Eliminating racial disparities in endometrial cancer clinical trial enrollment in the Deep South: a pathway to equity

Abstract

<h3>Objectives:</h3> Major racial underrepresentation onto gynecologic oncology clinical trials has been a systemic impediment towards racial equity in care. Previous work demonstrated a 9.8-fold lower enrollment of black patients onto national Gynecologic Oncology Group (GOG) trials compared to whites. In the Deep South, multiple barriers exist that further exacerbate this disparity. Our objective was to investigate clinical trial enrollment at our institution after the implementation of patient-based programs designed specifically to enhance minority enrollment in clinical trials. <h3>Methods:</h3> An intentional multifaceted intervention was created to address Black patient enrollment onto clinical trials. A lay navigation program was established at our cancer center in conjunction with oncology care models focused on improving quality of care by layering proper education of our patients on the risks and benefits of clinical trials in cancer. A diverse lay navigation workforce was hired that mirrored the demographics of our catchment area. We performed a retrospective cohort study of all endometrial cancer patients diagnosed and treated at our institution between 2012 and 2018. Expected and observed white: black ratios of racial participation in clinical trials were calculated utilizing CDC age-adjusted endometrial cancer incidence for race. <h3>Results:</h3> A total of 1,021 patients with endometrial cancer had adequate follow-up for evaluation of this study. Per our institutional goals for oncology care models, each new endometrial cancer patient was assigned a lay navigator with clinical trial education module required for all patients. Over the study period, 84 patients were enrolled onto clinical trials. Patients were similar in age, BMI, race, morbidity, stage and tumor histology. A total of 23 out of 277 black women (8.3%) and 61 of 718 white women (8.5%) with endometrial cancer participated in clinical trials. Accounting for age-adjusted incidence of endometrial cancer in the United States, observed enrollment of Black women was statistically similar to expected enrollment (1.03 fold lower than the expected p=0.77). Using regional "Deep South" data, we observed a 1.15 fold higher enrollment compared to expected enrollment for black patients (p=0.54). For the entire cohort, a progression-free survival (PFS) disadvantage was demonstrated for black patients compared to whites (14 vs 20 months, respectively p=0.02). Stratifying by clinical trial enrollment, PFS equity was achieved for black patients compared to white patients (13 vs 14 months, p=0.28) (Figure 1). <h3>Conclusions:</h3> Clinical trial inequities can be overcome in the Deep South with specific interventions aimed at improving care for black women. Particularly encouraging are the equal progression free survival data for those enrolled onto clinical trials regardless of race.