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Gynaecological cancers

3129 - Safety and Efficacy of Niraparib in Elderly Patients (Pts) with Recurrent Ovarian Cancer (OC)


09 Sep 2017


Gynaecological cancers


Cytotoxic Therapy;  Geriatric Oncology;  Ovarian Cancer


Michel Fabbro


Annals of Oncology (2017) 28 (suppl_5): v330-v354. 10.1093/annonc/mdx372


M. Fabbro1, K.N. Moore2, A. Dørum3, A.V. Tinker4, S. Mahner5, I. Bover6, S. Banerjee7, G. Tognon8, F. Goffin9, R. Shapira-Frommer10, R.M. Wenham11, K. Hellman12, D.M. Provencher13, P. Harter14, I. Palacio Vázquez15, P. Follana16, M.J. Pineda17, M.R. Mirza18, S.J. Hazard19, U.A. Matulonis20

Author affiliations

  • 1 Oncology, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Institut du Cancer de Montpellier, 34298 - Montpellier/FR
  • 2 Obstetrics And Gynecology, Stephenson Cancer Center, University of Oklahoma HSC; Sarah Cannon Research Institute (Nashville, TN), 73104 - Oklahoma City/US
  • 3 Gynecologic Oncology, The Nordic Society of Gynecological Oncology (NSGO) and Radiumhospitalet, Oslo University Hospital, Oslo/NO
  • 4 Systemic Therapy, BC Cancer Agency Vancouver, V5Z4E6 - Vancouver/CA
  • 5 Gynecologic Oncology, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and University of Munich, Munich/DE
  • 6 Medical Oncology, Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Hospital Son Llàtzer, Palma de Mallorca/ES
  • 7 Gynaecology Unit, The National Cancer Research Institute (NCRI) and The Royal Marsden NHS Foundation Trust, SW3 6JJ - London/GB
  • 8 Obstetrics And Gynecology, ASST Spedali Civili di Brescia, Brescia/IT
  • 9 Gynecologic Oncology, Belgium and Luxembourg Gynaecological Oncology Group (BGOG) and University of Liège, CHU de Liège, Site Hôpital de la Citadelle, Liege/BE
  • 10 Oncology, Israeli Society of Gynecologic Oncology (ISGO) and Sheba Medical Centre, Ramat Gan/IL
  • 11 Gynecologic Oncology, H. Lee Moffit Cancer Center & Research Institute, Tampa/US
  • 12 Gynaecologic Oncology, The Nordic Society of Gynecological Oncology (NSGO) and Karolinska University Hospital, Stockholm/SE
  • 13 Obstetrics And Gynecology, Centre Hospitalier de L'Universite de Montreal (CHUM), Montreal/CA
  • 14 Gynecology & Gynecologic Oncology, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Kliniken Essen-Mitte, 45136 - Essen/DE
  • 15 Oncology, Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Hospital Central de Asturias, Oviedo/ES
  • 16 Medical Oncology, Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Centre Antoine Lacassagne, 6100 - Nice/FR
  • 17 Gynecologic Oncology, Northwestern University, Chicago/US
  • 18 Oncology, Nordic Society of Gynecologic Oncology (NSGO) and Rigshospitalet, Copenhagen University Hospital, Copenhagen/DK
  • 19 Clinical Science, TESARO, Inc., 2451 - Waltham/US
  • 20 Gynecologic Oncology, Dana Farber Cancer Institute, 2115 - Boston/US


Abstract 3129


Niraparib (Zejula™) is a selective poly(ADP-ribose) polymerase 1/2 inhibitor (PARPi) approved for maintenance therapy in adults with recurrent OC who are in response to platinum-based therapy. Here, we report safety and efficacy of niraparib in the subgroup of pts from the ENGOT-OV16/NOVA trial who were aged ≥65 years (y).


Pts were assigned to one of two independent cohorts based on germline BRCA mutation (gBRCAmut) status and randomized 2:1 within each cohort to receive either niraparib (300 mg) or placebo once daily. Pts were stratified by age (


Efficacy of niraparib was comparable in pts


Niraparib was safe and highly effective in elderly patients.

Clinical trial identification


Legal entity responsible for the study





A.V. Tinker: Consulting or Advisory Role: AstraZeneca. S. Mahner: Consulting: Roche, Clovis, Sensor Kinesis, MEDAC, AstraZeneca; Grants from: Roche, PharmaMar, Tesaro, MEDAC, AstraZeneca; Honoraria/reimbursement from: Roche, PharmaMar, Clovis, Tesaro, Sensor Kinesis, MEDAC, AstraZeneca. S. Banerjee: Travel, Accommodations, Expenses: AstraZeneca, Clovis Oncology. R.M. Wenham: Honoraria: Genentech, Janssen, Tesaro; Speakers\' Bureau: Genentech, Janssen; Research Funding: Merck. D.M. Provencher: Consulting: AstraZeneca; Speakers\' Bureau: AstraZeneca. I. Palacio Vázquez: Research Funding: Novartis, Tesaro; Expert Testimony: AstraZeneca; Travel, Accommodations, Expenses: PharmaMar, Roche. M.R. Mirza: Consulting or Advisory Role: Clovis Oncology, AstraZeneca, Tesaro. S.J. Hazard: Employment: Tesaro; Stock: Tesaro. U.A. Matulonis: Consulting/Advisory: Merck KGaA, AstraZeneca, Immunogen, Tesaro, Genentech. All other authors have declared no conflicts of interest.

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