A phase III trial comparing FULV to FULV + oxaliplatin in stage II or III carcinoma of the colon: Survival results of NSABP Protocol C-07

LBA4005 Background: We previously reported that FULV + oxaliplatin (FLOX) significantly prolonged 3-year disease-free survival when compared to FULV (ASCO 2005; J Clin Oncol 2007) A secondary end point of this study was overall survival (S) at five years; the data are presented herein. Methods: Between February 2000 and November 2002, 2,409 eligible patients with follow-up (1209 FULV and 1200 FLOX) with stage II (28.9%) or III carcinoma of the colon were randomized to receive either FULV (5-FU, 500 mg/m2 iv bolus weekly×6; LV, 500 mg/m2 iv weekly×6, each 8 week cycle×3) or FLOX (same FULV regimen with oxaliplatin 85 mg/m2 iv administered on weeks 1, 3, and 5 of each 8 week cycle×3). A planned secondary end point of this study was overall survival 5 years after the completion of accrual. The hazard ratio estimate is from a Cox model stratified by positive nodes (0, 1–3, 4+). The p-value is from a log-rank test stratified by positive nodes. Results: The median follow-up for patients who were still alive was...