHILEABSTRACT:This work surveys the main associated variables of student drop-outs in the program of Education Licentiate and English Teaching offered by the Language Institute of the University of Atacama. Sixteen cohorts were studied, including the first one in 1991 and the corresponding cohort of 2006. It could be determined that the most frequent associated variables of student drop-outs are change of program and temporary leave of absence, where as poor academic performance, economic problems, change of residence, and pregnancy, have a minor impacton students’ decision to quit the program. Some suggestions are given so that student dropouts can be better controlled in future cohorts enrolled in the program.Key words: cohorts, drop-out, associated variables, remedial treatment

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Solera, J., A. Espinosa, E. Martínez-Alfaro, L. Sánchez, P. Geijo, E. Navarro, J. Escribano, and J. A. Fernández. "Treatment of human brucellosis with doxycycline and gentamicin." Antimicrobial Agents and Chemotherapy 41, no. 1 (January 1997): 80–84. http://dx.doi.org/10.1128/aac.41.1.80.

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The objective of the present prospective, noncomparative, multicenter study was assess the safety and efficacy of gentamicin and doxycycline therapy for human brucellosis. In the first part of the study, a cohort of 17 patients received 100 mg of doxycycline (or 50 mg/kg of body weight per day if the body weight was < 40 kg) orally every 12 h for 45 days (cohort 1). In the second part of the study a subsequent cohort of 35 patients was treated with doxycycline at the same dosage for 30 days (cohort 2). All patients were treated intramuscularly with gentamicin at 240 mg (or 5 mg/kg per day if the body weight was < 50 kg) once daily for the first 7 days. Both cohorts showed a favorable response during therapy, and there were no therapeutic failures. Relapse was noted in 1 (5.9%; 95% confidence interval [95% CI], 0.15 to 28.7%) of the 17 patients in cohort 1 and in 8 (22.9%; 95% CI, 10.4 to 40.1%) of the 35 patients in cohort 2. Nineteen patients (36.5%; 95% CI, 23.6 to 51.0%) had adverse effects, with no differences between cohorts, and no patients had a treatment-limiting adverse effect. The study indicates that the combination of doxycycline for 45 days and gentamicin for 7 days is an effective and well-tolerated therapy for human brucellosis. The relapse rates obtained with doxycycline treatment for 30 days appear to be higher than those obtained with doxycycline treatment for 45 days.

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Uddin, Omar M., Raqeeb Haque, Patrick A. Sugrue, Yousef M. Ahmed, Tarek Y. El Ahmadieh, Joel M. Press, Tyler Koski, and Richard G. Fessler. "Cost minimization in treatment of adult degenerative scoliosis." Journal of Neurosurgery: Spine 23, no. 6 (December 2015): 798–806. http://dx.doi.org/10.3171/2015.3.spine14560.

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OBJECT Back pain is an increasing concern for the aging population. This study aims to evaluate if minimally invasive surgery presents cost-minimization benefits compared with open surgery in treating adult degenerative scoliosis. METHODS Seventy-one patients with adult degenerative scoliosis received 2-stage, multilevel surgical correction through either a minimally invasive spine surgery (MIS) approach with posterior instrumentation (n = 38) or an open midline (Open) approach (n = 33). Costs were derived from hospital and rehabilitation charges. Length of stay, blood loss, and radiographic outcomes were obtained from electronic medical records. Functional outcomes were measured with Oswestry Disability Index (ODI) and visual analog scale (VAS) surveys. RESULTS Patients in both cohorts were similar in age (AgeMIS = 65.68 yrs, AgeOpen = 63.58 yrs, p = 0.28). The mean follow-up was 18.16 months and 21.82 months for the MIS and Open cohorts, respectively (p = 0.34). MIS and Open cohorts had an average of 4.37 and 7.61 levels of fusion, respectively (p < 0.01). Total inpatient charges were lower for the MIS cohort ($269,807 vs $391,889, p < 0.01), and outpatient rehabilitation charges were similar ($41,072 vs $49,272, p = 0.48). MIS patients experienced reduced length of hospital stay (7.03 days vs 14.88 days, p < 0.01) and estimated blood loss (EBL) (EBLMIS = 470.26 ml, EBLOpen= 2872.73 ml, p < 0.01). Baseline ODI scores were lower in the MIS cohort (40.03 vs 48.04, p = 0.03), and the cohorts experienced similar 1-year improvement (ΔODIMIS = −15.98, ΔODIOpen = −21.96, p = 0.25). Baseline VAS scores were similar (VASMIS = 6.56, VASOpen= 7.10, p = 0.32), but MIS patients experienced less reduction after 1 year (ΔVASMIS = −3.36, ΔVASOpen = −4.73, p = 0.04). Preoperative sagittal vertical axis (SVA) were comparable (preoperative SVAMIS = 63.47 mm, preoperative SVAOpen = 71.3 mm, p = 0.60), but MIS patients had larger postoperative SVA (postoperative SVAMIS = 51.17 mm, postoperative SVAOpen = 28.17 mm, p = 0.03). CONCLUSIONS Minimally invasive surgery demonstrated reduced costs, blood loss, and hospital stays, whereas open surgery exhibited greater improvement in VAS scores, deformity correction, and sagittal balance. Additional studies with more patients and longer follow-up will determine if MIS provides cost-minimization opportunities for treatment of adult degenerative scoliosis.

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Yamaguchi, Kensei, Yoon-Koo Kang, Do-Youn Oh, Shunsuke Kondo, Sun Young Rha, Yasutoshi Kuboki, Manabu Morimoto, et al. "Phase I study of BI 754091 plus BI 754111 in Asian patients with gastric/gastroesophageal junction or esophageal cancer." Journal of Clinical Oncology 39, no. 3_suppl (January 20, 2021): 212. http://dx.doi.org/10.1200/jco.2021.39.3_suppl.212.

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212 Background: Dual blockade of immune checkpoint molecules, PD-1 and LAG-3, has been proposed to restore T-cell function and thus enhance antitumor responses. This Phase I trial evaluated BI 754091 (anti-PD-1) with BI 754111 (anti-LAG-3) antibodies in Asian pts with advanced solid tumors (NCT03433898). Here, we present results from pts with anti-PD-(L)1 inhibitor-naïve gastric/gastroesophageal junction or esophageal cancer (Cohorts A and B). Methods: In Parts 1 and 2 (dose escalation), the recommended dose for the combination was determined as BI 754091 240 mg + BI 754111 600 mg IV Q3W. In Part 3, the combination was assessed in expansion cohorts including pts with gastric/gastroesophageal junction cancer (Cohort A) and esophageal cancer (Cohort B). Eligible pts had received ≥1 line of prior systemic therapy but no prior anti-PD-(L)1 therapy. The primary endpoint in Part 3 was objective response (OR; confirmed complete response or partial response [PR]) per RECIST 1.1. Results: In Cohort A/B, 36/37 pts were treated:26/31 (72/84%) male, median age 60/63 years. Patients were enrolled in Taiwan (1/7 pts, 3/19%), Japan (12/27 pts, 33/73%) or Korea (23/3 pts, 64/8%). The median number of regimens of prior systemic therapy was 2/2 (Cohorts A/B, range: 16/14). All pts in Cohort B had squamous cell carcinoma. At the time of analysis, pts in Cohort A/B had undergone a median of 84/73 days on treatment (range: 31346/8325), from the start of treatment until the date of snapshot, death or discontinuation. Confirmed OR (PR) was observed in 4/7 pts in Cohorts A/B; overall response rate (ORR) was 11% and 19%. Stable disease (SD) was observed in 10/8 (28/22%) pts in Cohorts A/B and overall disease control rate was 39/41%. In Cohorts A/B, adverse events (AEs) and treatment-related AEs were experienced by 30/34 (83/92%) and 12/22 (33/59%) pts, respectively. The most commonly reported AEs were pyrexia (25/19%), decreased appetite (17/19%), increased aspartate aminotransferase (11/14%), anemia (11/11%) and nausea (6/14%). In Cohort A/B, 9/15 (25/41%) pts experienced immune-related AEs, most commonly rash in Cohort A (4 pts; 11%) and hyperthyroidism in Cohort B (4 pts; 11%). In Cohorts A/B, 2/6 (6/16%) patients experienced AEs leading to discontinuation of treatment. Conclusions: Treatment was well tolerated and preliminary antitumor activity was seen. Addition of LAG3 did not improve ORR beyond that expected for an anti-PD-1 monotherapy in gastric and esophageal cancer without patient selection. Clinical trial information: NCT03433898. [Table: see text]

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Schreiber, S. W., M. Watanabe, C. Yun, Y. Zhou, S. Zhao, J. Hsieh, U. Moerch, G. Rogler, and E. V. Loftus Jr. "OP04 Safety analysis of filgotinib for Ulcerative Colitis: Results from the phase 2b/3 SELECTION study and phase 3 SELECTIONLTE long-term extension study." Journal of Crohn's and Colitis 15, Supplement_1 (May 1, 2021): S004—S006. http://dx.doi.org/10.1093/ecco-jcc/jjab075.003.

