Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer
- Mansoor R Mirza 1, Bradley J Monk 1, Jørn Herrstedt 1, Amit M Oza 1, Sven Mahner 1, Andrés Redondo 1, Michel Fabbro 1, Jonathan A Ledermann 1, Domenica Lorusso 1, Ignace Vergote 1, Noa E Ben-Baruch 1, Christian Marth 1, Radosław Mądry 1, René D Christensen 1, Jonathan S Berek 1, Anne Dørum 1, Anna V Tinker 1, Andreas du Bois 1, Antonio González-Martín 1, Philippe Follana 1, Benedict Benigno 1, Per Rosenberg 1, Lucy Gilbert 1, Bobbie J Rimel 1, Joseph Buscema 1, John P Balser 1, Shefali Agarwal 1, Ursula A Matulonis 1,
- 1From the Nordic Society of Gynecological Oncology and Rigshospitalet-Copenhagen University Hospital, Copenhagen (M.R.M.), Odense University Hospital (J.H.) and European Network for Gynacological Oncological Trial and Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense (R.D.C.) - all in Denmark; University of Arizona and Creighton University-Phoenix, Phoenix (B.J.M.), and Arizona Oncology Associates, Tuscon (B.J.M., J.B.) - all in Arizona; Princess Margaret Consortium, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto (A.M.O.), British Columbia Cancer Agency, Vancouver (A.V.T.), and McGill University-McGill University Health Centre, Montreal (L.G.) - all in Canada; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and the University of Munich, Munich (S.M.), and Kliniken Essen Mitte, Essen (A.B.) - both in Germany; Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Hospital Universitario La Paz (A.R.), and GEICO and M.D. Anderson Cancer Center Madrid (A.G.-M.), Madrid; French Investigator Group for Ovarian and Breast Cancer (GINECO) and Institut du Cancer de Montpellier, Montpellier (M.F.), and GINECO and Centre Antoine Lacassagne, Nice (P.F.) - both in France; National Cancer Research Institute and UCL Cancer Institute, University College London, London (J.A.L.); Multicenter Italian Trials in Ovarian Cancer/Mario Negri Gynecologic Oncology Group, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (D.L.); Belgium and Luxembourg Gynecological Oncology Group and University of Leuven, Leuven, Belgium (I.V.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); AGO-Austria and Medical University Innsbruck, Innsbruck, Austria (C.M.); Central and Eastern European Gynecologic Oncology Group and Uniwersytet Medyczny w Poznaniu, Poznan, Poland (R.M.); Stanford Comprehensive Cancer Institute, Stanford (J.S.B.), and Cedars-Sinai Medical Center, West Hollywood (B.J.R.) - both in California; Oslo University Hospital, Radiumhospitalet, Oslo (A.D.); Northside Hospital, Atlanta (B.B.); Universitetssjukhuset, Linköping, Sweden (P.R.); and Veristat, Southborough (J.P.B.), Tesaro, Waltham (S.A.), and Dana-Farber Cancer Institute, Boston (U.A.M.) - all in Massachusetts.
- 0From the Nordic Society of Gynecological Oncology and Rigshospitalet-Copenhagen University Hospital, Copenhagen (M.R.M.), Odense University Hospital (J.H.) and European Network for Gynacological Oncological Trial and Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense (R.D.C.) - all in Denmark; University of Arizona and Creighton University-Phoenix, Phoenix (B.J.M.), and Arizona Oncology Associates, Tuscon (B.J.M., J.B.) - all in Arizona; Princess Margaret Consortium, Princess Margaret Cancer Centre, University Health Network, University of Toronto, Toronto (A.M.O.), British Columbia Cancer Agency, Vancouver (A.V.T.), and McGill University-McGill University Health Centre, Montreal (L.G.) - all in Canada; Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and the University of Munich, Munich (S.M.), and Kliniken Essen Mitte, Essen (A.B.) - both in Germany; Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Hospital Universitario La Paz (A.R.), and GEICO and M.D. Anderson Cancer Center Madrid (A.G.-M.), Madrid; French Investigator Group for Ovarian and Breast Cancer (GINECO) and Institut du Cancer de Montpellier, Montpellier (M.F.), and GINECO and Centre Antoine Lacassagne, Nice (P.F.) - both in France; National Cancer Research Institute and UCL Cancer Institute, University College London, London (J.A.L.); Multicenter Italian Trials in Ovarian Cancer/Mario Negri Gynecologic Oncology Group, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan (D.L.); Belgium and Luxembourg Gynecological Oncology Group and University of Leuven, Leuven, Belgium (I.V.); Kaplan Medical Center, Rehovot, Israel (N.E.B.-B.); AGO-Austria and Medical University Innsbruck, Innsbruck, Austria (C.M.); Central and Eastern European Gynecologic Oncology Group and Uniwersytet Medyczny w Poznaniu, Poznan, Poland (R.M.); Stanford Comprehensive Cancer Institute, Stanford (J.S.B.), and Cedars-Sinai Medical Center, West Hollywood (B.J.R.) - both in California; Oslo University Hospital, Radiumhospitalet, Oslo (A.D.); Northside Hospital, Atlanta (B.B.); Universitetssjukhuset, Linköping, Sweden (P.R.); and Veristat, Southborough (J.P.B.), Tesaro, Waltham (S.A.), and Dana-Farber Cancer Institute, Boston (U.A.M.) - all in Massachusetts.
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View abstract on PubMed
Summary
This summary is machine-generated.Niraparib significantly extended progression-free survival in patients with recurrent ovarian cancer, regardless of BRCA mutation status. This PARP inhibitor demonstrated efficacy with manageable bone marrow toxicity in a phase 3 trial.
Area Of Science
- Oncology
- Pharmacology
- Genetics
Background
- Ovarian cancer recurrence presents a significant clinical challenge.
- Poly(adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitors offer a targeted therapeutic approach.
- Niraparib has demonstrated prior clinical activity in ovarian cancer patients.
Purpose Of The Study
- To evaluate the efficacy of niraparib as maintenance therapy for platinum-sensitive, recurrent ovarian cancer.
- To compare niraparib versus placebo in patients with and without germline BRCA mutations (gBRCA).
Main Methods
- A randomized, double-blind, phase 3 trial design.
- Patients were stratified into gBRCA and non-gBRCA cohorts.
- Random assignment in a 2:1 ratio to niraparib (300 mg daily) or placebo.
- Primary endpoint: progression-free survival.
Main Results
- Niraparib significantly improved progression-free survival compared to placebo across all patient groups.
- Median progression-free survival was 21.0 months for niraparib vs. 5.5 months for placebo in the gBRCA cohort.
- In the non-gBRCA cohort with HRD, median progression-free survival was 12.9 months (niraparib) vs. 3.8 months (placebo).
- Overall non-gBRCA cohort showed 9.3 months (niraparib) vs. 3.9 months (placebo).
- Common grade 3/4 adverse events included thrombocytopenia, anemia, and neutropenia, managed with dose adjustments.
Conclusions
- Niraparib maintenance therapy significantly prolongs progression-free survival in platinum-sensitive, recurrent ovarian cancer.
- Efficacy was observed irrespective of germline BRCA mutation or HRD status.
- Moderate bone marrow toxicity was noted and manageable through dose modifications.
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