Patient-reported outcomes from a subgroup analysis of the final analysis of the phase III PRIMA/ENGOT-OV26/GOG-3012 trial showed that first-line maintenance therapy with the PARP inhibitor niraparib did not adversely affect overall health-related quality of life in patients with newly diagnosed advanced ovarian cancer, regardless of homologous recombination deficiency status.1 Across both the homologous recombination–deficient (HRd) and homologous recombination–proficient (HRp) populations, overall quality-of-life measures were comparable between the niraparib and placebo groups.
“These findings add to the extensive body of safety and efficacy data reinforcing niraparib first-line maintenance as a well-tolerated treatment option for patients with advanced ovarian cancer who responded to first-line platinum-based chemotherapy,” said Floor J. Backes, MD, of The Ohio State University Comprehensive Cancer Center–The James, Columbus, who presented the findings at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer. “Initial side effects resolve over time, and overall quality of life is sustained over time regardless of HRd and HRp status.”
Initial side effects resolve over time, and overall quality of life is sustained over time regardless of HRd and HRp status.— FLOOR J. BACKES, MD
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At a median follow-up of 6.2 years, the final analysis of PRIMA showed no overall health-related quality-of-life difference between niraparib and placebo in the overall study population.2 Here, in this subsequent subgroup analysis, the investigators evaluated preprogression patient-reported outcomes within the HRd and HRp populations using four validated instruments: the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and ovarian cancer module QLQ-OV28, which assess general cancer–related and ovarian cancer–specific quality of life, respectively; the EuroQol 5-Dimension 5-Level Visual Analog Scale (EQ-5D-5L VAS), which measures broader health states not specific to cancer; and the Functional Assessment of Cancer Therapy–Ovarian Symptom Index (FOSI), which evaluates ovarian cancer–related symptoms.
No Difference in Health-Related Quality of Life
Patient-reported outcomes were assessed at baseline; every 8 weeks for the first 56 weeks; every 12 weeks thereafter until treatment discontinuation; and at the end of treatment and 4, 8, 12, and 24 weeks after discontinuation. Survey completion rates exceeded 89% through cycle 24. Because fewer patients remained on study in the HRp population, statistical analyses in this subgroup were limited to cycle 15.
Despite the aforementioned limitation, no differences in overall health-related quality of life were observed between niraparib and placebo in either the HRd or HRp population across the main patient-reported outcome instruments. EQ-5D-5L VAS scores appeared to trend upward over time, suggesting improved quality of life in both treatment arms. Dr. Backes said the subgroup findings were consistent with what had already been seen in the overall trial population and reinforce that niraparib maintenance does not adversely affect overall health-related quality of life regardless of homologous recombination deficiency status.
Early Gastrointestinal Symptoms Improved Over Time
The main differences between the treatment arms were seen in gastrointestinal symptoms. Appetite loss, nausea/vomiting, and constipation were worse early with niraparib, according to Dr. Backes, but most of these differences resolved or decreased over time. Constipation scores, however, were found to remain consistently lower with placebo than with niraparib in both the HRd and HRp populations.
“Regardless of the nature of potential side effects, it is extremely important to manage expectations and ensure patients are equipped to make well-informed decisions about their treatment,” said Dr. Backes. “It is valuable to have an open dialogue with patients about the benefits and potential side effects of treatment, as well as the steps that can be taken to mitigate treatment burdens, should they occur.” She added that the side effects reported in this analysis are all manageable with well-established approaches already used in routine oncology care.
KEY POINTS
- No differences in overall health-related quality of life were observed between niraparib and placebo in either the HRd or HRp population.
- Early differences in gastrointestinal symptoms, including appetite loss and nausea/vomiting, generally resolved or decreased over time, although constipation remained numerically worse with niraparib.
- Scores for the attitude toward disease/treatment domain appeared to improve over time in both the HRd and HRp populations.
