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
[1]Fudan Univ, Shanghai Canc Ctr, Shanghai 200433, Peoples R China.
[2]Shanghai First Peoples Hosp, Shanghai, Peoples R China.
[3]Shanghai Jiao Tong Univ, XinHua Hosp, Shanghai 200030, Peoples R China.
[4]81st Hosp PLA, Peoples Liberat Army PLA Canc Ctr, Nanjing, Jiangsu, Peoples R China.
[5]Nanjing Med Univ, Affiliated Hosp 2, Nanjing, Jiangsu, Peoples R China.
[6]Nanjing Med Univ, Nanjing, Jiangsu, Peoples R China.
[7]Acad Mil Med Sci, Hosp PLA 307, Beijing, Peoples R China.
[8]Chinese Acad Med Sci, Canc Hosp, Beijing 100730, Peoples R China.
[9]Nanchang Univ, Affiliated Hosp 1, Nanchang, Peoples R China.
[10]First Peoples Hosp Changzhou, Changzhou, Peoples R China.
[11]Harbin Med Univ, Canc Hosp, Harbin, Peoples R China.
[12]Hebei Med Univ, Hosp 4, Hebei Prov Tumor Hosp, Shijiazhuang, Peoples R China.
[13]Yangzhou 1 Peoples Hosp, Yangzhou, Jiangsu, Peoples R China.
[14]China Med Univ, Hosp 1, Shenyang 110001, Peoples R China.
[15]Sun Yat Sen Univ, Ctr Canc, Guangzhou 510275, Guangdong, Peoples R China.
[16]Shandong Canc Hosp, Jinan, Peoples R China.
[17]Jiangsu Jiangyin Peoples Hosp, Jiangyin, Peoples R China.
[18]Nanjing Mil Command, Fuzhou Gen Hosp, Nanjing, Jiangsu, Peoples R China.
[19]Fujian Prov Canc Hosp, Fuzhou, Peoples R China.
[20]Gansu Canc Hosp, Lanzhou, Peoples R China.
[21]Tianjin Med Univ, Canc Inst & Hosp, Tianjin, Peoples R China.
[22]Qingdao Univ, Affiliated Hosp Qingdao, Qingdao 266071, Peoples R China.
[23]Fujian Med Univ, Union Hosp, Fujian, Peoples R China.
[24]Sichuan Univ, West China Hosp, Chengdu 610064, Peoples R China.
[25]Bengbu Med Coll, Affiliated Hosp 1, Bengbu, Peoples R China.
[26]Xijing Hosp, Xian, Peoples R China.
[27]Anhui Med Univ, Affiliated Hosp 1, Hefei, Peoples R China.
[28]Third Mil Med Univ, Xinqiao Hosp, Chongqing, Peoples R China.
[29]Luzhou Med Coll, Affiliated Hosp, Luzhou, Peoples R China.
[30]Zhejiang Univ, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China.
[31]Jilin Prov Canc Hosp, Changchun, Peoples R China.
[32]Ningxia Med Univ, Gen Hosp, Ningxia, Yinchuan, Peoples R China.
[33]Shantou Univ, Coll Med, Canc Hosp, Shantou, Peoples R China.
[34]Jiangsu Hengrui Med, Lianyungang, Jiangsu, Peoples R China.
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