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Abstract Background Filgotinib (FIL) is an oral preferential Janus kinase (JAK) 1 inhibitor in development for the treatment of inflammatory diseases. FIL for the treatment of moderately to severely active ulcerative colitis (UC) was evaluated in the phase 2b/3, double-blind, placebo (PBO)-controlled SELECTION study (NCT02914522) and its long-term extension (LTE) study (NCT02914535). Here we report safety results from the FIL UC program. Methods Patients received FIL 100 mg, FIL 200 mg or PBO (2:2:1) once daily orally for up to 11 weeks for induction (cohort 1). At week 11, FIL induction responders were rerandomized 2:1 to continue FIL or receive PBO maintenance for 47 weeks (cohort 2). Week 10 non-responders and patients with worsening disease during the maintenance study were eligible for open-label FIL in the LTE. Patients completing the maintenance study could continue blinded dosing in the LTE. Cohort 3 comprised cohorts 1 and 2 and the LTE. Exposure-adjusted incidence rates (EAIRs) and exposure-adjusted event rates (EAERs) per 100 patient-years (PYs) were calculated for treatment-emergent adverse events (AEs) by treatment group in cohorts 1 and 2 (EAIR) and cohort 3 (EAER). Results In cohort 1, 1069 patients received FIL and 279 patients received PBO; baseline characteristics were generally similar across treatment groups (overall mean age, 43 years; mean UC duration, 8.4 years; mean Mayo Clinic Score, 9.0). EAIRs for AEs of interest were similar across treatment groups in cohorts 1 and 2 (Table 1). Treatment exposure for PBO, FIL 100 mg or FIL 200 mg in cohort 3 (i.e. cohorts 1 + 2 + the LTE) was 318, 360 and 1207 PYs, and median treatment duration was 12, 11 and 67 weeks, respectively. One case of pulmonary embolism occurred with FIL 200 mg induction and three venous thrombosis cases occurred with PBO maintenance/LTE (cohort 3) (Table 2). EAERs for all infections were similar across treatment groups, the most common being nasopharyngitis (Table 2). Opportunistic infections were rare. EAERs for serious infections were low across treatment groups (2.2 [PBO], 3.5 [FIL 100 mg], 2.2 [FIL 200 mg]), the most common being appendicitis (Table 2). EAERs for herpes zoster (HZ) were low in all treatment groups (0.3 [PBO], 0.3 [FIL 100 mg], 1.8 [FIL 200 mg]) (Table 2). HZ infections were cutaneous only and only one was serious. EAIRs for all infections in cohorts 1 and 2 were generally numerically higher for both PBO and FIL in patients over (vs under) 65 years old and in those with (vs without) biologic treatment failure (Figure 1). Conclusion FIL was well tolerated in patients with UC. Aggregation of AEs typical for pan-JAK inhibition was not observed, consistent with preferential JAK-1 inhibition with FIL.

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Selim, Ranya, Joyce Philip, and Vijaya Donthireddy. "Comparison of high dose methotrexate treatments in CNS lymphoma patients: The Henry Ford experience." Journal of Clinical Oncology 35, no. 15_suppl (May 20, 2017): 2028. http://dx.doi.org/10.1200/jco.2017.35.15_suppl.2028.

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2028 Background: The main backbone of therapy for CNS lymphoma involves systemic treatment with high dose methotrexate (HDMTX)-based regimens,with radiotherapy reserved only for cases that fail systemic therapy due to the significant cognitive toxicity of radiation. Over the last decade, rituximab and subsequently temozolomide were added to HDMTX chemotherapy regimens. Methods: Patients diagnosed with CNS lymphoma between 2009 and 2015 were identified. A retrospective cohort study was conducted of patients who received HDMTX alone (Cohort A), HDMTX and rituximab (Cohort B) and HDMTX, rituximab and temozolomide (Cohort C). Data collected included treatment related adverse events along with OS and PFS. Results: 31 patients were diagnosed with CNS lymphoma. 11, 10 and 6 patients were in cohorts A, B and C respectively. Median PFS and OS for the entire cohort were 14 and 25 months respectively. Cohort results were compared to the respective reference trials published in the literature. Cohort A had a PFS of 11 months and OS of 12 months compared to 12.8 months and 22.8+ months in the reference Phase II trial. Cohort B had a median PFS of 25+ months and OS of 41 months compared to 21 months and 33.5 months in the reference trial. Cohort C had a 2-year PFS of 0.50 compared to 0.57 in the reference trial. 3 (9.6%), 5 (16.1%), and 2 (6.4%) patients developed renal dysfunction in cohorts A, B and C respectively. 4 (12.9), 2 (6.4%), and 0 patients developed leukopenia in cohorts A, B and C respectively. 3 (9.6), 2 (6.4%), and 1 (3.2%) patients developed anemia in cohorts A, B and C respectively. 1 (3.2%), 1 (3.2%) and 1 (3.2%) patient developed thrombocytopenia in cohorts A, B and C respectively. Conclusions: The addition of Rituximab to HDMTX treatment for the treatment of CNS lymphoma increased the PFS and OS compared to HDMTX alone and is in concordance with the reference phase II trials reported in the literature if not better. In addition, our data at HFH shows no increased risk of adverse events with combination therapies compared to HDMTX alone. The addition of Temozolomide to Rituximab and High Dose methotrexate treatment showed a median 2 year PFS of 0.50 which is comparable to published reports of a 2-year PFS of 0.59.

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Ptushkin, Vadim V., Michail A. Kunst, Tatiana A. Mitina, Tatiana S. Konstantinova, Natalia N. Rachkova, Tatiana V. Shelekhova, Ilya V. Elykomov, et al. "Multiple myeloma: response to treatment and survival of patients according to the interim analysis of the Russian observational, retrospective-prospective, multicenter cohort study (MULTISPECT)." Terapevticheskii arkhiv 94, no. 7 (August 12, 2022): 827–35. http://dx.doi.org/10.26442/00403660.2022.07.201718.

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Aim. The primary objective of the interim analysis of the MULTISPECT study was to evaluate the short-term efficacy of the treatment and long-term outcomes in cohorts of primary and pretreated patients with multiple myeloma (MM) receiving treatment in actual clinical practice in various regions of the Russian Federation. Secondary objectives were a description of the main characteristics of patients; analysis of the most commonly used therapy regimens of the 1st and later lines and the sequence of their changes; evaluation of the response to therapy. Additional objectives included evaluation of the effect of the new COVID-19 coronavirus infection on the course of MM in patients. Materials and methods. The study is an observational retrospective-prospective multicenter cohort study. For its implementation, a structured database of patients with MM was used, provided by hematologists of the centers affiliated for the study. Results. The study included 1,294 patients (cohort 1 806, cohort 2 488). In both cohorts, patients aged 6069 years were in the majority. 3 lines of therapy (L1, L2, L3) were used for cohort 1; in cohort 2, the 4th line of therapy was also used in 2 patients. The therapy regimens were analyzed for 290 (22.41%) of all patients in the study. Responses to therapy were analyzed for 214 patients of cohort 1 and 109 patients of cohort 2. Autologous and allogeneic hematopoietic stem cell transplantations were carried out for a limited proportion of patients in both cohorts. At the end of the study and upon presentation of its results, the status of patients was the following: 96% of patients in cohort 1 and 89% in cohort 2 were alive. The therapy regimens in both cohorts were characterized by variability. The most commonly used regimens in each of the lines of therapy have been identified. The most used therapy regimen in patients with MM of both cohorts was the VCD-regime. Rd-regime in cohort 1 and RD-regime in cohort 2 were the second most frequent used regimens. In patients of both cohorts, the therapy regimens including Bortezomib were most often used. Conclusion. The variety of therapy regimens used to treat MM in actual clinical practice may be due to the factors of availability of new medicines and updated recommendations for the treatment of the disease. Further, in the context of this study, a more detailed analysis of the efficacy of certain therapy regimens in the 1st and later lines on progression free survival and overall survival of MM patients should be carried out.

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Standish, Leanna J., Fred Dowd, Erin Sweet, Linda Dale, and M. Robyn Andersen. "Do Women With Breast Cancer Who Choose Adjunctive Integrative Oncology Care Receive Different Standard Oncologic Treatment?" Integrative Cancer Therapies 17, no. 3 (April 27, 2018): 874–84. http://dx.doi.org/10.1177/1534735418769007.

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Purpose: To determine if women with breast cancer who choose adjunctive naturopathic oncology (NO) specialty care receive different standard oncologic treatment when compared with breast cancer patients who receive only standard care. Participants: Women with breast cancer stages 0 to 4, aged 18+ who spoke English and sought care from outpatient naturopathic doctor clinics were enrolled in an observational study of clinical and quality of life outcomes. Women who sought NO care 2 or more times within the first 2 years postdiagnosis were identified as NO cases. A matched comparison group of breast cancer patients were identified using the Western Washington Cancer Surveillance System(CSS). Methods: A longitudinal cohort design. In addition to self-report data, the CSS provided data on demographics, stage at the time of diagnosis, and initial treatment. Oncology medical records were abstracted in order to provide additional information on standard oncologic treatment for all participants. Results: Cohorts were well matched with regard to demographic, histologic, and prognostic indicators at the time of diagnosis. Approximately 70% of women in both cohorts received standard oncologic care that met the National Comprehensive Cancer Network guidelines. There were no statistically significant differences between the cohorts in treatment received. Fewer women in the NO cohort with estrogen receptor–positive breast cancer appear to have received antiestrogen therapy. Conclusions: Women in both cohorts appear to receive guideline-concordant care. However, women who receive adjunctive NO care may be less likely to receive antiestrogen therapy.

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Cornely, Oliver A., José M. Cisneros, Julian Torre-Cisneros, María Jesús Rodríguez-Hernández, Luis Tallón-Aguilar, Esther Calbo, Juan P. Horcajada, et al. "Pharmacokinetics and safety of aztreonam/avibactam for the treatment of complicated intra-abdominal infections in hospitalized adults: results from the REJUVENATE study." Journal of Antimicrobial Chemotherapy 75, no. 3 (December 12, 2019): 618–27. http://dx.doi.org/10.1093/jac/dkz497.

