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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

Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, et al.

J Clin Oncol. 2016 Feb 16. [Epub ahead of print]

Editorial comment by Dr Lee:
Apatinib is a small molecule tyrosine kinase inhibitor (TKI) which selectively inhibits vascular endothelial growth factor receptor 2 (VEGFR-2). This randomized, double-blind, placebo-controlled phase III trial shows that apatinib monotherapy significantly improves progression-free survival (median PFS, 2.6 months in the apatinib arm versus 1.8 months in the placebo arm; p < 0.001) and overall survival (median OS, 6.5 months in the apatinib arm versus 4.7 months in the placebo arm; p = 0.0149) in patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction after failure with second-line therapy or later. The survival improvements with apatinib therapy is statistically significant but modest, and is consistent with the prior observation with ramucirumab therapy, another VEGF targeting agent, in the second-line setting.

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