XELOX doublet regimen versus EOX triplet regimen as first-line treatment for advanced gastric cancer:An open-labeled,multicenter,randomized,prospective phase III trial(EXELOX)  

作　　者：Xiao-Dong Zhu Ming-Zhu Huang Yu-Sheng Wang Wan-Jing Feng Zhi-Yu Chen Yi-Fu He Xiao-Wei Zhang Xin Liu Chen-Chen Wang Wen Zhang Jie-Er Ying Jun Wu Lei Yang Yan-Ru Qin Jian-Feng Luo Xiao-Ying Zhao Wen-Hua Li Zhe Zhang Li-Xin Qiu Qi-Rong Geng Jian-Ling Zou Jie-Yun Zhang Hong Zheng Xue-Feng Song Shu-Sheng Wu Cheng-Yan Zhang Zhe Gong Qin-Qin Liu Xiao-Feng Wang Qi Xu Qi Wang Jian-Mei Ji Jian Zhao Wei-Jian Guo 

机构地区：[1]Department of Gastrointestinal Medical Oncology,Fudan University Shanghai Cancer Center,Shanghai 200032,P.R.China [2]Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,P.R.China [3]Department of Gastroenterology,Shanxi Cancer Hospital,Taiyuan,Shanxi 030013,P.R.China [4]Department of Medical Oncology,The First Affiliated Hospital,Division of Life Science and Medicine,University of Science and Technology of China,Hefei,Anhui 230031,P.R.China [5]Department of Abdominal Medical Oncology,Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital),Institute of Cancer and Basic Medicine(IBMC)Chinese Academy of Sciences,Hangzhou,Zhejiang 310005,P.R.China [6]Department of Medical Oncology,The First People’s Hospital of Changzhou,Changzhou,Jiangsu 213004,P.R.China [7]Department of Gastroenterology,Nantong Tumor Hospital,Nantong,Jiangsu 226006,P.R.China [8]Department of Oncology,Zhengzhou University First Affiliated Hospital,Zhengzhou,Henan 450052,P.R.China [9]Department of Biostatistics,School of Public Health,Fudan University,Shanghai 200032,P.R.China [10]Department of medical oncology,Cancer Hospital of Fudan University,Minhang Branch,Shanghai 200032,P.R.China

出　　处：《Cancer Communications》2022年第4期314-326,共13页癌症通讯（英文）

基　　金：National Key Research and Development Program of China,Grant/Award Number:2017YFC1308900;The clinical research and cultivation project of shanghai Shenkang hospital development center,Grant/Award Number:SHDC12017×01;Sun Yat-sen University Xie Tong Chuang Xin Program,Grant/Award Number:ZLYXXTCX201504。

摘　　要：Background:There is no consensus on whether triplet regimen is better than doublet regimen in the first-line treatment of advanced gastric cancer(AGC).We aimed to compare the efficacy and safety of oxaliplatin plus capecitabine(XELOX)and epirubicin,oxaliplatin,plus capecitabine(EOX)regimens in treating AGC.Methods:This phase III trial enrolled previously untreated patients with AGC whowere randomly assigned to receive the XELOXor EOXregimen.The primary endpoint was non-inferiority in progression-free survival(PFS)for XELOX as compared with EOX on an intention-to-treat basis.Results:Between April 10,2015 andAugust 20,2020,448AGCpatientswere randomized to receive XELOX(n=222)or EOX(n=226).The median PFS(mPFS)was 5.0 months(95%confidence interval[CI]=4.5-6.0 months)in the XELOX arm and 5.5 months(95%CI=5.0-6.0 months)in the EOX arm(hazard ratio[HR]=0.989,95%CI=0.812-1.203;P_(non-inferiority)=0.003).There was no significant difference inmedian overall survival(mOS)(12.0 vs.12.0months,P=0.384)or objective response rate(37.4%vs.45.1%,P=0.291)between the two groups.In patients with poorly differentiated adenocarcinoma and liver metastasis,the EOX arm had a significantly longer mOS(P=0.021)and a trend of longer mPFS(P=0.073)than the XELOX arm.The rate of grade 3/4 adverse events(AEs)was 42.2%(90/213)in the XELOX arm and 72.5%(156/215)in the EOX arm(P=0.001).The global health-related quality of life(QoL)score was significantly higher in the XELOX arm than in the EOX arm during chemotherapy.Conclusions:This non-inferiority trial demonstrated that the doublet regimen was as effective as the triplet regimen and had a better safety profile and QoL as a first-line treatment for AGC patients.However,the triplet regimen might have a survival advantage in patients with poorly differentiated adenocarcinoma and liver metastasis.

关 键 词：Advanced gastric cancer chemotherapy XELOX doublet regimen EOX triplet regimen NONINFERIORITY quality of life phase III trial 

分 类 号：R73[医药卫生—肿瘤]