- Niraparib monotherapy after first-line platinum-based chemotherapy “should be considered a new standard of care,” according to primary investigator A. González-Martin (Navarra University, Madrid).
Why this matters
- Ovarian cancer (OC) is the leading cause of cancer death in women with recurrence rates up to 85% after standard first-line platinum-based chemotherapy.
- Niraparib is the first oral PARP inhibitor approved as maintenance in recurrent OC for all patients, regardless of BRCA-status.
- 728 patients with newly diagnosed OC at high risk for recurrence after response to first-line platinum-based chemotherapy were randomised to niraparib or placebo.
- Planned interim analysis at 11% of expected data.
- A test for homologous recombination was used. Progression-free survival (PFS) and overall survival (OS) were calculated for homologous recombination proficient and homologous recombination deficient patients separately.
- Funding: GlaxoSmithKline.
- After a median follow-up of 13.8 months, 37% of patients with niraparib continued treatment vs 28% of patients with placebo.
- Median PFS overall with niraparib 13.8 months vs 8.2 months with placebo. In HR-deficient patients PFS with niraparib was 21.9 months vs 10.4 months with placebo (both P
- OS at 2 years did not achieve statistical significance in the overall population (84% vs 77%).
- Similarly, in homologous recombination-deficient 91% vs 85% had survived, and among homologous recombination-proficient patients survival rates were 81% vs 59%, but neither of those differences achieved statistical significance.
- Interim analysis, short follow-up.
- Comparison was with placebo.