Efficacy and safety of niraparib as maintenance treatment in older patients (≥ 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial

• Published in: Gynecologic oncology Vol. 152; no. 3; pp. 560 - 567
• Main Authors: Fabbro, Michel, Moore, Kathleen N., Dørum, Anne, Tinker, Anna V., Mahner, Sven, Bover, Isabel, Banerjee, Susana, Tognon, Germana, Goffin, Frederic, Shapira-Frommer, Ronnie, Wenham, Robert M., Hellman, Kristina, Provencher, Diane, Harter, Philipp, Vázquez, Isabel Palacio, Follana, Philippe, Pineda, Mario J., Mirza, Mansoor R., Hazard, Sebastien J., Matulonis, Ursula A.
• Format: Journal Article Web Resource
• Language: English
• Published: United States Elsevier Inc 01-03-2019; Elsevier; Academic Press Inc
• Subjects: Adult; Aged; Aged, 80 and over; Female; gBRCA mutation; Human health sciences; Humans; Indazoles; Indazoles/adverse effects; Indazoles/therapeutic use; Life Sciences; Maintenance Chemotherapy; Middle Aged; Neoplasm Recurrence, Local; Neoplasm Recurrence, Local/drug therapy; Niraparib; Obstetrics and Gynecology; Older patients; Oncologie; Oncology; Ovarian cancer; Ovarian Neoplasms; Ovarian Neoplasms/drug therapy; PARP inhibitors; Patient Reported Outcome Measures; Piperidines; Piperidines/adverse effects; Piperidines/therapeutic use; Poly(ADP-ribose) Polymerase Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors/adverse effects; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use; Sciences de la santé humaine; Older patients; Niraparib; gBRCA mutation; PARP inhibitors; Ovarian cancer
• ISSN: 0090-8258; 1095-6859; 1095-6859
• DOI: 10.1016/j.ygyno.2018.12.009

To analyze the safety and efficacy of niraparib in patients aged ≥70 years with recurrent ovarian cancer in the ENGOT-OV16/NOVA trial.
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.
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%).
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.
•Safety and efficacy of niraparib in pts. ≥70 years are similar to younger population.•Niraparib significantly prolongs PFS in gBRCAmut and non-gBRCAmut pts. ≥70 years.•Rates of myelosuppressive adverse events were similar in the <70 and ≥70 age groups.