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 : Official Journal of the American Society of Clinical Oncology
Jin LiHao Yu

Abstract

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. 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). 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...Continue Reading

Associated Clinical Trials

References

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Aug 7, 2013·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jin LiHao Yu

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Citations

Jan 17, 2019·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Letizia ProcaccioFotios Loupakis
Jan 13, 2018·Clinical Pharmacology and Therapeutics·Gaurav BajajJennifer Sheng
Mar 1, 2019·Experimental & Molecular Medicine·Zhichao LiaoJilong Yang
Dec 18, 2018·Endocrine Connections·Shan WuZai Wang
Apr 12, 2019·Cancer·Megan GreallyDavid H Ilson
Apr 14, 2016·Nature Reviews. Clinical Oncology·Toru Aoyama, Takaki Yoshikawa
Apr 16, 2019·Anti-cancer Drugs·Jingjing WangChunhong Hu
Dec 15, 2017·Cancer Medicine·Nikolaos CharalampakisAmanda Psyrri
Jun 1, 2017·American Society of Clinical Oncology Educational Book·Tomoyuki IrinoYuko Kitagawa
May 2, 2019·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·K ZhouQ Li
Dec 22, 2019·Gastric Cancer : Official Journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association·Li-Tzong ChenNarikazu Boku
Jun 1, 2018·Oncotarget·Feng LiJilong Yang
Dec 30, 2017·Oncotarget·Yinlong KongLunxiu Qin
Feb 23, 2020·Oncotarget·Raquel Carvalho MontenegroSusanne Müller

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