1160P - A Phase II Trial of Bevacizumab with Capecitabine in Progressive, Metastatic Well-Differentiated Digestive Endocrine Tumors (Better Study)

Abstract

ABSTRACT Background We assessed bevacizumab (Bv), a monoclonal antibody directed against VEGF, combined with capecitabine (CAP) in neuroendocrine digestive tumors (NET) known to be highly vascularized neoplasms Demographics and primary endpoint (PFS) will be presented at ASCO 2012 (abstract#4071). Here we emphasize on response (central review), PP analysis and safety data. Methods BETTER is a multicenter, open-label, non-randomized, two-group phase II trial. Patients (pts) with progressive, metastatic well-differentiated digestive tract endocrine tumors (WHO 2000 classification), ECOG-PS ≤2, Ki 67 index Results In the ITT population (n = 49), 26 (53.1%) pts were men; median age 60.3 years (41.2-82.3); ECOG-PS was 0/1 in 46 (93.9%) pts. Primary tumor site was mainly small intestine 40 (81.6%) pts. Ki-67 proliferative index was 0-2% in 17 (35.4%) pts and 3-14% in 31 (64.6%). After a maximum of 24 months of follow-up per patient, median PFS assessed by investigators was 23.4 months [95%CI: 13.2; not reached] based on 26 events. Centrally reviewed tumor control rate was 93.8% (n = 45) including partial response in 6 (12.5%) pts and stable disease in 39 (81.3%) pts (1 missing and 3 not evaluable), comparable to investigators assessment. Survival rate at 24 months was 85%. Median OS was not reached. All efficacy results were similar in the ITT and PP populations. CTC grade 3/4 Adverse Events (AEs) occurred in 41 (83.7%) pts, mainly digestive 14 (28.6%) pts. Main G3/4 AE of special interest to BV was hypertension in 15 (30.6%) pts. Eight patients died: 3 of disease progression, 2 of AEs (stroke, peritonitis) and 3 for other reasons (Parkinson disease, liver transplantation/septicemia, cardiac arrest). Conclusions In this phase II study assessing Bv and CAP in a chemotherapy resistant tumor; such encouraging results suggest that this combination may become a good alternative in the treatment of ileal NET. Disclosure E. Mitry: Honoraries: Roche. E. Baudin: Honoraries: Scientific committee of BETTER Trial. P. Ruszniewski: Consultant: Ipsen, Novartis, Pfizer Honoraries: Ipsen, Novartis, Pfizer. Clinical research project: Ipsen, Novartis, Pfizer. G. Cadiot: Honoraries: Novartis, Ipsen, Pfizer Other financing (please detail): Novartis, Ipsen, Pfizer. S. Kraemer: Employment: Roche. M.P. Ducreux: Consultant: Roche, Merck Serono Honoraries: Roche, Merck Serono, Amgen, Bayer, Fresenus, Pfizer, Sanofi Clinical research project: Pfizer, Chugai, Merck Serono. All other authors have declared no conflicts of interest.