Enrollment of Individuals From Racial and Ethnic Minority Groups in Gynecologic Cancer Precision Oncology Trials

Abstract

To characterize whether enrollment patterns in precision oncology clinical trials for gynecologic cancers reflect the racial and ethnic diversity of patients with gynecologic cancers in the United States. METHODS:ClinicalTrials.gov was queried to perform this cross-sectional review. We included precision oncology trials-defined as trials using molecular profiling of a tumor or the patient genome to identify targetable alterations to guide treatment-of ovarian, uterine, cervical, and vulvar cancers in the United States. National Cancer Institute Surveillance, Epidemiology, and End Results and United States Census Bureau data were used to estimate cancer burden and the expected number of trial participants by race and ethnicity for each gynecologic cancer. The ratio of actual-to-expected participants was calculated. A ratio greater than 1 signified overenrollment. A random effects meta-analysis was performed to assess the relative weights of individual trials. RESULTS:We identified 493 trials, 61 of which met inclusion criteria. There were 2,573 patients enrolled in ovarian cancer trials, 1,197 in uterine cancer trials and 162 in cervical cancer trials. Non-Hispanic White women were overrepresented overall (enrollment ratio 1.26, 95% CI 1.20-1.32) and across all cancer types on subgroup analysis. Asian women, non-Hispanic Black women, and Hispanic women were underrepresented overall (enrollment ratios 0.63, 95% CI 0.41-0.86; 0.51, 95% CI 0.36-0.66 and 0.30, 95% CI 0.23-0.36, respectively). In subgroup analyses, Asian women and non-Hispanic Black women were underrepresented in ovarian and uterine cancer trials and Hispanic women were underrepresented across all cancer types. CONCLUSION: Non-Hispanic Black women, Asian women, and Hispanic women with gynecologic cancers are underrepresented in precision oncology trials. Few U.S.-based precision oncology trials exist for uterine and cervical cancers, which have a high burden of morbidity and mortality among racial and ethnic minority groups. Failure to equitably enroll patients who belong to racial and ethnic minority groups may perpetuate existing disparities in gynecologic cancer outcomes.

Racial and Ethnic Disparities in Clinical Trial Enrollment Among Women With Gynecologic Cancer

“…18 Disparities between Black and White populations in gynecologic oncology have been frequently investigated; however, reports focused on other racial and ethnic groups are less common. Our PPR and logistic regression analyses showing underrepresentation and lower clinical trial enrollment odds of Asian and Hispanic women agree with data published by Mattei and colleagues, 8 where women in these groups were less commonly enrolled to precision oncology trials for ovarian and uterine cancer, with Hispanic women also less likely to be enrolled in cervical cancer clinical trials.…”

“…Prior studies 7,8 examining clinical trial representation among patients with gynecologic cancer have compared observed case counts of racial and ethnic groups from published trials (including In both time periods, Asian and Hispanic women were underrepresented in clinical trials for all 3 cancer sites. Black women with an endometrial or cervical cancer diagnosis were either adequately represented or overrepresented in both time periods, but Black women with ovarian cancer were underrepresented.…”

“…Our findings that Black women with endometrial or cervical cancers were adequately or overrepresented in clinical trials are in line with the findings of 2 prior studies. 8,16 For example, Mattei and colleagues 8 reported that Black women with either a uterine or cervical cancer were proportionately enrolled in precision medicine trials, whereas Mishkin and colleagues 16 similarly noted no enrollment disparities for Black women with uterine or cervical cancer in National Cancer Institute-sponsored treatment trials. However, an evaluation of racial representation in Gynecologic Oncology Group-sponsored clinical trials revealed that enrollment of Black women was 9.8-fold lower than expected for endometrial cancer trials and 4.5-fold lower for cervical cancer trials.…”

“…Structural barriers (eg, lack of clinical trials in regions with a higher density of minoritized patients) and clinical factors (eg, narrow eligibility criteria that disproportionately affect underrepresented populations) have resulted in lower clinical trial enrollment of racial and ethnic minoritized groups, 4 with evidence that this contributes to poorer survival. [6][7][8][9] In a recent review, Barry and colleagues 10 outlined the extent of racial disparities in clinical trial enrollment of patients with gynecologic cancer. Most of the reviewed studies compared observed enrollment in clinical trials identified through ClinicalTrials.gov with expected enrollment derived from population-based, age-adjusted incidence rates.…”

“…Recent reports suggest that between 6% and 8% of the US adult population with cancer participates in clinical trials, with lower representation of patients from minoritized racial and ethnic groups. Structural barriers (eg, lack of clinical trials in regions with a higher density of minoritized patients) and clinical factors (eg, narrow eligibility criteria that disproportionately affect underrepresented populations) have resulted in lower clinical trial enrollment of racial and ethnic minoritized groups, with evidence that this contributes to poorer survival …”