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Abstract Objectives To investigate pharmacokinetics (PK) and safety (primary objectives) and efficacy (secondary objective) of the investigational monobactam/β-lactamase inhibitor combination aztreonam/avibactam in patients with complicated intra-abdominal infection (cIAI). Methods This Phase 2a open-label, multicentre study (NCT02655419; EudraCT 2015-002726-39) enrolled adults with cIAI into sequential cohorts for 5–14 days treatment. Cohort 1 patients received an aztreonam/avibactam loading dose of 500/137 mg (30 min infusion), followed by maintenance doses of 1500/410 mg (3 h infusions) q6h; Cohort 2 received 500/167 mg (30 min infusion), followed by 1500/500 mg (3 h infusions) q6h. Cohort 3 was an extension of exposure at the higher dose regimen. Doses were adjusted for creatinine clearance of 31–50 mL/min (Cohorts 2 + 3). All patients received IV metronidazole 500 mg q8h. PK, safety and efficacy were assessed. Results Thirty-four patients (Cohort 1, n = 16; Cohorts 2 + 3, n = 18) comprised the modified ITT (MITT) population. Mean exposures of aztreonam and avibactam in Cohorts 2 + 3 were consistent with those predicted to achieve joint PK/pharmacodynamic target attainment in >90% patients. Adverse events (AEs) were similar between cohorts. The most common AEs were hepatic enzyme increases [n = 9 (26.5%)] and diarrhoea [n = 5 (14.7%)]. Clinical cure rates at the test-of-cure visit overall were 20/34 (58.8%) (MITT) and 14/23 (60.9%) (microbiological-MITT population). Conclusions Observed AEs were consistent with the known safety profile of aztreonam monotherapy, with no new safety concerns identified. These data support selection of the aztreonam/avibactam 500/167 mg (30 min infusion) loading dose and 1500/500 mg (3 h infusions) maintenance dose q6h regimen, in patients with creatinine clearance >50 mL/min, for the Phase 3 development programme.

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Hong, Casara, Gregory Egan, and Byron Sherk. "Burning for Treatment: Impact of Staff Education on Asymptomatic Bacteriuria Management in the Elderly." Canadian Geriatrics Journal 23, no. 3 (September 1, 2020): 216–22. http://dx.doi.org/10.5770/cgj.23.409.

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Background Studies indicate that elderly patients are often inappropriately treated with antimicrobials for asymptomatic bacteriuria (ASB). Interprofessional education may help improve the assessment and management of ASB. Methods Retrospective chart audits were conducted on two cohorts of positive urine cultures (n = 201) obtained from a geriatric acute care unit to determine the incidence of treated ASB. The first cohort (n = 101) was analyzed from January to July 2017. Education was provided to unit staff (e.g., nurses, physicians, pharmacists) in Fall 2017. The second cohort (n = 100) was analyzed from January to July 2018. Descriptive statistics were used to summarize and compare the results from the cohorts. Results 152 patients (n = 201 positive urine cultures) were reviewed: 74% (159) of positive urine cultures were ASB and 21% (42) were urinary tract infections. The incidence of treated ASB was 15% (30) and untreated ASB was 65% (129). The incidence of UTI, treated ASB, and untreated ASB were not significantly different between the two cohorts examined. Conclusion The implementation of education did not result in lasting changes in ASB management. Our study suggests that future systemic solutions are necessary to reduce the incidence of treated ASB in the geriatric population.

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Fernandez, Chris, Sam Rusk, Nick Glattard, Fred Turkington, Yoav Nygate, Mark Kaiser, Jen McClurg, Maggie Richard, Ian Duncan, and Nathaniel Watson. "0068 Impact of OSA Therapy on Healthcare Economics: Actuarial Analysis of OSA Prevalence, Therapy Adherence, Co-morbidity, and Costs in a Large CMS Population Cohort." Sleep 45, Supplement_1 (May 25, 2022): A31—A32. http://dx.doi.org/10.1093/sleep/zsac079.066.

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Abstract Introduction Research studying the economics of OSA therapy faces confounds including the prevalence of undiagnosed OSA, rate of diagnosed patients declining therapy, spectrum of treatment adherence, and effects of concurrent co-morbidity. We provide an actuarial analysis to study the economic impact of OSA therapy, accounting for these confounds, using the 2016-2018 Medicare 5% LDS Analytical File, a random sample of Medicare Claims containing approximately 2.9 million patients/year, resulting in N=2,001,538 eligible Fee-For-Service patients excluding managed care patients and incomplete data. Methods We segmented the study population into three cohorts and three 12-month time-periods. The cohorts analyzed were A) patients with OSA diagnosis and >12 months treatment, B) patients with OSA and <12 months treatment, and C) patients with OSA diagnosis who never received treatment, resulting in 1,351,838 patient-months. We analyzed the healthcare costs in each cohort in the year before treatment, the first year of treatment, and following treatment year. We applied actuarial risk adjustment within each cohort and time-period to provide a risk-adjusted cost comparison. Results were analyzed cross-sectionally given zero-to-seven co-morbidities among obesity, hypertension, type-II diabetes, depression, COPD, CHF, and/or prior stroke, facility-vs-home testing, and with-or-without surgical procedures. Results The average per-patient-per-month (PPPM) total medical spending was highest in the diagnosed-but-never-treated cohort-C ($1,375), second highest in <12-months treatment cohort-B ($1,005), and lowest in >12-months treatment cohort-A ($983). In both cohorts that started therapy, average/quantile costs decreased from pre-treatment year to post-treatment year, and from the first-to-second year on therapy. Compared to no-therapy cohort-C, costs were 29% lower in cohort-A and 27% lower in cohort-B. Among co-morbid, 75th quartile of cost members, we observed similar differences (18% and 16%) but larger absolute dollars. Patients undergoing surgical procedures had higher costs but lower spend reduction in initial and following year of therapy (22% and 5%). Conclusion We observed significant differences in cost between OSA patients that started treatment versus those that did not, and those differences further increased the year following therapy onset. These findings imply that receiving treatment for OSA reduces a patients overall medical spend. In terms of mean cost, the >12-month and <12-month cohorts costs fell in both follow-up treatment years. Support (If Any)

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Boschen, Mark J., Lynne M. Drummond, and Anusha Pillay. "Treatment of Severe, Treatment-Refractory Obsessive-Compulsive Disorder: A Study of Inpatient and Community Treatment." CNS Spectrums 13, no. 12 (December 2008): 1056–65. http://dx.doi.org/10.1017/s1092852900017119.

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ABSTRACTIntroduction:This research reports on a prospective outcome study of two cohorts of patients with severe, chronic, resistant obsessive-compulsive disorder (OCD).Methods:One cohort consisted of a total of 52 patients treated in an inpatient setting, while the second group comprised 65 patients treated in a community-outpatient setting. Treatment consistent primarily of intensive graded exposure and self-imposed response prevention augmented with cognitive restructuring.Results:The groups demonstrated significant improvement over the course of treatment. In the inpatient and community groups, there was significant improvement over the first 12 weeks of treatment, and further improvement between 12 and 24 weeks.Conclusion:These results suggest that even for patients who have demonstrated treatment-resistance, there may be benefit in intensive behavioral treatment of OCD. In addition it was found that even for those patients with the most profound refractory OCD and complicating factors inpatient stays of up to 24 weeks were effective in reducing symptoms.

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Herman, Benjamin V., Mark Nyland, Lyndsay Somerville, Steven J. MacDonald, Brent A. Lanting, and James L. Howard. "Functional Outcomes of Infected Hip Arthroplasty: A Comparison of Different Surgical Treatment Options." HIP International 27, no. 3 (November 28, 2016): 245–50. http://dx.doi.org/10.5301/hipint.5000455.

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Background Periprosthetic joint infection (PJI) following total hip arthroplasty (THA) can be treated with irrigation and debridement with head and polyethylene exchange (IDHPE) or 2-stage revision (2SR). Few studies have compared patient-reported outcome measures (PROMs) in patients managed with these treatments. Methods A retrospective review identified 137 patients who had an infected primary THA between 1986-2013. Control cohorts were matched according to age and Charlton Comorbidity Index (CCI). Harris Hip Scores (HHS), Short Form 12 (SF12), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were compared between the control and infected cohorts. Results 68 patients underwent a 2SR and 69 patients underwent an IDHPE. IDHPE had a 59% success rate in eradicating infection. PROMs for the 2SR cohort were significantly worse than the noninfected controls (SF12-PCS [34.0 vs. 38.3, p = 0.03]; HHS [76.6 vs. 91.7, p<0.001]; and WOMAC [67.3 vs. 79.3, p = 0.005]). There were no significant differences between the noninfected cohort and the successful IDHPE. Significant differences were found between failed IDHPE and noninfected controls (SF12-PCS [42.5 vs. 34.0, p = 0.011]; HHS [92.3 vs. 79.6, p = 0.004]). There was only difference in SF12-MCS scores (50.3 vs. 57.3, p = 0.012) between the 2SR and failed IDHPE cohorts. Conclusions Patients treated with a successful IDHPE had similar outcomes to noninfected patients. Patients that failed IDHPE and went onto 2SR had similar outcomes to those that had a 2SR alone. IDHPE demonstrated a 59% success rate with PROMs equivalent to a noninfected cohort and should be considered in the treatment algorithm of infected THA.

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Mehra, Maneesha, Robert Stellhorn, Yvette Ng, and Mary Beth Todd. "G-CSF utilization during abiraterone acetate (AA) and cabazitaxel (C) therapy: A retrospective U.S. claims analysis." Journal of Clinical Oncology 31, no. 6_suppl (February 20, 2013): 205. http://dx.doi.org/10.1200/jco.2013.31.6_suppl.205.

