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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 期刊论文 WOS高被引论文

编号：

81c785a8-8b08-43cb-815d-3194b616d491
作者：

Li, Jin^[1] Qin, Shukui^[4] Xu, Jianming^[7] Xiong, Jianping^[9] Wu, Changping^[10] Bai, Yuxian^[11] Liu, Wei^[12] Tong, Jiandong^[13] Liu, Yunpeng^[14] Xu, Ruihua^[15] Wang, Zhehai^[16] Wang, Qiong^[17] Ouyang, Xuenong^[18] Yang, Yan^[20] Ba, Yi^[21] Liang, Jun^[22] Lin, Xiaoyan^[23] Luo, Deyun^[24] Zheng, Rongsheng^[25] Wang, Xin^[26] Sun, Guoping^[27] Wang, Liwei^[2,3] Zheng, Leizhen Guo, Hong^[28] Wu, Jingbo^[29] Xu, Nong^[30] Yang, Jianwei^[19] Zhang, Honggang^[8] Cheng, Ying^[31] Wang, Ningju^[32] Chen, Lei^[33] Fan, Zhining^[5] Sun, Piaoyang^[34] Yu, Hao^[6]
语种：

英文
期刊：

JOURNAL OF CLINICAL ONCOLOGY ISSN：0732-183X 2016 年 34 卷 13 期 (1448 - +) ; MAY 1
收录：
摘要：

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
推荐引用方式
GB/T 7714：

Li Jin,Qin Shukui,Xu Jianming, 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-+.
APA：

Li Jin,Qin Shukui,Xu Jianming,Xiong Jianping,&Yu Hao.(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):1448-+.
MLA：

Li Jin, 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-+.

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