The highly selective poly(ADP-ribose) polymerase (PARP) 1/2 inhibitor niraparib (ZEJULA™) concentrated in the tumor vs plasma in preclinical studies, delivering ≥90% durable PARP inhibition, and showed significantly longer progression-free survival vs placebo in patients (pts) with recurrent OC following complete (CR) or partial response (PR) to platinum-based chemotherapy (PBC) regardless of germline BRCA mutation (gBRCAmut) or homologous recombination deficiency (HRD) status in the phase 3 ENGOT-OV16/NOVA trial. Quality of life (QoL) measures are important to determine the benefit of drug therapy in this population. We evaluated patient-reported outcomes (PROs) associated with QoL and individual patient-reported symptoms using the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index (FOSI) and European Quality of Life Scale 5-Dimensions (EQ-5D-5L) in ENGOT-OV16/NOVA pts treated with niraparib vs placebo.
A mixed-effects growth-curve model adjusted for baseline demographic values and 3 stratification factors was constructed to model the relationship between treatment and PRO score for each measure. The relationship between health status and PROs was evaluated through a cross-sectional analysis of adjusted EQ-5D-5L health utility index (HUI) scores. A disutility analysis of hematologic adverse events was conducted at different time points.
No significant difference in mean PRO scores was observed between niraparib and placebo arms in either cohort. Adjusted HUI scores were similar in both arms at baseline, but average adjusted HUI pre-progression scores trended higher in the niraparib arm (0.812 vs 0.803 in gBRCAmut cohort; 0.845 vs 0.828 in non-gBRCAmut cohort). Hematologic toxicities had no detrimental effect on pts’ overall health utility.
These data suggest pts with recurrent OC treated with niraparib following CR or PR to PBC can continuously maintain their QoL while on treatment.
Clinical trial identification
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A.M. Oza: Consulting/Advisory: Amgen, Verastem, Clovis Oncology, Immunovaccine; Travel, Accommodations, Expenses: AstraZeneca; Honoraria: WebRx. U.A. Matulonis: Consulting/Advisory: Merck KGaA, AstraZeneca, Immunogen, Tesaro, Genentech. S. Malander: Honoraria: AstraZeneca, Roche. J. Sehouli: Honoraria: Roche, AstraZeneca, Tesaro, PharmaMar; Consulting/Advisory: Clovis Oncology, Roche, AstraZeneca, Tesaro, Novocure Research; Funding: Amgen, Novartis, Lilly, Bayer. J.M. del Campo: Speakers’ Bureau: Roche, MSD Oncology, PharmaMar, Boehringer Ingelheim. S. Banerjee: Travel, Accommodations, Expenses: AstraZeneca, Clovis Oncology. G. Scambia: Honoraria: Roche, AstraZeneca, PharmaMar Consulting/Advisory: Roche, AstraZeneca, PharmaMar Speakers’ Bureau: Roche, AstraZeneca, PharmaMar; Travel, Accommodations, Expenses: Roche, AstraZeneca, PharmaMar. J.S. Berek: Consulting/Advisory: Atara Biotherapeutics. A.V. Tinker: Consulting/Advisory: AstraZeneca. F. Hilpert: Honoraria: Roche, AstraZeneca, Novartis, Medac, MSD, PharmaMar; Consulting/Advisory: PharmaMar, Roche, AZ, MSD; Travel, Accommodations, Expenses: AZ, Roche, PharmaMar. I. Palacio Vázquez: Research Funding: Novartis, Tesaro; Expert Testimony: AstraZeneca; Travel, Accommodations, Expenses: Roche, PharmaMar. V. D’hondt: Travel, Accommodations, Expenses: Amgen. B. Benigno: Honoraria: AstraZeneca, Insys Therapeutics; Research funding: Tesaro. D.M. Provencher: Consulting or Advisory Role: AstraZeneca; Speakers\' Bureau: AstraZeneca. S. Hudgens: Consulting/Advisory: Tesaro; Research Funding: Tesaro. S. Agarwal: Employment: TESARO, Inc. Stock: TESARO, Inc. M.R. Mirza: Consulting or Advisory Role: Clovis Oncology, AstraZeneca, Tesaro. All other authors have declared no conflicts of interest.