- The findings seem to support first-line maintenance therapy with niraparib as a well-tolerated option for advanced ovarian cancer after response to first-line platinum-based chemotherapy.
Scores for the EORTC QLQ-OV28 domain on attitude toward disease/treatment were generally increased with longer follow-up in both the HRd and HRp populations, according to Dr. Backes, indicating better functioning over time. No differences were observed between treatment arms across the other EORTC QLQ-OV28 domains. She said these findings suggest that patients viewed treatment as tolerable over time and that the final analysis provides a more complete picture of how patients experience niraparib maintenance therapy in practice.
Clinical Implications
The investigators concluded that long-term patient-reported outcomes from PRIMA support first-line maintenance therapy with niraparib as a well-tolerated option for patients with advanced ovarian cancer who responded to first-line platinum-based chemotherapy. They found no adverse effect on overall health-related quality of life regardless of homologous recombination deficiency status and characterized the gastrointestinal symptom burden as early and transient overall.
Premal H. Thaker, MD, MS
In her discussion of the session, Premal H. Thaker, MD, MS, Chief of the Division of Gynecologic Oncology and Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, St. Louis, said patient-reported outcomes are especially important in the maintenance setting, where the goal is for patients to “regain quality of life after chemotherapy.” She highlighted PRIMA as reassuring evidence that maintenance therapy with niraparib does not impair quality of life in either the HRd or HRp populations, noting that the gastrointestinal symptoms seen early in treatment improved over time.
Dr. Thaker also used PRIMA to make a broader point about why patient-reported outcomes matter. She argued that clinician-reported toxicity alone may not capture important aspects of the patient experience, so patient-reported outcomes are critical to understanding the full treatment journey. In that sense, the final PRIMA analysis adds more than another tolerability datapoint; it offers a longer-term view of how patients experience niraparib maintenance therapy over time.
According to Dr. Backes, this analysis adds to the broader safety and efficacy profile of niraparib and helps contextualize the risk-benefit discussion, supporting continued use of niraparib maintenance therapy in patients with advanced ovarian cancer who respond to first-line platinum-based chemotherapy.
DISCLOSURE: This study was funded by GSK. Dr. Backes has received institutional research grants from AstraZeneca, Eisai, ImmunoGen/AbbVie, Merck, and Natera; royalty fees from UpToDate; advisory board fees from AbbVie, AstraZeneca, BioNTech, Daiichi Sankyo, Eisai, Genentech, Genmab, GSK, ImmunoGen, MacroGenics (Data and Safety Monitoring Board), and Merck; CME lecture fees from Clinical Care Options, CMR Institute, Curio, GOG Foundation, Medscape/WebMD, Med Learning Group, MJH Life Sciences, OncLive, Research To Practice, and Targeted Oncology; support for attending meetings and/or travel from BioNTech, Genmab, and GSK; and has held unpaid leadership roles within International Gynecologic Cancer Society (IGCS) Education360 and the NRG Oncology Developmental Therapeutics Committee. Dr. Thaker has received institutional grants from Merck, GSK (formerly GlaxoSmithKline), AstraZeneca; consulting fees from AstraZeneca, Merck, GSK (formerly GlaxoSmithKline), AstraZeneca, BioNTech, Genelux, Corcept, Verastem, Tubulis, Iovance, ImmunoGen, Zentalis, and Caris; and has served on the Data and Safety Monitoring Board for Iovance and Imunon.
REFERENCES
1. Backes F, Barretina-Ginesta M-P, Monk B, et al: Patient-reported outcomes from the final analysis of the PRIMA/ENGOT-OV26/GOG3012 trial of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer: Results from the homologous recombination-deficient (HRd) and -proficient (HRp) populations. 2026 SGO Annual Meeting. Abstract 331. Presented April 13, 2026.
2. Lorusso D, Monk BJ, Barretina-Ginesta M-P, et al: Updated patient-reported outcomes in the PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer. Int J Gynecol Cancer 35(suppl 1):100093, 2025.
