942TiP - ENCOURAGE: The use in routine practice of bevacizumab in first-line therapy for patients with ovarian cancer- a GINECO prospective cohort study

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Ovarian Cancer
Presenter Dominique Berton-Rigaud
Citation Annals of Oncology (2014) 25 (suppl_4): iv305-iv326. 10.1093/annonc/mdu338
Authors D. Berton-Rigaud1, F. Selle2, I.L. Ray-Coquard3, A. Floquet4, R. Largillier5, A. Hardy-Bessard6, D. Jaubert7, C. Roemer-Becuwe8, L. Venat-Bouvet9, A. Lesoin10, E. Guardiola11, J. Alexandre12, M. Provansal13, E. Blot14, N. Achour15, E. Pujade-Lauraine16
  • 1Oncology, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint Herblain/FR
  • 2Medical Oncology, Hôpital Tenon, 75020 - Paris/FR
  • 3Medical Oncology, Centre Léon Bérard, FR-69008 - Lyon CEDEX/FR
  • 4Oncologie, Institut Bergonié, Bordeaux/FR
  • 5Medical Oncology, Centre Azuréen de Cancérologie, 06250 - Mougins/FR
  • 6Medical Oncology, Clinique Armoricaine de Radiologie, 22015 - Saint Brieuc/FR
  • 7Medical Oncology, Clinique Tivoli, 33000 - Bordeaux/FR
  • 8Medical Oncology, Centre d'Oncologie de Gentilly, 54100 - Nancy/FR
  • 9Oncology, CHU de limoges, limoges/FR
  • 10Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 11Medical Oncology, Centre Hospitalier la Dracénie, 83300 - Draguignan/FR
  • 12Service D'oncologie Médicale, Hopital Cochin, 75014 - paris/FR
  • 13Oncology, Institut Paoli Calmettes, Marseille/FR
  • 14Medical Oncology, Centre Hospitalier Bretagne Sud, 56017 - Vannes/FR
  • 15Medical Oncology, Clinique Pasteur, 29200 - Brest/FR
  • 16Medical Oncology, GINECO and Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, 75004 - Paris/FR

Abstract

Background

The two phase III first-line trials GOG 218 and ICON 7 met their primary progression free survival endpoint, leading to an European Union approval in december 2011 of bevacizumab in combination with carboplatin and paclitaxel during 6 cycles, followed by a maintenance period for a total time of 15 months for the treatment of patients with FIGO IIIb-IV stage ovarian cancer. The ENCOURAGE prospective, multicenter cohort study has been developped to describe bevacizumab administration in ovarian cancer, in the daily practice, outside of trials with their usual patient selections and specific follow-up methods

Trial design

A total number of 500 patients with ovarian cancer, treated with bevacizumab in first-line, in 100 French centers, will be included. Investigators will record the reasons why they indicate or exclude bevacizumab administration in the first-line treatment strategy of each of their patients with ovarian cancer. The primary endpoint is to report the cardio-vascular, renal and digestive toxicity of bevacizumab delivered in a wide scape of French centers (academic or not hospitals, private clinics, anticancer centers). The secondary endpoints include evaluation in real life of bevacizumab use in ovarian cancer treatment in first-line (the characteristics of the treated population, the reason of non administration of bevacizumab in first line), the modalities of use and the monitoring pratices. At last, the efficacy of the bevacizumab treatment strategy will be also evaluated by analysing the progression free survival in both first line and relapse with or without bevacizumab. From April 2013, to April 2014, more than 200/500 patients have been registered.

Disclosure

I.L. Ray-Coquard: Roche, Pharmamar, Amgen, AstraZeneca board and lecture; A. Floquet: Investigator fees and congress participation support in Roche Clinical Studies; J. Alexandre: I am a member of an advisory board concerning bevacizumab. All other authors have declared no conflicts of interest.