A total of 154 patients were randomized in 2:1 ratio to double-blind treatment with either single-agent famitinib – a multitargeted tyrosine kinase inhibitor that mainly targets the vascular endothelial growth factor receptor 2 (VEGFR2), c-Kit, and the platelet-derived growth factor receptor (PDGFR) – or placebo, each taken once daily.
Results showed that median progression-free survival was 2.8 months with famitinib versus 1.5 months with placebo (hazard ratio, 0.59; P = .0053), Dr. Xu reported. Findings were similar across subgroups. There was no significant difference in overall survival, which stood at about 7.5 months in each group. The overall response rate was statistically indistinguishable between groups, but the famitinib group had a higher disease control rate (59% vs. 31%, P = .0016).
There was no significant difference in quality of life, according to Dr. Xu, who disclosed that he had no relevant conflicts of interest.
Patients treated with famitinib had a higher rate of grade 3 or worse drug-related adverse events (46% vs. 20%) and drug-related adverse events leading to treatment discontinuation (13% vs. 5%).
The main grade 3 or 4 adverse events in the famitinib group were hypertension (11%), thrombocytopenia (10%), hand-foot syndrome (10%), and neutropenia (9%).