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Gynaecological cancers

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

Date

09 Sep 2017

Session

Gynaecological cancers

Presenters

Michel Fabbro

Citation

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

Authors

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
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Resources

Abstract 3129

Background

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).

Methods

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 (

Results

Efficacy of niraparib was comparable in pts

Conclusions

Niraparib was safe and highly effective in elderly patients.

Clinical trial identification

NCT01847274

Legal entity responsible for the study

TESARO, Inc.

Funding

None

Disclosure

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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