Ⅱ期结肠癌术后替加氟尿嘧啶口服辅助化疗 1 年与单纯手术的随机对照临床试验：SACURA 试验。
A randomised-controlled trial of 1-year adjuvant chemotherapy with oral tegafur-uracil versus surgery alone in stage II colon cancer: SACURA trial.
机构信息
Osaka General Medical Center, Department of Surgery, 3-1-56 Bandaihigashi, Sumiyoshi-ku, Osaka 558-8558, Japan.
Tokyo Medical and Dental University, Graduate School, Department of Translational Oncology, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
出版信息
Eur J Cancer. 2018 Jun;96:54-63. doi: 10.1016/j.ejca.2018.03.009. Epub 2018 Apr 17.
BACKGROUND
Efficacy of adjuvant chemotherapy in patients with stage II colon cancer is still controversial. The SACURA trial is a randomised-controlled study evaluating the superiority of 1-year adjuvant treatment with oral tegafur-uracil (UFT) to surgery alone for stage II colon cancer.
METHODS
Patients were randomly assigned to the surgery-alone group or UFT group (UFT at 500-600 mg/day for 5 days, followed by 2-day rest, for 1 year). The primary end-point was disease-free survival (DFS). Target sample size was 2000, determined with one-sided alpha of 0.05, power of 0.9 and assumed hazard ratio (HR) 0.729.
RESULTS
A total of 1982 patients (997 in the surgery-alone group and 985 in the UFT group) were analysed. Median follow-up was 69.5 months, median age was 66 years and for stage IIA/IIB/IIC, the distribution was 84%/13%/3%. The 5-year DFS rate was 78.4% in the surgery-alone group and 80.2% in the UFT group. The HR for DFS was 0.91 (95% confidence interval [CI], 0.75-1.10; p = 0.31); superiority of UFT was not demonstrated. Approximately 9% of patients experienced second cancers, which consist 40.7% of the DFS events. The 5-year relapse-free and overall survival rates of the surgery-alone and UFT group were 84.6% and 87.2% (HR, 0.82; 95% CI, 0.65-1.04) and 94.3% and 94.5% (HR, 0.93; 95% CI, 0.66-1.31), respectively. Subgroup analysis failed to disclose superiority in prognosis of adding UFT to the patients with risk factors for recurrence.
CONCLUSIONS
Superiority of 1-year adjuvant UFT over surgery alone was not demonstrated in stage II colon cancer. Patients with risk factors for recurrence did not benefit from UFT.
TRIAL REGISTRATION
ClinicalTrials. Gov. #NCT00392899.
背景
辅助化疗在 II 期结肠癌患者中的疗效仍存在争议。SACURA 试验是一项随机对照研究，旨在评估为期 1 年的口服替加氟-尿嘧啶（UFT）辅助治疗与单纯手术相比，用于 II 期结肠癌的优越性。
方法
患者被随机分配至单纯手术组或 UFT 组（UFT 剂量为 500-600mg/天，连用 5 天，然后休息 2 天，持续 1 年）。主要终点是无病生存（DFS）。目标样本量为 2000 例，单侧α值为 0.05，效能为 0.9，假设的风险比（HR）为 0.729。
结果
共分析了 1982 例患者（单纯手术组 997 例，UFT 组 985 例）。中位随访时间为 69.5 个月，中位年龄为 66 岁，其中 IIA/IIB/IIC 期的分布分别为 84%/13%/3%。单纯手术组的 5 年 DFS 率为 78.4%，UFT 组为 80.2%。DFS 的 HR 为 0.91（95%置信区间[CI]，0.75-1.10；p=0.31）；未显示 UFT 的优越性。约 9%的患者发生了第二原发癌，占 DFS 事件的 40.7%。单纯手术组和 UFT 组的 5 年无复发生存率和总生存率分别为 84.6%和 87.2%（HR，0.82；95%CI，0.65-1.04）和 94.3%和 94.5%（HR，0.93；95%CI，0.66-1.31）。亚组分析未能发现对有复发风险的患者加用 UFT 可改善预后。
结论
在 II 期结肠癌中，1 年辅助 UFT 治疗并不优于单纯手术。有复发风险的患者不能从 UFT 中获益。
临床试验注册
ClinicalTrials.gov。#NCT00392899。
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