87P Health-related quality of life (HRQoL) with maintenance niraparib: 6-month preliminary results from the MONITOR-UK trial

Abstract

Background: MONITOR-UK assesses real-world experience of maintenance niraparib for newly diagnosed or recurrent ovarian cancer (OC) within UK clinical practice. Method(s): HRQoL was assessed as a prespecified secondary end point of patient-reported outcomes (PRO) using EORTC QLQ-OV28, FACT-O, and EQ-5D-5L questionnaires. Assessments were conducted at baseline, regular timepoints on treatment up to 24 months and at the end of niraparib treatment. Result(s): Between 2.2020-4.2024, 379 eligible patients were enrolled from 16 centres: 194 (51%) in the first-line cohort and 185 (49%) in the recurrent cohort. PRO questionnaire (EQ-5D, EORTC, OV28, FACT-O) completion rates were >70% (baseline, 1, 3 and 6 months). In the first-line cohort, the Mixed-Model Repeated-Measures analysis showed gradual improvements in EQ-5D VAS and Index scores over time, with the largest change from baseline at 6 months. FACT-O total scores reflecting physical, emotional, social, and functional well-being increased after 1 month, reached their highest scores at 3 months, and stabilisation at 6 months. Body image concerns gradually declined, with slight improvements in perceived attractiveness and satisfaction over time, while hormonal symptoms such as hot flushes and night sweats remained stable or worsened slightly. In the recurrent cohort, a decline in both EQ-5D VAS and Index scores was observed at each time point. FACT-O total scores also showed a consistent decline at all time points. Hormonal symptoms, including hot flushes and night sweats, remained stable or worsened slightly at 6 months. Conclusion(s): In real-world practice, HRQoL changes on maintenance niraparib were reported over time, with improvements observed at 3 and 6 months in first-line ovarian cancer patients but a steady decline in recurrent ovarian cancer patients may reflect disease burden. Action should focus on providing information and support to patients receiving maintenance therapy, particularly in addressing hormonal symptoms and body image concerns, to enhance survivorship care. Clinical trial identification: NCT04295577. Legal entity responsible for the study: The authors. Funding(s): Academic-sponsored study, funding from GSK. Disclosure: J.E. Ang: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, MSD; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca, Pfizer, GSK, MSD. S. Banerjee: Financial Interests, Personal, Advisory Board: Lilly, ITM Oncologics, pharma&, TORL Biotherapeutics, Zymeworks, BeiGene, Bioncotech Therapeutics, Gilead, Grey Wolf Therapeutics, Incyte, ITM oncologic, ImmunoGen, Mersana, MSD, AstraZeneca, GSK, Oncxerna, Epsilogen, Seagen, Eisai, Verastem, Myriad; Financial Interests, Personal, Invited Speaker: Zymeworks, GSK, Research to Practice, AstraZeneca, Takeda, Medscape, Peerview, AbbVie; Financial Interests, Personal, Stocks/Shares: PerciHealth; Financial Interests, Institutional, Research Grant: AstraZeneca, GSK; Non-Financial Interests, Personal, Leadership Role, Oncology Section President: Royal Society of Medicine; Non-Financial Interests, Personal, Principal Investigator, ENGOT-GYN1/ATARI phase II international trial (academic sponsored): AstraZeneca; Non-Financial Interests, Personal, Principal Investigator, Phase II clinical trial Global lead, ENGOTov60/GOG3052/RAMP201: Verastem; Non-Financial Interests, Personal, Principal Investigator, Academic sponsored trial PI (MONITOR-UK): GSK; Non-Financial Interests, Personal, Leadership Role, Board Member: International Cancer Foundation (ICF); Non-Financial Interests, Personal, Advisory Role, Medical advisor to UK ovarian cancer charity: Ovacome Charity. All other authors have declared no conflicts of interest. Copyright © 2025