Fresh research into the oral poly polymerase inhibitor olaparib (AZD2281) published in the New England Journal of Medicine shows that the experimental drug from AstraZeneca has anti-tumor activity in patients with high-grade serous ovarian cancer with or without BRCA1 or BRCA2 germline mutations.
"Olaparib Maintenance Therapy in Platinum-Sensitive Relapsed Ovarian Cancer."
Researchers carried out a randomized, double-blind, placebo-controlled, Phase II study to evaluate maintenance treatment with olaparib in patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer who had received two or more platinum-based regimens and had had a partial or complete response to their most recent platinum-based regimen. Patients were randomly assigned to receive olaparib (400 mg 2x daily) or placebo.
The primary end point was progression-free survival (PFS) according to the Response Evaluation Criteria in Solid Tumors guidelines.
265 patients were recruited and ultimately underwent randomization. 136 were assigned to the olaparib arm and 129 to the placebo arm.
PFS was significantly longer with olaparib than with placebo, demonstrating a median PFS of 8.4 months against 4.8 months with placebo.
Researchers concluded that using olaparib as maintenance treatment substantially improved PFS among this patient population, although an interim analysis showed no overall survival benefit.
Source: NEJM
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