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

Abstract

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 tegafureuracil (UFT) to surgery alone for stage II colon cancer. Methods: Patients were randomly assigned to the surgery-alone group or UFT group (UFT at 500e600 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], 0.75e1.10; p Z 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 surgeryalone and UFT group were 84.6% and 87.2% (HR, 0.82; 95% CI, 0.65e1.04) and 94.3% and 94.5% (HR, 0.93; 95% CI, 0.66e1.31), 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.

Lymph Node Positivity in One-Step Nucleic Acid Amplification is a Prognostic Factor for Postoperative Cancer Recurrence in Patients with Stage II Colorectal Cancer: A Prospective, Multicenter Study

“…Recurrences in patients with OSNA-positive pStage II CRC that this study has limitation of small sample size, which may be associated with relatively high relapse rate of stage II patient compared with the largescale study 32. Another limitation is that 22 of 70 stage II (31.4%) CRC patients had \ 12 LNs examined.…”

Neoadjuvant Chemotherapy without Radiation in Colorectal Cancer

“…61,62 The magnitude of benefit may nowadays be diluted by the major improvements in the quality of surgery for CRC, achieved over the past two decades 63 leading to better OS, particularly in stage II colon cancer. 64…”

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Tumour budding in preoperative biopsy specimens is a useful prognostic index for identifying high-risk patients in early-stage (pN0) colon cancer

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