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Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer
Antonio González-Martín1, Bhavana Pothuri1, Ignace Vergote1
1From Grupo Español de Investigación en Cáncer de Ovario (GEICO) and the Medical Oncology Department, Clínica Universidad de Navarra (A.G.-M.) and GEICO and Hospital Universitario La Paz-IdiPAZ (A.R.), Madrid, GEICO and Medical Oncology, Catalan Institute of Oncology, Girona Biomedical Research Institute, and the Department of Medical Sciences, Medical School University of Girona, Girona (P.B.-G.), and GEICO and Hospital Universitario Reina Sofía, Cordoba (M.J.R.-P.) - all in Spain; the Gynecologic Oncology Group (GOG) and the Department of Obstetrics/Gynecology, Perlmutter Cancer Center, NYU Langone Health (B.P.), and GOG and the Department of Medicine, Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College (R.E.O.), New York, and US Oncology Research (USOR) and the Division of Gynecologic Oncology, Wilmot Cancer Institute, Department of Obstetrics and Gynecology, University of Rochester, Rochester (R.G.M.) - all in New York; Belgium and Luxembourg Gynecologic Oncology Group (BGOG) and the Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven (I.V.), BGOG and the Department of Medical Oncology and Hematology, AZ Maria Middelares, Ghent (C.V.), and the Department of Molecular Imaging, Pathology, Radiotherapy, and Oncology, Center for Oncological Research, Antwerp University, Antwerp (C.V.) - all in Belgium; the Nordic Society of Gynecologic Oncology (NSGO) and the Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense (R.D.C.), NSGO and Rigshospitalet-Copenhagen University Hospital, Copenhagen (M.R.M.), and NSGO and the Department of Oncology, Aalborg University, Aalborg (B.L.) - all in Denmark; GOG and Gynecologic Oncology, Medical University of South Carolina, Charleston (W.G.); GOG and Legacy Medical Group Gynecologic Oncology, Portland, OR (C.M.); Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO) and Fondazione IRCCS National Cancer Institute of Milan (D.L.), and MITO and the Department of Obstetrics and Gynecology, San Raffaele Scientific Institute (G.M.) - both in Milan; USOR and the Department of Medical Oncology, BC Cancer, Vancouver, BC (P.H.), and GOG and the Department of Obstetrics and Gynecology, McGill University, and the Department of Oncology, McGill University Health Centre, Division of Gynecologic Oncology, Montreal (K.J.) - all in Canada; Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens and Service d'Oncologie Médicale, Centre Hospitalier Lyon-Sud, Lyon, France (G.F.); Arbeitsgemeinschaft Gynäkologische Onkologie and the Department of Gynecology and Obstetrics, Klinikum der Stadt Ludwigshafen, Ludwigshafen, Germany (K.B.); the Division of Gynecologic Oncology, Ohio State University, Columbus (F.B.); GOG and the Division of Gynecologic Oncology, University of Pennsylvania, Philadelphia (A.F.H.), and GOG and Hanjani Institute for Gynecologic Oncology, Asplundh Cancer Pavilion, Abington Jefferson Hospital, Sidney Kimmel Medical College of Thomas Jefferson University, Willow Grove (M.S.S.) - all in Pennsylvania; GOG and the Department of Obstetrics and Gynecology, Medical College of Wisconsin, Milwaukee (W.H.B.); Israeli Society of Gynecologic Oncology and Department of Gynecology and Gynecologic Oncology, Hillel Yaffe Medical Center, Technion Israel Institute of Technology, Haifa, Israel (I.B.); GlaxoSmithKline/Tesaro, Waltham, MA (K.S., I.A.M., Y.L., D.G.); and Arizona Oncology (US Oncology Network), University of Arizona College of Medicine, Creighton University School of Medicine, Phoenix (B.J.M.).
Niraparib significantly improved progression-free survival in patients with newly diagnosed advanced ovarian cancer post-chemotherapy. This PARP inhibitor demonstrated efficacy regardless of homologous recombination deficiency status.
Area of Science:
- Oncology
- Pharmacology
Background:
- Niraparib, a PARP inhibitor, previously showed efficacy in recurrent ovarian cancer.
- Its role in newly diagnosed advanced ovarian cancer after first-line chemotherapy was not established.
Purpose of the Study:
- To evaluate the efficacy of niraparib versus placebo in patients with newly diagnosed advanced ovarian cancer.
- To assess progression-free survival (PFS) and overall survival (OS) as primary and secondary endpoints.
Main Methods:
- A randomized, double-blind, phase 3 trial (PRIMA/ENGOT-OV26/GOG-3012) involving 733 patients.
- Patients received niraparib or placebo daily after responding to platinum-based chemotherapy.
- Primary endpoint: PFS in homologous-recombination deficient (HRD) and overall populations.
Main Results:
- Median PFS significantly longer with niraparib: 21.9 months (HRD+) vs. 10.4 months (placebo); 13.8 months (overall) vs. 8.2 months (placebo).
- Overall survival interim analysis showed a trend favoring niraparib (84% vs. 77% at 24 months).
- Most common grade 3/4 adverse events: anemia (31.0%), thrombocytopenia (28.7%), neutropenia (12.8%).
Conclusions:
- Niraparib significantly extended PFS in newly diagnosed advanced ovarian cancer patients responding to chemotherapy.
- Efficacy was consistent across patients with and without HRD.
- Niraparib represents a valuable treatment option for this patient population.
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