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 , Ruihua Xu 1
2 October 2015
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.