bluuebunny/crossref_metadata_2025_split huggingface dataset:
Improving ethnic and racial diversity within clinical trial populations through community recruitment and inclusion initiatives: Experience from MyTACTIC.
Authors: Zuniga Richard Michael , Spigel David R. , Schwartzberg Lee S. , Hong Jason , Passler Luke , Darbonne Walter C. , Szado Tania , VanderWalde Ari , Daniel Davey 
Published: May 2024

e13679 Background: Clinical trial populations are not typically ethnically diverse, restricting healthcare equity and the generalizability of clinical trial data to real-world populations. Moreover, mostpatients (pts) with cancer in the US receive treatment in the more diverse community setting, where minority groups are usually better represented but with lower trial enrollment rates than academic centers. MyTACTIC (NCT04632992) is a phase II, non-randomized basket trial evaluating targeted therapies in pts with advanced solid tumors with specific biomarkers. Inclusive research practices, including mostly community recruitment, were implemented in MyTACTIC to improve access for patients who may otherwise not have been able to enroll. This retrospective analysis presents their impact on the diversity of the trial population. Methods: Adult pts with advanced solid tumors were enrolled from community cancer clinics (private practices and community hospitals) or large academic centers, into 1 of 15 arms based on biomarker alterations. Inclusive research practices implemented to diversify pt recruitment included: revision of eligibility requirements to be more inclusive for minorities; language simplification and streamlining of study protocol; training activities; free transportation. We compared race and ethnicity data between the study population and trial sites’ catchment area (geographical area of pts around the clinical site). Results: Forty pts, all of White race, were initially enrolled across 14 sites, which prompted additional focus on diversity efforts. The trial was expanded to 45 sites across 21 states: 252 pts were enrolled (83% of White race) (Table). Most (96%) selected sites (n=249 pts) were community clinics. The proportion of pts from racial minorities was generally higher in study centers from ethnically diverse catchment areas. Protocol streamlining and staff training were also beneficial to pt recruitment. Free-ride transportation removed the barrier of access to clinical trial sites. The impact of other initiatives will be presented. Conclusions: Running clinical trials at community oncology sites does not, in itself, equal increased diversity of study populations: other efforts, including but not limited to free transportation and community site selection, are also needed. Here we share some learnings from the MyTACTIC study, based on outcomes from the various inclusive research practices implemented in this trial. Clinical trial information: NCT04632992 . [Table: see text]
Availability of cranial prostheses for Black patients at comprehensive cancer centers.
Authors: Rose Lucy , Minta Abena , Shareef Sarah , Adame Stephanie , Dulmage Brittany 
Published: May 2024

e13681 Background: For patients who seek to camouflage cancer-related hair loss, cranial prostheses such as wigs and hair pieces exist. We sought to determine the availability of yaki-textured, type IV curls, and afro wigs at boutiques in Comprehensive Cancer Centers (CCCs). Methods: The 56 CCCs in the United States were surveyed to see if they had an affiliated wig boutique or shop for patients experiencing hair loss. Boutique workers were then asked a series of seven questions regarding cranial prostheses options for patients seeking yaki-textured, type IV curls, and afro wigs. The availability of these wigs was compared to US Census data on population size and density of Black residents. Results: Of the 56 CCCs, 27 (46%) institutions had active affiliated hair boutiques. We were able to reach 19 of the 27 boutiques (70%), of which 53% (n=10) offered yaki-textured wigs, and 37% (n=7) offered type IV curls or afro wigs, and 47% (n= 9) offered neither. Two additional boutiques offered in-store catalogues for Black patients who were interested in naturally appearing wigs. Though two institutions offered a wig bank that was free to all patients, neither had yaki-textured or afro wigs in stock. There was no significant relationship between population or density of Black residents and availability of these wigs. Therefore, most Black patients with cancer who are seeking cranial prostheses will not have access to racially inclusive wigs where they are receiving treatment. Conclusions: Not being able to purchase wigs at CCCs poses potential financial challenges when seeking insurance coverage or reimbursement. Thus, Black patients may disproportionately experience emotional and financial hardships secondary to cancer-related hair loss. With increased inventory of racially inclusive wigs, partnerships with third-party vendors, and support for the prior authorization process, we can better support Black patients experiencing cancer-related hair loss. [Table: see text]
Association between socioeconomic factors and utilization of next-generation sequencing in metastatic breast cancer.
Authors: Kudaravalli Sriya , Carleton Neil , Rosenzweig Margaret Q. , Foldi Julia 
Published: May 2024

