Sunitinib (Sutent®): A novel agent for the treatment of metastatic renal cell carcinoma

Objective. To provide a review of the clinical data supporting the use of sunitinib (Sutent®), a multi-targeted, small molecule, tyrosine kinase inhibitor, with focus on its approved indication for the treatment of advanced renal cell carcinoma in patients with metastatic disease requiring drug therapy. Data sources. A MEDLINE search of the medical literature was conducted using the terms 'sunitinib' and 'SU11248'. References from the articles were reviewed and relevant sources were included. Data summary. The introduction of dual tyrosine kinase receptor inhibitors is a novel approach to treating advanced metastatic renal cell carcinoma (mRCC) by preventing angiogenesis and tumor growth. Based on its ability to inhibit several targets involved in angiogenesis and endothelial cell proliferation, sunitinib offers patients with mRCC an alternative for treatment. A recent Phase III study evaluating sunitinib as first-line therapy showed a significant difference when compared to interferon-alfa (IFN-α) for a progression-free survival of 11 months in the sunitinib arm and 5 months in the IFN-α arm (hazard ratio 0.42; 95% CI 0.32-0-54; P<0.001). Two Phase II trials determined sunitinib was effective as second-line therapy in mRCC patients who failed previous cytokine treatment. Partial response rates were 40% (95% CI 28%-53%) and 34% (95% CI 25%-44%). Multiple ongoing trials are currently underway to evaluate sunitinib for first-line therapy in mRCC.