Abstract
BackgroundNiraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor that is approved for use in heavily pretreated pts and as maintenance treatment of pts with newly diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy (CT). Here we report PROs in pts receiving niraparib and placebo (PBO) in the PRIMA/ENGOT-OV26/GOG-3012 trial.MethodsThis double-blind, PBO-controlled, phase 3 study randomised 733 pts with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response (CR or PR) to first-line (1L) platinum-based CT. Pts received niraparib or PBO once daily for 36 months or until disease progression. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review. PROs, a secondary endpoint, were collected every 8 weeks for 56 weeks, then every 12 weeks thereafter while treatment was ongoing. Once a pt discontinued treatment, PRO evaluations were performed at the time of treatment discontinuation and then at 4, 8, 12, and 24 weeks (±1 week for each time point) after the end of treatment, regardless of the status of subsequent treatment. The validated PRO instruments utilised were FOSI, EQ-5D-5L, EORTC-QLQ-C30, and EORTC-QLQ-OV28.ResultsCompliance 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 pts 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 pts who received niraparib vs placebo.ConclusionConsistent with PRO results in the NOVA study, pts receiving niraparib in the PRIMA trial did not experience a decrease in quality of life compared with those receiving placebo.DisclosuresSponsor: GlaxoSmithKline, Waltham, MA, USANCT number: NCT02655016Encore statement: This data is presented on behalf of the original authors with their permission. Presented at the European Society for Medical Oncology (ESMO) Annual Meeting, September 19–21, 2020, Virtual.Dr. Mäenpää reports Honoraria from Tesaro, AstraZeneca, Clovis, Roche, MSD and OrionPharmaDr. Pothuri reports grants, personal fees and non-financial support from GSK; Advisory Board fees from AstraZeneca and Clovis Oncology.Dr. Chase reports speakers’ bureau fees from GSK.Dr. González-Martín reports personal fees and non-financial support from AstraZeneca; Grant and personal fees from GSK, Clovis Oncology, Roche Holding AG, Merck & Co., Inc., Genmab, INMUNOGEN, Pharma Mar, S.A., and Oncoinvent AS.Dr. Monk reports consulting and advisory role at Merck, GSK, Roche/Genentech, AstraZeneca, Advaxiz, Cerulean Pharma, Amgen, Immunogen, NuCana BioMed, Clovis Oncology, Pfizer, Mateon Therapeutics, Precision Oncology, Perthera, Abbvie, Myriad Pharmaceuticals, Incyte, VBL Therapeutics, Takeda, Samumed, Oncomed, OncoSec, ChemoID, Geistlich Pharma, Eisai and Chemocare; Speakers’ bureau at Roche/Genentech, AstraZeneca, Janssen, Clovis Oncology and GSK; Honoraria from Merck, GSK, Roche/Genentech, AstraZeneca, Advaxis, Immunogen, NuCana BioMed, Clovis Oncology, Pfizer, Mateon Therapeutics, Precision Oncology, Pethera, Abbvie, Myriad Pharmaceuticals, Incyte, Janssen, Amgen, Genmab, Samumed, Takeda, VBL Therapeutics, Puma Biotechnology, Immunomedics, Conjupro Biotherapeutics, Agenus, OncoQuest, ChemoID, Geistlich Pharma, Eisai and Chemocare; and Research funding from Novartis, Amgen, Genentech, Lilly, Janssen, Array BioPharma, GSK, Morphotek, Pfizer, Advaxis, AstraZeneca, Immunogen, Regeneron, and Nucana.Drs. Han, Bender, and Follana have nothing to disclose.Drs. Bacque and Li are employees of GlaxoSmithKline.