Among patients with BRCA-mutant platinum-sensitive recurrent serous ovarian cancer, olaparib maintenance monotherapy after platinum-based chemotherapy failed to significantly prolong overall survival, despite improving progression-free survival, according to a study published in The Lancet Oncology.1
Previously reported data demonstrate that maintenance monotherapy with olaparib significantly prolongs progression-free survival, in contrast with placebo, in this patient population. After more than 5 years of follow-up, researchers evaluated overall survival, a secondary endpoint of the study.
Among the 265 patients randomly assigned to olaparib or placebo, median overall survival was 29.8 months (95% CI, 26.9-35.7) for olaparib, compared with 27.8 months (95% CI, 24.9-33.7) for placebo (hazard ratio [HR], 0.73; 95% CI, 0.55-0.96; P = .025).
Among the 136 patients with deleterious BRCA mutations, median overall survival was 34.9 months (95% CI, 29.2-54.6) and 30.2 months (95% CI, 23.1-40.7) with olaparib and placebo, respectively (HR, 0.62; 95% CI, 0.41-0.94; P = .025).
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In those with BRCA wild-type, median overall survival was 24.5 months (95% CI, 19.8-35.0) for those treated with olaparib, versus 26.6 months (95% CI, 23.1-32.5) for those treated with placebo (HR, 0.83; 95% CI, 0.55-1.24; P = .37).
The most common grade 3 or worse adverse events in the olaparib arm were fatigue and anemia. No new safety signals were observed; adverse events occurred mostly during the first 2 years of treatment.
- Ledermann JA, Harter P, Gourley C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016 Sep 8. doi: 10.1016/S1470-2045(16)30376-X [Epub ahead of print]