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205 Background: AA and C are two recently approved therapies shown to extend survival in men with metastatic castrate-resistant prostate cancer (mCRPC) progressing after docetaxel treatment. The toxicity profiles of AA and C differ, and therefore it was hypothesized that the utilization of concomitant medications and supportive care measures, in particular G-CSF for the treatment of neutropenia, would differ as well. Methods: The Pharmetrics database (2008 to Jan 2012), a nationally representative, nonpayer-owned, integrated, commercial U.S. claims database, was used for this analysis. Eligible patients included those identified with a diagnosis of prostate cancer (ICD 9 code 185.X or 233.4) and a claim for either AA or C (identified by the appropriate NDC or J codes). Use of G-CSF was analyzed during treatment (defined as the period between the first claim to the last claim, full months inclusive) and also analyzed for the year prior to the first claim of either AA or C (index date). Results: 278 patients were identified with a claim for both cohorts. Median ages of patients in the two cohorts were similar (69 years in the AA cohort, 67.5 years in the C cohort). Docetaxel use in the year prior to the index date was 57% and 64% in the AA and C cohorts, respectively. The median duration of follow-up post-index date was 2.6 months in the AA cohort and 6.0 months in the C cohort. While the median number of prescriptions (3) was the same for the AA and C cohorts, the mean was slightly higher for C (4.4 vs 3.3). In the AA cohort, the use of G-CSF was as follows: 35% in the year before the index date and 3% during treatment. In the C cohort, the use of G-CSF was as follows: 42% in the year before the index date, and 67% during treatment. Conclusions: Based on this claims analysis, patients who received C were more likely to receive concomitant G-CSF vs patients who were receiving AA. This finding is consistent with the known risks/precautions relating to neutropenia as described in the TROPIC study for C. Prior to treatment, both cohorts had G-CSF use, which may be attributed to neutropenia during or following docetaxel therapy.

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Barlesi, Fabrice, Martijn Lolkema, Kristoffer Staal Rohrberg, Cinta Hierro, Aurelien Marabelle, Albiruni Abdul Razak, Luis Teixeira, et al. "291 Phase Ib study of selicrelumab (CD40 agonist) in combination with atezolizumab (anti-PD-L1) in patients with advanced solid tumors." Journal for ImmunoTherapy of Cancer 8, Suppl 3 (November 2020): A318. http://dx.doi.org/10.1136/jitc-2020-sitc2020.0291.

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BackgroundSelicrelumab is a human IgG2 agonistic anti-CD40 monoclonal antibody. Binding of the antibody to CD40 expressed on antigen-presenting cells results in T- cell priming and T-cell dependent anti-tumor activity. In response to T-cell activation, tumor cells express programmed-death ligand 1 (PD-L1) that can suppress effector T-cells. Atezolizumab interrupts this feedback loop by blocking PD-L1, thereby supporting the combination with selicrelumab.MethodsThis phase Ib open-label, multicenter, dose escalation (DE)/expansion clinical study (NCT02304393) investigated safety, pharmacokinetic (PK), pharmacodynamics (PD) and efficacy of selicrelumab in combination with atezolizumab in unselected patients with advanced/metastatic solid tumors, not amenable to standard therapy. In DE cohorts, a single dose of selicrelumab was given, either by intravenous (IV) infusion at a 16 mg fixed dose or subcutaneously (SC) at a range from 1 to 64 mg/dose. In dose-expansion cohorts (small bowel and colorectal cancer, head and neck squamous cell carcinoma [HNSCC] and non-small cell lung carcinoma), patients received multiple doses of selicrelumab SC at a dose of 16 mg. In all treatment cohorts, patients received atezolizumab at a fixed dose of 1200 mg IV Q3W.ResultsIn this study, 140 patients were treated. This included 95 patients in DE cohorts (6 patients in the IV cohort, 89 patients in the SC cohorts) and 45 patients in dose-expansion cohorts. In the IV cohort, infusion related reaction was the most frequent treatment-related adverse event (TRAE; 50%), while Grade ≥ 3 TRAE occurred in 1 patient (16.7%). In this cohort one dose-limiting toxicity (DLT) was reported (Grade 3 pancytopenia). In the SC cohorts, the most frequent TRAE was injection site reaction (ISR; 92%). Four DLTs were reported in four patients: three Grade 3 ISR and one Grade 3 transaminase increase. Grade ≥ 3 TRAE were reported in 22 patients (16.4%). Anti-tumor activity was observed across cohorts receiving SC selicrelumab (dose range 1 to 36 mg). Eight of 80 evaluable patients in DE cohorts experienced objective responses (9% ORR). In the dose-expansion HNSCC cohort, three of 16 evaluable patients responded (15.8% ORR). There were no objective responses in the IV cohort. Treatment with selicrelumab resulted in significant peripheral B-cell depletion and activation and CD8+ T cell proliferation.ConclusionsTreatment with selicrelumab in combination with atezolizumab was well tolerated in patients with advanced solid tumors. Signals of clinical and PD activity were observed. However, efficacy of the combination in this unselected population was limited, when compared to monotherapy efficacy of atezolizumab.Trial RegistrationNCT02304393Ethics ApprovalThis study was approved by the local IRB at each participating study site.

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Gamberi, Barbara, Miguel Hernandez, Christian Berthou, Eleni Tholouli, Elena Zamagni, Roman Hájek, Monique Minnema, et al. "European Post-Approval Safety Study (PASS) of Relapsed/Refractory Multiple Myeloma (RRMM): Safety, Including SPM, in a Large Cohort of Patients Treated with Lenalidomide, Thalidomide, and Bortezomib." Blood 128, no. 22 (December 2, 2016): 3331. http://dx.doi.org/10.1182/blood.v128.22.3331.3331.

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Abstract Background: EU PASS is an observational, noninterventional study designed to investigate the safety of lenalidomide (LEN) and other agents in the treatment of RRMM in a real-world setting. Aims:To assess the incidence of adverse events (AEs) of special interest, including neutropenia, thrombocytopenia, venous thromboembolism (VTE), peripheral neuropathy (PN), and second primary malignancies (SPMs) in RRMM patients (pts) treated with LEN and other antimyeloma therapies according to current clinical practice. Methods: Pts with RRMM who were commencing LEN treatment were enrolled at the investigator's discretion into a LEN cohort (LEN + dexamethasone, the approved combination for the treatment of RRMM); pts who received ≥ 1 prior therapy and were commencing a non-LEN-based therapy were enrolled into a background cohort (all other treatments, including novel agents). Thromboprophylaxis was per local standard practice. AEs were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (version 3). SPMs were defined using Medical Dictionary for Regulatory Activities (MedDRA) terms under the category Neoplasms SOC. Following protocol amendment in 2011, assessments for SPMs were to be conducted up to 36 mos after treatment discontinuation. Results: As of June 2016, 3632 pts across 269 institutions in 17 European countries were included in the safety population. Of those, 59.2% received LEN (n = 2151), 32.7% received bortezomib (BORT; n = 1188), 3.8% received thalidomide (THAL; n = 137), and 4.3% received other therapies (n = 156). The majority of pts had discontinued from treatment (97.9%; n = 3556); of the 2.1% (n = 76) ongoing pts, 66 are treated with LEN, 6 with BORT, 0 with THAL, and 4 with other substances. Baseline characteristics were similar across the cohorts. Median age was 70 yrs (range, 25-95 yrs) and 54.0% were male. Of 2985 pts with available ECOG data, 2865 (96.0%) had good performance status (ECOG score 0-2), and the remaining 4.0% had an ECOG score of 3/4. The median number of prior therapies was 1 (range, 1-6) but was higher in the LEN cohort (2; range, 1-6) than in the BORT (1; range, 1-6) and THAL (1; range, 1-5) cohorts; the proportion of pts with only 1 prior treatment was also lower in the LEN cohort (44.3%), whereas BORT was 70.8% and THAL 56.2%. Overall, 50.7% of pts (n = 1842) had grade 3/4 AEs. Grade 3/4 neutropenia occurred in 17.1%, 3.5%, and 4.4% of pts in the LEN, BORT, and THAL cohorts, respectively, and grade 3/4 thrombocytopenia in 9.2%, 7.3%, and 3.6%. The incidence rate of SPM was 3.63 per 100 pt-yrs, with 3.18 per 100 pt-yrs in the LEN cohort, 5.23 per 100 pt-yrs in the BORT cohort, 2.73 per 100 pt-yrs in THAL, and 6.48 per 100 pt-yrs in others. AEs of interest of all grades are listed in Table 1. The median duration on study treatment was 6.6 mos (range, 0.1-81.6 mos) for LEN, 4.1 mos (range, 0-63.6 mos) for BORT, and 4.6 mos (range, 0.2-36.9 mos) for THAL. Treatment discontinuation rate due to AEs was similar in each cohort (22.1% in the LEN, 20.0% in the BORT, and 21.2% in the THAL cohorts). In the LEN cohort, dose reductions occurred in 38.1% of pts, with a median time to first dose reduction due to AEs of 12.4 weeks. Treatment-emergent adverse events leading to dose reductions were similar across cohorts, with 23.7% in the LEN cohort, 21.4% in the BORT cohort, and 17.5% in the THAL cohort. Conclusions: Results of this noninterventional study in RRMM show that AEs were similar across cohorts except for higher rates of neutropenia and lower rates of PN with LEN compared with THAL or BORT. Higher rates of neutropenia did not translate into increased febrile neutropenia. Infections, independent from neutrophil counts, occurred in all cohorts, but few pts developed serious infections such as pneumonia. VTEs as well as myocardial infarctions were low throughout all cohorts. The occurrence of SPMs was generally low and comparable between cohorts. LEN was generally well tolerated. Disclosures Tholouli: Johnson and Johnson: Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Celgene: Honoraria; MSD: Speakers Bureau; Giles: Speakers Bureau. Hájek:Janssen: Honoraria; Takeda: Consultancy; BMS: Honoraria; Amgen: Consultancy, Honoraria, Research Funding; Celgene: Consultancy, Research Funding. Minnema:Celgene: Consultancy; BMS: Consultancy; Amgen: Consultancy; Jansen Cilag: Consultancy. Dimopoulos:Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Genesis: Consultancy, Honoraria; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Frost Andersen:Celgene: Research Funding. Waage:Amgen: Speakers Bureau; Celgene: Consultancy, Honoraria; Novartis, Amgen, Celgene: Membership on an entity's Board of Directors or advisory committees. Crotty:BMS, Takeda, Novartis, Janssen, Roche: Honoraria. Kueenburg:Celgene International Sarl: Consultancy, Honoraria. Di Micco:Celgene: Employment. Bacon:Celgene: Employment, Equity Ownership.

