bluuebunny/crossref_metadata_2025_split huggingface dataset:
An evaluation of gender discrepancies in genetic referrals for BRCA testing for indicated malignancies.
Authors: Smith Wesley , Smith Kayla , Sessions William , Evins Connor , Baker Michael , Blumer Mary 
Published: June 2021

10584 Background: Tumor suppressing genes BRCA1 and BRCA2 were discovered in 1990 and 1994, respectively, with mutations linked to hereditary breast-ovarian cancer syndromes (HBOCs). The discovery of these mutations has led to screening of at-risk patient populations and their family members. Women with BRCA1 or BRCA2 mutations are generally recommended to have prophylactic bilateral mastectomies and oophorectomies to decrease their future risk of cancer. While the initial discovery mostly focused on cancers in women, research has shown that BRCA mutations increase the risk of other cancers such as prostate cancer and pancreatic cancer, that also affect men. Previous research suggests that men are three times less likely to receive genetic testing in cancer driven by a 10:1 disparity in HBOC genetic testing. This was thought to be due to the lack of information on the importance of HBOC testing along with social roles in health. We wanted to evaluate the magnitude of the potential gender gap in BRCA testing in men compared to women. Methods: This was an IRB-approved, single center retrospective study to evaluate the rate of referrals to genetics for BRCA testing. Eligible patients had a personal history of cancer meeting criteria for BRCA testing per NCCN recommendations. Chart review was performed for patients with ovarian cancer, female breast cancer 45 years and younger, female triple negative breast cancer 60 years and younger, metastatic prostate cancer, all male breast cancer that have made an office visit since 2017, and pancreatic cancer since 2019. Rates of referral for genetic testing was the primary outcome and the groups were compared via the Chi-Square test. Results: 1,320 patients were included in the study, of which 664 were men and 656 were women. 128/664 (19.3%) of men were referred to genetics for screening compared to 527/656 (80.3%) for women ( p <.001). Additionally, 42/128 (32.8%) men who were referred for screening did not complete genetic screening compared to 72/527 (13.7%) women ( p <.001). A total of 62/541 (11.5%) patients who completed screening had either a BRCA1 or BRCA2 mutation. Conclusions: In our study, men were referred for BRCA testing significantly less than women for primary cancers, despite recommendation from the NCCN. In addition, men were also more than twice as likely not to complete genetic screening even if referred. The integration of genetics and oncology will continue to grow as personalized medicine continues to drive more treatment options. Closing this gender gap is important not only for familial screening purposes but also for treatment implications as patients with germline BRCA mutations are eligible for poly ADP ribose polymerase (PARP) inhibitors (e.g. olaparib) in both metastatic prostate cancer and pancreatic cancer. Further quality improvement initiatives are needed in order to close this gap by increasing education of the importance of BRCA testing in men.
Compliance with germline testing in pancreatic cancer in a rural tertiary care hospital.
Authors: Travaline Catherine , Elliott Leighton Andrew , Ramdin Nadia N. , Vadakara Joseph 
Published: June 2021

10599 Background: Pancreatic cancer is the 7th most common cause of cancer death worldwide and is projected to be the second leading cause of cancer death in the next decade. Personalized care is becoming more of a reality with pharmacological regimens targeting specific genetic mutations. In March 2019, the National Comprehensive Cancer Network (NCCN) guidelines were updated to recommend germline testing (GT) in all patients with pancreatic adenocarcinoma (PDAC) considering 1 in 10 may have a germline mutation (GM). The goal of this study was to quantify compliance with these recently updated guidelines. Methods: The electronic medical records and survivorship data of all patients diagnosed with PDAC between January 1, 2017 and October 1, 2020 were reviewed. April 1, 2019 was used as the transition point (TP) for guideline updates. Descriptive statistics for all variables were determined. The rate of ordered referrals to genetic counseling (GC), as well as completion rate, was calculated. Results: A total of 304 patients were diagnosed with PDAC during the study period (223 prior to the TP). A total of 54 patients were referred for GC and 41 had GT ordered. The rate of GC referrals ordered after the TP was significantly higher than before the TP (22/81, 26.6% vs. 32/223, 14.4%; p-value 0.010). Almost 60% of patients who had genetic evaluation had private insurance. The patients who completed GT were significantly more likely to have a documented family history of cancer (61.0% vs 4.2%; p-value <.0001Patients who completed GT had more problems on their problem list (median 10 vs 7, p = 0.001). The median overall survival (OS) for all patients in the study was 7.8 months (95% CI: 6.3-9.8). Conclusions: Overall compliance with the updated NCCN guidelines significantly improved; however, it was below 25%. This study showed that there may be some lingering bias toward GT in PDAC solely for those who have a family history of cancer. Although patients with stage IV PDAC have poor outcomes, GT may still improve surveillance for family members. The approval of olaparib in patients with BRCA1/2 mutations based on the POLO trial is likely to increase provider compliance as it provides a viable maintenance strategy in these patients. Patient complexity was unlikely to affect GT rate. Assessment of provider awareness was outside the scope of this study. There is need for continued advocacy for awareness and implementation of guidelines that highlight the importance of germline evaluation on prevention, surveillance, and treatment in pancreatic adenocarcinoma.
