- Email: [email protected]
Encourage: the Use in Routine Practice of Bevacizumab in First-Line Therapy for Patients with Ovarian Cancer– a Gineco Prospective Cohort Study
Annals of Oncology 25 (Supplement 4): iv305–iv326, 2014 doi:10.1093/annonc/mdu338.66
gynaecological cancers 942TiP
abstracts
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 1 Oncology, ICO Institut de Cancerologie de l’Ouest René Gauducheau, Saint Herblain, FRANCE 2 Medical Oncology, Hôpital Tenon, Paris, FRANCE 3 Medical Oncology, Centre Léon Bérard, Lyon, FRANCE 4 Oncologie, Institut Bergonié, Bordeaux, FRANCE 5 Medical Oncology, Centre Azuréen de Cancérologie, Mougins, FRANCE 6 Medical Oncology, Clinique Armoricaine de Radiologie, Saint Brieuc, FRANCE 7 Medical Oncology, Clinique Tivoli, Bordeaux, FRANCE 8 Medical Oncology, Centre d’Oncologie de Gentilly, Nancy, FRANCE 9 Oncology, CHU de Limoges, Limoges, FRANCE 10 Medical Oncology, Centre Oscar Lambret, Lille, FRANCE 11 Medical Oncology, Centre Hospitalier la Dracénie, Draguignan, FRANCE 12 Service d’Oncologie Médicale, Hopital Cochin, Paris, FRANCE 13 Oncology, Institut Paoli Calmettes, Marseille, FRANCE 14 Medical Oncology, Centre Hospitalier Bretagne Sud, Vannes, FRANCE 15 Medical Oncology, Clinique Pasteur, Brest, FRANCE 16 Medical Oncology, GINECO and Université Paris Descartes, AP-HP, Hôpitaux
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.
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv336/2241660 by guest on 25 October 2019
ENCOURAGE: THE USE IN ROUTINE PRACTICE OF BEVACIZUMAB IN FIRST-LINE THERAPY FOR PATIENTS WITH OVARIAN CANCER– A GINECO PROSPECTIVE COHORT STUDY
Universitaires Paris Centre, Paris, FRANCE
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
gynaecological cancers 942TiP
abstracts
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 1 Oncology, ICO Institut de Cancerologie de l’Ouest René Gauducheau, Saint Herblain, FRANCE 2 Medical Oncology, Hôpital Tenon, Paris, FRANCE 3 Medical Oncology, Centre Léon Bérard, Lyon, FRANCE 4 Oncologie, Institut Bergonié, Bordeaux, FRANCE 5 Medical Oncology, Centre Azuréen de Cancérologie, Mougins, FRANCE 6 Medical Oncology, Clinique Armoricaine de Radiologie, Saint Brieuc, FRANCE 7 Medical Oncology, Clinique Tivoli, Bordeaux, FRANCE 8 Medical Oncology, Centre d’Oncologie de Gentilly, Nancy, FRANCE 9 Oncology, CHU de Limoges, Limoges, FRANCE 10 Medical Oncology, Centre Oscar Lambret, Lille, FRANCE 11 Medical Oncology, Centre Hospitalier la Dracénie, Draguignan, FRANCE 12 Service d’Oncologie Médicale, Hopital Cochin, Paris, FRANCE 13 Oncology, Institut Paoli Calmettes, Marseille, FRANCE 14 Medical Oncology, Centre Hospitalier Bretagne Sud, Vannes, FRANCE 15 Medical Oncology, Clinique Pasteur, Brest, FRANCE 16 Medical Oncology, GINECO and Université Paris Descartes, AP-HP, Hôpitaux
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.
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv336/2241660 by guest on 25 October 2019
ENCOURAGE: THE USE IN ROUTINE PRACTICE OF BEVACIZUMAB IN FIRST-LINE THERAPY FOR PATIENTS WITH OVARIAN CANCER– A GINECO PROSPECTIVE COHORT STUDY
Universitaires Paris Centre, Paris, FRANCE
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].