Activity and Safety of Tivozanib in Advanced Renal Cell Carcinoma
Dmitry A. Nosov, MD, PhD, of Blokhin Oncology Research Center in Moscow, and colleagues found tivozanib to be active and well tolerated in patients with advanced/metastatic renal cell carcinoma. The results of their phase II randomized discontinuation trial with this vascular endothelial growth factor receptor inhibitor, which appeared in the Journal of Clinical Oncology, seem to support the ongoing phase III evaluation of this agent in this patient population.
A total of 272 patients took part in the study. At 16 weeks, the 78 patients whose tumors had shrunk by 25% or more continued treatment with tivozanib, and the 118 patients whose tumor shrinkage was less were randomly divided into two groups: one received placebo and the other, tivozanib.
After 16 weeks of tivozanib, the objective response rate was 18%. Of the 118 randomized patients, more patients who had been continuously treated with tivozanib were free of disease progression after 12 weeks than those who received placebo (49% vs. 21%). In the overall study population, the median progression-free survival was 11.7 months. As for toxicity, hypertension was the most common grade 3 and 4 treatment-related adverse event, occurring in 12% of patients treated with tivozanib.