1. Use of bevacizumab (Bev) in real life for first-line (fl) treatment of ovarian cancer (OC)/ The GINECO ENCOURAGE cohort of 500 French patients
- Author
-
W. Lescaut, Anne Floquet, C.B. Levaché, C. Garnier Tixidre, Dominique Berton-Rigaud, E. Malaurie, Frédéric Selle, H. Barletta, D. Mollon-Grange, Olivier Tredan, Eric Pujade-Lauraine, Philippe Follana, Catherine Delbaldo, Rémy Largillier, M-C. Kaminsky-Forrett, Jérôme Alexandre, A.M. Savoye, H. Laharie-Mineur, C. Bosacki, and Agnès Dechartres
- Subjects
0301 basic medicine ,medicine.medical_specialty ,Bevacizumab ,business.industry ,First line ,Hematology ,Newly diagnosed ,Gingivorrhagia ,Routine practice ,03 medical and health sciences ,030104 developmental biology ,0302 clinical medicine ,Oncology ,Private practice ,030220 oncology & carcinogenesis ,Family medicine ,Cohort ,medicine ,In real life ,business ,medicine.drug - Abstract
Background Bevacizumab (bev) is approved in Europe (EU) for first line therapy of OC patients (pts). This study aimed to evaluate the use of Bev in real life, with a focus on toxicity. Methods Representative centers in France of French regions and of mode of practice were asked to participate. From 04/13 to 02/15, among the consecutive OC pts treated in each center, were selected those who were newly diagnosed and planned to receive Bev. An independent CRA captured the clinical data at baseline, 6, 12, 18 and 36 months. Results A total of 104 centers participated: Private practice (44%), non-academic hospital (31%), academic (11%), anticancer center (14%). 1290 pts were screened, 500 registered and 468 were evaluable. Pts characteristics at baseline were: median age 65 yrs, antihypertensive therapy (26%), anticoagulant (10%), cardiac history (5%), serous histology (83%), interval surgery (47%), complete surgical debulking (74%) and carboplatin-paclitaxel chemotherapy (98%). Only 3.4% were not FIGO stage IIIB-IV. Pts received Bev at 15 mg/kg (80%) during a median of 18 cycles (10-21) and 7.8% stopped treatment for toxicity. Main toxicity was HTA requiring new therapy (38%), PRES (1.3%), venous thrombosis (5%), proteinuria (9.8%) and nephrotic syndrome (2.6%). Other toxicities mostly reported include low grade epistaxis, gingivorrhagia, arthralgia, headache and dysphonia. Gastrointestinal perforation, fistula, arterial events and grade 3-4 bleeding were very low: 0.2%, 0.8%, 0,1% and 0.2% respectively. No pts developed congestive heart failure nor died from toxicity. Median PFS was 17.4 months (IC95% [16.4-19.1]) and % of pts alive at 3 years was 62.4% (IC95 % [58.1-67.1]). Conclusions In routine practice among French centers, first-line Bev administration is consistent with the EU label in most of the cases. Efficacy and safety in the real life were in line with that reported in trials excepted for a higher incidence of observed HTA and complications, suggesting the importance of increased education on HTA monitoring. Legal entity responsible for the study ARCAGY-GINECO. Funding Roche. Disclosure A. Floquet: Advisory / Consultancy: Tesaro; Advisory / Consultancy: Clovis; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche. O. Tredan: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Pfizer; Honoraria (self): Novartis; Honoraria (self): Lilly; Honoraria (self): BMS; Honoraria (self): MSD. J. Alexandre: Honoraria (self): Roche; Honoraria (self): AstraZeneca; Honoraria (self): Ipsen; Honoraria (self): Novartis; Honoraria (self): PharmaMar; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Janssen; Travel / Accommodation / Expenses: Janssen; Travel / Accommodation / Expenses: Novartis. C. Garnier Tixidre: Honoraria (self): Lilly; Honoraria (self): AstraZeneca; Advisory / Consultancy: Pfizer; Advisory / Consultancy: AstraZeneca; Travel / Accommodation / Expenses: Pfizer. P. Follana: Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: AstraZeneca; Travel / Accommodation / Expenses: Novartis; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: Tesaro. C. Levache: Travel / Accommodation / Expenses: Sanofi. E. Pujade-Lauraine: Honoraria (self): AstraZeneca; Honoraria (self): Tesaro; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Clovis; Advisory / Consultancy: Tesaro; Advisory / Consultancy: Genmab; Advisory / Consultancy: Incyte; Advisory / Consultancy: MSD; Advisory / Consultancy: Pfizer; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Tesaro; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Roche; Research grant / Funding (institution): Tesaro. F. Selle: Honoraria (self): Roche; Honoraria (self): MSD France; Honoraria (self): PharmaMar; Honoraria (self): Tesaro; Honoraria (self): Clovis; Honoraria (self): AstraZeneca; Advisory / Consultancy: Roche; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: MSD France; Travel / Accommodation / Expenses: Tesaro; Travel / Accommodation / Expenses: AstraZeneca. All other authors have declared no conflicts of interest.
- Published
- 2019
- Full Text
- View/download PDF