• S Sadahiro, T Tsuchiya, K Sasaki, K Kondo, K Katsumata, G Nishimura, Y Kakeji, H Baba, S Sato, K Koda, Y Yamaguchi, T Morita, J Matsuoka, H Usuki, C Hamada, and S Kodaira.
• Department of Surgery, Tokai University, Isehara sadahiro@is.icc.u-tokai.ac.jp.
• Ann. Oncol. 2015 Nov 1; 26 (11): 2274-80.

BackgroundWhile adjuvant chemotherapy is preferable for high-risk colon cancer, treatment duration is controversial. Oral uracil and tegafur (UFT)/leucovorin (LV) is widely used as a standard adjuvant chemotherapy for colon cancer in Japan. We conducted a phase III trial to investigate the optimal duration of adjuvant chemotherapy for stage IIB/III colon cancer.Patients And MethodsPatients with curatively resected stage IIB/III colon cancer were eligible for enrollment in this trial. Patients were registered within 6 weeks after surgery and were randomly assigned to receive UFT/LV for 28 of 35 days for 6 months in the control group or for 5 consecutive days per week for 18 months in the study group. The primary end point was the disease-free survival (DFS), and the secondary end points were overall survival (OS) and safety.ResultA total of 1071 patients were registered from 233 centers. A statistically significant difference in DFS was not observed between the study group and the control group; the 5-year DFS was 69% in the study group and 69% in the control group. The 5-year OS was 85% in the study group and 85% in the control group.ConclusionEighteen-month treatment with UFT/LV did not improve DFS or OS compared with 6-month UFT/LV treatment in patients with stage IIB/III colon cancer. The important finding from this study is that not 18 months but 6 months of treatment is enough for postoperative UFT/LV for stage IIB/III colon cancer.Clinical Trial NumberUMIN-CTR C000000245.© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

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