• M Yoshida, M Ishiguro, K Ikejiri, I Mochizuki, Y Nakamoto, Y Kinugasa, A Takagane, T Endo, H Shinozaki, Y Takii, H Mochizuki, K Kotake, S Kameoka, K Takahashi, T Watanabe, M Watanabe, N Boku, N Tomita, E Nakatani, K Sugihara, and ACTS-CC study group.
• Cancer Chemotherapy Center, Osaka Medical College Hospital, Osaka.
• Ann. Oncol. 2014 Sep 1; 25 (9): 1743-1749.

BackgroundS-1 is an oral fluoropyrimidine whose antitumor effects have been demonstrated in treating various gastrointestinal cancers, including metastatic colon cancer, when administered as monotherapy or in combination chemotherapy. We conducted a randomized phase III study investigating the efficacy of S-1 as adjuvant chemotherapy for colon cancer by evaluating its noninferiority to tegafur-uracil plus leucovorin (UFT/LV).Patients And MethodsPatients aged 20-80 years with curatively resected stage III colon cancer were randomly assigned to receive S-1 (80-120 mg/day on days 1-28 every 42 days; four courses) or UFT/LV (UFT: 300-600 mg/day and LV: 75 mg/day on days 1-28 every 35 days; five courses). The primary end point was disease-free survival (DFS) at 3 years.ResultsA total of 1518 patients (758 and 760 in the S-1 and UFT/LV group, respectively) were included in the full analysis set. The 3-year DFS rate was 75.5% and 72.5% in the S-1 and UFT/LV group, respectively. The stratified hazard ratio for DFS in the S-1 group compared with the UFT/LV group was 0.85 (95% confidence interval: 0.70-1.03), demonstrating the noninferiority of S-1 (noninferiority stratified log-rank test, P < 0.001). In the subgroup analysis, no significant interactions were identified between the major baseline characteristics and the treatment groups.ConclusionAdjuvant chemotherapy using S-1 for stage III colon cancer was confirmed to be noninferior in DFS compared with UFT/LV. S-1 could be a new treatment option as adjuvant chemotherapy for colon cancer.ClinicaltrialsgovNCT00660894.© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

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