Hannah C. Karpel, MS, Talks Increasing Clinical Trial Accrual in Patients With Gynecologic Malignancies Following NCI Call-to-Action

A recent single-institution study presented at the 2022 Annual Meeting of International Gynecologic Cancer Society depicted the change in accrual of racially or ethnically diverse patients into clinical trials, specifically those of gynecologic cancers, following the June 2020 National Cancer Institute (NCI) call-to-action for more diversity.

The study examined 205 patients who were enrolled across 22 gynecologic cancer trials between 2018 to 2022, of whom 62.9% had ovarian cancer, 25.4% had endometrial cancer, and 11.7% had cervical cancer. The study compared clinical trial enrollment prior to and following the NCI directive in non-Hispanic White patients (58.3% vs 50.5%; P = .3) and underrepresented minorities (41.7% vs 49.5%; P = .3). Of patients considered to be underrepresented, Black or African American patients saw the most significant uptick in accrual (7.4% vs 24.7%; P = .001), rates stayed about the same for Hispanic or Latino individuals (14.8% vs 17.5; P = .6), and rates went down in Asians (19.4% vs 7.2%; P = .01).

During the conference, CancerNetwork^® spoke with Hannah C. Karpel, MS, a medical student at New York University Langone Perlmutter Cancer Center in New York and lead author of the study, about the motivation behind conducting this study, which results she was most surprised to see, and the take-home points for her colleagues.

CancerNetwork^®: What was the rationale for this study?

Karpel: There is strong evidence that non-White and historically marginalized populations have been excluded from oncologic clinical trials and due to this inequity, the NCI issued a call-to-action in 2020 to focus on diversity. At our institution which serves a diverse catchment area, we were interested in assessing changes in accrual by race and ethnicity following the NCI’s call to action. We also wanted to evaluate trial enrollment by race/ethnicity as compared with their SEER [Surveillance, Epidemiology, and End Results Program] disease prevalence estimates in endometrial and ovarian cancer

What were the results of this study and were there any you were most surprised by?

Overall for both endometrial and ovarian cancer, we found that trial enrollment exceeded the SEER disease prevalence estimates for historically marginalized racial and ethnic groups, except for patients who self-identified as Asian or Asian American in endometrial cancer trials. We also found that the overall enrollment of Black patients significantly increased following the NCI call-to-action from 7.4% to 24.7%, but enrollment of Asian or Asian American patients decreased from 19.4% to 7.2%, which was the result that we were most surprised by. In looking further into this we noted this was specific to endometrial cancer.

What should your colleague’s takeaway from this presentation?

We think it is important to consider racially specific disease estimates and catchment areas when designing and evaluating racial and ethnic participation in clinical trials. The true measure of success in what constitutes success in terms of clinical trial enrollment is complex, but looking at the prevalence of recurrent cancers is a start. It is also worth noting that specific guidance for race and ethnicity reporting may improve the accuracy of these data. Further evaluation is needed to understand the disparity in Asian and Asian American participation. It may be related to the number of trials open for endometrial cancer, social stigma related to COVI-19 on the Asian race, or possibly a decrease in prevalence in this subgroup.

Reference

Karpel HC, Lara O, Lightfoot M, et al. Clinical trial accrual of underrepresented patients with gynecologic malignancies. Presented at: 2022 Annual Global Meeting of the International Gynecologic Cancer Society; New York, NY; September 29-October 1, 2022. Abstract O024.