Patients with newly diagnosed ovarian cancer who were randomized to niraparib in the phase 3 PRIMA/ENGOT-OV26/GOG-3012 clinical trial did not experience a decline in quality of life (QOL) compared with patients assigned to placebo.
Patient-reported outcomes (PROs) from the study were presented at the European Society for Medical Oncology Virtual Congress 2020 by Bhavana Pothuri, MD, gynecologic oncologist, Perlmutter Cancer Center, NYU Langone Health, New York City.
PRIMA enrolled 733 patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer who were at high risk for recurrence after achieving a complete or partial response to frontline platinum-based chemotherapy. They were randomized 2:1 to receive niraparib at a dose level based on body weight and platelet count or matching placebo, each over a 28-day cycle.
PROs were a secondary end point of PRIMA, and were collected every 8 weeks for 56 weeks, then every 12 weeks thereafter while treatment was ongoing. Once a patient discontinued treatment, PRO evaluations were performed at treatment discontinuation and then at 4, 8, 12, and 24 weeks after the end of treatment, regardless of the status of subsequent treatment.
PROs were assessed by 4 different instruments: Functional Ovarian Symptom Index (FOSI), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), EORTC Questionnaire Ovarian Cancer Module (EORTC QLQ-OV28), and EurQol 5-Dimension 5-Level (EQ-5D-5L) assessment. Compliance with all PRO instruments was >80% throughout the trial.
Mean FOSI health utility index (HUI) scores were similar in both the niraparib-treated and placebo patients. The overall percentage of patients with FOSI-assessed symptoms (lethargy, nausea, vomiting, stomach cramps) was also similar between the 2 arms.
Likewise, EORTC QLQ-C30 scores were comparable between the niraparib and placebo arms. No difference in QOL, physical function, fatigue, or pain was reported between the 2 groups.
Ovarian-specific EORTC QLQ-OV28 assessments showed no difference in mean abdominal symptoms and other chemotherapy side-effect scores.
Finally, the EQ-5D-5L assessment revealed no meaningful difference in HUI-assessed change from baseline between niraparib and placebo. EQ-5D-5L scores on a visual analog scale also showed no differences between the 2 arms.The PRO results from PRIMA are consistent with those from the NOVA study, noted Dr Pothuri. “Patients receiving niraparib in the PRIMA trial did not experience a decrement in QOL compared with placebo during their treatment, despite adverse events including grade ≥3 hematologic toxicity,” she said.