Clinical outcomes and subsequent therapy in patients with platinum-sensitive recurrent ovarian cancer deriving long-term benefit from maintenance niraparib: a subgroup analysis of the GEICO-88R study
- PMID: 40974837
- DOI: 10.1016/j.ijgc.2025.102116
Clinical outcomes and subsequent therapy in patients with platinum-sensitive recurrent ovarian cancer deriving long-term benefit from maintenance niraparib: a subgroup analysis of the GEICO-88R study
Abstract
Objective: To describe characteristics, clinical outcomes, and subsequent therapies in patients receiving long-term maintenance niraparib in the Spanish expanded-access program.
Methods: This retrospective observational study (NCT04546373) described patient characteristics, treatment exposure, and clinical outcomes in patients receiving maintenance niraparib for high-grade serous platinum-sensitive recurrent ovarian cancer. Subgroup analyses in patients receiving niraparib for ≥1 year ("long-term responders") were prespecified; additional post hoc analyses explored outcomes in patients treated for ≥2 years ("sustained long-term responders").
Results: In this real-world population of 316 patients (predominantly BRCA wildtype), 107 (34%) were long-term responders and 61 (19%) were sustained long-term responders. Compared with patients discontinuing niraparib within 1 year, the long-term responders subgroup included a higher proportion with primary debulking surgery and no residual disease after cytoreductive surgery and a lower proportion with >4 prior lines of systemic therapy, International Federation of Gynecology and Obstetrics stage IV disease, measurable disease at niraparib initiation, and Eastern Cooperative Oncology Group performance status 1. Tolerability was similar regardless of treatment duration. After discontinuing niraparib, the most frequently administered regimens were platinum-based. Response rates to the first post-niraparib line were 37% to 44%, and median progression-free survival was 7.0 months in non-long-term responders and 7.9 months in long-term responders. Median overall survival was 56.9 months in long-term responders (49.1 months' median follow-up) and was not reached in the sustained long-term responders subgroup.
Conclusions: Mature results from the GEICO-88R study continue to support the effectiveness and tolerability of maintenance niraparib in platinum-sensitive recurrent ovarian cancer. A subset of patients experienced long-term disease control. The efficacy of subsequent treatment appeared similar irrespective of niraparib duration.
Keywords: Long-Term Response; Maintenance Therapy; Niraparib; PARP Inhibitor; Real-World.
Copyright © 2025 European Society of Gynaecological Oncology and the International Gynecologic Cancer Society. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of Competing Interests JFC reports consulting/advisory roles for GlaxoSmithKline (GSK), AstraZeneca, and Clovis, and travel/accommodation/expenses from GSK and AstraZeneca. BP reports consulting/advisory roles for GSK, Merck Sharp & Dohme (MSD), AstraZeneca, Clovis Oncology, PharmaMar, Pharma&, Roche, and Eisai. LM reports advisory/consultancy roles for AstraZeneca, GSK, Eisai, and Clovis, and travel/accommodation/expenses from AstraZeneca, MSD, GSK, and Pharma&. PE-G reports advisory/consultancy roles for AstraZeneca, GSK, Eisai, and Clovis, and travel/accommodation/expenses from AstraZeneca, MSD, GSK, and Pharma&. ML reports speaker bureaus for GSK, AstraZeneca, Eisai, Pfizer, Lilly, and Novartis. GM has received financial support for advisory board participation from PharmaMar, Clovis Oncology, GSK/Tesaro, Lilly, Pfizer, Boehringer Ingelheim, Deciphera, and Eisai, for lectures from Roche, AstraZeneca, GSK/Tesaro, Clovis Oncology, Medicamenta, Eisai, PharmaMar, Bayer, Lilly, Ipsen, MSD, and Inhibrx Biosciences Inc, and for congress attendance from Roche, PharmaMar, GSK/Tesaro, MSD, Medicamenta, Pfizer, Angelini, Novartis, Merck, Lilly, and Eisai. SG-S reports speaker bureau for Novartis, advisory/consultancy roles for AstraZeneca, and travel expenses from Pfizer outside the submitted work. MVA reports advisory/consultancy roles for Roche, Novartis, Pfizer, and Seagen, speaker bureaus for Novartis, Pfizer, Lilly, Roche, AstraZeneca, MSD, Gilead, Eisai, Daiichi Sankyo, and Seagen, and travel/accommodation/expenses from Novartis, Pfizer, Roche, Gilead, Daiichi Sankyo, Lilly, and GSK. LG reports advisory/consultancy roles for AstraZeneca, GSK, AbbVie, and MSD, speaker bureaus for AstraZeneca, PharmaMar, GSK, MSD, Eisai, and Clovis, and travel/accommodation/expenses from AstraZeneca, MSD, and GSK. CG-R reports consulting/advisory roles for GSK, AstraZeneca, and MSD, and travel/accommodation/expenses from GSK and Roche. AT reports personal fees and non-financial support from GSK, Regeneron, Roche, Takeda, Sanofi, BMS, MSD, AstraZeneca, Pfizer, and Eisai. MCor reports speaker bureaus for GSK, Daiichi Sankyo/AstraZeneca, Novartis, and Pfizer/Merck, and travel/accommodation/expenses from GSK, Roche, and Pfizer/Merck. AG-M reports advisory/consultancy roles for Alkermes, Amgen, AstraZeneca, Clovis Oncology, Genmab, GSK, Hedera Dx, AbbVie/ImmunoGen, Incyte, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Regeneron, Roche, Sotio, Sutro, Seagen, Takeda, Tubulis, and Zai Lab, speaker bureaus for AstraZeneca, Clovis, GSK, Immunogen, Mersana, MSD, Novocure, PharmaMar, Roche, Takeda, Seagen, and Zai Lab, research grant/funding from Roche and GSK/Tesaro, and travel/accommodation/expenses from AstraZeneca, PharmaMar, Roche, and GSK/Tesaro. The remaining authors report no competing interests.
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