Randomized, double-blind, placebo-controlled phase III trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
机构：[1]Fudan University Shanghai Cancer Center[2]Shanghai First People’s Hospital[3]XinHua Hospital Affiliated to Shanghai Jiaotong University, Shanghai[4]People’s Liberation Army (PLA) Cancer Center, 81st Hospital of PLA[5]Second Affiliated Hospital of Nanjing Medical University[6]NanjingMedical University, Nanjing[7]307th Hospital of PLA, Academy of MilitaryMedical Sciences[8]Chinese Academy ofMedical Sciences Cancer Hospital, Beijing[9]First Affiliated Hospital of Nanchang University, Nanchang[10]First People’s Hospital of Changzhou, Changzhou[11]Harbin Medical University Cancer Hospital, Harbin[12]Hebei Medical University Fourth Hospital, Hebei Provincial Tumor Hospital, Shijiazhuang河北医科大学第四医院[13]Yangzhou No. 1 People’s Hospital, Yangzhou[14]First Hospital of China Medical University, Shenyang[15]Sun Yat-Sen University Cancer Center, Guangzhou[16]Shandong Cancer Hospital, Jinan[17]Jiangsu Jiangyin People’s Hospital, Jiangyin[18]Fuzhou General Hospital of Nanjing Military Command[19]Fujian Provincial Cancer Hospital, Fuzhou[20]Gansu Cancer Hospital, Lanzhou[21]Tianjin Medical University Cancer Institute and Hospital, Tianjin[22]Affiliated Hospital of Qingdao University, Qingdao[23]Fujian Medical University Union Hospital, Fujian[24]West China Hospital, Sichuan University, Chengdu四川大学华西医院[25]First Affiliated Hospital of Bengbu Medical College, Bengbu[26]Xijing Hospital, Xi’an[27]First Affiliated Hospital of Anhui Medical University, Hefei[28]Xinqiao Hospital, Third Military Medical University, Chongqing[29]Affiliated Hospital of LuzhouMedical College, Luzhou[30]First Affiliated Hospital of Zhejiang University, Hangzhou浙江大学医学院附属第一医院[31]Jilin Provincial Cancer Hospital, Changchun[32]General Hospital of Ningxia Medical University, Ningxia, Yinchuan[33]Cancer Hospital of Shantou University Medical College, Shantou[34]Jiangsu Hengrui Medicine, Jiangsu, People’s Republic of China.
Purpose There is currently no standard treatment strategy for patients with advanced metastatic gastric cancer experiencing progression after two or more lines of chemotherapy. We assessed the efficacy and safety of apatinib, a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, in patients with advanced gastric or gastroesophageal junction adenocarcinoma for whom at least two lines of prior chemotherapy had failed. Patients and Methods This was a randomized, double-blind, placebo-controlled phase III trial. Patients from 32 centers in China with advanced gastric or gastroesophageal junction adenocarcinoma, for whom two or more prior lines of chemotherapy had failed, were enrolled. Patients were randomly assigned to oral apatinib 850 mg or placebo once daily. The primary end points were overall (OS) and progression-free survival (PFS). Results Between January 2011 and November 2012, 267 patients were enrolled. Median OS was significantly improved in the apatinib group compared with the placebo group (6.5 months; 95% CI, 4.8 to 7.6 v 4.7 months; 95% CI, 3.6 to 5.4; P = .0149; hazard ratio, 0.709; 95% CI, 0.537 to 0.937; P = .0156). Similarly, apatinib significantly prolonged median PFS compared with placebo (2.6 months; 95% CI, 2.0 to 2.9 v 1.8 months; 95% CI, 1.4 to 1.9; P < .001; hazard ratio, 0.444; 95% CI, 0.331 to 0.595; P < .001). The most common grade 3 to 4 nonhematologic adverse events were hand-foot syndrome, proteinuria, and hypertension. Conclusion These data show that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. (C) 2016 by American Society of Clinical Oncology
基金：
Supported by Jiangsu Hengrui Medicine,
Jiangsu, and Shanghai Hengrui
Pharmaceutical, Shanghai, People’s
Republic of China, and in part by Grant No.
2010ZX09401-301-8 from the Key Special
Program for Innovative Drugs from the
Ministry of Science and Technology of
China. The Department of Epidemiology
and Biostatistics, Nanjing Medical
University, provided statistical analysis.
通讯机构：[4]People’s Liberation Army (PLA) Cancer Center, 81st Hospital of PLA[*1]People’s Liberation Army Cancer Center, 81st Hospital of People’s Liberation Army, No. 34, 34 Biao, Yanggongjing St, Nanjing, Jiangsu 210002, China
推荐引用方式(GB/T 7714)：
Jin Li,Shukui Qin,Jianming Xu,et al.Randomized, double-blind, placebo-controlled phase III trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction[J].Journal Of Clinical Oncology.2016,34(13):1448-+.doi:10.1200/JCO.2015.63.5995.
APA：
Jin Li,Shukui Qin,Jianming Xu,Jianping Xiong,Changping Wu...&Hao Yu.(2016).Randomized, double-blind, placebo-controlled phase III trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction.Journal Of Clinical Oncology,34,(13)
MLA：
Jin Li,et al."Randomized, double-blind, placebo-controlled phase III trial of apatinib in patients with chemotherapy-refractory advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction".Journal Of Clinical Oncology 34..13(2016):1448-+
医学