Apatinib treatment significantly improved overall survival and progression-free survival in patients with advanced gastric cancer who had received 2 or more prior lines of chemotherapy, a study published in the Journal of Clinical Oncology has shown.1
Because there are currently no standard treatment options for patients with advanced metastatic gastric cancer who experience disease progression following 2 or more lines of chemotherapy, research sought to evaluate the safety and efficacy of apatinib in this setting. Apatinib is a novel vascular endothelial growth factor receptor 2 (VEGFR2) tyrosine kinase inhibitor.
For the double-blind, placebo-controlled, phase 3 study, researchers enrolled 267 patients with advanced gastric or gastroesophageal junction adenocarcinoma from 32 centers in China. All participants were refractory to 2 or more prior lines of treatment. Patients were randomly assigned to receive apatinib 850 mg orally once daily or placebo.
Results showed that median overall survival was 6.5 months (95% CI, 4.8 – 7.6) with apatinib compared with 4.7 months (95% CI, 3.6 – 5.4) with placebo (HR, 0.709; 95% CI, 0.537 – 0.937; P = .0156).
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Researchers found that apatinib also significantly improved median progression-free survival vs placebo (2.6 months; 95% CI, 2.0 – 2.9 vs 1.8 months; 95% CI, 1.4 – 1.9; HR, 0.444; 95% CI, 0.331 – 0.595; P < .001).
In terms of safety, the most frequently reported grade 3 to 4 nonhematologic adverse events were hand-foot syndrome, proteinuria, and hypertension, demonstrating an acceptable safety profile.
- Li J, Qin S, Xu J, 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 [published online ahead of print February 16, 2016]. J Clin Oncol. doi: 10.1200/JCO.2015.63.5995.