Real-world quality of life (QoL) in black, indigenous and people of color (BIPOC) treated with palbociclib (PAL) and endocrine therapy for hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): A subgroup analysis from POLARIS.
Authors: Rocque Gabrielle Betty , Blum Joanne Lorraine , Montero Aldemar , Karuturi Meghan Sri , Manning Kenneth , Shabazz Lloyd , Gallagher Christopher , Zuberi Lara , Cappelleri Joseph C , Drucker Marc , Wang Yao , Tripathy Debu 
Published: June 2021

1071 Background: Racial disparities in breast cancer incidence, mortality, and care are well documented. PAL plus endocrine therapy is indicated for patients (pts) with HR+/HER2− ABC. Findings from the PALOMA clinical trials have shown that pts receiving PAL maintained stable QoL; however, limited QoL data are available from real-world settings for BIPOC receiving PAL. Methods: POLARIS is a noninterventional, prospective, primarily US-based study in pts with HR+/HER2– ABC receiving PAL. QoL was assessed with the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) at baseline, monthly for the first 3 mo of treatment (Tx) with PAL, and then every 3 mo. In this interim analysis, we report Tx patterns and QoL assessments at baseline and at 6 mo and 12 mo in BIPOC from POLARIS. Results: Of 1280 pts treated with PAL as November 10, 2020, 233 were included in the BIPOC subgroup of whom 159 (68.2%) completed PAL Tx for ≥6 mo and 112 (48.1%) for ≥12 mo. In the BIPOC cohort, 59.2% of pts were black, 35.2% Hispanic, 3.4% American Indian or Alaskan native, 2.1% Pacific Islander. PAL in combination with letrozole/anastrozole was received by 116 pts, 94 received PAL plus fulvestrant, 13 received PAL plus exemestane, and 10 received PAL plus another Tx; 175 pts (75.1%) received PAL as first-line Tx. Mean EORTC QLQ-C30 global health QoL and functional scales scores remained stable over the first 12 mo of PAL Tx, without any changes at or above the 10-point threshold considered clinically meaningful, and were similar to those previously reported in an earlier analysis of the entire POLARIS population (Table and Rocque et al SABCS 2019). Symptom scales scores, including nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, and diarrhea, also remained stable over 12 mo. Conclusions: In this subgroup analysis, PAL had no significant adverse impact on QOL in BIPOC with HR+/HER2– ABC, consistent with previous findings from the total POLARIS study population. Pfizer (NCT03280303). Clinical trial information: NCT03280303 .[Table: see text]
A phase Ib study of TQB2450 plus anlotinib in patients with advanced triple-negative breast cancer.
