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J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

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.

Author information

1
Jin Li, Fudan University Shanghai Cancer Center; Liwei Wang, Shanghai First People's Hospital; Leizhen Zheng, XinHua Hospital Affiliated to Shanghai Jiaotong University, Shanghai; Shukui Qin, People's Liberation Army (PLA) Cancer Center, 81st Hospital of PLA; Zhining Fan, Second Affiliated Hospital of Nanjing Medical University; Hao Yu, Nanjing Medical University, Nanjing; Jianming Xu, 307th Hospital of PLA, Academy of Military Medical Sciences; Honggang Zhang, Chinese Academy of Medical Sciences Cancer Hospital, Beijing; Jianping Xiong, First Affiliated Hospital of Nanchang University, Nanchang; Changping Wu, First People's Hospital of Changzhou, Changzhou; Yuxian Bai, Harbin Medical University Cancer Hospital, Harbin; Wei Liu, Hebei Medical University Fourth Hospital, Hebei Provincial Tumor Hospital, Shijiazhuang; Jiandong Tong, Yangzhou No. 1 People's Hospital, Yangzhou; Yunpeng Liu, First Hospital of China Medical University, Shenyang; Ruihua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Zhehai Wang, Shandong Cancer Hospital, Jinan; Qiong Wang, Jiangsu Jiangyin People's Hospital, Jiangyin; Xuenong Ouyang, Fuzhou General Hospital of Nanjing Military Command; Jianwei Yang, Fujian Provincial Cancer Hospital, Fuzhou; Yan Yang, Gansu Cancer Hospital, Lanzhou; Yi Ba, Tianjin Medical University Cancer Institute and Hospital, Tianjin; Jun Liang, Affiliated Hospital of Qingdao University, Qingdao; Xiaoyan Lin, Fujian Medical University Union Hospital, Fujian; Deyun Luo, West China Hospital, Sichuan University, Chengdu; Rongsheng Zheng, First Affiliated Hospital of Bengbu Medical College, Bengbu; Xin Wang, Xijing Hospital, Xi'an; Guoping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Hong Guo, Xinqiao Hospital, Third Military Medical University, Chongqing; Jingbo Wu, Affiliated Hospital of Luzhou Medical College, Luzhou; Nong Xu, First Affiliated Hospital of Zhejiang University, Hangzhou; Ying Cheng, Jilin Provincial Cancer Hospital, Changchun;

Abstract

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.

PMID:
26884585
DOI:
10.1200/JCO.2015.63.5995
[Indexed for MEDLINE]

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