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

Interessenkonflikt

F. Heitz reports non-financial support from NewOncology during the conduct of the study; and personal fees from Roche, AstraZeneca, Clovis, Tesaro, and PharmaMar outside the submitted work. B. Pothuri reports grants, personal fees and non-financial support from Tesaro; and has been a compensated Advisory Board member for AstraZeneca and Clovis Oncology outside the submitted work. H. Han has no disclosures to report. D. Chase reports speakers’ bureau fees from Tesaro/GSK outside the submitted work R. Burger reports consulting fees from Amgen, Astra Zeneca, Tesaro, Clovis Oncology, Genentech, Gradalis, Janssen Research & Development, Merck, and VBL Therapeutics outside of the submitted work. L. Gaba has nothing to disclose. L. Van Le has nothing to disclose. E. Guerra reports Consulting fees, advisory board fees, and travel support from Roche; consulting fees and advisory board fees from Clovis Oncology, Tesaro, PharmaMar, AstraZeneca, Merck Sharp & Dohme, and GlaxoSmithKline; and travel support from Baxter and GlaxoSmithKline/Tesaro, D. Bender has nothing to disclose. J. Korach has nothing to disclose. N. Cloven has nothing to disclose. P. Follana has nothing to disclose. J. F. Baurain has nothing to disclose. C. Pisano has nothing to disclose. U. Peen has nothing to disclose. J. Mäenpää reports Honoraria from Tesaro, AstraZeneca, Clovis, Roche, MSD and OrionPharma. E. Bacque is an employee of GlaxoSmithKline. Y. Li is an employee of GlaxoSmithKline. A. González-Martín reports personal fees and non-financial support from AstraZeneca; grants, personal fees and non-financial support from TESARO and Roche Holding AG; and personal fees from Clovis Oncology, Merck & Co. Inc., Genmab, INMUNOGEN, Pharma Mar, and Oncoinvent AS outside the submitted work. W. Graybill reports personal fees from TESARO outside the submitted work. B. Monk reports grants and personal fees from Tesaro outside of the submitted work.

Publikationsverlauf

Artikel online veröffentlicht:
07. Oktober 2020