Expert Discusses Disparities in Ovarian Cancer Trials

Dr. Alex Francoeur, an oncology fellow at the University of California Irvine and study author, discussed findings showing that Black and Asian patients were underrepresented in four ovarian cancer trials, making up 6.36% and 1.84% of participants. While progression-free survival was similar across racial groups, overall survival was shorter for Black patients.

She suggested that structured oversight during trials may help reduce disparities, but differences may reemerge after patients return to community care. The findings underscore the value of trial participation and the need to improve awareness, revisit eligibility criteria and encourage more diverse enrollment.

CURE: Your study found that Black and Asian patients were underrepresented in these trials, with Black patients making up just 6.36% and Asian patients 1.84% of participants. What do these numbers tell you about who is and is not getting access to clinical trials?

Francoeur: I think this really highlights what many studies have shown over the last few decades: Patients who are non-White tend to be significantly underrepresented in clinical trials. When we look at trials outside of gynecologic oncology, women are also significantly underrepresented. That doesn’t apply here, because we enroll all women.

It’s also important to highlight that when these trials were conducted, they weren’t collecting information on ethnicity. So we aren’t able to report how many Hispanic patients were included or not included. This is another issue that a lot of studies have examined — the lack of reporting on race and ethnicity in trials limits our ability to truly understand the patient populations being studied.

Progression-free survival was similar across racial groups, but overall survival was shorter for Black patients. How do you explain that difference, and what might be happening after patients leave a trial?

This was a really interesting finding that we uncovered in this study. Our hypothesis is that when patients are enrolled in a clinical trial, there is a higher degree of oversight and strict protocols that must be followed. Patients generally have more frequent visits to check on toxicities, very regimented time points for imaging and lab work and a preset protocol with less room for deviation.

When patients progress, they come off the trial. After that, they may return to their regular oncologist, especially if they traveled to participate. At that point, decisions about next steps are more individualized.

Our hypothesis is that while patients are on a clinical trial, we see more of a leveling of the playing field in terms of disparities that have been highlighted in other studies. But once patients come off trials, those disparities may become more pronounced again. This underscores the importance of enrolling a representative patient population in clinical trials and encouraging diverse participation.

For patients with advanced epithelial ovarian cancer who are considering a trial, what does your research suggest about the potential benefit of participating compared with receiving care only in their community?

I think it demonstrates that there is a benefit to participating in these trials, regardless of whether patients are randomized to the experimental arm or the control arm. In this study, we looked at all patients enrolled in four large clinical trials — including those receiving standard of care in the control group and those in the experimental groups.

What we found is that outcomes were equal across race and ethnicity when patients were on trial, regardless of which arm they were assigned to.

Many patients face practical barriers like travel, cost or limited awareness of trials. From your perspective, what are the biggest real-world obstacles preventing more diverse enrollment, and what solutions could make participation easier?

That’s a good question. A couple of factors are at play. One is where patients are receiving care — whether at a community or academic institution — and whether they are even offered clinical trials or made aware that they are an option.

Another major barrier is trial enrollment criteria. Inclusion and exclusion criteria have been shown to disproportionately exclude patients of non-White race and ethnicity based on factors such as preexisting conditions, kidney disease, immunosuppressive diseases or heart, lung or liver disease. These criteria can make it harder to enroll a diverse patient population.

From my perspective, two key areas are increasing awareness in communities so patients know to ask about trials and, on the research side, being more thoughtful about how enrollment criteria are designed so we can include a more representative population.

These trials were conducted between 1996 and 2006. How relevant are these findings today, and do you think similar disparities still exist in modern ovarian cancer trials?

Almost certainly. While this study looks at outcomes within trials, many contemporaneous studies have examined trial composition. Even in the 2020s, the composition of patients enrolled in clinical trials is not representative of the general U.S. population.

There are now many global clinical trials conducted in collaboration with Europe and Asia. Because of that, we see a significant proportion of Asian and Pacific Islander patient enrollment in some modern studies. However, Black and Hispanic groups remain underrepresented.

To wrap up, what advice do you have for patients?

Ask questions. Don’t be afraid to come to your doctor with questions. Cancer is a complicated disease, and it’s normal to feel overwhelmed or unsure where to start. Our job as doctors is to answer those questions, spend time with you and talk through your concerns and options.

Patients and their families are often their own best advocates. Our role is to help guide them through the process. Never be afraid to look things up and bring questions to your appointments. If you feel like you’re not getting the time or answers you need, ask for a second opinion.

Cancer care can often feel like managing a chronic disease, and I have patients I’ve cared for more than a decade. It’s important to feel that you have a good relationship with your oncologist — that’s one of the most important things.

Transcript has been edited for clarity and conciseness.

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