Racial Gaps Seen in Advanced Ovarian Cancer Trials

Patients with advanced epithelial ovarian cancer experience differences in clinical trial participation and survival based on race, according to a cohort study published in JAMA Network Open.

Researchers analyzed data from 1,903 patients with stage 3 or stage 4 epithelial ovarian cancer who were enrolled in four first-line randomized clinical trials and found that Black and Asian patients were underrepresented, and that Black patients had lower overall survival compared with White patients.

The study evaluated racial representation and survival outcomes among patients treated within controlled clinical trial settings, where treatment protocols and follow-up procedures were standardized.

In an interview with CURE, Dr. Alex Francoeur — oncology fellow at the University of California Irvine, and the author of the study — stated, “I think this really highlights what many studies over the past few decades have shown: patients who are nonwhite tend to be significantly underrepresented in clinical trials. When we look beyond gynecologic oncology, women are also significantly underrepresented in clinical trials overall. That does not apply here, since these trials enroll only women.”

She continued, “It is also important to note that when these trials were conducted, they did not collect information on ethnicity. As a result, we are not able to report how many Hispanic patients were not included. This reflects another issue that many studies have examined — the lack of consistent reporting on race and ethnicity in clinical trials, which limits our ability to fully understand the patient populations being studied.”

Main data that support the findings

Among the 1,903 patients included in the analysis, 1,747, or 91.80%, self-identified as White, 121, or 6.36%, as Black and 35, or 1.84%, as Asian. The researchers examined overall survival, defined as the time from trial enrollment to death, and progression-free survival, defined as the time from enrollment to disease progression or recurrence.

After adjusting for clinical and demographic factors, including age, cancer stage, tumor characteristics and route of chemotherapy administration, the analysis showed that Black patients had a higher risk of death compared with White patients. Asian patients had overall survival outcomes similar to White patients in adjusted analyses.

Progression-free survival did not significantly differ among Black, White and Asian patients. This finding suggests that the timing of cancer recurrence or progression during the study period was similar across racial groups, even though overall survival outcomes differed.

The researchers also evaluated baseline characteristics among participants, including age at enrollment, cancer stage and tumor histology, to better understand whether differences in survival outcomes could be explained by measurable clinical factors. Statistical adjustments were made to account for these variables.

Trial details

The study included patients from four randomized clinical trials: GOG-111, GOG-114, GOG-158 and GOG-172. These trials were conducted between 1996 and 2006 and evaluated first-line chemotherapy strategies for patients with stage 3 or stage 4 epithelial ovarian cancer.

All participants had histologically confirmed advanced epithelial ovarian cancer at enrollment. Surgical outcomes differed among the trials. Patients enrolled in GOG-111 had suboptimally resected disease, defined as residual tumor measuring greater than or equal to 1 centimeter after surgery. Patients in GOG-114, GOG-158 and GOG-172 had optimally resected disease, defined as complete gross resection or residual tumor measuring less than 1 centimeter.

The chemotherapy regimens evaluated in the trials varied based on the study protocol, but all participants received first-line treatment that reflected the standard approaches during the study period. Because patients were treated within clinical trials, treatment delivery, follow-up schedules and data collection were structured according to predefined research protocols.

The investigators conducted a secondary analysis using shared data from these completed trials to evaluate racial representation and survival outcomes within a controlled clinical research environment.

Safety

This study did not report new safety findings related to the treatments used in the four clinical trials. Instead, the analysis focused on enrollment patterns and survival outcomes by race among patients already treated within those studies.

Side effects and safety outcomes were collected and reported in the original trial publications. The current analysis did not re-evaluate treatment-related side effects but examined whether differences in survival outcomes were observed among racial groups participating in the trials.

References

1. “Trial Enrollment and Survival Disparities Among Patients With Advanced Epithelial Ovarian Carcinoma” by Dr. Caitlin Ruth Johnson, et al., JAMA Network Open.

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