S-1 plus Cisplatin versus fluorouracil plus cisplatin in advanced gastric or gastro-esophageal junction adenocarcinoma patients: A pilot study

// Yuhong Li 1,* , Miaozhen Qiu 1,2,* , Jianming Xu 3,* , Guoping Sun 4 , Huishan Lu 5 , Yunpeng Liu 6 , Meizuo Zhong 7 , Helong Zhang 8 , Shiying Yu 9 , Wei Li 10 , Xiaohua Hu 11 , Jiejun Wang 12 , Ying Cheng 13 , Juntian Zhou 14 , Zengqing Guo 15 , Zhongzhen Guan 1 and Ruihua Xu 1 1 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 2 Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins University School of Medicine, Baltimore, MD, USA 3 Department of Oncology, 307 Hospital of the People’s Liberation Army, Beijing, China 4 Department of Oncology, The First Affiliated Hospital of AnHui Medical University, Hefei, China 5 Department of General Surgery, Affiliated Union Hospital, Fujian Medical University, Fuzhou, China 6 The Second Lab of Cancer Research Institute, The First Hospital of China Medical University, Shenyang, China 7 Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan, China 8 Department of Oncology, Tangdu Hospital, The Fourth Military Medical University, Xi’an, China 9 Department of Oncology, Tongji Cancer Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China 10 Stem Cell and Cancer Center, First Affiliated Hospital, Jilin University, Changchun, Jilin, China 11 Department of Oncology, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China 12 Department of Oncology, Changzheng Hospital, Shanghai, China 13 Department of Oncology, Tumor Hospital of Jilin Province, Changchun, China 14 Department of Oncology, Tumor Hospital of Hunan Province, Changsha, China 15 Department of Oncology, Tumor Hospital of Fujian Province, Fuzhou, China * These authors have contributed equally to this work Correspondence to: Ruihua Xu, email: // Keywords : gastric cancer, first-line chemotherapy, fluorouracil, S-1 Received : June 11, 2015 Accepted : August 31, 2015 Published : October 02, 2015 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.