多西他赛联合奥沙利铂及S-1新辅助化疗后手术加辅助S-1与直接手术加辅助S-1治疗可切除晚期胃癌的Ⅲ期对比研究--PRODIGY研究解读  

Summary of A PhaseⅢStudy(PRODIGY)of Neoadjuvant Docetaxel,Oxaliplatin,and S-1 Plus Surgery and Adjuvant S-1 Versus Surgery and Adjuvant S-1 for Resectable Advanced Gastric Cancer

作　　者：田一童 刘成成 陈晓锋[1,3] TIAN Yi-tong;LIU Cheng-cheng;CHEN Xiao-feng(The First Affiliated Hospital with Nanjing Medical University,Nanjing 210029,China;The Second Affiliated Hospital,Zhejiang University School of Medicine,Hangzhou 310058,China;Pukou Branch of Jiangsu People’s Hospital,Nanjing 211800,China)

机构地区：[1]南京医科大学第一附属医院,江苏南京210029 [2]浙江大学医学院附属第二医院,浙江杭州310058 [3]江苏省人民医院浦口分院,江苏南京211800

出　　处：《肿瘤学杂志》2022年第4期336-344,共9页Journal of Chinese Oncology

摘　　要：PRODIGY研究是一项对可切除晚期胃癌患者进行新辅助多西他赛联合奥沙利铂及S-1(DOS)治疗后手术加辅助S-1(CSC组)与直接手术加辅助S-1(SC组)的疗效差异比较的研究。研究对象按部位和cTNM分期进行分层,通过交互式网络响应系统将患者(1∶1)随机分配到CSC组或SC组。主要研究终点为无进展生存时间(PFS)。该研究有1次中期分析,组间差异未达到预先设定的显著性阈值(0.0031),故未中途终止研究。最终分析提示,两组共发生183例PFS事件,CSC组的PFS较SC组明显延长;亚组分析提示分期较晚的胃癌患者获益更显著,且安全性可接受。新辅助DOS后D2胃切除术联合术后S-1辅助化疗可作为亚洲人群可切除性进展期胃癌的一种治疗选择。The PRODIGY study is a study comparing the efficacy of neoadjuvant DOS(docetaxel plus oxaliplatin,S-1)followed by surgery plus adjuvant S-1(CSC group)and post-operative adjuvant S-1(SC group)in patients with resectable advanced gastric cancer.Subjects were stratified by site and cTNM staging,and patients were randomly assigned(1∶1)to CSC or SC group by interactive web-response system.The primary endpoint was progression free survival.The study had1 interim analysis while the difference did not reach the prespecified significance threshold(0.0031),and the study continued.In the final analysis,a total of 183 PFS events were identified.The results showed that PFS was significantly prolonged in the CSC group compared with the SC group with acceptable safety,and the benefit was more pronounced for patients with advanced gastric cancer.Neoadjuvant DOS followed by surgery plus adjuvant S-1 may be a treatment option for resectable advanced gastric cancer in Asia.

关 键 词：胃癌 新铺助治疗 辅助治疗 临床研究 

分 类 号：R735.2[医药卫生—肿瘤]