The PRIMA study was a phase 3, double-blind, placebo-controlled study designed to evaluate the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib for patients with newly diagnosed advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete or partial response to first-line platinum-based chemotherapy. In this study, patients received niraparib or placebo once daily for 36 months or until disease progression. Although the primary end point of the study was progression-free survival, this analysis reports on patient-reported outcomes (PROs), a secondary end point of the trial, with relevant data having been collected every 8 weeks for 56 weeks, and then every 12 weeks thereafter until treatment was no longer ongoing. If patients discontinued treatment, PRO evaluations were completed at discontinuation and at 4, 8, 12, and 24 weeks. PRO instruments included FOSI, EQ-5D-5L, EORTC-QLQ-C30, and EORTC-QLQ-OV28.
All PRO evaluations were completed with a high rate of compliance (>80%) during the study. The EORTC-QLQ-C30 outcomes indicated that there is no difference in health-related quality-of-life outcomes or physical function between those treated with niraparib and those treated with placebo. At each time point, mean scores for the FOSI-assessed symptoms of lack of energy, nausea, vomiting, and stomach cramps were similar for those treated with niraparib and those treated with placebo. Mean FOSI health utility index scores were similar between treatment arms throughout the treatment period. There were no reported differences between treatments for fatigue or pain. The ovarian-specific EORTC-QLQ-OV28 showed no difference in abdominal/gastrointestinal symptoms or other chemotherapy-related side-effect scores. In addition, the EQ-5D-5L showed no significant difference in health utility index–assessed change from baseline between the 2 study arms, nor was there a difference in the scores obtained with visual analog scale.
These results are consistent with previously reported PRO results and indicate that receiving niraparib in the PRIMA study was not associated with a decrease in quality of life compared with placebo.
Abstract and Mini-Oral Presentation 810MO. ESMO 2020. September 19-21, 2020. Patient-reported outcomes (PROs) in patients (pts) receiving niraparib in the PRIMA/ENGOT-OV26/GOG-3012 trial.