Safety and Efficacy of Niraparib in Elderly Patients (Pts) with Recurrent Ovarian Cancer (OC)

Abstract

Background: Niraparib (ZejulaTM) is a selective poly(ADP-ribose) polymerase 1/2 inhibitor (PARPi) approved for maintenance therapy in adults with recurrent OC who are in response to platinum-based therapy. Here, we report safety and efficacy of niraparib in the subgroup of pts from the ENGOT-OV16/NOVA trial who were aged>=65 years (y). Method(s): Pts were assigned to one of two independent cohorts based on germline BRCA mutation (gBRCAmut) status and randomized 2:1 within each cohort to receive either niraparib (300 mg) or placebo once daily. Pts were stratified by age (<65 vs>=65 y) to analyze efficacy (measured by progression-free survival [PFS]) and safety. Efficacy and safety were also tested in patients <70 vs>=70 y. Result(s): Efficacy of niraparib was comparable in pts <65 vs>=65 y in both gBRCAmut and non-gBRCAmut cohorts (Table). Efficacy was also similar in pts<70 vs>=70 y in both cohorts (gBRCAmut:<70 y, HR=0.30; >=70 y, HR=0.09. Non-gBRCAmut: <70 y, HR=0.47; >=70 y, HR=0.35), although the sample size of pts who were >=70 y in the gBRCAmut cohort was small (14 niraparib vs 7 placebo). The most common adverse events (AEs; nausea, constipation, fatigue, hypertension, anemia, thrombocytopenia, neutropenia) in the niraparib arm occurred with similar incidence in pts <65 vs>=65 y as well as in pts <70 vs>=70 y. Grade 3/4 AEs occurring in>10% of niraparib-treated pts were consistent in pts <65 vs>=65 y (thrombocytopenia, 27% vs 31%; anemia, 27% vs 20%; neutropenia, 12% vs 10%) and in pts <70 vs>=70 y (thrombocytopenia, 28% vs 31%; anemia, 27% vs 13%; neutropenia, 11% vs 10%, respectively). There were no Grade 5 events. Conclusion(s): Niraparib was safe and highly effective in elderly patients. (Table Presented).