A multicenter randomized trial has shown Sutent (sunitinib malate) improves responses and progression-free survival over interferon for the treatment of metastatic kidney cancer. The details of this study were published in the January 11, 2006, issue of the New England Journal of Medicine.

Sutent is an oral kinase inhibitor of fms-like tyrosine kinase 3 (Flt3), Kit, VEGF, and PDGF receptors that is currently in clinical trials for treatment of a variety of malignancies. It produces anti-cancer effects through targeted mechanisms that include anti-angiogenesis, as well as direct killing of the cancer cell. In phase I-II studies, Sutent demonstrated anti-tumor and anti-angiogenic activity in RCC, as well as other solid tumors. In January 2006 the U.S. Food and Drug Administration (FDA) approved the use of Sutent for the treatment of gastrointestinal stromal tumors (GIST) that had progressed after Gleevec® (imatinib mesylate) and for advanced RCC.

Researchers from several medical institutions recently conducted a clinical trial to further evaluate Sutent in the treatment of metastatic RCC. This trial included 750 patients with metastatic RCC who had not received prior therapies. Patients were randomly allocated to be treated with Sutent or interferon.

• Progression-free survival was more than twice as long for patients treated with Sutent compared with those treated with interferon: 11 months with Sutent and five months with interferon.
• Responses were 31% for patients treated with Sutent, compared with just 6% for those treated with interferon.
• Patients treated with Sutent reported a better quality of life compared with those treated with interferon.

The researchers concluded that patients with metastatic RCC who have not received prior therapies have improved progression-free survival and improved quality of life if treated with Sutent rather than interferon.

Comments: This randomized trial confirms phase II studies.

Reference: Motzer R, Hutson T, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. New England Journal of Medicine 2007; 356:115-124.

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