A phase III trial comparing mFOLFOX6 to mFOLFOX6 plus bevacizumab in stage II or III carcinoma of the colon: Results of NSABP Protocol C-08

摘要: LBA4 Background: The primary aim of this two-arm randomized prospective study was to determine whether mFOLFOX6 plus bevacizumab (mFF6+B) would prolong disease-free survival (DFS) compared (mFF6) alone. Methods: Between September 2004 and October 2006, 2,672 patients with follow-up (1,338 1,334 in respective arms) stage II (24.9%) or III carcinoma the colon were receive either mFF6 (oxaliplatin 85 mg/m2 IV d1, leucovorin 400 5-FU bolus 2400 mg/ m2 CI over 46 hrs (d1+2) q14d × 12 cycles) mFF6+B (same regimen + 5 mg/kg q 2 wks 1 yr). end point DFS. Events defined as first recurrence, second cancer, death. Results: median for still alive 36 months. hazard ratio (HR: FF6+B vs. mFF6) 0.89; 95% (0.76=1.04); p=0.15. Data censored at intervals disclosed an initial benefit that diminished time: smoothed estimate D...