Clinical trials of PARP inhibitors in patients with ovarian cancer do not accurately reflect the racial and ethnic makeup of the real-world patient population, according to research published in Gynecologic Oncology.
For this study, researchers evaluated data from phase 2-3 trials reported on ClinicalTrials.gov and in the Surveillance, Epidemiology, and End Results program.
Of 48 trials identified, 15 met inclusion criteria. Ten trials were phase 2, and 5 were phase 3. Twelve trials enrolled ovarian cancer patients only, but 3 studies enrolled breast cancer patients as well. The trials opened enrollment between 2007 and 2017.
The trials enrolled a total of 3414 patients — 3043 who were non-Hispanic White, 222 who were Asian/Pacific Islander, 86 who were Hispanic, and 63 who were non-Hispanic Black.
Enrollment fractions were calculated for each of these groups — 2.38% for Asian/Pacific Islander patients, 1.52% for non-Hispanic White patients, 0.47% for non-Hispanic Black patients, and 0.34% for Hispanic patients.
Statistical analyses showed significant underrepresentation of non-Hispanic Black patients (odds ratio [OR], 0.23; P <.001) and Hispanic patients (OR, 0.30; P <.001), compared with non-Hispanic White patients. Asian/Pacific Islander patients were overrepresented (OR, 1.57; P <.001).
“Phase 2 and 3 ovarian cancer trials identified between 2007 and 2017 do not accurately represent the patient population that is diagnosed with these cancers, nor the US population at large,” the researchers wrote.
“Therefore, the applicability of trial results and the utility of these therapies is not generalizable to all racial and ethnic groups,” the team added. “Strategies to improve enrollment of racially and ethnic diverse participants are needed immediately.”
Disclosures: One study author disclosed a relationship with AstraZeneca. Please see the original reference for a full list of disclosures.
Wagar MK, Mojdehbakhsh RP, Godecker A, Rice LW, Barroilhet L. Racial and ethnic enrollment disparities in clinical trials of poly(ADP-ribose) polymerase inhibitors for gynecologic cancers. Gynecol Oncol. Published online February 7, 2022. doi:10.1016/j.ygyno.2022.01.032