Del Campo, Josep M.Matulonis, Ursula A.Malander, SusanneProvencher, DianeMahner, SvenFollana, PhilippeWaters, JustinBerek, Jonathan S.Woie, KathrineOza, Amit M.Canzler, UlrichGil-Martín, MartaLesoin, AnneMonk, Bradley J.Lund, BenteGilbert, LucyWenham, Robert M.Benigno, BenedictArora, SujataHazard, Sebastien J.Mirza, Mansoor R.2020-07-072020-07-072019-11-10https://hdl.handle.net/2445/168022PURPOSEIn 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.10 p.application/pdfengcc by-nc-nd (c) Del Campo, Josep M. et al., 2019http://creativecommons.org/licenses/by-nc-nd/3.0/es/Càncer d'ovariQuimioteràpia del càncerOvarian cancerChemotherapyinfo:eu-repo/semantics/article2020-07-06info:eu-repo/semantics/openAccess31173551