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

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  • 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 Jong
  • D Gupta
  • U A Matulonis
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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.

Original languageEnglish
JournalGynecologic Oncology
Volume159
Issue number2
Pages (from-to)442-448
Number of pages7
ISSN0090-8258
DOIs
Publication statusPublished - Nov 2020

    Research areas

  • Gynecologic oncology, Long-term safety, Niraparib, Ovarian cancer, Poly(ADP ribose) polymerase inhibitor

ID: 60987656