Marina Frimer, MD, spoke about the goals of a phase 2 trial and how it can impact patients with platinum-sensitive recurrent uterine serous carcinoma.
At The Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer, CancerNetwork® spoke with Marina Frimer, MD, associate chief of Research & Academic Development Central Region and associate professor at the Donald and Barbara Zucker School of Medicine at Hofsta/Nortwell Health in New Hyde Park, New York, about the rationale behind an ongoing phase 2 trial (NCT04080284) of niraparib (Zejula) for patients with stage III or IV platinum-sensitive recurrent uterine cancer. Frimer also spoke about how these results can impact future research in the field.
PARP inhibitors have shown significant evidence in treatment of serous ovarian cancer, and uterine serous cancer [which] often presents in advanced stage. There are also studies that have shown that uterine serous cancer can exhibit the BRCAness of genomic alterations that we see with ovarian cancer. That’s why we felt that PARP inhibitors should be tried in this type of tumor.
The goals for the trial were to evaluate progression-free survival [PFS], overall survival, and overall response rate [ORR] at 1 year, with secondary outcomes focusing on [results at] 2 and 3 years. The design for this trial includes a 2-stage Simon design, where we’re looking for a difference that’s greater than 40% compared with no difference of the null hypothesis, which is less than 20% change in PFS and ORR.
At this time, we have limited ability to treat patients who recur with uterine serous carcinoma. In the future, if there is promise with maintenance PARP therapy, then we hope that we will have a maintenance option for these patients as well as an option at the time of recurrence.
Frimer M, Nizam A, Sison C, et al. Phase II trial of maintenance niraparib in patients with stage III, stage IV or platinum-sensitive recurrent uterine serous carcinoma. Presented at: 2022 SGO Annual Meeting on Women’s Cancer; March 18-21, 2022. Phoenix, Arizona.