Authors: Wang Jiayu , Xu Binghe , Sun Tao , Ouyang Quchang , Han Yiqun , Li Qing , Zhang Pin , Ma Fei , Luo Yang , Fan Ying , Cai Ruigang , Li Qiao , Lan Bo , Mo Hongnan , Wang Jiani , Li Yiqun 
Published: June 2021

1074 Background: TQB2450 is a humanized monoclonal antibody targeting programmed death-ligand 1 (PD-L1). Anlotinib is an antiangiogenic small molecule, multi-target tyrosine kinase inhibitor that has improved clinical outcomes in various solid tumors. This phase 1b study aims to evaluate the safety and efficacy of TQB2450 plus anlotinib for patients with advanced triple-negative breast cancer (TNBC) after the failure of standard therapy. Methods: This ongoing study included a dose-escalation phase and an expansion phase. Advanced TNBC patients with prior anthracyclines and/or taxanes treatment and failed at least first-line therapy were enrolled. In the dose-escalation phase, eligible patients received anlotinib (8mg, 10mg, and 12mg, qd, days 1-14; 21 days per cycle) plus TQB2450 (1200mg, day 1; 21 days per cycle) following the conventional 3+3 design. If the starting dose of 10mg anlotinib led to ≥2 dose-limiting toxicities (DLTs), 8mg anlotinib would be administered. After the dose-escalating phase, eligible patients were enrolled into the expansion cohort. The primary endpoint was objective response rate (ORR), and the secondary endpoints were overall survival (OS), disease control rate (DCR), progression-free survival (PFS), and safety. Results: Between May 29, 2019, and December 31, 2020, in the dose-escalation phase, three patients receiving 10mg anlotinib plus 1200mg TQB2450 had no DLTs in the first cycle, neither did three patients with 12mg anlotinib plus TQB2450. Next, 28 patients with advanced TNBC received 12 mg anlotinib plus TQB2450 in the expansion phase. Finally, a total of 34 patients were included with median age of 49.5 (32-70) and median prior lines of 2 (1-6). Numbers of patients with prior platinum therapy: 16, prior anthracycline therapy: 32. The ORR was 26.47% (9/34) and DCR was 82.35% (28/34). The median PFS was 8.57 months. Seventeen patients experienced grade 3 treatment-related AEs (TRAEs). Most frequently occurring (>5%) grade 3 TRAEs were QT interval prolongation (17.65%), hypertension (14.71%), diarrhea (8.82%), hand-foot syndrome (HFS) (8.82%), and hypertriglyceridemia (5.88%). Conclusions: TQB2450 plus anlotinib showed an acceptable safety profile with promising activity for previously anthracyclines and/or taxanes-treated advanced TNBC patients. Clinical trial information: NCT03855358 .[Table: see text]
Control arm heterogeneity in trials for unselected advanced triple-negative breast cancer (aTNBC).
Authors: Gala Kinisha , Kalucha Ankit , Martinet Samuel , Goel Anushri , Narisetty Kalpana Devi , Larvol Bruno , Punie Kevin 
Published: June 2021

1082 Background: Primary endpoints of clinical trials frequently include subgroup-analyses. Several solid cancers such as aTNBC are heterogeneous, which can lead to unpredictable control arm performance impairing accurate assumptions for sample size calculations. We explore the value of a comprehensive clinical trial results repository in assessing control arm heterogeneity with aTNBC as the pilot. Methods: We identified P2/3 trials reporting median overall survival (mOS) and/or median progression-free survival (mPFS) in unselected aTNBC through a systematic search of PubMed, clinical trials databases and conference proceedings. Trial arms with sample sizes ≤25 or evaluating drugs no longer in development were excluded. Due to inconsistency among PD-L1 assays, PD-L1 subgroup analyses were not assessed separately. The primary aim was a descriptive analysis of control arm mOS and mPFS across all randomized trials in first line (1L) aTNBC. Secondary aims were to investigate time-to-event outcomes in control arms in later lines and to assess time-trends in aTNBC experimental and control arm outcomes. Results: We included 33 trials published between June 2013-Feb 2021. The mOS of control arms in 1L was 18.7mo (range 12.6-22.8) across 5 trials with single agent (nab-) paclitaxel [(n)P], and 18.1mo (similar range) for 7 trials including combination regimens (Table). The mPFS of control arms in 1L was 4.9mo (range 3.8-5.6) across 5 trials with single-agent (n)P, and 5.6mo (range 3.8-6.1) across 8 trials including combination regimens. Control arm mOS was 13.1mo (range 9.4-17.4) for 3 trials in first and second line (1/2L) and 8.7mo (range 6.7-10.8) across 5 trials in 2L and beyond. R2 for the mOS best-fit lines across control and experimental arms over time was 0.09, 0.01 and 0.04 for 1L, 1/2L and 2L and beyond, respectively. Conclusions: Median time-to-event outcomes of control arms in 1L aTNBC show considerable heterogeneity, even among trials with comparable regimens and large sample sizes. Disregarding important prognostic factors at stratification can lead to imbalances between arms, which may jeopardize accurate sample size calculations, trial results and interpretation. Optimizing stratification and assumptions for power calculations is of utmost importance in aTNBC and beyond. A digitized trial results repository with precisely defined patient populations and treatment settings could improve accuracy of assumptions during clinical trial design.[Table: see text]
COVID-19 and medical education: Rethinking student assessment—The Virtual Observational Standard Clinical Examination.
