Background

Adjuvant chemotherapy is an accepted treatment to improve survival rates in patients with stage III colon cancer, and regimens including oxaliplatin have been shown to be superior to those containing 5-FU alone. The purpose of this study was to examine the efficacy and feasibility of S-1 plus oxaliplatin (C-SOX) as adjuvant chemotherapy for patients with stage III colon cancer following curative resection.

Methods

Patients with colon cancer who underwent curative resection were enrolled and received oral S-1 40–60 mg twice daily on days 1–14 every 3 weeks plus intravenous oxaliplatin 130 mg/m² on day 1 for eight courses. The primary endpoint was 3-year disease-free survival rate. Secondary endpoints were the rate of treatment completion, adverse events, relative dose intensity, and overall survival.

Results

Between February 2014 and December 2014, 89 patients were enrolled. One patient was excluded from the analysis because of ineligibility, and the remaining 88 patients were included. The rate of protocol treatment completion was 72.3%. The relative dose intensity of S-1 and oxaliplatin was 72% and 76.3%, respectively. Hematological severe adverse events (Grade 3/4) were neutropenia (21.3%) and thrombocytopenia (15.7%). The most frequent symptom was diarrhea (Grade 3/4: 5.6%). The incidence of grade 2 neuropathy has decreased from 8.1 to 2.7% after 3 years of the therapy. Three-year disease-free survival rate was 73.9% (95% CI 63.8–81.9), and 3-year overall survival rate was 94.3% (95% CI 86.8–97.6)

Conclusions

C-SOX is a safe and feasible adjuvant chemotherapy regimen in patients with stage III colon cancer undergoing curative resection.

中文翻译：

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S-1 加奥沙利铂 (C-SOX) 治疗 III 期结肠癌 (KSCC1303) 患者的疗效和可行性：3 年无病生存期的最终分析。

背景

辅助化疗是一种公认​​的提高 III 期结肠癌患者生存率的治疗方法，包括奥沙利铂在内的方案已被证明优于仅含 5-FU 的方案。本研究的目的是检查 S-1 加奥沙利铂 (C-SOX) 作为根治性切除术后 III 期结肠癌患者辅助化疗的疗效和可行性。

方法

接受根治性切除的结肠癌患者入组，每 3 周第 1-14 天口服 S-1 40-60 mg，每天两次，第 1 天静脉注射奥沙利铂 130 mg/m ^{2 共}8 个疗程。主要终点是 3 年无病生存率。次要终点是治疗完成率、不良事件、相对剂量强度和总生存期。

结果

2014 年 2 月至 2014 年 12 月期间，共招募了 89 名患者。一名患者因不符合条件而被排除在分析之外，其余 88 名患者被包括在内。方案治疗完成率为 72.3%。S-1 和奥沙利铂的相对剂量强度分别为 72% 和 76.3%。血液学严重不良事件（3/4 级）是中性粒细胞减少症 (21.3%) 和血小板减少症 (15.7%)。最常见的症状是腹泻（3/4 级：5.6%）。治疗 3 年后，2 级神经病变的发生率从 8.1% 降至 2.7%。三年无病生存率为 73.9%（95% CI 63.8-81.9），3 年总生存率为 94.3%（95% CI 86.8-97.6）

结论

C-SOX 是一种安全可行的辅助化疗方案，用于接受根治性切除的 III 期结肠癌患者。