A randomised-controlled trial of 1-year adjuvant chemotherapy with oral tegafur-uracil versus surgery alone in stage II colon cancer: SACURA trial

作者：Matsuda Chu; Ishiguro Megumi; Teramukai Satoshi; Kajiwara Yoshiki; Fujii Shoichi; Kinugasa Yusuke; Nakamoto Yoshihiko; Kotake Masanori; Sakamoto Yoshiyuki; Kurachi Kiyotaka; Maeda Atsuyuki; Komori Koji; Tomita Naohiro; Shimada Yasuhiro; Takahashi Keiichi; Kotake Kenjiro; Watanabe Masahiko; Mochizuki Hidetaka; Nakagawa Yoko; Sugihara Kenichi^*

来源：European Journal of Cancer, 2018, 96: 54-63.

DOI：10.1016/j.ejca.2018.03.009

• Colon cancer
• Adjuvant chemotherapy
• Stage II
• Tegafur-uracil (UFT)

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; pZ0.31); 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.

• 出版日期2018-6