Authors: Abal Mariana , Gil Deza Lourdes , Gil Deza Ernesto , Dragosky Marta , Acuna Claudia Lorena , Marin Ordoñez Alba , Montiel Monica , Tognelli Flavio A , Smolje Leonel , Gonzalez Cesar , Brandon Maximiliano , Garcia Gerardi Carlos , Martin Reinas Gaston , Jaunarena María del Huerto , Gercovich Natasha , Rivarola Edgardo G. J. , Morgenfeld Eduardo L. , Gercovich Felipe G. ,   IOHM-USAL-ECOE-2020
Published: June 2021

11005 Background: The COVID-19 pandemic introduced new challenges for medical education. In particular, student assessment posed some of the most urging questions. How do we evaluate practical skills when our universities are on lockdown and our hospitals are working on a shortage of personnel? Is it possible to evaluate these skills via online means, mitigating the effects in students’ career development? This paper presents an online evaluation experience implemented at Instituto Oncológico Henry Moore-Universidad del Salvador, Buenos Aires in the postgraduate program of Clinical Oncology. The Virtual Observational Standard Clinical Examination (V-OSCE) is a technology-based adaptation of the Observational Standard Clinical Examination (OSCE) (JCO 34 (15), Abstract e18150, 2017) implemented in previous years. Methods: The V-OSCE took place in November 14, 2020 and consisted on a half-day evaluation during which students rotated through 8 stations (Table). The exam ran on three platforms: Blackboard Collaborate for the interactive elements of all stations; University online campus (Moodle platform) for student questionnaires, and Google Forms for the evaluators’ assessment of each student. Students and evaluators participated in various training sessions, and were given a month to practice before the exam. All interactions were recorded and an anonymous survey on students’ experience and opinions was conducted after the exam. Results: A total of 25 postgraduate Oncology students participated in the V-OSCE. 24 students (96%) completed all stations on time with minimum or no network connection issues. Student opinions: 24 students completed the exam experience anonymous survey; 23 found the exam tech-friendly and valued the practice time provided. When asked to score the exam in a scale of 1 to 10: 80% of the students ranked the exam with 9 or 10; and 20%, with 7 or 8. Conclusions: A) It is feasible to design new ways to assess medical students via online means. B) The experience of an OSCE can be translated to an online environment with minimum technological requirements. C) The COVID-19 pandemic effects are extensive, with serious implications in medical education. However, it has proved to be an opportunity to rethink our educational practices, design innovative formative experiences, and assess new skills that will remain significant even long after the pandemic has ended.[Table: see text]
Where are the women and underrepresented minorities in medicine? Race/ethnicity and gender representation in oncology journals’ editorial boards.
