© 2005-2012 American Society of Clinical Oncology (ASCO). All rights reserved worldwide.
June 4, 2007
A new study shows that sorafenib (Nexavar) helps patients with advanced liver cancer live about 44% longer than patients who did not receive this drug. Sorafenib is a pill that is taken by mouth. It is approved in the United States for treating a type of advanced kidney cancer and is being studied for treating other cancers.
Advanced liver cancer has spread throughout the liver and/or to other parts of the body, such as the lungs and bones. About 40% of liver cancers are diagnosed at an advanced stage. Treatment options include surgery (if possible), radiation therapy, and/or chemotherapy delivered directly to the liver, but no effective systemic drug (medication that enters the bloodstream) has proven effective for treating this type of liver cancer.
In this phase III clinical trial, researchers measured the overall survival and time it took for the cancer to grow among 602 patients with previously untreated liver cancer. About half (299 patients) received sorafenib, and 303 patients received a placebo (inactive pill) for six months. The researchers found that patients who received sorafenib lived an average of nearly 11 months, compared with 8 months for those who received the placebo. The cancer took about five and a half months to grow in patients taking sorafenib and nearly three months for patients taking the placebo. Because the findings from this study were so positive, the study was stopped early.
The occurrence of side effects was similar between the two groups of patients. Some of the patients taking sorafenib experienced diarrhea (11%) compared with 2% of the patients taking the placebo, and 8% of those taking sorafenib had skin reactions to the hands and feet compared with 1% of the patients taking the placebo.
What This Means for Patients
"This is the first time that we've had an effective systemic treatment for liver cancer," said Joseph Llovet, MD, Director of Research in Liver Cancer at the Mount Sinai School of Medicine in New York City, Professor of Research at the Institut d'Investigacions Biomediques August Pi i Sunyer Hospital Clinic in Barcelona, and lead author of the study. "Our findings demonstrated meaningful survival advantages for patients with liver cancer."