Axitinib shows promise in kidney cancer

October 29, 2007

NEW YORK (Reuters Health) - Axitinib has promising activity and manageable toxicity in patients with metastatic cytokine-refractory renal cell cancer, according to study results released today and published in the November issue of The Lancet Oncology.

Axitinib is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, which are important in renal cell cancer pathogenesis.

Dr. Olivier Rixe, from the University of Paris, France, and colleagues assessed the clinical activity and safety of axitinib at a starting dose of 5 mg twice daily in 52 patients with metastatic kidney cancer who had failed previous cytokine-based therapy. Fifty-one of the study subjects had clear-cell renal cancer.

The researchers report that two patients had complete responses and 21 had partial responses to axitinib treatment, for an objective response rate of 44.2%. However, 12 responders experienced disease progression during the study, with duration of response ranging from 4 months to 26 months.

Additionally, 22 patients saw their disease stabilize for longer than 8 weeks during the study, including 13 patients who had stable disease for 24 weeks or longer. Four patients had early disease progression.

Axitinib-related side effects included diarrhea, hypertension, fatigue, nausea, and hoarseness, Dr. Rixe and colleagues report. Treatment-related hypertension, seen in 30 patients, resolved with antihypertensive treatment in all but 8 patients, 7 of whom had a history of hypertension at baseline.

In a commentary on the study, Dr. W. Marston Linehan of the National Cancer Institute, Bethesda, Maryland, states that these findings "suggest that a drug such as axitinib has promise as a second-line treatment in cytokine-refractory metastatic renal-cell carcinoma, and might have potential as first-line treatment or in combination with other agents targeting the Von Hippel-Lindau pathway (or both)."