Efficacy and safety of niraparib in older patients with advanced ovarian cancer (OC): results from the PRIMA/ENGOT-OV26/GOG-3012 trial

Objective To assess the efficacy and safety of niraparib from older patients enrolled in the PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016).

Materials and methods This double-blind, placebo-controlled phase 3 trial evaluated niraparib in patients with newly diagnosed, advanced, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line platinum-based chemotherapy. Patients were randomized 2:1 to receive either a fixed starting dose (FSD) of 300 mg niraparib or placebo QD. A protocol amendment introduced an individualized starting dose (ISD): 200 mg QD in patients with bodyweight < 77 kg or platelet count < 150,000/µL or 300 mg QD for all others. Here, patients were dichotomized by age group < 65 vs ≥65 years old (yo) to analyze efficacy and safety of niraparib vs placebo in older patients. The primary endpoint was PFS assessed by blinded independent central review.

Results Of 733 enrolled patients, 444 were < 65 yo (297 niraparib, 147 placebo), and 289 were ≥65 yo (190 niraparib, 99 placebo). Efficacy was comparable in patients < 65 yo (HR 0.61; 95% CI 0.47-0.81) and ≥65 yo (HR 0.53; 95% CI 0.39-0.74) who received niraparib compared with placebo. Safety data by age group, older patients who received FSD/ISD, and patient-reported outcomes will be presented.

Summary Niraparib efficacy, safety, and QOL were similar in compared age groups. Implementation of an ISD regimen improved rates of grade ≥3 thrombocytopenia events in older patients.

Sponsor GlaxoSmithKline, Waltham, MA, USA

Publication History

Article published online:
07 October 2020