Li Yu Hong, Qiu Miao Zhen, Xu Jian Ming, Sun Guo Ping, Lu Hui Shan, Liu Yun Peng, Zhong Mei Zuo, Zhang He Long, Yu Shi Ying, Li Wei, Hu Xiao Hua, Wang Jie Jun, Cheng Ying, Zhou Jun Tian, Guo Zeng Qing, Guan Zhon Gzhen, Xu Rui Hua
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.
Oncotarget. 2015 Oct 27;6(33):35107-15. doi: 10.18632/oncotarget.5959.
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.
S-1联合顺铂用于中国一线晚期胃癌患者的安全性和有效性尚不清楚。在这项前瞻性研究中，纳入了晚期胃癌或胃食管交界腺癌患者，并按1:1比例随机分配接受S-1联合顺铂（CS组）或5-氟尿嘧啶联合顺铂（CF组）。主要终点为疾病进展时间（TTP）。次要终点包括总生存期（OS）和安全性。本研究已在ClinicalTrials.gov注册，注册号为NCT01198392。共纳入236例患者。CS组的中位TTP为5.51个月，而CF组为4.62个月[风险比（HR）1.028，95%置信区间（CI）0.758-1.394，p = 0.859]。CS组和CF组的中位OS分别为10.00个月和10.46个月（HR 1.046，95%CI 0.709-1.543，p = 0.820）。两组最常见的不良事件为贫血、白细胞减少、中性粒细胞减少、恶心、血小板减少、呕吐、厌食和腹泻。我们发现，S-1联合顺铂对于中国晚期胃癌或胃食管交界腺癌患者是一种有效且可耐受的选择。