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Xiong, Ying, Zewei Wang, Quan Zhou, Han Zeng, Hongyu Zhang, Zhaopei Liu, Qiuren Huang, et al. "Identification and validation of dichotomous immune subtypes based on intratumoral immune cells infiltration in clear cell renal cell carcinoma patients." Journal for ImmunoTherapy of Cancer 8, no. 1 (March 2020): e000447. http://dx.doi.org/10.1136/jitc-2019-000447.

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BackgroundIncreasing evidence has elucidated the clinical significance of tumor infiltrating immune cells in predicting outcomes and therapeutic efficacy. In this study, we comprehensively analyze the tumor microenvironment (TME) immune cell infiltrations in clear cell renal cell carcinoma (ccRCC) and correlated the infiltration patterns with anti-tumor immunity and clinical outcomes.MethodsWe analyzed immune cell infiltrations in four independent cohorts, including the KIRC cohort of 533 patients, the Zhongshan ccRCC cohorts of 259 patients, the Zhongshan fresh tumor sample cohorts of 20 patients and the Zhongshan metastatic ccRCC cohorts of 87 patients. Intrinsic patterns of immune cell infiltrations were evaluated for associations with clinicopathological characteristics, underlying biological pathways, genetic changes, oncological outcomes and treatment responses.ResultsUnsupervised clustering of tumor infiltrating immune cells identified two microenvironment subtypes, TMEcluster-A and TMEcluster-B. Gene markers and biological pathways referring to immune evasion were upregulated in TMEcluster-B. TMEcluster-B associated with poor overall survival (p<0.001; HR 2.629) and recurrence free survival (p=0.012; HR 1.870) in ccRCC validation cohort. TMEcluster-B cases had worse treatment response (p=0.009), overall survival (p<0.001; HR 2.223) and progression free survival (p=0.015; HR 2.7762) in metastatic ccRCC cohort. The predictive accuracy of International Metastatic Database Consortium risk score was improved after incorporation of TME clusters.ConclusionsTMEcluster-A featured increased mast cells infiltration, prolonged survival and better treatment response. TMEcluster-B was a heavily infiltrated but immunosuppressed phenotype enriched for macrophages, CD4+T cells, Tregs, CD8+T cells and B cells. TMEcluster-B predicted dismal survival and worse treatment response in clear cell renal cell carcinoma patients.

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LeLorier, Jacques, Véronique Pagé, Anne-Marie Castilloux, and Yvette LeLorier. "Management of New Symptoms of Dyspepsia in the Elderly in Quebec." Canadian Journal of Gastroenterology 11, no. 8 (1997): 669–72. http://dx.doi.org/10.1155/1997/395236.

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OBJECTIVE:To use the Régie de l'assurance-maladie du Québec (RAMQ) database to study the clinical strategies used by Quebec physicians in the management of dyspepsia in the elderly.DESIGN:A 20% random sample of the RAMQ database for Quebec residents aged 65 years and older for the three years from July 1, 1991 to June 30, 1992 was used. Patients were placed in three cohorts according to the following treatment strategies: endoscopy, x-ray examination or drug therapy. Patients in each cohort were then categorized as either nonsteroidal anti-inflammatory drug (NSAID) users or non-NSAID users. The choice of drug treatment used to manage the dyspepsia in each cohort was recorded. Drug treatments were divided into the following six antidyspeptic categories: H2blockers, omeprazole, sucralphate, misoprostol, prokinetic drugs or no drugs. The number of duodenal, oesophageal and stomach cancers diagnosed in each cohort was also counted.RESULTS: Drug therapy was the most frequently used strategy in all patients, and was used more frequently in NSAID users (87%) than in non-NSAID users (69%). A total of 22% of NSAID users in each group, and 46% of NSAID users in the drug therapy group, underwent investigation. H2blockers were the most prescribed drug in all three treatment strategies, and omeprazole was the second most prescribed drug in the endoscopy and x-ray cohorts. Overall omeprazole was the least prescribed drug. There was a higher rate of cancer detection in the endoscopy and x-ray cohorts than in the drug therapy group.CONCLUSIONS:Previous NSAID use greatly influences the way in which physicians treat patients with dyspepsia.

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Feng, Snow X., Alex Z. Fu, Vipin Khare, Augustina Ogbonnaya, and Shuchita Kaila. "Characteristics and Treatment of Patients with Multiple Myeloma Who Received Daratumumab in a Large Claims Database in the United States." Blood 138, Supplement 1 (November 5, 2021): 4031. http://dx.doi.org/10.1182/blood-2021-149001.

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Abstract Introduction: Daratumumab (DARA) is a human IgGk monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. Since its approval for relapsed or refractory multiple myeloma (MM) in 2015 and newly diagnosed MM (NDMM) in 2018, DARA has become the foundation of treatment for MM. However, there is limited real-world evidence describing patients (pts) with MM treated with DARA-containing regimens in the US, especially for NDMM pts. Thus, using a large US claims database, we evaluated pt and treatment characteristics among MM pts who received DARA-containing regimens as first-line (1L) or second-line (2L) therapy, and separately for the subset who received DARA plus lenalidomide/dexamethasone (D-Rd) given its more recent approval in NDMM. Methods: This retrospective, observational cohort study evaluated pts aged ≥18 years at the index date (first observed treatment date with ≥1 medical or pharmacy claim for DARA) from the Optum Clinformatics Data Mart database between January 1, 2013 and December 31, 2020, with ≥1 diagnosis code for MM before the index date, and who were continuously enrolled in a medical benefit plan and pharmacy plan from ≥6 months before the initial MM diagnosis date to the index date. Pts with a hematopoietic stem cell transplant from 6 months before the observed initial MM diagnosis date to the index date were excluded. Eligible pts were categorized into 4 cohorts: pts with (1) a DARA-containing regimen as 1L (1L DARA-based cohort), (2) a DARA-containing regimen as 2L (2L DARA-based cohort), (3) D-Rd as 1L (1L D-Rd cohort), and (4) D-Rd as 2L (2L D-Rd cohort) after the observed initial MM diagnosis. Demographics were assessed on the index date; clinical characteristics, all-cause healthcare resource utilization (HCRU), and total all-cause healthcare costs (medical + pharmacy costs) were measured during the 6-month baseline period before the index date. Results: Among the 1L DARA-based cohort (n=235), 48 (20.4%) pts received D-Rd (1L D-Rd cohort). Overall, the most common 1L DARA-based regimens (with or without dexamethasone or prednisone) were D-R (28.5%), DARA plus bortezomib (V)/R (D-VR; 23.8%), D-V (18.7%), and D (14.9%). Among the 2L DARA-based cohort (n=310), 44 (14.2%) pts received D-Rd (2L D-Rd cohort). In the 1L DARA-based and 1L D-Rd cohorts, the mean (SD) age on the index date was 72.4 (9.0) and 76.1 (7.9) years, respectively. In the 2L DARA-based and 2L D-Rd cohorts, the mean (SD) age on the index date was 72.7 (9.3) and 70.5 (11.5) years, respectively. Mean baseline Quan-Charlson Comorbidity index was higher in the 2L cohorts versus 1L cohorts (1L DARA-based: 3.1; 1L D-Rd: 2.8; 2L DARA-based: 3.5; 2L D-Rd: 3.6). Hypercalcemia, renal impairment, anemia, and/or bone lesions (CRAB symptoms) were identified in about 50% of pts in all cohorts. Renal impairment was identified in 32.3%, 22.9%, 32.9%, and 34.1% of pts in the 1L DARA-based, 1L D-Rd, 2L DARA-based, and 2L D-Rd cohorts, respectively. Cardiovascular conditions (myocardial infarction, angina, peripheral vascular disease, and/or congestive heart failure) were found in 26.4% of pts in the 1L DARA-based cohort, 29.2% in the 1L D-Rd cohort, 34.5% in the 2L DARA-based cohort, and 47.7% in the 2L D-Rd cohort. The most common (>5% of pts) 1L regimens for pts in the 2L D-Rd cohort were VRd (17 [38.6%] pts), Vd (6 [13.6%]), V/cyclophosphamide (C)/d (4 [9.1%]), Rd (4 [9.1%]), and VC (3 [6.8%]). In the 1L DARA-based, 1L D-Rd, 2L DARA-based, and 2L D-Rd cohorts, 47.7%, 41.7%, 47.7%, and 54.5% of pts, respectively, had ≥1 hospitalization, and mean numbers of outpatient encounters were 26.4, 25.1, 50.6, and 52.8 within the 6-month baseline period. Mean 6-month baseline total healthcare cost (in 2020 USD) was $53,874 (medical: $51,837; pharmacy: $2,038) in the 1L DARA-based cohort, $39,695 ($35,896; $3,799) in the 1L D-Rd cohort, $131,832 ($96,737; $35,095) in the 2L DARA-based cohort, and $136,218 ($97,380; $38,838) in the 2L D-Rd cohort. Conclusions: In this real-world assessment using claims data, pts with MM receiving DARA-based therapy in 1L or 2L had median age ≥70 years, with high clinical burden as observed by their comorbidities, HCRU, and costs. Understanding the characteristics of real-world pts with MM treated with DARA-based therapy can further aid in the understanding of effective use of DARA in the real world. Disclosures Feng: Janssen: Current Employment. Fu: Janssen: Current Employment. Khare: Janssen: Current Employment. Ogbonnaya: Janssen: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment.

