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 Control Observation in Postoperative Patients with Biliary Tract Cancer:Interpretation of JCOG1202/ASCOT Study

作　　者：韦青 谢丽 WEI Qing;XIE Li(Zhejiang Cancer Hospital,Institute of Basic Medicine and Cancer(IBMC),Chinese Academy of Sciences,Hangzhou 310022,China;Clinical Research Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]浙江省肿瘤医院,中国科学院基础医学与肿瘤研究所,浙江杭州310022 [2]上海交通大学医学院临床研究中心,上海200025

出　　处：《肿瘤学杂志》2023年第2期165-171,共7页Journal of Chinese Oncology

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。JCOG1202(ASCOT)is a phaseⅢclinical study evaluate whether adjuvant S-1 improved overall survival compared with observation for resected biliary tract cancer.This is a multicenter,superiority openlabel,parallel-design randomized controlled clinical trial in Japan,enrolled patients were randomly assigned to either the observation or the S-1 group 440 patients were required and 220 patients in each group.The primary outcome was overall survival in all the randomized patients.The secondary outcomes were relapse-free survival,adverse events,proportion of treatment completion,and serious adverse events.In terms of results,primary analysis of S-1 monotherapy versus the observation group showed that the primary endpoint of the study was met,with 3-year overall survival rate in the observation group being 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 benefit from 3-year OS and RFS in female,node-positive,and patients with stageⅢtoⅣA disease.While long-term clinical benefit is required to draw definitive conclusions,significant improvements in survival suggest that adjuvant S-1 could be considered a standard of care for patients with resectable biliary cancer in Asia.The results of the ASCOT study are positive and a bit controversial,deserve further discussion and consideration.

关 键 词：S-1 辅助治疗 胆道系统恶性肿瘤 临床研究 

分 类 号：R735.8[医药卫生—肿瘤]