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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)

引用

Cancer Communications 2022年第4期42卷 314-326页

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 Department of Gastrointestinal Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200032P.R.China Department of Oncology Shanghai Medical CollegeFudan UniversityShanghai 200032P.R.China Department of Gastroenterology Shanxi Cancer HospitalTaiyuanShanxi 030013P.R.China Department of Medical Oncology The First Affiliated HospitalDivision of Life Science and MedicineUniversity of Science and Technology of ChinaHefeiAnhui 230031P.R.China 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 SciencesHangzhouZhejiang 310005P.R.China Department of Medical Oncology The First People’s Hospital of ChangzhouChangzhouJiangsu 213004P.R.China Department of Gastroenterology Nantong Tumor HospitalNantongJiangsu 226006P.R.China Department of Oncology Zhengzhou University First Affiliated HospitalZhengzhouHenan 450052P.R.China Department of Biostatistics School of Public HealthFudan UniversityShanghai 200032P.R.China Department of medical oncology Cancer Hospital of Fudan UniversityMinhang BranchShanghai 200032P.R.China

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

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