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Lai, Dominic W., June Kim, Ariel Marciscano, Sarah A. Buckley, Brian L. Schmidt, Richard F. Cohen, Mary Lynn R. Nierodzik, et al. "The impact of interventions on provider and treatment delays in head and neck cancer patients." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e16052-e16052. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e16052.

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e16052 Background: Diagnosis and management of squamous cell carcinoma of head and neck (SCCHN) involves a multidisciplinary approach. Navigation at a public hospital can be difficult and lead to delays. In a previous study, we reported English-speaking and employed patients having longer provider delays (Lai 2011). In July 2010, we instituted the use of patient navigators, bimonthly management conferences, and improved inter-disciplinary communication in order to improve the patient experience. Aims: 1. Study differences in “provider delay” (time between first contact with health care provider and positive biopsy) between patients in cohort A (diagnosed between 1/2007 and 6/2010) and cohort “B” (diagnosed between 7/2010 and 6/ 2011). 2. Study differences in “treatment delay” (time between biopsy and initiation of treatment) between the two cohorts. 3. Determine what factors influence delays in both cohorts. Methods: The delays of the two cohorts were compared using the student t-test. Independent t-test and chi-square tests were used to examine associations between delays and the following characteristics: language, employment, presence of partner, gender, ethnicity, age, cancer sub-site, staging, number of co-morbidities, tobacco use, and alcohol use. The likelihood ratio test was used for multivariate analysis. Results: 133 patients in cohort A and 20 patients in cohort B were evaluable. Both provider and treatment delays in cohort B (50.5 and 39.3 days, respectively) were shorter than cohort A (60.2 and 41.6 days), but this was not statistically significant. The standard deviations of both delays were lower in cohort B, pointing towards a greater consistency in this group. In cohort A, provider delay was significantly shorter (p-value=0.003) for non-English speakers than English speakers on univariate and multivariate analysis. Other trends were not observed. Conclusions: Simple interventions can reduce provider and treatment delays. Our observations suggest that these interventions can mitigate the effect of patient factors on provider and treatment delay. However, our results may be affected by small sample size and demographic shifts. With time, we will accrue more patients to address these issues.

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Uvarov, I. B., D. D. Sichinava, and A. M. Manuilov. "Vacuum-assisted laparostomy with staged peritoneal lavage in management of secondary postoperative diffuse peritonitis: a prospective comparative non-randomised clinical trial." Kuban Scientific Medical Bulletin 29, no. 1 (January 25, 2022): 62–76. http://dx.doi.org/10.25207/1608-6228-2022-29-1-62-76.

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Background. Secondary postoperative diffuse peritonitis (SPDP) associates with a high incidence of abdominal sepsis and 35–92% mortality rate. An optimal surgical doctrine in this complication in lacking to date.Objectives. An efﬁcacy assessment of vacuum-assisted laparostomy (VAL) with staged lavage relative to relaparotomy on demand (RD) in SPDP patients.Methods. Patient enrolment and analyses were conducted within period 01.11.2017-31.12.2020, totalling for 141 SPDP patients, 77 (54.6%) males and 64 (45.4%) females aged 64.5 (5972.7) years. Cohort I patients (n = 52) had post-abdominal-lavage VAL using Suprasorb® SNP (SNP-1 and SNP-2) equipment and consumables (Lohmann & Rauscher GmbH, Austria). Staged lavage was performed 48-72 h apart. Cohort II (n = 78) had a standard RD technique. Cohort III (n = 11) treatment included RD-to-VAL transition. The endpoint was the inpatient treatment outcome, a favourable completion or death. The additional estimated criteria were complications rate and severity (in ACCORDION-modiﬁed Clavien-Dindo classiﬁcation), sepsis rate, C-reactive protein level, abdominal index dynamics, patient’s intensive-care and total-hospital lengths of stay.Results. Cohort I included 157 staged-lavage VALs, cohort II — 107 RDs, cohort III — 49 operations. The mortality rate was 3/52 (5.8%), 24/78 (30.8%) and 7/11 (63.6%) in cohorts I, II and III (respectively, p < 0.001). No difference was observed in the length of hospital stay, with a shorter intensive care stay after ﬁnal abdominal closure in cohort I. Clavien — Dindo grade 3a complications were observed for 25.0% of cohort I, 60.3 and 45.5% — of cohorts II and III (respectively, p < 0.01); grade 3b complications were 0 (0%), 24.4 and 100% in cohorts I, II and III (respectively, p < 0.001; all 11 patients were reoperated). Multiple organ failure (grade 4b) was reported in 5.8, 30.8 and 63.6% of cohorts I, II and III (respectively, p < 0.001). By end of treatment, sepsis had resolved in 9/11 (81.8%) patients in cohort I, 5/24 (20.8%) and 1/6 (16.7%) — in cohorts II and III (respectively, p = 0.002).Conclusion. Programmed staged-lavage VAL is an optimal surgical treatment tactics in SPDP. Relative to RD, VAL provides a more effective management of local and systemic abdominal sepsis, lower mortality, fewer and less sever complications, shorter intensive care stays after abdominal closure.

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Lalla, Deepa, Melissa Brammer, Annie Guérin, Geneviève Gauthier, Philippe Giguere-Duval, Eric Q. Wu, and Eduardo Santos. "Do oncology patients in an outpatient hospital receive the same care as patients in an office/clinic setting? A case study evaluating patients with non-metastatic HER2+ breast cancer (BC) receiving adjuvant trastuzumab." Journal of Clinical Oncology 31, no. 15_suppl (May 20, 2013): e11603-e11603. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e11603.

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e11603 Background: It is unknown if quality of care received by patients (pts) with BC is impacted by the location at which care is received. Using a sample of pts with HER2+ BC receiving adjuvant trastuzumab (T), we compared T treatment patterns between pts treated in office/clinic (MD) or outpatient hospital (HOSP) settings. Methods: Non-metastaticBCadult women who received ≥2 T infusions in an MD or HOSP setting from 2008-2012 were selected from the US-based Humana database. Based on the site of care where T was received, pts were classified into MD or HOSP cohorts. Pts were followed from first T infusion date to treatment discontinuation, first metastasis, or end of continuous eligibility, for a maximum of 12 months (mos). T treatment duration, discontinuation (treatment gap of ≥45 consecutive days), and the proportion of pts completing the recommended 12 mos treatment indication were compared between cohorts. Results: 730 pts were included; 67% received T in an MD setting vs. 33% in a HOSP setting. Differences between cohorts were observed in terms of healthcare insurance plan: more pts in the HOSP setting had Medicare coverage (55.5% vs. 67.1%; p=.003). Average T duration was shorter in the HOSP setting (MD cohort: 241.9 days ; HOSP cohort: 191.3 days). Among pts observed for 12 mos, a higher proportion in the MD cohort completed the 12-mo treatment (84.3% in MD vs. 75.6% in HOSP [p=.034]). After adjusting for confounding factors, the HOSP cohort was 2.4 times more likely to discontinue treatment compared to the MD cohort ( p<.001). Conclusions: Duration of adjuvant T treatment for pts with non-metastatic HER2+ BC differed based on the site at which treatment was received. This suggests that oncology pts treated in an HOSP setting, vs. MD, may be at higher risk for treatment discontinuation or to receive a shorter course of treatment than recommended. Further research should explore the impact of these differing treatment patterns on outcomes.

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Charyshkin, A. L., and E. A. Keshyan. "Acute Bowel Obturation: Treatment Outcomes." Creative surgery and oncology 11, no. 1 (April 13, 2021): 15–19. http://dx.doi.org/10.24060/2076-3093-2021-11-1-15-19.

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Background. Two-stage colostomy is a common choice in treatment for obstruction-complicated colorectal cancer.Aim. Research into paracolostomy complications in obese and non-obese patients.Materials and methods. Material on obstruction-complicated colorectal cancer was collected from 50 patients divided into two cohorts by the body mass index (BMI). Cohort 1 contained 25 patients with BMI <24, and cohort 2 — patients with BMI >30.Results. Compared to cohort 1 with BMI <24, obese cohort 2 revealed more paracolostomy complications, the increase in parastomal skin lesions by 32% (p < 0.05), pyoinflammatory complications by 36% (p < 0.05) and abscesses by 24% (p < 0.05).Discussion. Paracolostomy complications in patients with BMI >30 are due to obesity, a poorly fitting colostomy bag, faecal leakage, skin irritation, infection and crude coagulation in haemostasis. Stoma gradually becomes difficult to visualise, faecal leakage continues and the paracolostomy space is poorly drained in obese patients, contributing to pyoinflammatory parastomal complications.Conclusion. The main causes of pyoinflammatory parastomal complications in obese patients are a low stoma positioning and poor paracolostomy drainage. The circumstances described warrant improvement of colostomy techniques in obese patients.

