March 31, 2009

Nexavar® Is Better Tolerated than Interferon in Patients with Metastatic Renal Cell Carcinoma


In patients with untreated renal cell cancer (RCC), Nexavar® (sorafenib) results in a similar progression-free survival (PFS) to interferon, yet patients experience greater rates of tumor shrinkage and report a better quality of life (QOL) with Nexavar than with interferon. The results of this study were published in the Journal of Clinical Oncology.1 

The kidneys are each filled with tiny tubules that clean and filter the blood—the process that removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. Metastatic RCC refers to cancer that has spread from the kidney to distant sites in the body.

Typically, RCC has a poor prognosis and is resistant to chemotherapy. Nexavar is an oral targeted agent that blocks the growth of cancer cells by inhibiting several biological pathways that are involved in cellular replication and spread. It is currently approved for the treatment of advanced RCC, as well as inoperable liver cancer.

Researchers conducted a Phase II study to compare the efficacy and safety of first-line Nexavar with that of interferon in patients with metastatic RCC. The study included 189 patients who were randomly assigned to receive 400 mg of oral Nexavar twice daily or injections of interferon three times per week (period one of study). In period two of the study, the Nexavar patients who experienced disease progression had their dose escalated to 600 mg twice daily, while the interferon patients who progressed were switched to 400 mg of Nexavar twice daily.

In period one of the study, the PFS was similar between the two groups (5.7 months for Nexavar versus 5.6 months for interferon). However, 68.2% of the Nexavar patients experienced tumor shrinkage compared with 39% of patients treated with interferon. Furthermore, the patients treated with Nexavar reported fewer side effects and a better quality of life than those treated with interferon.

During period two of the study, the median PFS was 3.6 months for patients who were dose-escalated to 600 mg of Nexavar twice daily and 5.3 months for the patients who crossed over from interferon to 400 mg of Nexavar twice daily. In the dose-escalated group, 41.9% experienced tumor shrinkage, while 76.2% of patients who crossed over to Nexavar experienced tumor shrinkage.

The researchers concluded that Nexavar produced a similar PFS to interferon in patients with advanced RCC; however, Nexavar appeared to be better tolerated.


1 Escudier B, Szcylik C, Hutson TE, et al. Randomized phase II trial of first-line treatment with sorafenib versus interferon alfa-2a in patients with metastatic renal cell carcinoma. Journal of Clinical Oncology. 2009; 27:1280-1289.

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Tags: Renal Cancer, Uncategorized