Christophe Massard, MD, researcher, department of immunotherapy and innovative therapy unit, Gustave Roussy Institute, Villejuif, France, and colleagues reviewed the charts and X-rays of 189 renal-cancer patients who had been randomized to treatment with sorafenib 400 mg twice daily or best supportive care plus placebo.

All subjects had histologically/cytologically confirmed disease that was unresectable and/or metastatic with clear cell histology. They also had measurable disease and failed 1 prior systemic therapy in the last 8 months. Subjects' Eastern Cooperative Oncology Group performance status was 0 or 1, and they had good organ function.

Overall, 7% of 139 patients in this series had brain metastasis, Dr. Massard said in his presentation on October 1^st. Brain metastasis occurred in 3% of the 73 sorafenib-treated patients compared with 12% of 66 patients in the group that received best supportive care.

The incidence of brain metastases was also lower for sorafenib than placebo at 1 year (3% vs 10%) and 2 years (4% vs 20%).

Dr. Massard said that it is not clear which of the molecular targets of sorafenib contribute to this antimetastatic effect, nor is it clear whether this effect is due to sorafenib acting on the primary tumor to prevent the formation of metastases or crossing the blood-brain barrier to prevent growth of metastatic cells in the brain.

He added that further studies are needed to investigate the antimetastatic effects of sorafenib in advanced renal-cell carcinoma and to determine the mechanisms by which sorafenib exerts these effects.

On the basis of its significant progression-free survival benefit over placebo, sorafenib has been approved for the treatment of advanced renal-cell carcinoma in the U.S., Canada, Switzerland, Mexico, Chile, Brazil, Korea, and Argentina.

Sorafenib has also received marketing approval from the European Commission for the treatment of patients with advanced renal-cell carcinoma who have failed prior interferon or interleukin-2 therapy or who are ineligible for cytokine therapy.

The study was sponsored by Bayer Pharmaceuticals Corporation.


[Presentation title: Incidence of Brain Metastasis in Advanced Renal Carcinoma Among Patients Randomized in a Phase III Trial of Sorafenib, an Oral Multi-Kinase Inhibitor. Abstract 454P]

Copyright © 2009 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.