Health-related quality of life in patients with newly diagnosed advanced ovarian cancer treated with niraparib vs placebo: Results from the phase 3 randomized PRIMA/ENGOT-OV26/GOG-3012 trial

Objective. To assess patient -reported health -related quality of life (HRQoL) in patients with ovarian cancer (OC) who received niraparib as first -line maintenance therapy. Methods. PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) enrolled patients with newly diagnosed advanced OC who responded to first -line platinum -based chemotherapy. Patients were randomized (2:1) to niraparib or placebo once daily in 28 -day cycles until disease progression, intolerable toxicity, or death. HRQoL was assessed as a prespecified secondary end point using patient -reported responses to the European Organisation for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30), the EORTC QLQ Ovarian Cancer Module (EORTC QLQ-OV28), the Functional Assessment of Cancer Therapy-Ovarian Symptom Index (FOSI), and EQ-5D-5L questionnaires. Assessments were collected at baseline and every 8 weeks (+/- 7 days) for 56 weeks, beginning on cycle 1/day 1, then every 12 weeks (+/- 7 days) thereafter while the patient received study treatment. Results. Among trial participants (niraparib, n = 487; placebo, n = 246), PRO adherence exceeded 80% for all instruments across all cycles. Patients reported no decline over time in HRQoL measured via EORTC QLQ-C30 Global Health Status/QoL and FOSI overall scores. Scores for abdominal/gastrointestinal symptoms (EORTC QLQ-OV28) and nausea and vomiting, appetite loss, and constipation (EORTC QLQ-C30) were higher (worse symptoms) in niraparib-treated patients than placebo -treated patients; except for constipation, these differences resolved over time. Patients did not self -report any worsening from baseline of fatigue, headache, insomnia, or abdominal pain on questionnaires. Conclusions. Despite some early, largely transient increases in gastrointestinal symptoms, patients with OC treated with niraparib first -line maintenance therapy reported no worsening in overall HRQoL. (c) 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).