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

Abstract

LBA3500 Background: The primary aim of this two-arm randomized prospective study was to determine whether FULV + oxaliplatin (FLOX) would prolong 3-year disease-free survival when compared to FULV. Methods: Between February 2000 and November 2002, 2,492 patients (1245 and 1247 in each arm) with stage II and III carcinoma of the colon were randomized to receive either FULV (5-FU, 500 mg/m2 iv bolus weekly x 6; LV, 500 mg/m2 iv weekly x 6, each 8 week cycle x 3) or FLOX (same FULV regimen with oxaliplatin 85 mg/m2 iv administered on weeks 1, 3 and 5 of each 8 week cycle x 3). Results: Three year disease-free survival and toxicity results will be presented using an analysis file with data received by December 31, 2004. We expect to observe approximately 600 events (first recurrence, second primary cancer, or death) with a median follow-up among patients without an event of approximately 33 months. Conclusions: To follow No significant financial relationships to disclose.