Intergroup randomized phase III study of postoperative oxaliplatin, 5-fluorouracil and leucovorin (mFOLFOX6) vs mFOLFOX6 and bevacizumab (Bev) for patients (pts) with stage II/ III rectal cancer receiving pre-operative chemoradiation.

3616Background: Metastatic colorectal cancer trials have shown improved outcomes when Bev was added to chemotherapy. E5204 was designed to test whether the addition of Bev to postoperative mFOLFOX6 could improve OS in pts with stage II/ III rectal cancer after preoperative chemoradiation. Methods: Eligible pts had rectal adenocarcinoma , clinical Stage T3N0M0, T4N0M0, TanyN1-2M0 before neoadjuvant therapy; had received preoperative chemoradiation (may have included oxaliplatin); had a completely resected tumor and able to begin adjuvant treatment by day 56. Pts were randomized to mFOLFOX6 (Arm A) or mFOLFOX6 and Bev (5mg/kg) (Arm B) administered every 2 wks for 12 cycles. Results: E5204 was terminated on 4/29/09 due to poor accrual. 355 pts were registered (17% of accrual goal). Median follow-up was 72 mos. There was no significant difference in OS between arm A and arm B (one-sided stratified log rank p = 0.876, HR = 0.72, 95% CI: 0.41, 1.26). 5-yr OS was 88.3% (95% CI: 52.3, 92.4) in arm A and 83.7% (95...