TY - JOUR
T1 - Efficacy and safety of niraparib as maintenance treatment in older patients (≥ 70 years) with recurrent ovarian cancer
T2 - Results from the ENGOT-OV16/NOVA trial
AU - Fabbro, Michel
AU - Moore, Kathleen N
AU - Dørum, Anne
AU - Tinker, Anna V
AU - Mahner, Sven
AU - Bover, Isabel
AU - Banerjee, Susana
AU - Tognon, Germana
AU - Goffin, Frederic
AU - Shapira-Frommer, Ronnie
AU - Wenham, Robert M
AU - Hellman, Kristina
AU - Provencher, Diane
AU - Harter, Philipp
AU - Vázquez, Isabel Palacio
AU - Follana, Philippe
AU - Pineda, Mario J
AU - Mirza, Mansoor R
AU - Hazard, Sebastien J
AU - Matulonis, Ursula A
N1 - Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.
PY - 2019/3
Y1 - 2019/3
N2 - 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.
AB - 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.
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Female
KW - Humans
KW - Indazoles/adverse effects
KW - Maintenance Chemotherapy
KW - Middle Aged
KW - Neoplasm Recurrence, Local/drug therapy
KW - Ovarian Neoplasms/drug therapy
KW - Patient Reported Outcome Measures
KW - Piperidines/adverse effects
KW - Poly(ADP-ribose) Polymerase Inhibitors/adverse effects
UR - https://www.scopus.com/pages/publications/85059618330
U2 - 10.1016/j.ygyno.2018.12.009
DO - 10.1016/j.ygyno.2018.12.009
M3 - Journal article
C2 - 30638768
SN - 0090-8258
VL - 152
SP - 560
EP - 567
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 3
ER -