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

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-Martin, Marta; Lesoin, Anne; Monk, Bradley J.; Lund, Bente; Gilbert, Lucy; Wenham, Robert M.; Benigno, Benedict; Arora, Sujata; Hazard, Sebastien J. und Mirza, Mansoor R. (2019): 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. In: Journal of Clinical Oncology, Bd. 37, Nr. 32

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.

• Dokumententyp: Zeitschriftenartikel
• Fakultät: Medizin
• Themengebiete: 600 Technik, Medizin, angewandte Wissenschaften > 610 Medizin und Gesundheit
• ISSN: 0732-183X
• Sprache: Englisch