(ChemotherapyAdvisor) – Olaparib as maintenance treatment significantly improved progression-free survival in patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer, investigators reported in the New England Journal of Medicine online March 27.
The Phase 2 trial randomly assigned 265 patients who had received two or more platinum-based regimens and had a complete or partial response to their most recent platinum-based regimen to receive the oral PARP inhibitor olaparib 400mg twice daily (n=136) or placebo (n=129).
The primary end point, progression-free survival, was found to be significantly longer with olaparib, 8.4 months, than with placebo, 4.8 months; hazard ratio for progression or death was 0.35; P<0.001.
“Subgroup analyses of progression-free survival showed that, regardless of subgroup, patients in the olaparib group had a lower risk of progression,” the investigators wrote. An interim analysis of overall survival at a point at which 38% of the patients had died showed no significant difference between groups (HR, 0.94).
Adverse events more commonly reported in the olaparib group were nausea, fatigue, vomiting, and anemia, with most of the AEs grade 1 or 2.