S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).
S-1 as adjuvant chemotherapy for stage III colon cancer: a randomized phase III study (ACTS-CC trial).
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DOI：
10.1093/annonc/mdu232
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发表时间：
2014-09
期刊：
影响因子：
--
通讯作者：
ACTS-CC study group
中科院分区：
文献类型：
--
作者：
Yoshida M;Ishiguro M;Ikejiri K;Mochizuki I;Nakamoto Y;Kinugasa Y;Takagane A;Endo T;Shinozaki H;Takii Y;Mochizuki H;Kotake K;Kameoka S;Takahashi K;Watanabe T;Watanabe M;Boku N;Tomita N;Nakatani E;Sugihara K;ACTS-CC study group
这项名为ACTS-CC的III期研究首次证实了口服氟嘧啶S-1作为III期结肠癌的辅助化疗的有效性，证实了其在无病生存方面对UFT/LV的非劣效性。S-1可能成为结肠癌辅助化疗的新选择。S-1是一种口服氟嘧啶，其抗肿瘤作用已被证明用于治疗各种胃肠道癌症，包括转移性结肠癌，当作为单一疗法或联合化疗时。我们进行了一项随机III期研究，通过评估S-1作为结肠癌辅助化疗的有效性，评估其与替加福-尿嘧啶加亚叶酸钙（UFT/LV）的非劣效性。年龄20-80岁的治愈性切除III期结肠癌患者被随机分配接受S-1 （80-120 mg/天，每42天，4个疗程）或UFT/LV （UFT: 300-600 mg/天，LV: 75 mg/天，每35天，1-28天，5个疗程）。主要终点为3年无病生存期（DFS）。总共1518例患者（S-1组758例，UFT/LV组760例）被纳入完整分析集。S-1组和UFT/LV组的3年DFS分别为75.5%和72.5%。与UFT/LV组相比，S-1组DFS的分层风险比为0.85(95%置信区间：0.70-1.03)，表明S-1的非劣效性（非劣效性分层log-rank检验，P < 0.001）。在亚组分析中，在主要基线特征和治疗组之间没有发现显著的相互作用。与UFT/LV相比，S-1辅助化疗治疗III期结肠癌的DFS无明显差异。S-1可能成为结肠癌辅助化疗的新选择。NCT00660894。
This phase III study, ACTS-CC, is the first study in which demonstrated the efficacy of S-1, an oral fluoropyrimidine, as adjuvant chemotherapy for stage III colon cancer by confirming its noninferiority to UFT/LV in terms of disease-free survival. S-1 could be a new treatment option as adjuvant chemotherapy for colon cancer. S-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 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. A 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. Adjuvant 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. NCT00660894.
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