Apatinib Shows Efficacy In Heavily Pretreated Patients With Gastric Cancer

Overall and progression-free survival may be extended in gastric and gastro-oesophageal junction cancer patients given apatinib for advanced, chemotherapy-refractory disease

medwireNews: Phase III trial results suggest the vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor apatinib may prolong the survival of patients with advanced or metastatic, heavily pretreated, gastric and gastro-oesophageal junction cancer.

The study included Chinese patients who had received at least two prior lines of chemotherapy and for whom there are no widely accepted standard treatments, explain Shukui Qin, from 81st Hospital of People’s Liberation Army in Nanjing, China and co-workers.

Overall survival was significantly longer for the 176 patients randomly assigned to take apatinib 850 mg/day in 4-week cycles than the 91 patients given placebo, at an average of 6.5 versus 4.7 months and a hazard ratio (HR) of 0.71.

This was confirmed by per protocol analysis – after withdrawal of five apatinib- and one placebo-treated patient from the trial before treatment – showing a significant improvement in overall survival for the apatinib group, at 7.6 months versus 5.0 months (HR=0.62)

And progression-free survival was also significantly longer with apatinib than placebo for both the full and per protocol analyses, at a mean of 2.8 months versus 1.9 months (HR=0.44), and 2.8 versus 1.9 months (HR=0.46), respectively.

Apatinib-treated patients more often required dose adjustment (21.0 vs 3.3%) and the drug was associated with significantly higher rates of grade 3 hand–foot skin reactions (8.5 vs 0%) and grade 3–4 hypertension (4.5 vs 0%) and proteinuria (2.3 vs 0%). Patients given apatinib also had a trend towards an increased rate of grade 3–4 neutropenia but this was not significant.

However, apatinib was used for a significantly longer duration than placebo (median, 11.6 vs 7.6 weeks) and the investigators describe apatinib in the Journal of Clinical Oncology as having “moderate, reversible, and easily managed adverse events.”

Indeed, noting that apatinib may have a “favourable safety profile in comparison with other antiangiogenic agents”, especially with regard to cardiovascular toxicity, the authors suggest that apatinib may be a “promising” option for recurrent gastric cancer.

Apatinib is now also being assessed for the treatment of other solid tumours including non-small-lung cancer and hepatocellular carcinoma, they add.


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. J Clin Oncol 2016; Advance online publication 16 February. doi: 10.1200/JCO.2015.63.5995

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