A phase III trial comparing oral UFT to FULV in stage II and III carcinoma of the colon: Results of NSABP Protocol C-06

3508 Background: The primary aim of this two-arm randomized prospective study was to compare the relative efficacy of oral UFT+LV with that of FULV in prolonging disease-free survival (DFS) and survival (S). Methods: Between February 1997 and March 1999, 1,608 patients (805 and 803 in each arm) with stage II and III carcinoma of the colon were randomized to receive either oral UFT+LV (tegafur, 300 mg/m2/day and uracil in a 1:4 molar ratio p.o. x 28 days; leucovorin 90 mg/day p.o. x 28 days, each 35 day cycle x 5) or 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 Results: With a mean time on study of 64 months for patients with follow-up there were no significant differences in disease-free survival or overall survival between the two treatment arms. Results (%) at 5 years were: The two regimens were equitoxic and well tolerated. The Fact C quality of life metric disclosed no significant difference; other secondary quality of life measurements during chemother...