Underrepresentation of racial and ethnic minority groups in gynecologic oncology: An analysis of over 250 trials.

OBJECTIVE: To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. METHODS: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. RESULTS: 2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001). CONCLUSION: Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.

Molecular subtyping in endometrial cancer: A promising strategy to guide fertility preservation.

OBJECTIVES: To investigate the association of molecular subtype with progesterone response in patients with endometrial cancer (EC) or atypical endometrial hyperplasia (AEH). METHODS: Premenopausal patients aged ≤48 years with tumor-normal sequencing data who received progesterone for EC/AEH from 1/1/2010-6/30/2021 were identified. Tumors were classified as POLE-ultramutated, microsatellite instability-high (MSI-H), copy number-high (CN-H), or copy number-low (CN-L) molecular subtype. Best response to progesterone was compared by subtype. Appropriate statistical tests were performed. RESULTS: Of 20 patients, 7 (35%) had AEH and 13 (65%) had EC. Sixteen tumors (80%) were CN-L, 3 (15%) were MSI-H, and 1 (5%) was POLE-ultramutated. Median time on progesterone was 22 months (range, 3-115). Ten patients (50%) had complete response (CR); median time to CR was 9 months (range, 3-32). Four patients (20%) had stable disease (SD) and 6 (30%) had progressive disease (PD). For CN-L tumors, 10 patients (62%) had CR, 3 (19%) had SD, and 3 (19%) had PD. For MSI-H tumors, 1 patient (33%) had SD and 2 (66%) had PD. For POLE-ultramutated tumors, 1 patient had PD. Median follow-up was 48 months (range, 12-123). Four of 10 patients (40%) with CR recurred; median time from CR to recurrence was 16 months (range, 5-102). CONCLUSION: Molecular subtype may be associated with progesterone response in patients with EC/AEH. CN-L tumors had the best response, and MSI-H tumors had the poorest. Recurrence after CR is common, and close surveillance is warranted. Larger studies investigating the role of molecular classification in medical management of EC/AEH are needed.

Large Publication Gap for Gynecologic Cancers in High-Impact Factor Journals.

OBJECTIVE: To analyze research publication trends in high-impact factor journals, comparing gynecologic cancers with other cancers from 2000 to 2018. METHODS: Abstracts from the 55 journals with the highest impact factors, as measured by Clarivate, from 2000 to 2018 were extracted from PubMed. We developed an algorithm to search the title of the abstract to determine whether the abstract was about cancer and to identify the cancer type. The algorithm was validated against the gold standard of human review in 1,143 abstracts. Article proportion was compared with site-specific incidence, mortality, and lethality from the National Cancer Institute's Surveillance, Epidemiology and End Results database using scatterplots and nonparametric Wilcoxon signed-rank test. RESULTS: We identified 128,377 articles; 31,045 (24.1%) were about cancer and 1,189 (3.8%) were about gynecologic cancers. Gynecologic cancers (ovarian, cervical, and uterine) were all poorly represented in high-impact factor journals compared with their incidence, mortality, and lethality. Ovarian, uterine, and cervical cancers ranked in the bottom half of Article-to-Lethality scores ( P <.01 for all comparisons). Analyses of the trends for gynecologic cancers over the past 18 years showed no change over time in Article-to-Lethality scores. Comparison of rankings by lethality with rankings by funding indicates relative underfunding of the gynecologic cancers. CONCLUSION: Research publications in high-impact factor journals by cancer site are not proportionate with individual cancer burden on society. Gynecologic cancers are significantly underrepresented in research publications relative to their disease burden, indicating a disparity that persists over the past 18 years. Relative underfunding of gynecologic cancers likely contributes to this publication gap.

Enrollment of Racial and Ethnic Minoritized Groups in Gynecologic Oncology Clinical Trials: A Review of the Scope of the Problem, Contributing Factors, and Strategies to Improve Inclusion.

Racial inequities are well-documented across the gynecologic oncology care continuum, including the representation of racial and ethnic minoritized groups (REMGs) in gynecologic oncology clinical trials. We specifically reviewed the scope of REMG disparities, contributing factors, and strategies to improve inclusion. We found systematic and progressively worsening under-enrollment of REMGs, particularly of Black and Latinx populations. In addition, race/ethnicity data reporting is poor, yet a prerequisite for accountability to recruitment goals. Trial participation barriers are multifactorial, and successful remediation likely requires multi-level strategies. More rigorous, transparent data on trial participants and effectiveness studies on REMG recruitment strategies are needed to improve enrollment.