High-dose bevacizumab improves survival when combined with FOLFOX4 in previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200

2 Background: The humanized monoclonal antibody bevacizumab (BEV) binds VEGF, inhibits angiogenesis, and improves survival when combined with chemotherapy for advanced colorectal cancer. Methods: E3200 is a randomized phase 3 trial of high-dose BEV (10 mg/kg, IV, biweekly) either alone, or in combination with FOLFOX4 (biweekly administration of: oxaliplatin 85 mg/m2, day 1; leucovorin 200 mg/m2 IV 2hrs and fluorouracil 400 mg/m2 IV bolus followed by fluorouracil 600 mg/m2 CIV for 22hrs, days 1 & 2), compared to FOLFOX4 alone, in patients with previously treated advanced colorectal cancer. Eligible patients had an ECOG PS of 0–2 and must have been treated with a fluoropyrimidine and an irinotecan-based regimen used either alone or in combination. Prior BEV use was not allowed. The endpoints of E3200 include survival (OS), progression free survival (PFS) and response rate (RR). Results: 829 patients were accrued from November 2001 to April 2003. The bevacizumab alone arm of the study was closed in March 2003. Median follow-up is 18.7 months. Efficacy results and limited toxicity findings of E3200 will be presented. Bowel perforation was infrequent (1.1%) but occurred only in patients on E3200 treated with BEV. Conclusion: BEV administered at 10 mg/kg in combination with FOLFOX4 is well tolerated and improves OS and PFS in advanced colorectal cancer patients previously treated with irinotecan and a fluoropyrimidine. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech BioOncology, Sanofi-Synthelabo Genentech BioOncology, Pfizer, Sanofi-Synthelabo Genentech BioOncology, Sanofi-Synthelabo Genentech, Sanofi-Synthelabo