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Ab Ghani, SM, TF Tengku Mohd Ariff, TK Ong, and TW Lim. "The Implementation of the Minimal Intervention Dentistry in the Undergraduate Dental Clinical Teaching: A Retrospective Audit." Compendium of Oral Science 9, no. 2 (September 1, 2022): 63–68. http://dx.doi.org/10.24191/cos.v9i2.19234.

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Objectives: This study aims to assess the prevalence of minimal intervention dentistry (MID) treatment planned during the undergraduate clinical teaching. Materials and Methods: In this retrospective audit, clinical records from 108 dental students were collected and categorized into three cohorts; 2009/2014, 2010/2015, and 2011/2016. The number of direct restorations [amalgam restorations (AR) and composite restorations (CR)], fixed partial dental prostheses [conventional bridges (CB) and resin-bonded-bridges (RBB)] and single tooth indirect restorations (crowns and onlays) prescribed clinically by the undergraduate clinicians were retrieved. Results: Among the three cohorts, a trend was observed in the decrease of AR and the increase of CR prescribed by the dental students. The highest AR (9.6%) was performed by Cohort 2009/2014 and the highest CR (97.7%) was performed by Cohort 2011/2016. For fixed partial dental prostheses, RBB (67.6%) was the main treatment of choice, as compared to CB (32.4%). The cohort 2011/2016 prescribed the highest number of RBB as compared to earlier cohorts. In cases where teeth required cuspal protection, crowns (91.4%) dominated the treatment modality compared to onlays (8.6%). Conclusion: This study showed the dental undergraduates in UiTM endorsed the MID approach as recommended in the contemporary restorative dentistry.

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Chen, Ching-Jen, Thomas J. Buell, Dale Ding, Ridhima Guniganti, Akash P. Kansagra, Giuseppe Lanzino, Waleed Brinjikji, et al. "Observation Versus Intervention for Low-Grade Intracranial Dural Arteriovenous Fistulas." Neurosurgery 88, no. 6 (February 13, 2021): 1111–20. http://dx.doi.org/10.1093/neuros/nyab024.

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Abstract BACKGROUND Low-grade intracranial dural arteriovenous fistulas (dAVF) have a benign natural history in the majority of cases. The benefit from treatment of these lesions is controversial. OBJECTIVE To compare the outcomes of observation versus intervention for low-grade dAVFs. METHODS We retrospectively reviewed dAVF patients from institutions participating in the CONsortium for Dural arteriovenous fistula Outcomes Research (CONDOR). Patients with low-grade (Borden type I) dAVFs were included and categorized into intervention or observation cohorts. The intervention and observation cohorts were matched in a 1:1 ratio using propensity scores. Primary outcome was modified Rankin Scale (mRS) at final follow-up. Secondary outcomes were excellent (mRS 0-1) and good (mRS 0-2) outcomes, symptomatic improvement, mortality, and obliteration at final follow-up. RESULTS The intervention and observation cohorts comprised 230 and 125 patients, respectively. We found no differences in primary or secondary outcomes between the 2 unmatched cohorts at last follow-up (mean duration 36 mo), except obliteration rate was higher in the intervention cohort (78.5% vs 24.1%, P < .001). The matched intervention and observation cohorts each comprised 78 patients. We also found no differences in primary or secondary outcomes between the matched cohorts except obliteration was also more likely in the matched intervention cohort (P < .001). Procedural complication rates in the unmatched and matched intervention cohorts were 15.4% and 19.2%, respectively. CONCLUSION Intervention for low-grade intracranial dAVFs achieves superior obliteration rates compared to conservative management, but it fails to improve neurological or functional outcomes. Our findings do not support the routine treatment of low-grade dAVFs.

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Patel, Manish R., Aung Naing, Howard A. Burris III, Chia-Chi Lin, Giuseppe Curigliano, Fiona Thistlethwaite, Anna Rachel Minchom, et al. "A phase 1/2 open-label study of KY1044, an anti-ICOS antibody with dual mechanism of action, as single agent and in combination with atezolizumab, in adult patients with advanced malignancies." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 2624. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.2624.

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2624 Background: KY1044, is a fully human IgG1 anti ICOS antibody designed to stimulate Teffs and to deplete ICOS high Tregs in the tumor microenvironment. Methods: Patients with advanced/metastatic malignancies received escalating doses of KY1044 as a single agent and in combination with atezolizumab 1200 mg by IV infusion every 3 weeks until disease progression or unacceptable toxicity. Dose escalation was guided by a modified toxicity probability interval design. The primary objective was to determine safety, tolerability, and maximum tolerated dose. Cohorts that were tolerated were later enriched with more subjects. AEs were classified according to CTCAE v5 and efficacy measures performed according to RECIST v1.1 every 8 weeks for the first 16 weeks and then every 12 weeks. Results: As of 16-Dec-2020, a total of 103 patients have been enrolled in the study (38 patients as monotherapy in 6 cohorts at doses ranging from 0.8 to 240 mg and 65 in combination with atezolizumab in 5 cohorts at doses 0.8 – 80 mg). 63% and 55% of patients received ≥4 prior anti-cancer therapies in the single agent and combination cohorts, respectively. All cohorts were completed without DLTs during the first 21 days of treatment. In the KY1044 single agent cohorts, 47.4% of patients experienced treatment-related AEs (TRAEs), all were grades 1 or 2. In the combination cohorts, TRAEs were observed in 58% of patients. Most of the TRAEs were grade 1 or 2 apart from 8 TRAEs that were ≥grade 3 occurring in <8% of patients. Infusion-related reactions, pyrexia and lymphopenia were the most commonly occurring TRAEs in ≥10% of patients. TRAE leading to dose interruptions occurred in 1 patient in the single agent cohort and in 4 patients in the combination cohort. Only 1 patient discontinued treatment due to myositis that was considered related to the combination. Preliminary KY1044 PK data from 69 patients agree with the PK model predictions. Median treatment duration for all enrolled patients was 9 weeks. Treatment duration ≥16 weeks was observed in 24% (9/38) and 27% (17/64) patients in the single agent and combination cohorts, respectively. Five objective responses, including 1 CR in triple negative breast cancer (TNBC) and 4 PRs in TNBC, head and neck squamous cell carcinoma, penile and pancreatic cancer were observed. Four of the 5 responding patients were still on treatment at the data cut, with 3 patients on treatment for >43 weeks (range 45 to 66 weeks). Conclusions: KY1044 is well tolerated as single agent and in combination with atezolizumab. Objective responses have been observed in this phase 1 part of the study. The phase 1 expansion and phase 2 part of the study is ongoing. Clinical trial information: NCT03829501.

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Shore, Neal D., Rana R. McKay, Mark A. Preston, Justin R. Gregg, Simpa Samuel Salami, Ashley Ross, Amanda Bruno, Shankar Srinivasan, Jorge A. Ortiz, and Niculae Constantinovici. "Time trends of overall survival and other outcomes in patients with mHSPC: An observational study of U.S. EHR data (TIMES)." Journal of Clinical Oncology 40, no. 16_suppl (June 1, 2022): e17051-e17051. http://dx.doi.org/10.1200/jco.2022.40.16_suppl.e17051.

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e17051 Background: Patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) are responsive to androgen deprivation therapy (ADT), but within 1–3 years most will develop metastatic castration-resistant prostate cancer (mCRPC). The CHAARTED trial showed a clear benefit of adding docetaxel (DTX) to ADT, prolonging median overall survival (OS) by 10.4 months (mo). ARASEC is a single-arm US study evaluating darolutamide + ADT in pts with mHSPC. Participants will be matched for comparison using patient-level data to the ADT alone arm of CHAARTED. The TIMES study evaluated a potential time bias in treatment patterns and clinical outcomes in pts with mHSPC before and after the OS analysis of CHAARTED was reported. Methods: This retrospective study used Flatiron Metastatic PC Core Registry data from January 1, 2013, to June 30, 2020, and the sample was divided into two cohorts: before and after June 30, 2016 (cohort 1: pre-CHAARTED; cohort 2: post-CHAARTED). Differences in OS and time to mCRPC were assessed using Cox proportional hazard models, controlling for baseline characteristics, including age, initial mHSPC treatment, Gleason score, and time from PC diagnosis to mHSPC. The test for equivalence used hazard ratio (HR) limits of 0.80 to 1.25 at a 2-sided 0.05 level. Results: Data from 9256 pts with mHSPC (4503 in cohort 1; 4753 in cohort 2) were analyzed; median age was 73 years for both cohorts. M1 status at initial diagnosis was 55% in cohort 1 and 60% in cohort 2. All other clinical characteristics and laboratory values were similar. Initial mHSPC treatment with DTX was 10.5% and 13.9%, whereas treatment with novel anti-hormonal agents (NAH) was 1.6% and 18.3% in cohorts 1 and 2, respectively. The percentage of pts who started with first-generation androgen receptor inhibitors decreased from 29.3% in cohort 1 to 19.6% in cohort 2, whereas the percentage of pts receiving ADT alone and/or supportive care remained stable (25.7% and 26.5%, respectively). In cohorts 1 and 2, treatment records during the mHSPC period could not be retrieved for 32.9% and 21.7% of pts, respectively. Median OS was 5.4 months longer for cohort 1 (43.7 mo) vs cohort 2 (38.3 mo). In multivariate analyses, cohort 2 had poorer survival, with an HR slightly outside the predefined limits for equivalence (HR 1.19; 95% CI 1.09, 1.29; P < 0.0001). The HR for time to mCRPC fell within the predefined limits (HR 1.16; 95% CI 1.09, 1.23). Conclusions: Changes in treatment patterns were observed following CHAARTED. Although DTX and NAH have demonstrated prolonged survival, their use increased only from 12% to 32%, comparing the cohorts before and after 2016, which is not in line with guideline recommendations. Clinical outcomes, despite the influence of multiple factors, have changed minimally during the past 5 years, suggesting that the risk of historical time bias associated with using the CHAARTED ADT alone arm as a comparator for ARASEC is low.

