Randomized phase III study of adjuvant chemotherapy with oral uracil and tegafur plus leucovorin versus intravenous fluorouracil and levofolinate in patients (pts) with stage III colon cancer (CC): Final results of Japan Clinical Oncology Group study (JCOG0205).

3524 Background: NSABP C-06 reported the non-inferiority of oral adjuvant uracil and tegafur plus leucovorin (UFT/LV) to weekly fluorouracil and folinate (5-FU/LV) in disease-free survival (DFS) in stage II/III CC. Although adjuvant FOLFOX for stage III is standard care in US or EU, its toxicity and cost is major problem. This is the first report of JCOG0205, which compared UFT/LV to standard 5-FU/levofoloinate (l-LV) in stage III CC. Methods: Pts were randomized to 3 courses of 5-FU/l-LV (5-FU 500 mg/m2, l-LV 250 mg/m2, on days 1, 8, 15, 22, 29, 36, q8w), or 5 courses of UFT/LV (UFT 300 mg/m2/day, LV 75 mg/day, on days 1–28, q5w). Primary endpoint was DFS. Sample size was 1,100, determined with one-sided alpha of 0.05, power of 0.78, and non-inferiority margin of hazard ratio (HR) of 1.27. Owing to interim analyses, the multiplicity-adjusted alpha and confidence coefficient of CI in the final analysis were 0.0433 and 91.3%. Results: Between Feb 2003 and Nov 2006, 1,101 pts (1,092 eligible) were randomize...