Racial Disparities in Endometrial Cancer Clinical Trial Representation: Exploring the Role of Eligibility Criteria
Abstract
Objective: This study aimed to determine whether Black patients with recurrent endometrial cancer were more likely than White patients to be ineligible for a recently published clinical trial due to specific eligibility criteria. Methods: Patients with recurrent or progressive endometrial cancer diagnosed from January 2010 to December 2021 who received care at a single institution were identified. Demographic and clinicopathologic information was abstracted and determination of clinical trial eligibility was made based on 14 criteria from the KEYNOTE-775 trial. Characteristics of the eligible and ineligible cohorts were compared, and each ineligibility criterion was evaluated by race. Results: One hundred seventy-five patients were identified, 89 who would have met all inclusion and no exclusion criteria for KEYNOTE-775, and 86 who would have been ineligible by one or more exclusion criteria. Patients in the ineligible cohort were more likely to have lower BMI (median 26.5 vs. 29.2, P<0.001), but were otherwise similar with regard to insurance status, histology, and stage at diagnosis. Black patients had 33% lower odds of being eligible (95% CI: 0.33-1.34) and were more likely to meet the exclusion criterion of having a previous intestinal anastomosis, but the result was not statistically significant. If this criterion were removed, the racial distribution of those ineligible for the trial would be more similar (46.4% Black vs. 42.2% White). Conclusions: Clinical trial…
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Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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