Watanabe J, Sasaki S, Kusumoto T, Sakamoto Y, Yoshida K, Tomita N, Maeda A, Teshima J, Yokota M, Tanaka C, Yamauchi J, Uetake H, Itabashi M, Takahashi K, Baba H, Kotake K, Boku N, Aiba K, Morita S, Takenaka N, Sugihara K
Gastroenterological Center, Yokohama City University Medical Center, Kanagawa, Japan.
Department of Surgical Oncology, Japanese Red Cross Medical Center, Tokyo, Japan.
ESMO Open. 2021 Apr;6(2):100077. doi: 10.1016/j.esmoop.2021.100077. Epub 2021 Mar 11.
The ACTS-CC 02 trial demonstrated that S-1 plus oxaliplatin (SOX) was not superior to tegafur-uracil and leucovorin (UFT/LV) in terms of disease-free survival (DFS) as adjuvant chemotherapy for high-risk stage III colon cancer (any T, N2, or positive nodes around the origin of the feeding arteries). We now report the final overall survival (OS) and subgroup analysis according to the pathological stage (TNM 7th edition) for treatment efficacy.
Patients who underwent curative resection for pathologically confirmed high-risk stage III colon cancer were randomly assigned to receive either UFT/LV (300 mg/m of UFT and 75 mg/day of LV on days 1-28, every 35 days, five cycles) or SOX (100 mg/m of oxaliplatin on day 1 and 80 mg/m/day of S-1 on days 1-14, every 21 days, eight cycles). The primary endpoint was DFS and the patients' data were updated in February 2020.
A total of 478 patients in the UFT/LV group and 477 patients in the SOX group were included in the final analysis. With a median follow-up time of 74.3 months, the 5-year DFS rate was 55.2% in the UFT/LV group and 58.1% in the SOX group [stratified hazard ratio (HR) 0.92; 95% confidence interval (CI) 0.76-1.11; P = 0.3973], and the 5-year OS rates were 78.3% and 79.1%, respectively (stratified HR 0.97; 95% CI 0.76-1.24; P = 0.8175). In the subgroup analysis, the 5-year OS rates in patients with T4N2b disease were 51.0% and 64.1% in the UFT/LV and SOX groups, respectively (HR 0.72; 95% CI 0.40-1.31).
Our final analysis reconfirmed that SOX as adjuvant chemotherapy is not superior to UFT/LV in terms of DFS in patients with high-risk stage III colon cancer. The 5-year OS rate was similar in the UFT/LV and SOX groups.
ACTS-CC 02试验表明，对于高危III期结肠癌（任何T、N2或供血动脉起源周围淋巴结阳性），作为辅助化疗，S-1联合奥沙利铂（SOX）在无病生存期（DFS）方面并不优于替加氟-尿嘧啶和亚叶酸钙（UFT/LV）。我们现在报告根据病理分期（TNM第7版）进行治疗疗效分析的最终总生存期（OS）和亚组分析结果。
对经病理确诊为高危III期结肠癌并接受根治性切除术的患者，随机分配接受UFT/LV（UFT 300 mg/m²，亚叶酸钙75 mg/天，第1 - 28天给药，每35天为一个周期，共五个周期）或SOX（奥沙利铂100 mg/m²，第1天给药，S-1 80 mg/m²/天，第1 - 14天给药，每21天为一个周期，共八个周期）治疗。主要终点为DFS，患者数据于2020年2月更新。
最终分析纳入UFT/LV组478例患者和SOX组477例患者。中位随访时间为74.3个月，UFT/LV组5年DFS率为55.2%，SOX组为58.1%[分层风险比（HR）0.92；95%置信区间（CI）0.76 - 1.11；P = 0.3973]，5年OS率分别为78.3%和79.1%（分层HR 0.97；95% CI 0.76 - 1.24；P = 0.8175）。亚组分析中，T4N2b疾病患者的UFT/LV组和SOX组5年OS率分别为51.0%和64.1%（HR 0.72；95% CI 0.40 - 1.31）。
我们的最终分析再次证实，对于高危III期结肠癌患者，SOX作为辅助化疗在DFS方面并不优于UFT/LV。UFT/LV组和SOX组的5年OS率相似。
