942TiP - Encourage: the Use in Routine Practice of Bevacizumab in First-Line Therapy for Patients with Ovarian Cancer– a Gineco Prospective Cohort Study

Abstract

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.