Olaparib Plus Bevacizumab Improves Outcomes in Patients with High-Grade Serous Ovarian Cancer

Maintenance olaparib plus bevacizumab (BEV) improved outcomes compared with bevacizumab monotherapy in patients with newly diagnosed advanced high-grade serous ovarian cancer (HGOC) regardless of the timing of surgery or residual disease status after surgery, according to a study presented via the Society of Gynecologic Oncology 2020 Annual Meeting on Women’s Cancer. However, the magnitude of the progression-free survival (PFS) benefit is greatest when surgery achieved complete surgical debulking, specifically in the upfront setting.

The objective of the PAOLA-1 study was to evaluate the efficacy of olaparib plus bevacizumab by timing of surgery and presence of residual tumor after surgery.

PAOLA-1 is a randomized, double-blind phase 3 trial in patients with newly diagnosed, FIGO stage 3-5, high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer. Patients had received platinum-based chemotherapy plus BEV and were in clinical complete or partial response.

Each patient was randomized to receive olaparib tablets plus bevacizumab or placebo, stratified by first-line treatment outcome and tumor BRCA mutation status. PFS was assessed by investigators and blinded independent central review.

Five hundred and thirty-seven patients were randomized to olaparib plus bevacizumab and 269 to placebo plus bevacizumab, with a median follow-up of 22.9 months. Of these patients, 51% and 42% of patients had upfront and interval surgery, respectively, whereas 60% and 33% had no residual and residual macroscopic disease after surgery, respectively, regardless of timing.

For PFS, HR = 0.52 (95% CI 0.40—0.69, median 29.6 vs 18.2 months [olaparib plus bevacizumab placebo plus bevacizumab]) in patients undergoing upfront surgery; HR = 0.66 (0.50–0.87, median 21.4 vs 16.7 months) in patients undergoing interval surgery; HR = 0.54 (0.42–0.71, median 29.6 vs 19.3 months) in patients with no residual macroscopic disease after cytoreductive surgery; and HR = 0.63 (0.47–0.85, median 18.2 vs 12.9 months) in patients with residual macroscopic disease after cytoreductive surgery.

REFERENCE

Grimm C, Cropet C, Ray-Coquard I. Maintenance olaparib plus bevacizumab (bev) after platinum-based chemotherapy plus bev in patients (pts) with newly diagnosed advanced high-grade ovarian cancer (HGOC): Efficacy by timing of surgery and residual tumor status in the Phase III PAOLA-1 trial. SGO 2020. https://sgo.confex.com/sgo/2020/meetingapp.cgi/Paper/16928. Presented March 29, 2020. Accessed April 2, 2020.