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Title: | Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial |
Author: | Del Campo, Josep M. Matulonis, Ursula A. Malander, Susanne Provencher, Diane Mahner, Sven Follana, Philippe Waters, Justin Berek, Jonathan S. Woie, Kathrine Oza, Amit M. Canzler, Ulrich Gil-Martín, Marta Lesoin, Anne Monk, Bradley J. Lund, Bente Gilbert, Lucy Wenham, Robert M. Benigno, Benedict Arora, Sujata Hazard, Sebastien J. Mirza, Mansoor R. |
Keywords: | Càncer d'ovari Quimioteràpia del càncer Ovarian cancer Chemotherapy |
Issue Date: | 10-Nov-2019 |
Publisher: | Amer Soc Clinical Oncology |
Abstract: | PURPOSEIn the ENGOT-OV16/NOVA trial (ClinicalTrials.gov identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy.PATIENTS AND METHODSA total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non?gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer?specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy?Ovarian Symptom Index.RESULTSProgression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non?gBRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes.CONCLUSIONPatients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy. |
Note: | Reproducció del document publicat a: https://doi.org/10.1200/JCO.18.02238 |
It is part of: | Journal Of Clinical Oncology, 2019-11-10, Vol. 37, Issue 32, P. 2968-2973 |
URI: | http://hdl.handle.net/2445/168022 |
Related resource: | https://doi.org/10.1200/JCO.18.02238 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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