Authors: Patel Shruti Rajesh , Riano Ivy , Geiger Gabriella , Pimienta Jacqueline , Abuali Inas , Ai Angela , Ramirez Roggio Adriana , Dhawan Natasha , Dizman Nazli , Salinas Alexandra Lizette , Duma Narjust 
Published: June 2021

11007 Background: The proportion of women & underrepresented groups in medicine (URM) in the field of hematology and oncology remains low, particularly in academic leadership positions. Editorial board appointments allow physicians to have a substantial impact on the nature of the published scholarly work and serve as a platform for academic opportunities. We aimed to assess gender and race/ethnicity representation in editorial board positions in hematology and oncology journals. Methods: Editorial leadership board members from 60 journals from oncology, hematology, radiation oncology, and surgical oncology were reviewed, 54 journals were included in the analysis. Gender and race/ethnicity were determined based on publicly available data for editor-in-chief (EiC) and second-in-command (SiC) (including deputy, senior, or associate editors). Descriptive statistics and chi-squared were estimated. Results: A total of 793 editorial board members are included in the analysis. 72.6 % were men and 27.4 % were women. 71.3% of editorial leadership were non-Hispanic white with Asian editorial board members representing the second largest majority at 23.3%. The editorial position was significantly different among men and women (p = 0.038) with women filling only 15.9% (10/63) of the EiC positions. Of these 10 women, the racial breakdown was 90% white and 10% Asian. In the prevalence odds ratio (pOR), women were about half as likely to be in the EiC position compared with men [pOR: 0.47, 95%CI (0.23, 0.95, p = 0.03)]. Women represented 28.4% (207/730) of SiC editorial positions. White editors had the highest representation at 71.0% in the SiC editorial positions, followed by Asian editors at 16.0%. Notable differences were seen in gender proportions between journal specialties (p = 0.001); with surgical oncology and hematology having the lowest female representation at 11.9% and 22.7%, respectively. Conclusions: Women and UIM are markedly underrepresented in leadership roles on Editorial Boards in hematology and oncology journals. Importantly, the representation of minority women physicians in EiC positions is at an inexorable zero which is a sign of unconscious attitudes that may exclude women and minorities from certain positions. It is imperative that we work to move towards a more diverse and inclusive editorial board to ensure critical perspectives are heard and scientific discovery is fostered.[Table: see text]
Authorship gender equity in global oncology publications.
Authors: Hornstein Paula , Tuyishime Hubert , Mutebi Miriam Claire , Lasebikan Nwamaka , Rubagumya Fidel , Fadelu Temidayo 
Published: June 2021

11008 Background: There is increasing recognition of authorship inequity in academic medicine specialty publications. Analyses in other specialties note that female authors consistently comprise a minority of the first authors and an even smaller percentage of last authors. While this trend may be improving, we hypothesize that significant authorship gender disparities still exist in global oncology journals. Methods: This study comprehensively analyzes the gender distribution of authors for articles published in the Journal of Clinical Oncology Global Oncology (JCO GO), a premier journal in the field, from its inauguration in 2016 to March 2020. A total of 608 articles were identified as matching one of the following six article types: original report, editorial, commentary, case report, special article, and review article. We collected data such as the author’s position, gender, institutional affiliation, and country affiliation. Author gender was categorized as male, female, or indeterminate based on first name probabilities assessed by genderize.io, with a threshold probability of 0.8 based on prior studies. Authorship distribution was analyzed by region and country income level according to the World Bank classification. Results: Of the 608 article first authors, 47.5% were identified as male, while 41.4% were female. Male authors made up a comparatively higher proportion of the 592 last authors; 57.1% were identified as male compared to 32.1% who were female. A similar trend was seen among the 4102 middle authors; 51.4% were identified as male and 38.1% were female. The percentage of authors deemed indeterminate in the cohort was less than 11%. Female authors were more underrepresented among authors from low-income countries; they made up 21.6% of first authors and 9.1% of last authors. Authorship gender by world regions is summarized in Table below. Conclusions: Our analysis shows that authorship inequities persist in global oncology publications. Female authors from lower-income countries, and regions in Sub-Saharan Africa and South Asia, were markedly underrepresented. The underlying reasons for underrepresentation of female authors are multifactorial; further studies are needed to elucidate these factors and to develop and evaluate mitigating strategies.[Table: see text]