e13700 Background: Targeted therapies such as PI3K inhibitors have revolutionized the treatment of patients with metastatic breast cancer (MBC). Their selective use is enabled by next-generation sequencing (NGS) approaches, which help identify actionable tumor alterations. There may be socioeconomic disparities in NGS testing and NGS-guided treatment selection. This study aimed to investigate the role of socioeconomic status (SES) (race and area deprivation index [ADI]) among patients with MBC undergoing NGS. Methods: Our retrospective study included 418 adult patients (pts) with MBC treated at the Magee Women’s Cancer Center in Pittsburgh, PA between September 2016 and December 2022. Demographic information, including race and ADI, clinicopathologic information, and NGS results were collected. ADI based on zip code was derived utilizing Neighborhood Atlas. Scores range from 0-10 (higher score = higher deprivation), representing the census-based ranking of the ZIP code at the state level based on the composite of several factors, including income, education, employment, and housing quality. Descriptive statistics, chi-squared, and independent sample t tests were used. Multivariate logistic regression analysis was done to evaluate potential associations with receipt of NGS and NGS-directed therapy. Results: 89% of pts were non-Hispanic white (NHW); 11% were non-Hispanic black (NHB). A greater proportion of NHB pts were from higher ADI (6-10) neighborhoods (p=0.00001), suggesting lower SES. NHW pts were more likely to have hormone receptor (HR)+/human epidermal growth factor receptor (HER)2- tumors compared with NHB pts (p=0.022). 219 (52.4%) total pts had NGS tumor testing performed: 53% of NHW and 47.8% of NHB pts (p=0.511). 55.1% (102/185) of pts living in higher SES neighborhoods (ADI 1-5) and 50.2% (117/233) living in lower SES neighborhoods (ADI 6-10) received NGS testing (p=0.317). Of the 219 pts who got NGS testing, 62.6% (137) had a clinically actionable alteration identified, and of those, 46% (63) received corresponding targeted therapy. Of the 63 pts who received NGS-guided therapy, 88.9% were NHW and 11.1% were NHB (p=0.849), and 50.8% were from neighborhoods with ADI 1-5 and 49.2% were from neighborhoods with ADI 6-10 (p=0.571). In multivariate analysis including race, ADI, insurance status, year of MBC diagnosis, and tumor subtype, only tumor subtype (non-HR+/HER2- tumors) was significantly associated with a lower likelihood of both receiving NGS testing (p=0.032) and receiving NGS-directed therapy (p=0.001). Conclusions: There was a higher numerical rate of NGS testing and NGS-guided therapy initiation in NHW pts and pts from lower ADI (1-5 vs. 6-10) neighborhoods, but this did not reach statistical significance. Overall, in this single institution cohort limited by small numbers, there were no differences in NGS tumor testing based on race and SES.
Racial/ethnic distribution of participants in NRG oncology clinical trials: 2014-2023.
Authors: Dignam James J. , Romitti Paul A , Yom Sue S. , Feng Felix Y , Bradley Jeffrey D. , Mehta Minesh P. , Bruner Deborah Watkins , Wenzel Jennifer , Mamounas Eleftherios P. , George Thomas J. , Hong Theodore S. , Aghajanian Carol , Werner-Wasik Maria , Thomas Alexandra 
Published: May 2024

