Niraparib 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.
This double-blind, PBO-controlled, phase III study randomized 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 utilized were FOSI, EQ-5D-5L, EORTC-QLQ-C30, and EORTC-QLQ-OV28.
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 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.
Consistent 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.
Clinical trial identification
Writing and editorial support, funded by GlaxoSmithKline (Waltham, MA, USA) and coordinated by Ashujit Tagde, PhD of GlaxoSmithKline, was provided by Eric Scocchera, PhD and Anne Cooper, MA of Ashfield Healthcare Communications (Middletown, CT, USA).
Legal entity responsible for the study
GlaxoSmithKline, Waltham, MA, USA.
GlaxoSmithKline, Waltham, MA, USA.
B. Pothuri: Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Tesaro; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Clovis Oncology. D. Chase: Speaker Bureau/Expert testimony: Tesaro. F. Heitz: Non-remunerated activity/ies: NewOncology; Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Clovis; Advisory/Consultancy: Tesaro; Advisory/Consultancy: PharmaMar. R. Burger: Advisory/Consultancy: Amgen; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Tesaro; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy: Genentech; Advisory/Consultancy: Gradalis; Advisory/Consultancy: Janssen Research & Development; Advisory/Consultancy: Merck; Advisory/Consultancy: VBL Therapeutics. E. Guerra: Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy, Travel/Accommodation/Expenses: GlaxoSmithKline; Advisory/Consultancy: PharmaMar; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Merck Sharp & Dohme; Travel/Accommodation/Expenses: Baxter. J. Maenpaa: Honoraria (institution): Tesaro; Honoraria (institution): AstraZeneca; Honoraria (institution): Clovis; Honoraria (institution): Roche; Honoraria (institution): MSD; Honoraria (institution): OrionPharma. E. Bacqué: Full/Part-time employment: GlaxoSmithKline. Y. Li: Full/Part-time employment: GlaxoSmithKline. A. González Martín: Advisory/Consultancy, Non-remunerated activity/ies: AstraZeneca; Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Tesaro; Advisory/Consultancy: Clovis Oncology; Advisory/Consultancy, Research grant/Funding (institution), Non-remunerated activity/ies: Roche Holding AG; Advisory/Consultancy: Merck & Co. Inc.; Advisory/Consultancy: Genmab; Advisory/Consultancy: Immunogen; Advisory/Consultancy: PharmaMar, S.A; Advisory/Consultancy: Oncoinvent AS. B.J. Monk: Advisory/Consultancy, Research grant/Funding (institution): Tesaro. All other authors have declared no conflicts of interest.