2026-08-05T15:46:02Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/226822024-11-29T02:08:26Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16967

00925njm 22002777a 4500 dc Fabbro, Michel author Moore, Kathleen N author Dorum, Anne author Tinker, Anna, V author Mahner, Sven author Bover Barceló, Isabel author Banerjee, Susana author Tognon, Germana author Goffin, Frederic author Shapira-Frommer, Ronnie author Wenham, Robert M author Hellman, Kristina author Provencher, Diane author Harter, Philipp author Palacio Vazquez, Isabel author Follana, Philippe author Pineda, Mario J author Mirza, Mansoor R author Hazard, Sebastien J author Matulonis, Ursula A author 2019-03 Objective. To analyze the safety and efficacy of niraparib in patients aged >= 70 years with recurrent ovarian cancer in the ENGOT-OV16/NOVA trial. Methods. The trial enrolled 2 independent cohorts with histologically diagnosed recurrent ovarian, fallopian tube, or peritoneal cancer who responded to platinum rechallenge, on the basis of germline breast cancer susceptibility gene mutation (gBRCAmut) status. Patients were randomized 2:1 to receive niraparib (300 mg) or placebo once daily until disease progression. The primary endpoint was progression-free survival (PFS) by blinded independent central review. Adverse events (AEs) of special interest were based on the known safety profile of poly(ADP-ribose) polymerase inhibitors. Results. Patients aged >= 70 years in the gBRCAmut cohort receiving niraparib (n = 14) had not yet reached a median PFS compared with a median PFS of 3.7 months for the same age group in the placebo arm (hazard ratio [HR], 0.09 [95% confidence interval (CI), 0.01 to 0.73]). Non-gBRCAmut patients aged >= 70 years receiving niraparib (n = 47) had a median PFS of 11.3 months compared with 3.8 months in the placebo arm (HR, 0.35 [95% CI, 0.18 to 0.71]). Median duration of follow-up in the niraparib arm was 17.3 months in patients >= 70 years and 17.2 months in patients <70 years. Frequency, severity of AEs, and dose reductions in the niraparib arm were similar in patients aged <70 and >= 70 years population. The most common grade >= 3 AEs in patients >= 70 years were hematologic: thrombocytopenia event (34.4%), anemia event (13.1%), and neutropenia event (16.4%). Conclusions. For patients >= 70 years of age receiving niraparib as maintenance treatment in the ENGOT-OV16/NOVA trial, PFS benefits and incidence of any grade or serious treatment-emergent AEs were comparable to results in the younger population. Use of niraparib should be considered in this population. Fabbro M, Moore Kathleen N, Dorum A, Tinker Anna V, Mahner S, Bover I, et al. Efficacy and safety of niraparib as maintenance treatment in older patients (>= 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial. Gynecol Oncol. 2019 Mar;152(3):560-7. Epub 2019 Jan 9. 10.1016/j.ygyno.2018.12.009 1095-6859 0090-8258 Gynecologic Oncology http://hdl.handle.net/20.500.13003/17266 30638768 L2001444257 2-s2.0-85059618330 https://hdl.handle.net/20.500.12105/22682 461726100020 Ovarian cancer Older patients PARP inhibitors Niraparib gBRCA mutation Efficacy and safety of niraparib as maintenance treatment in older patients (>= 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial