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. doi: 10.1038/bjc.2012.86. Epub 2012 Mar 13.
The 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.
Patients 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.
Of 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.
Although 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.
替吉奥胶囊用于结肠癌辅助化疗的临床试验（ACTS-CC）是一项旨在验证 S-1 不劣于 UFT/LV（UFT，替加氟 300mg/m2/天；LV，第 1-28 天，每天 75mg，每 35 天 1 个疗程，共 5 个疗程）作为 III 期结肠癌术后辅助化疗的 III 期临床试验。我们报告了一项计划中的安全性分析结果。
年龄在 20-80 岁之间、经根治性切除的 III 期结肠癌患者被随机分配接受 UFT/LV（UFT，替加氟 300mg/m2/天；LV，第 1-28 天，每天 75mg，每 35 天 1 个疗程，共 5 个疗程）或 S-1（S-1，第 1-28 天，每天 80、100 或 120mg，每 42 天 1 个疗程，共 4 个疗程）治疗。评估治疗情况和安全性。
共纳入 1535 例患者，1504 例（S-1 组 756 例，UFT/LV 组 748 例）纳入分析。S-1 组和 UFT/LV 组的方案治疗完成率分别为 77%和 73%。S-1 组和 UFT/LV 组的总体不良事件（AE）发生率分别为 80%和 74%。S-1 组常见的 AE 包括口腔炎、食欲不振、皮肤色素沉着和血液学毒性，而 UFT/LV 组常见的 AE 包括丙氨酸氨基转移酶和天冬氨酸氨基转移酶升高。AE 发生率为 3 级的分别为 16%和 14%。
虽然两组的 AE 谱不同，但方案治疗的可行性良好。S-1 和 UFT/LV 均可安全用于辅助化疗。
