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http://hdl.handle.net/2445/168022
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DC Field | Value | Language |
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dc.contributor.author | Del Campo, Josep M. | - |
dc.contributor.author | Matulonis, Ursula A. | - |
dc.contributor.author | Malander, Susanne | - |
dc.contributor.author | Provencher, Diane | - |
dc.contributor.author | Mahner, Sven | - |
dc.contributor.author | Follana, Philippe | - |
dc.contributor.author | Waters, Justin | - |
dc.contributor.author | Berek, Jonathan S. | - |
dc.contributor.author | Woie, Kathrine | - |
dc.contributor.author | Oza, Amit M. | - |
dc.contributor.author | Canzler, Ulrich | - |
dc.contributor.author | Gil-Martín, Marta | - |
dc.contributor.author | Lesoin, Anne | - |
dc.contributor.author | Monk, Bradley J. | - |
dc.contributor.author | Lund, Bente | - |
dc.contributor.author | Gilbert, Lucy | - |
dc.contributor.author | Wenham, Robert M. | - |
dc.contributor.author | Benigno, Benedict | - |
dc.contributor.author | Arora, Sujata | - |
dc.contributor.author | Hazard, Sebastien J. | - |
dc.contributor.author | Mirza, Mansoor R. | - |
dc.date.accessioned | 2020-07-07T15:27:48Z | - |
dc.date.available | 2020-07-07T15:27:48Z | - |
dc.date.issued | 2019-11-10 | - |
dc.identifier.uri | http://hdl.handle.net/2445/168022 | - |
dc.description.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. | - |
dc.format.extent | 10 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Amer Soc Clinical Oncology | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1200/JCO.18.02238 | - |
dc.relation.ispartof | Journal Of Clinical Oncology, 2019-11-10, Vol. 37, Issue 32, P. 2968-2973 | - |
dc.relation.uri | https://doi.org/10.1200/JCO.18.02238 | - |
dc.rights | cc by-nc-nd (c) Del Campo, Josep M. et al., 2019 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Càncer d'ovari | - |
dc.subject.classification | Quimioteràpia del càncer | - |
dc.subject.other | Ovarian cancer | - |
dc.subject.other | Chemotherapy | - |
dc.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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2020-07-06T08:27:31Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 31173551 | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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delCampoJM.pdf | 853.26 kB | Adobe PDF | View/Open |
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