Long-term safety in patients with recurrent ovarian cancer treated with niraparib versus placebo: Results from the phase III ENGOT-OV16/NOVA trial

Mansoor R Mirza, B Benigno, A Dørum, S Mahner, P Bessette, I Bover Barceló, D Berton-Rigaud, J A Ledermann, B J Rimel, J Herrstedt, S Lau, A du Bois, A Casado Herráez, E Kalbacher, J Buscema, D Lorusso, I Vergote, T Levy, P Wang, F A de JongD Gupta, U A Matulonis

Publikation: Bidrag til tidsskriftArtikelForskningpeer review


OBJECTIVE: Niraparib is a poly(ADP-ribose) polymerase (PARP) inhibitor approved for use in heavily pretreated patients and as maintenance treatment in patients with newly-diagnosed or recurrent ovarian cancer following a response to platinum-based chemotherapy. We present long-term safety data for niraparib from the ENGOT-OV16/NOVA trial.

METHODS: This multicenter, double-blind, randomized, controlled phase III trial evaluated the efficacy and safety of niraparib for the treatment of recurrent ovarian cancer. Patients were randomly assigned 2:1 to receive either once-daily niraparib 300 mg or placebo. Two independent cohorts were enrolled based on germline BRCA mutation status. The primary endpoint was progression-free survival, reported previously. Long-term safety data were from the most recent data cutoff (September 2017).

RESULTS: Overall, 367 patients received niraparib 300 mg once daily. Dose reductions due to TEAEs were highest in month 1 (34%) and declined every month thereafter. Incidence of any-grade and grade ≥ 3 hematologic and symptomatic TEAEs was also highest in month 1 and subsequently declined. Incidence of grade ≥ 3 thrombocytopenia decreased from 28% (month 1) to 9% and 5% (months 2 and 3, respectively), with protocol-directed dose interruptions and/or reductions. Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) were reported in 2 and 6 niraparib-treated patients, respectively, and in 1 placebo patient each. Treatment discontinuations due to TEAEs were <5% in each month and time interval measured.

CONCLUSION: These data demonstrate the importance of appropriate dose reduction according to toxicity criteria and support the safe long-term use of niraparib for maintenance treatment in patients with recurrent ovarian cancer.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01847274.

Sider (fra-til)442-448
Antal sider7
TidsskriftGynecologic Oncology
Udgave nummer2
Tidlig onlinedato24 sep. 2020
StatusUdgivet - nov. 2020

Bibliografisk note

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.


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