title: S-1 plus cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: a pilot study.
abstract: The safety and efficacy of S-1 plus cisplatin in Chinese advanced gastric cancer patients in first line setting is unknown. In this pilot study, patients with advanced gastric or gastro-esophageal junction adenocarcinoma were enrolled and randomly assigned in a 1:1 ratio to receive S-1 plus cisplatin (CS group) or 5-FU plus cisplatin (CF group). The primary endpoint was time to progression (TTP). Secondary end points included overall survival (OS) and safety. This study was registered on ClinicalTrials. Gov, number NCT01198392. A total of 236 patients were enrolled. Median TTP was 5.51 months in CS group compared with 4.62 months in CF group [hazard ratio (HR) 1.028, 95% confidential interval (CI) 0.758-1.394, p = 0.859]. Median OS was 10.00 months and 10.46 months in CS and CF groups (HR 1.046, 95%CI 0.709-1.543, p = 0.820), respectively. The most common adverse events in both groups were anemia, leukopenia, neutropenia, nausea, thrombocytopenia, vomiting, anorexia and diarrhea. We find that S-1 plus cisplatin is an effective and tolerable option for advanced gastric or gastro-esophageal junction adenocarcinoma patients in China.
authors.affiliation: Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Yu Hong
authors.initials: YH
authors.lastname: Li
authors.affiliation: Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.|Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD, USA.
authors.forename: Miao Zhen
authors.initials: MZ
authors.lastname: Qiu
authors.affiliation: Department of Oncology, 307 Hospital of the People's Liberation Army, Beijing, China.
authors.forename: Jian Ming
authors.initials: JM
authors.lastname: Xu
authors.affiliation: Department of Oncology, The First Affiliated Hospital of AnHui Medical University, Hefei, China.
authors.forename: Guo Ping
authors.initials: GP
authors.lastname: Sun
authors.affiliation: Department of General Surgery, Affiliated Union Hospital, Fujian Medical University, Fuzhou, China.
authors.forename: Hui Shan
authors.initials: HS
authors.lastname: Lu
authors.affiliation: The Second Lab of Cancer Research Institute, The First Hospital of China Medical University, Shenyang, China.
authors.forename: Yun Peng
authors.initials: YP
authors.lastname: Liu
authors.affiliation: Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
authors.forename: Mei Zuo
authors.initials: MZ
authors.lastname: Zhong
authors.affiliation: Department of Oncology, Tangdu Hospital, The Fourth Military Medical University, Xi'an, China.
authors.forename: He Long
authors.initials: HL
authors.lastname: Zhang
authors.affiliation: Department of Oncology, Tongji Cancer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Shi Ying
authors.initials: SY
authors.lastname: Yu
authors.affiliation: Stem Cell and Cancer Center, First Affiliated Hospital, Jilin University, Changchun, Jilin, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Oncology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China.
authors.forename: Xiao Hua
authors.initials: XH
authors.lastname: Hu
authors.affiliation: Department of Oncology, Changzheng Hospital, Shanghai, China.
authors.forename: Jie Jun
authors.initials: JJ
authors.lastname: Wang
authors.affiliation: Department of Oncology, Tumor Hospital of Jilin Province, Changchun, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Cheng
authors.affiliation: Department of Oncology, Tumor Hospital of Hunan Province, Changsha, China.
authors.forename: Jun Tian
authors.initials: JT
authors.lastname: Zhou
authors.affiliation: Department of Oncology, Tumor Hospital of Fujian Province, Fuzhou, China.
authors.forename: Zeng Qing
authors.initials: ZQ
authors.lastname: Guo
authors.affiliation: Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Zhon Gzhen
authors.initials: ZG
authors.lastname: Guan
authors.affiliation: Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
authors.forename: Rui Hua
authors.initials: RH
authors.lastname: Xu
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004338:Drug Combinations; D004943:Esophagogastric Junction / Q000473:pathology*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D002945:Cisplatin; D005472:Fluorouracil
keywords: S-1; first-line chemotherapy; fluorouracil; gastric cancer