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Samani, Amit, Shuai Zhang, Laura Spiers, Ali Abdulnabi Mohamed, Sophie Merrick, Zayd Tippu, Miranda Payne, et al. "Impact of age on the toxicity of immune checkpoint inhibition." Journal for ImmunoTherapy of Cancer 8, no. 2 (October 2020): e000871. http://dx.doi.org/10.1136/jitc-2020-000871.

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Indications for immune checkpoint inhibitor therapy are increasing. As the population ages, many patients receiving such drugs will be older adults. Such patients are under-represented in clinical trials, and therefore the safety of immune checkpoint inhibitors in this population has not been adequately assessed. A retrospective multicenter analysis of toxicities was performed in patients with advanced or metastatic solid cancers receiving anti-programmed cell death protein 1 (anti-PD-1) and/or anti-CTLA4 antibodies across three age cohorts (<65 years, 65–74 years and ≥75 years) using univariable and multivariable analyzes. Eligible patients (n=448) were divided into age cohorts: <65 years (n=185), 65–74 years (n=154) and ≥75 years (n=109). Fewer patients in the oldest cohort (7.3%) received an anti-CTLA4 antibody containing regimen compared with the younger cohorts (21.1% and 17.5%). There was no significant difference overall in all grade or ≥G3 toxicities between age cohorts. Significantly fewer patients in the older (65–74 years and ≥75 years) age cohorts discontinued treatment because of toxicity (10.1% and 7.4%) compared with in the <65 years cohort (20.5%; p=0.006). Using logistic regression, only treatment type (ipilimumab containing) was significantly associated with all grade toxicity. However, there was a significantly lower incidence of all-grade endocrine toxicity in the oldest cohort (11.0%) compared with the youngest cohort (22.7%, p=0.02; OR 0.43, 95% CI 0.21 to 0.87), while all-grade dermatological toxicity showed the reverse trend (28.4% vs 18.9%; OR 1.85, 95% CI 1.04 to 3.30). Results were corroborated in the sensitivity analysis using only data from patients who received PD-1 inhibitor monotherapy. This multicenter, real-world cohort demonstrates that immune checkpoint inhibitor therapy is safe and well tolerated regardless of age, with no appreciable increase in adverse events in older adult patients.

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Llop Serna, Sandra, Clara Ejarque Martinez, Jesús Brenes Castro, Macarena Honorato, M. Esther Vilajosana Altamis, Mireia Melero, Oriol Bermejo, et al. "Impact of comprehensive geriatric assesment (CGA) in the treatment decision and outcome of older patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC)." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): 6057. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.6057.

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6057 Background: Up to 24% of patients (pts) newly-diagnosed with LA-HNSCC are 70 years old (yo). NCCN guidelines recommend a geriatric assessment to guide treatment decisions in this pts population. Comprehensive geriatric assessment (CGA) of older HNSCC pts was implemented at our institution in 2018. We evaluated the impact of CGA in treatment decision and outcome and compare it to a control cohort with no CGA treated within the same institution. Methods: Retrospective single-institution analysis of two consecutively-treated cohorts of newly-diagnosed elderly LA-HNSCC pts treated at the Catalan Institute of Oncology: a cohort treated based on CGA between 2018-2020; and a control cohort with no CGA treated based on physician criteria following tumor board decision between 2016-2018. Pts demographics and disease characteristics were obtained from our in-site prospective database. Treatment received (standard, adjusted, palliative-intent, best supportive care [BSC]), treatment completion rate (TCR) an overall response rate (ORR) after conservative treatment were collected and compared for both cohorts using chi-square. Results: A total of 197 pts were included: CGA cohort =81; Control cohort=96. Baseline characteristics were similar between cohorts (Table). Pts in CGA cohort were classified as fit (F) 35 (34.7%), medium-fit (MF) 51 (50.5%) and unfit (UF) 15 (14.9%) according to CGA results. CGA changed final treatment decision following tumor board in 31 % of the cases. Pts were more likely to receive standard treatment in the CGA cohort when compared control (36 vs 21%; p = 0.048), with no differences observed in TCR (84% vs 86%; p = 0.805). In pts who underwent conservative treatment, ORR was similar between CGA and control cohort (73.9% vs 66.7 %; p = 0.082), respectively. Tumor progression was the major cause of death in both groups. Conclusions: Older pts with LA-HNSCC who underwent CGA were more likely to receive standard treatment than those who did not, supporting the relevance of CGA for clinical decision-making in this pt population. No differences were observed in CRR, TCR or death cause. In-deep survival analysis are on-going.[Table: see text]

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Wittermans, Esther, Philip A. van der Zee, Hongchao Qi, Ewoudt M. W. van de Garde, Claudine A. Blum, Mirjam Christ-Crain, Diederik Gommers, et al. "Community-acquired pneumonia subgroups and differential response to corticosteroids: a secondary analysis of controlled studies." ERJ Open Research 8, no. 1 (November 4, 2021): 00489–2021. http://dx.doi.org/10.1183/23120541.00489-2021.

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BackgroundLatent class analysis (LCA) has identified subgroups with meaningful treatment implications in acute respiratory distress syndrome. We performed a secondary analysis of three studies to assess whether LCA can identify clinically distinct subgroups in community-acquired pneumonia (CAP) and whether the treatment effect of adjunctive corticosteroids differs between subgroups.MethodsLCA was performed on baseline clinical and biomarker data from the Ovidius trial (n=304) and the Steroids in Pneumonia (STEP) trial (n=727), both randomised controlled trials investigating adjunctive corticosteroid treatment in CAP, and the observational TripleP cohort (n=201). Analyses were conducted independently in two cohorts (Ovidius–TripleP combined and the STEP trial). In both cohorts, differences in clinical outcomes and response to adjunctive corticosteroid treatment were examined between subgroups identified through LCA.ResultsA two-class model fitted both cohorts best. Class 2 patients had more signs of systemic inflammation compared to class 1. In both cohorts, length of stay was longer and in-hospital mortality rate was higher in class 2. In the Ovidius trial, corticosteroids reduced the median length of stay in class 2 (6.5 versus 9.5 days) but not in class 1 (p-value for interaction=0.02). In the STEP trial, there was no significant interaction for length of stay. We found no significant interaction between class assignment and adjunctive corticosteroid treatment for secondary outcomes.ConclusionsIn two independent cohorts, LCA identified two classes of CAP patients with different clinical characteristics and outcomes. Given the different response to adjunctive corticosteroids in the Ovidius trial, LCA might provide a useful basis to improve patient selection for future trials.

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Hall, Rasheeda, Alyssa Platt, Jonathan Wilson, Patti L. Ephraim, Angelina S. Hwang, Angel Chen, Daniel E. Weiner, L. Ebony Boulware, Jane Pendergast, and Julia J. Scialla. "Trends in Mineral Metabolism Treatment Strategies in Patients Receiving Hemodialysis in the United States." Clinical Journal of the American Society of Nephrology 15, no. 11 (October 12, 2020): 1603–13. http://dx.doi.org/10.2215/cjn.04350420.

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Background and objectivesWith multiple medications indicated for mineral metabolism, dialysis providers can apply various strategies to achieve target phosphate and parathyroid hormone (PTH) levels. We describe common prescribing patterns and practice variation in mineral metabolism treatment strategies over the last decade.Design, setting, participants, & measurementsIn a cohort of adults initiating hemodialysis at Dialysis Clinic, Inc. facilities, we assessed prescriptions of vitamin D sterols, phosphate binders, and cinacalcet longitudinally. To identify the influence of secular trends in clinical practice, we stratified the cohort by dialysis initiation year (2006–2008, 2009–2011, and 2012–2015). To measure practice variation, we estimated the median odds ratio for prescribing different mineral metabolism treatment strategies at 12 months post–dialysis initiation across facilities using mixed effects multinomial logistic regression. Sensitivity analyses evaluated strategies used after detection of first elevated PTH.ResultsAmong 23,549 incident patients on hemodialysis, there was a decline in vitamin D sterol–based strategies and a corresponding increase in strategies without PTH-modifying agents (i.e., phosphate binders alone or no mineral metabolism medications) and cinacalcet-containing treatment strategies between 2006 and 2015. The proportion with active vitamin D sterol–based strategies at dialysis initiation decreased across cohorts: 15% (2006–2008) to 5% (2012–2015). The proportion with active vitamin D sterol–based strategies after 18 months of dialysis decreased across cohorts: 52% (2006–2008) to 34% (2012–2015). The odds of using individual strategies compared with reference (active vitamin D sterol with phosphate binder) varied from 1.5- to two-fold across facilities in 2006–2008 and 2009–2011 cohorts, and increased to two- to three-fold in the 2012–2015 cohort. Findings were similar in sensitivity analyses starting from first elevated PTH measurement.ConclusionsOver time, mineral metabolism management involved less use of vitamin D sterol–based strategies, greater use of both more conservative and cinacalcet-containing strategies, and increased practice variation, suggesting growing equipoise.

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Journal articles on the topic 'Cohorts Treatment'

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