• I Mochizuki, H Takiuchi, K Ikejiri, Y Nakamoto, Y Kinugasa, A Takagane, T Endo, H Shinozaki, Y Takii, Y Takahashi, H Mochizuki, K Kotake, S Kameoka, K Takahashi, T Watanabe, M Watanabe, N Boku, N Tomita, Y Matsubara, and K Sugihara.
• Department of Gastroenterological Surgery, Iwate Central Prefectural Hospital, 1-4-1 Ueda, Morioka, Iwate 020-0066, Japan.
• Br. J. Cancer. 2012 Mar 27; 106 (7): 1268-73.

BackgroundThe Adjuvant Chemotherapy Trial of TS-1 for Colon Cancer (ACTS-CC) is a phase III trial designed to validate the non-inferiority of S-1 to UFT/leucovorin (LV) as postoperative adjuvant chemotherapy for stage III colon cancer. We report the results of a planned safety analysis.MethodsPatients aged 20-80 years with curatively resected stage III colon cancer were randomly assigned to receive UFT/LV (UFT, 300 mg m(-2) per day as tegafur; LV, 75 mg per day on days 1-28, every 35 days, 5 courses) or S-1 (80, 100, or 120 mg per day on days 1-28, every 42 days, 4 courses). Treatment status and safety were evaluated.ResultsOf 1535 enrolled patients, a total of 1504 (756 allocated to S-1 and 748 to UFT/LV) were analysed. The completion rate of protocol treatment was 77% in the S-1 group and 73% in the UFT/LV group. The overall incidence of adverse events (AEs) were 80% in S-1 and 74% in UFT/LV. Stomatitis, anorexia, hyperpigmentation, and haematological toxicities were common in S-1, whereas increased alanine aminotransferase and aspartate aminotransferase were common in UFT/LV. The incidences of grade 3 AEs were 16% and 14%, respectively.ConclusionAlthough AE profiles differed between the groups, feasibility of the protocol treatment was good. Both S-1 and UFT/LV could be safely used as adjuvant chemotherapy.

26 keywords...

hide…