Researchers from the M. D. Anderson Cancer Center have reported that the addition of low-dose interferon-alfa (IFN) to Nexavar® (sorafenib) did not improve survivals of patients with advanced renal cell carcinoma (RCC). The details of this study were published early online in Cancer on October 27. 2009.[1]

Both Nexavar and IFN have shown significant activity in metastatic RCC, and it is possible that each agent will enhance the activity of the other. A previous Phase II study carried out by researchers at Duke University suggested that the combination of Nexavar and IFN had significant activity as first- or second-line therapy in patients with metastatic RCC.[2]

In the current study, 80 patients with previously untreated RCC were randomly allocated to treatment with Nexavar or Nexavar plus low-dose IFN. The median follow-up of this study was 19.7 months.

• Overall response rate was 30% for Nexavar alone and 25% for Nexavar plus IFN.
• Median progression-free survival was 7.39 months for Nexavar alone and 7.56 months for Nexavar plus IFN.
• Median overall survival was not reached in the Nexavar arm and was 27.04 months for the Nexavar plus IFN arm.
• Toxicities were similar between the two groups.
• Increased phosphorylated protein kinase B (pAKT) levels were associated with poorer outcomes.

Comments: These data show that the addition of IFN to Nexavar did not improve outcomes of patients with RCC as suggested in the Phase II study.

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