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| |  Long-Term Data Confirm Sunitinib Superior to Interferon-Alpha in Treatment of Renal-Cell Carcinoma: Presented at ASCO By Cameron Johnston CHICAGO -- June 1, 2008 -- The final results of a large, multicentre trial have demonstrated superior overall survival when comparing sunitinib against interferon (IFN)-alpha in the treatment of metastatic renal cell carcinoma, according to research presented here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting. Robert Figlin, MD, City of Hope National Medical Center, Duarte, California reported the final findings from the phase 3 trial here on June 1 in a symposium on genitourinary cancers. A previous study had demonstrated superior progression-free survival and objective response rates when the 2 treatment options were compared (Motzer RJ et al. N Engl J Med. 2007;356:115-124). In a preliminary review of the data, which date back as far as 2004, mean progression-free survival of 11 months and an objective response rate of 39% were seen in patients treated with sunitinib 50 mg/day in a 6-week cycle, with 4 weeks on treatment followed by 2 weeks off. In an arm of patients who received IFN-alpha 9 million units subcutaneously 3 times per week, progression-free survival was 4 months and an objective response rate of 8% was seen. When the interim analysis was done in 2005, there was no statistically significant difference in overall survival, with approximately 60% of patients surviving 1 year. In the final analysis, however, mean overall survival for those patients receiving sunitinib (n = 375) was 26.4 months, compared with 21.8 months for patients receiving IFN-alpha (n = 375). While this difference was not significant, the data were reanalysed to exclude patients who had crossed over from IFN-alpha to sunitinib, and that difference was statistically significant (P = .0362). There were 190 deaths and 200 deaths in the 2 groups respectively. In a multivariate analysis, sunitinib was associated with a 24% improvement in overall survival compared with IFN-alpha (P = .009). The rate of progression-free survival was more or less unchanged from the interim analysis. Once the primary endpoint of progression-free survival had been reached, patients were allowed to go on to other therapies. The overall survival rate of almost 22 months in patients receiving IFN-alpha was interesting, Dr Figlin said, and reflects the fact that one-third of patients who were receiving this treatment in the initial study crossed over and received sunitinib at some point during the study. This difference might indicate that patients who received sunitinib initially had recovered enough from the disease that no further treatment was needed. In fact, there were 11 complete responses in the sunitinib arm compared with 4 in the IFN-alpha arm. On that basis, Dr. Figlin said sunitinib should now be considered the reference treatment for metastatic renal cell carcinoma, since it offers an improvement in overall survival, as well as improvements in objective response and progression-free survival. [Presentation title: Overall Survival With Sunitinib Versus Interferon (IFN)-Alfa as First-Line Treatment of Metastatic Renal Cell Carcinoma (mRCC). Abstract 5024]
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