e13706 Background: External validity and applicability of clinical research relies upon characteristics of trial participants matching those of the respective disease groups in the general population. Understanding the racial/ethnic distribution of patients enrolled in recent US-based, federally sponsored Phase II and III clinical trials could inform strategies to further align characteristics of trial participants with those of disease group populations. As such, we report the racial/ethnic distribution of participants in NRG Oncology studies during 2014-2023 and compare the distribution to that from the Surveillance, Epidemiology, and End Results (SEER) program data during 2014-2020 (most recent data available). Methods: Proportions of self-reported race/ethnicity were summarized for the 33,370 trial participants enrolled since Mar 1, 2014 (NRG Oncology inception) to therapeutic, symptoms management, and other interventional trials. SEER proportions were used to benchmark NRG trials for representativeness of disease burden in the population. Results: Among NRG trial participants, 71.5% were non-Hispanic (NH) White, 9.7% NH Black, 4.9% Hispanic, and 7.8% N-H Asian (Table). Examining distributions within selected cancer sites relative to cancer proportional incidence in 2014-2020 SEER data, NRG accrual to prostate, lung, cervix, and breast cancer trials is commensurate with observed disease burden for NH Blacks and modestly lower for Asians. For other sites shown, representation was 2 to 5 percentage points lower than SEER frequencies for Blacks and Asians. For all sites, accrual of individuals of Hispanic background was lower than that reported in SEER. As the NRG trials do not reflect sampling across stages and other features of a given cancer in the population, further analysis to be presented will consist of more detailed breakdowns of trial participant disease-specific cancer stage and tumor subtype and comparison to relevant observations from the 2014-2020 SEER database. Conclusions: This high-level comparison of the racial/ethnic distribution of NRG trial participants provides supportive information for population representative enrollment in several cancer sites, but also identifies opportunities to improve enrollment diversity to represent more closely the respective affected population. Areas of success identified merit further investigation to understand if there are best practices which may be applied more broadly towards expanding access to federally funded clinical trials. [Table: see text]
A systematic review of racial disparity in pivotal poly (ADP-ribose) polymerase (PARP) inhibitor trials.
Authors: John Elizabeth , Sekhon Simranjit , Bagchi Arindam 
Published: May 2024

e13737 Background: Breast cancer is the most common cancer diagnosed worldwide. Breast cancer related mortality has decreased in the US, however this did not extend equally to African American women (AAW). According to CDC mortality rate from breast cancer in AAW is 20% higher than other ethnic groups. Younger age at diagnosis in AAW, higher incidence of triple negative breast cancer (TNBC), and higher incidence of AA males with breast cancer suggest genetic predisposition plays an important role in the disparate outcomes based on race. In an unbiased analysis of TNBC cases, the prevalence of pathogenic germline BRCA 1 & 2 mutations are twice as high as in breast cancer overall. Poly (ADP-ribose) polymerase (PARP) inhibitors have proven to be effective in germline BRCA 1 and BRCA 2 mutation associated breast cancer. However, data regarding the enrollment of racial and ethnic minorities in these pivotal trials that lead to the approval of these drugs is limited. Methods: We examined the demographic data reporting in Phase II/ III clinical trials of PARP inhibitors in breast cancer from 2016 to 2023. In order to highlight the disparities in the enrollment of minority groups we calculated an enrollment percentage of various racial groups in these trials. We conducted a systematic review of Phase II/III clinical trials of PARP inhibitors in BRCA 1 & 2 mutated breast cancer reported studies with sources from PubMed, Embase, Scopus, Clinicaltrials.gov, CENTRAL and Cochrane. 56 full text studies were identified, out of which 14 met inclusion criteria. The total number of patients included was N=5,067. Five trials did not include racial data. Results: Among trials that reported race and ethnicity (N=4004), the enrollment percentage was lowest for racial and ethnic minorities. AA: 3.4%, N=136. Non- Hispanic Whites were the most common to be enrolled: 71.05%, N=2845, Asians were 16.53% N= 662, Hispanics 2.03 %; N=83 and other 6.17%, N=247. Conclusions: Racial minorities are consistently underrepresented in all the pivotal PARP inhibitor trials and contributing to the race-based disparities in breast cancer. [Table: see text]
Increased NGS testing and real-world clinical usage of targeted therapy: All dressed up, nowhere to go.
Authors: Batra Ullas , Nathany Shrinidhi , Sharma Mansi , Patel Amrith , Mattoo Sakshi , Mehta Anurag 
Published: May 2024

