Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer
December 19, 2019
Does the addition of Niraparib maintenance improve PFS in women with advanced ovarian cancer?
Placebo PO daily
q28 day cycles x36 months or until disease progression
Niraparib 300mg/200mg PO daily
PFS
Stage III/IV endometrioid or high grade serous ovarian cancer
prior platinum based chemotherapy with CR or PR
Niraparib vs Placebo:
median PFS, HRD: 21.9 vs 10.4 months (SS)
median PFS, HRD/BRCAm: 22.1 vs 10.9 months (SS)
median PFS for HRD/BRCAwt: 19.6 vs 8.2 months (SS)
median PFS for HR proficient: 8.1 vs 5.4 months (SS)
median PFS: 13.8 vs 8.2 months (SS)
2yr OS: 84% vs 77% (not mature)
2yr OS, HRD: 91% vs 85% (not mature)
Grade >3 adverse events: 70.5% vs 18.9% (most common: anemia, thrombocytopenia, neutropenia)
Treatment with niraparib maintenance imrpoved PFS in all considered populations, including the whole cohort.