| 韦 青,谢 丽.S-1 辅助治疗对照观察在胆道癌术后患者中的效果对比：JCOG1202/ASCOT研究解读[J].肿瘤学杂志,2023,29(2):165-171. |
| S-1 辅助治疗对照观察在胆道癌术后患者中的效果对比：JCOG1202/ASCOT研究解读 |
| Comparison of the Effects of S-1 Adjuvant Therapy Versus Observation Control for Postoperative Patients with Biliary Tract Cancer： Interpretation of JCOG1202/ASCOT Study |
| 投稿时间：2023-02-18 |
| DOI：10.11735/j.issn.1671-170X.2023.02.B014 |
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| 中文关键词: S-1 辅助治疗 胆道系统恶性肿瘤 临床研究 |
| 英文关键词:S-1 adjuvant therapy biliary tract cancer clinical trial |
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| 中文摘要: |
| 摘 要：JCOG1202(ASCOT)是一项立足于胆道系统肿瘤术后治疗的Ⅲ期临床研究。研究设计上，该研究是一项日本多中心、优效性、平行设计的随机对照临床试验，纳入人群被随机分配至S-1单药组或观察组，预期两组各纳入220例，共计440例患者。主要研究终点为总生存时间，次要研究终点包括无复发生存时间、治疗完成度、不良事件等。研究结果上，S-1单药治疗对比观察组，初步分析显示达到了研究的主要终点，观察组的3年总生存率为67.6%（95%CI：61.0%~73.3%），而S-1组为77.1%（70.9%~82.1%）（校正HR=0.69，95%CI：0.51~0.94，单侧P=0.0080）。分层分析显示，S-1较观察组在女性、淋巴结阳性和Ⅲ~ⅣA期患者中，3年总生存期（OS）和无复发生存期（RFS）均有获益。虽然需要长期临床获益才能得出明确结论，但生存率的显著改善表明，辅助 S-1 可被视为亚洲胆道癌术后患者的标准治疗。JCOG1202研究的结果有亮点，也有少量争议，值得进一步讨论与思考。 |
| 英文摘要: |
| Abstract： JCOG1202 (ASCOT) is a phase Ⅲ clinical study to evaluate the efficacy of adjuvant S-1 therapy for patients with resected biliary tract cancer. This is a multicenter， superiority open-label， parallel-design randomized controlled clinical trial carried on in Japan. The enrolled patients were randomly assigned to the observation control group and the S-1 group with 220 patients in each group. The overall survival was the primary outcome of the study； the secondary outcomes were relapse-free survival， adverse events， proportion of treatment completion， and serious adverse events. The results showed that the primary endpoint of the study was met， the 3-year overall survival rate in the observation group was 67.6% (95%CI：61.0%～73.3%) compared with 77.1% (95%CI：70.9%～82.1%) in the S-1 group (adjusted HR=0.69， 95% CI：0.51～0.94； One-sided P=0.0080). Stratification analysis showed the benefit from 3-year OS and RFS in female patients， patients with node-positive and those with stage Ⅲ to ⅣA disease. The results of ASCOT study suggest that adjuvant S-1 therapy might be considered as a standard protocol for patients with resectable biliary cancer in Asia and deserves further discussion and consideration. |
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