PRIMA: niraparib maintenance in newly diagnosed advanced ovarian cancer
Niraparib maintenance after first-line chemotherapy delayed progression in newly diagnosed advanced ovarian cancer whether or not the tumour had a homologous recombination deficiency, though the gain was much larger when it did.
Overview
Phase 3 placebo-controlled trial of 733 patients with newly diagnosed advanced high-grade ovarian cancer at high risk of relapse who had responded to platinum chemotherapy, randomised to niraparib or placebo maintenance.
In homologous recombination-deficient tumours median progression-free survival was 21.9 versus 10.4 months (hazard ratio 0.43); in the overall population it was 13.8 versus 8.2 months (hazard ratio 0.62), with a smaller benefit in homologous recombination-proficient disease (hazard ratio 0.68).
- Homologous recombination-deficient: median progression-free survival 21.9 vs 10.4 months; hazard ratio 0.43.
- Overall population: 13.8 vs 8.2 months; hazard ratio 0.62.
Niraparib is approved as first-line maintenance for all comers, making PARP inhibitor maintenance available beyond BRCA-mutated disease, though the benefit in proficient tumours is modest and long-term survival data are neutral.
- No overall survival benefit at final analysis.
- Haematological toxicity requires individualised starting doses.
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