e13758 Background: National and International recommendations mandate panel- based biomarker testing for all advanced cases of NSCLC. However, analogous to uptake of many other state of the art cancer management strategies, the uptake of NGS based testing and subsequent targeted therapy varies greatly across socio-demographic groups, explained by awareness and economic restraints. This study investigates the potential differences in uptake of NGS based testing and precision medicine in advanced NSCLC patients from India. Methods: This is a single center non-interventional study where retrospective review of patient data of biomarker driven advanced NSCLC patients was carried out. The records were recovered from electronic health records of the hospital. Single gene testing for EGFR and ALK are performed using Roche Cobas V2 and D5F3 Ventana systems respectively. A machine learning algorithm: Classification and Regression Tree (CART) was employed. Results: A total of 5894 patients of advanced NSCLC were identified. Of these 33% received NGS based biomarker testing at diagnosis. The proportion of patients who received NGS tests increased over calendar time from 2014-2023, with an average increment of 15.8% every year, and peak increase in 2022 of 51%. NGS based testing yielded a positive result in 80% cases with a median turnaround time of 18.2+/-3 days. NGS detected 10.2% cases more in EGFR, 3.2% cases less in ALK, 3.1% more in ROS1. Overall NGS was able to detect 37.8% extra cases of biomarker driven cases. Among the biomarker driven, uptake of targeted therapy was 65% for MET, 83% for ROS1, 52% for RET, 17.6% for ERBB2, 63% for BRAF V600E, 75% for EGFR and 79% for ALK at any given point in the disease. None of the G12C KRAS received selective treatment owing to drug unavailability in the country. Applying the CART model, targeted therapy was received by patients younger than 68 years of age, male gender, with ECOG status 0-2, and absence of brain metastases at diagnosis. Patients with brain metastases at diagnosis, females and those >69 years of age were less likely to opt for TKI(p<0.02*). Conclusions: This is the largest cohort from India reporting real world uptake of NGS based biomarker testing and targeted therapy. There is a clear disparity in terms of gender and age group, possibly attributable to social stigmata and taboos prevailing in rural parts of the country. Despite increased detection rates, access to targeted therapy is still a concern owing to inaccessibility to drugs/ lack of global clinical trials in India as well as lack of patient support programs/groups.
Visualizing veterans’ care: Understanding the breadth of older veterans’ paid and family support network and implications for cancer care in the older adult population.
Authors: Ali Imran Yousuf , Koufacos Nicholas , Franzosa Emily , Hall Lauren 
Published: May 2024

e13777 Background: Many older adults rely on a complex network of paid and unpaid caregivers to age safely at home. Strong social networks have been long associated with improved cancer treatment outcomes in older adults. Yet medical records often only capture a primary family caregiver, and assessing support networks has not been a routine part of the equation in cancer treatment planning. We tested a novel visual tool, care mapping, with older veterans to better understand the scope of their caregiving networks. Methods: We created collaborative care maps with 10 dyads/triads of veterans and their primary paid and family caregivers receiving care at a large, urban, Veterans Health Administration medical center. Veterans were age 65+ and eligible for VA-paid home care. 50% of the veteran cohort had a cancer diagnosis. We compared the maps to veterans’ electronic medical records (EMRs) and assessed care network structure, function and adequacy. Results: For most veterans, care maps identified a larger number of care partners than EMRs alone. Functional, medical, socioemotional and spiritual supports included family, paid aides, neighbors, veteran service organizations and community groups. Unmet needs included inadequate home health workers to assist with functional decline associated with malignancy diagnosis. Veterans and caregivers largely described their networks as adequate, but mapping conversations surfaced a need for contingency care plans to relieve caregiver strain or if a caregiver could no longer provide support. Conclusions: Cancer care in older adults requires a broad, comprehensive approach and innovative ways to identify caregiver support. Such collaborative care maps can impact clinical outcomes by ensuring treatment adherence and symptom surveillance.
Fertility Preservation and Assisted Reproduction in Patients With Breast Cancer Interrupting Adjuvant Endocrine Therapy to Attempt Pregnancy
Authors: Azim Hatem A. , Niman Samuel M. , Partridge Ann H. , Demeestere Isabelle , Ruggeri Monica , Colleoni Marco , Saura Cristina , Shimizu Chikako , Saetersdal Anna B. , Kroep Judith R. , Mailliez Audrey , Warner Ellen , Borges Virginia F. , Amant Frédéric , Gombos Andrea , Kataoka Akemi , Rousset-Jablonski Christine , Borstnar Simona , Takei Junko , Lee Jeong Eon , Walshe Janice M. , Ruíz-Borrego Manuel , Moore Halle C.F. , Saunders Christobel , Bjelic-Radisic Vesna , Susnjar Snezana , Cardoso Fatima , Klar Natalie J. , Spanic Tanja , Ruddy Kathryn , Piccart Martine , Korde Larissa A. , Goldhirsch Aron , Gelber Richard D. , Pagani Olivia , Peccatori Fedro A. 
Published: May 2024

