Niraparib Maintenance Therapy in Patients With Recurrent Ovarian Cancer After a Partial Response to the Last Platinum-Based Chemotherapy in the ENGOT-OV16/NOVA Trial

Research output: Contribution to journalArticle


PURPOSE: In the ENGOT-OV16/NOVA trial ( identifier: NCT01847274), maintenance therapy with niraparib, a poly(ADP-ribose) polymerase inhibitor, prolonged progression-free survival in patients with platinum-sensitive, recurrent ovarian cancer who had a response to their last platinum-based chemotherapy. The objective of the study was to assess the clinical benefit and patient-reported outcomes in patients who had a partial response (PR) and complete response (CR) to their last platinum-based therapy. PATIENTS AND METHODS: A total of 553 patients were enrolled in the trial. Of 203 patients with a germline BRCA mutation (gBRCAmut), 99 had a PR and 104 had a CR to their last platinum-based therapy; of 350 patients without a confirmed gBRCAmut (non-gBRCAmut), 173 had a PR and 177 had a CR. Post hoc analyses were carried out to evaluate safety and the risk of progression in these patients according to gBRCAmut status and response to their last platinum-based therapy. Ovarian cancer-specific symptoms and quality of life were assessed using the Functional Assessment of Cancer Therapy-Ovarian Symptom Index. RESULTS: Progression-free survival was improved in patients treated with niraparib compared with placebo in both the gBRCAmut cohort (PR: hazard ratio [HR], 0.24; 95% CI, 0.131 to 0.441; P < .0001; CR: HR, 0.30; 95% CI, 0.160 to 0.546; P < .0001) and the non-gBRCAmut cohort (PR: HR, 0.35; 95% CI, 0.230 to 0.532; P < .0001; CR: HR, 0.58; 95% CI, 0.383 to 0.868; P = .0082). The incidence of any-grade and grade 3 or greater adverse events was manageable. No meaningful differences were observed between niraparib and placebo in PR and CR subgroups with respect to patient-reported outcomes. CONCLUSION: Patients achieved clinical benefit from maintenance treatment with niraparib regardless of response to the last platinum-based therapy.


  • Josep M. Del Campo
  • Ursula A. Matulonis
  • Susanne Malander
  • Diane Provencher
  • Sven Mahner
  • Philippe Follana
  • Justin Waters
  • Jonathan S. Berek
  • Kathrine Woie
  • Amit M. Oza
  • Ulrich Canzler
  • Marta Gil-Martin
  • Anne Lesoin
  • Bradley J. Monk
  • Bente Lund
  • Lucy Gilbert
  • Robert M. Wenham
  • Benedict Benigno
  • Sujata Arora
  • Sebastien J. Hazard
  • And 1 others
  • Mansoor R. Mirza
External organisations
  • Vall d'Hebron University Hospital
  • Dana-Farber Cancer Institute
  • Skåne University Hospital
  • Centre hospitalier de l'Université de Montréal
  • Ludwig-Maximilian University of Munich
  • Stanford University
  • Haukeland University Hospital
  • Princess Margaret Hospital University of Toronto
  • Dresden University of Technology
  • L'Hospitalet de Llobregat, Barcelona
  • Centre Oscar Lambret
  • University of Arizona
  • Aalborg University Hospital
  • McGill University Health Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • Northside Hospital Atlanta
  • Copenhagen University Hospital
  • University Hospital Munich
  • Centre Antoine Lacassagne
  • Maidstone Hospital
  • Bellvitge University Hospital-IDIBELL
  • St. Joseph's Hospital and Medical Center
  • McGill University
Research areas and keywords

Subject classification (UKÄ) – MANDATORY

  • Cancer and Oncology
  • Pharmacology and Toxicology
Original languageEnglish
Pages (from-to)2968-2973
Number of pages6
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Issue number32
Publication statusPublished - 2019
Publication categoryResearch
Externally publishedYes