Trial Enrollment and Survival Disparities Among Patients With Advanced Epithelial Ovarian Carcinoma

TL;DR

Black patients with advanced ovarian cancer were underrepresented in clinical trials and had lower survival rates compared to White and Asian patients, highlighting the need for more diverse trial enrollment.

Contribution

This study reveals racial disparities in clinical trial enrollment and survival outcomes for advanced ovarian cancer patients.

Findings

Black patients made up 6.4% of trial participants, while Asian patients represented 1.8%.

Black patients had lower overall survival than White and Asian patients, but similar progression-free survival.

The study emphasizes the need for equitable enrollment to improve cancer care outcomes for all patients.

Abstract

Do enrollment and survival outcomes vary by race among patients participating in randomized clinical trials?

In this cohort study analyzing data from 4 completed randomized phase 3 trials with 1903 evaluable participants, Black patients made up 6.4% and Asian patients represented 1.8% of these trials’ populations. Overall survival (the primary end point) was lower among Black patients compared with White and Asian patients, whereas progression-free survival rates were not significantly different among racial groups.

A lack of diversity was observed in clinical trials, highlighting the need for more equitable enrollment and outcomes for all patients.

This cohort study examines racial differences in randomized clinical trial enrollment and overall survival among patients with advanced epithelial ovarian carcinoma.

Racial differences in epithelial ovarian cancer (EOC) might result in survival inequities.

To evaluate enrollment and outcomes by race in Gynecologic Oncology Group (GOG) randomized clinical trials (RCTs) among patients with EOC.

This cohort study used ancillary data from completed RCTs using protocols GOG-111, GOG-114, GOG-158, and GOG-172 under a data sharing agreement with National Research Group Oncology. Patients with stage III or IV EOC in first-line RCT protocol GOG-111 had suboptimally resected disease, whereas those in GOG-114, GOG-158, or GOG-172 had optimally resected disease. RCTs were conducted and published between 1996 and 2006, and data for this study were analyzed in August 2024.

Race was categorized as Asian, Black or African American (Black), or White or Caucasian (White). Patients of other races were excluded. Spanish ethnicity and additional details regarding residual disease status were not available for analysis.

Overall survival (OS) was the primary end point and progression-free survival (PFS) was the secondary end point, evaluated using multivariable Cox proportional-hazards modeling and log-rank testing. Statistical significance was set at P < .05.

This study included 1903 evaluable participants, of whom 35 (1.84%) self-identified as Asian, 121 (6.36%) as Black, and 1747 (91.80%) as White. Black patients had lower OS (median [IQR], 36.8 [19.2-73.4] months) than Asian (50.9 [23.9-109.2] months) or White (48.4 [24.5-93.4] months) patients (P = .03), with a higher risk of death than White patients (adjusted hazard ratio, 1.30; 95% CI, 1.06-1.59; P = .01). PFS and adjusted risk of disease progression were statistically similar across racial groups. Median (IQR) PFS was 18.9 (9.7-84.6), 18.0 (9.1-34.0), and 19.7 (11.5-43.3) months among Asian, Black, and White patients, respectively (P = .08). Adjusted risk of disease progression was similar for Black patients compared with White patients (adjusted hazard ratio, 1.21; 95% CI, 1.00-1.47; P = .06).

In this cohort study, Black and Asian patients were underrepresented in RCT trial populations. Black patients had lower OS than White and Asian patients but similar PFS. Equitable enrollment in clinical trials ensures access to cutting-edge treatments and can lead to outcomes comparable to those of White counterparts. Sustained efforts to improve RCT diversity remain essential to long-term equity in cancer care and survival.

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