According to updated results from a Phase III clinical trial, initial treatment of metastatic renal cell cancer (RCC) with Sutent® (sunitinib) results in significantly better response rates and progression-free survival than treatment with interferon alfa. These results were presented at the 2008 annual meeting of the American Society of Clinical Oncology (ASCO).

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 anticancer 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.

To compare Sutent to interferon in the initial treatment of metastatic RCC, researchers conducted a Phase III clinical trial among 750 patients. Patients were assigned to receive either Sutent or interferon.

Initial results from this study, published in 2007, indicated that patients treated with Sutent experienced significantly longer progression-free survival than patients treated with interferon.¹ At the 2008 ASCO meeting, researchers provided updated results from this study;² these updated results confirmed the benefits of Sutent that were reported previously:

• Progression-free survival was 11 months among patients treated with Sutent compared with five months among patients treated with interferon.
• Responses occurred in 47% of patients treated with Sutent compared with 12% of patients treated with interferon.
• Overall survival was 26.4 months among patients treated with Sutent compared with 21.8 months among patients treated with interferon. This result did not meet the criteria for statistical significance, which means that it could have occurred by chance alone.
• The most common serious (grade 3 or 4) adverse events among patients treated with Sutent were high blood pressure, fatigue, diarrhea, and hand-foot syndrome. The most common serious adverse events among patients treated with interferon were fatigue and loss of appetite.

Comments: These results provide additional evidence that Sutent improves outcomes among patients with metastatic kidney cancer.

Related News:

Sutent® Linked with Heart Problems (1/11/2008)

Sutent® Improves Progression-Free Survival Over Interferon in Kidney Cancer (1/18/2007)

Multicenter Trial Confirms Effectiveness of Sutent® for Treatment of Metastatic Renal Cell Carcinoma (6/23/2006)

Sutent® Approved by FDA for Treatment of Renal Cell Carcinoma and Gastrointestinal Stromal Tumor (4/4/2006)

Reference:

¹ 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.

² Figlin RA, Hutson TE, Tomczak P et al. Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). Proceedings from the 44th annual meeting of the American Society of Clinical Oncology. Chicago, IL. 2008. Abstract #5024.