PURPOSE We investigated time to pregnancy, efficacy and safety of fertility preservation, and assisted reproductive technologies (ARTs) in women with early hormone receptor–positive breast cancer (BC) desiring future pregnancy. PATIENTS AND METHODS POSITIVE is an international, single-arm, prospective trial, in which 518 women temporarily interrupted adjuvant endocrine therapy to attempt pregnancy. We evaluated menstruation recovery and factors associated with time to pregnancy and investigated if ART use was associated with achieving pregnancy. The cumulative incidence of BC-free interval (BCFI) events was estimated according to the use of ovarian stimulation at diagnosis. The median follow-up was 41 months. RESULTS Two hundred seventy-three patients (53%) reported amenorrhea at enrollment, of whom 94% resumed menses within 12 months. Among 497 patients evaluable for pregnancy, 368 (74%) reported at least one pregnancy. Young age was the main factor associated with shorter time to pregnancy with cumulative incidences of pregnancy by 1 year of 63.5%, 54.3%, and 37.7% for patients age <35, 35-39, and 40-42 years, respectively. One hundred and seventy-nine patients (36%) had embryo/oocyte cryopreservation at diagnosis, of whom 68 reported embryo transfer after enrollment. Cryopreserved embryo transfer was the only ART associated with higher chance of pregnancy (odds ratio, 2.41 [95% CI, 1.75 to 4.95]). The cumulative incidence of BCFI events at 3 years was similar for women who underwent ovarian stimulation for cryopreservation at diagnosis, 9.7% (95% CI, 6.0 to 15.4), compared with those who did not, 8.7% (95% CI, 6.0 to 12.5). CONCLUSION In POSITIVE, fertility preservation using ovarian stimulation was not associated with short-term detrimental impact on cancer prognosis. Pregnancy rates were highest among those who underwent embryo/oocyte cryopreservation followed by embryo transfer.
Apelin and Copeptin Levels in Patients With Chronic SIAD Treated With Empagliflozin
Authors: Monnerat Sophie , Drivakos Nikolaos , Chapman Fiona A , Dhaun Neeraj , Refardt Julie , Christ-Crain Mirjam 
Published: May 2024

Abstract

Background
Empagliflozin increases sodium levels in patients with a chronic syndrome of inappropriate antidiuresis (SIAD), and dapagliflozin increases apelin levels in patients with diabetes mellitus. Exogenous apelin increases sodium levels in rats with SIAD. We aimed to investigate whether an increase in plasma apelin concentration may contribute to the efficacy of empagliflozin in SIAD.

Methods
Post hoc secondary analysis of a double-blind, crossover, placebo-controlled trial performed from December 2017 to August 2021 at the University Hospital Basel, Switzerland, investigating the effect of 4-week treatment with empagliflozin 25 mg/day as compared to placebo in 14 outpatients with chronic SIAD (NCT03202667). The objective was to investigate the effect of empagliflozin on plasma apelin and copeptin concentrations and their ratio.

Results
Fourteen patients, 50% female, with a median [interquartile range] age of 72 years [65–77] were analyzed. Median apelin concentration was 956 pmol/L [853, 1038] at baseline. Median [interquartile range] apelin relative changes were +11% [0.7, 21] and +8% [−5, 25] (P = .672) at the end of the placebo and empagliflozin phases, respectively. Median copeptin concentration was 2.6 [2.2, 4.5] pmol/L at baseline and had a relative change of +5 [−2. 11]% and +25% [10, 28] (P = .047) over the placebo and empagliflozin phases, respectively.

Conclusion
Empagliflozin did not lead to significant changes in apelin or the apelin/copeptin ratio in patients with chronic SIAD but led to an increase in copeptin. This suggests that the efficacy of empagliflozin in SIAD is independent of apelin and is not blunted by the adaptative increase in copeptin.
Dead but Not Buried
Authors: Powell Julie M. 
Published: May 2024

Abstract
On April 12, 1919, Paris police arrested Henri Désiré Landru, a man who had spent the last four years of war luring women into engagements and confiscating their assets. Many of them were never seen again. Landru, charged with their murders, became an international media sensation—the inspiration for popular crime stories, including books, articles, films, television and radio programs, and theatrical performances, from his execution in 1922 to 2020. This article examines these stories for the revealing ways they bring together conceptions of war and violent crime. It considers a 1926 nonfiction account of Landru by the South African journalist and military veteran William Bolitho, the film Monsieur Verdoux (1947) written by Charlie Chaplin, Claude Chabrol's film Landru (1963), and a 2006 graphic novel by Christophe Chabouté. These narratives suggest, and this article argues, that stories about Landru—and the multiple murders he committed for profit—have served, at various times and in various places, as vehicles for critiquing warfare and the societies that embrace it.