Patient-reported outcomes (PRO) in patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial

Objective To assess PROs in patients receiving niraparib or placebo in the PRIMA/ENGOT-OV26/GOG-3012 trial (NCT02655016).

Materials and methods This double-blind, placebo-controlled, phase 3 study randomized 733 patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line platinum-based chemotherapy. Patients received niraparib or placebo QD for 36 months or until disease progression. The primary endpoint was progression-free survival assessed by blinded independent central review. PROs, a secondary endpoint, were collected Q8W for 56 weeks, then Q12W thereafter while treatment was ongoing. Once a patient discontinued treatment, PRO evaluations were performed at the time of treatment discontinuation and then at 4, 8, 12, and 24 weeks after the end of treatment, regardless of subsequent treatment. The validated PRO instruments utilized were FOSI, EQ-5D-5L, EORTC-QLQ-C30, and EORTC-QLQ-OV28.

Results Compliance rates were high for all of the PRO instruments used in the study. PRO analysis of the EORTC-QLQ-C30 and EORTC-QLQ-OV28 did not indicate a difference in health-related quality of life scores of patients treated with niraparib vs placebo. Mean scores between niraparib and placebo arms were similar at each time point. Overall, the health utility index showed a slight improvement trend in patients who received niraparib vs placebo.

Summary Consistent with PRO results in the ENGOT-OV16/NOVA study, patients receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial did not experience a decrease in quality of life compared with those receiving placebo.

Sponsor GlaxoSmithKline, Waltham, MA, USA

Publication History

Article published online:
07 October 2020