According to a new study published in the journal The Lancet Oncology, olaparib plus paclitaxel and carboplatin followed by olaparib monotherapy significantly improved progression-free survival compared with paclitaxel plus carboplatin alone for the treatment of patients with platinum-sensitive, recurrent, high-grade serous ovarian cancer.
For this international, multicenter, open-label, phase 2 study, 162 patients were randomly assigned to receive either olaparib 200mg orally twice daily on days 1-10 of each 21-day cycle plus paclitaxel 175mg/m2 intravenously on day 1 and carboplatin AUC 4 intravenously on day 1, followed by olaparib monotherapy 400mg orally twice daily until disease progression, or paclitaxel 175mg/m2 intravenously and carboplatin AUC 6 intravenously on day 1 with no maintenance phase.
Results showed that progression-free survival was significantly improved in the chemotherapy plus olaparib group (median 12.2 months; 95% CI: 9.7 - 15.0) compared with the chemotherapy alone group (median 9.6 months; 95% CI: 9.1 - 9.7; P = 0.0012).
Patients with BRCA gene mutations in the olaparib arm had particularly longer progression-free survival than those in the chemotherapy alone arm (HR = 0.21 [0.08 - 0.55]; P = 0.0015). Adverse effects more common in the olaparib arm were: alopecia, diarrhea, dyspepsia, headache, nausea, neutropenia, and peripheral neuropathy. Serious adverse effects were more common in those that received chemotherapy alone compared with olaparib plus chemotherapy.
The findings suggest that olaparib prolongs progression-free survival when added to paclitaxel and carboplatin for the treatment of patients with recurrent, high-grade serious ovarian cancer, especially those with BRCA gene mutations, and is well-tolerated.
The aim of this study was to assess the efficacy and tolerability of olaparib in combination with chemotherapy, followed by olaparib maintenance monotherapy, versus chemotherapy alone in patients with platinum–sensitive, recurrent, high–grade serous ovarian cancer.