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Targeted Drug Boosts Survival Among Liver Cancer Patients

Sorafenib added three months for those with advanced disease, study finds

WEDNESDAY, July 23, 2008 (HealthDay News) -- The drug Nexavar can prolong the lives of people with liver cancer by an average of three months, new research shows.

"The results unequivocally showed that sorafenib (Nexavar) increased the survival of patients with a more than 30 percent reduction in the likelihood to die at any time point during follow-up," said study senior author Dr. Jordi Bruix, a senior consultant in the liver unit of the Hospital Clinic of Barcelona.

"These results identify sorafenib as the first agent that is effective in improving survival in patients with this devastating disease," said Bruix. His report is in the July 24 issue of the New England Journal of Medicine.

"Up to now, the patients diagnosed with advanced hepatocellular carcinoma had no effective treatment that could improve their survival. Now, we have an option that is based on oral treatment that is effective if liver function is still preserved," added study author Dr. Josep Maria Llovet, director of research in liver cancer at Mount Sinai School of Medicine in New York City, and a professor at the Barcelona Clinic Liver Cancer (BCLC) Group in Barcelona.

More than 21,000 Americans are diagnosed with liver cancer each year, according to the American Cancer Society (ACS). About 18,410 people will die because of liver cancer during 2008, reports the ACS. The disease is much more common in men and is more likely to occur in people who've been infected with viral hepatitis B or C.

Treatment options for liver cancer are often limited. If the disease is caught early, it's sometimes possible to remove the tumor or perform a liver transplant. Chemotherapy isn't particularly effective in liver cancers, because one of the liver's main functions is to detoxify drugs.

"When you administer drugs you want to affect the liver, the liver wants to detoxify them and render them ineffective. The liver is also very active in getting rid of drugs and pumping the drugs out of the liver," explained Dr. Lewis Roberts, director of the hepatobiliary neoplasia clinic at the Mayo Clinic in Rochester, Minn.

The current study was a randomized, placebo-controlled study that included 602 people with advanced liver cancer. Despite that, however, the study volunteers still retained liver function.

Although there was no significant difference in the time to symptomatic progression of the disease, there was approximately a three-month increase in survival, on average, for the sorafenib group.

Sorafenib works by slowing down cell proliferation and reducing the formation of new blood vessels that feed the tumor mass, according to Llovet. So, while the medication doesn't reduce the size of the tumor, it can delay the progression of the disease. In fact, Llovet said, they've had patients who have remained progression-free for more than three years.

Llovet also said the researchers are combining sorafenib with other treatments to see if they can make further progress against this deadly cancer. And the researchers are testing sorafenib earlier in the course of the disease to see if it might be even more effective then.

The drug was generally well-tolerated. Fatigue was the most common side effect.

Roberts said the findings are very exciting. "For the first time, we have a drug that has been clearly shown to improve survival." But, he added, "this is clearly just a first step," and he'd like to see more emphasis on prevention and screening for high-risk populations. He said that anyone who has been diagnosed with hepatitis B or C should be screened with an ultrasound every six months, so that if liver cancer develops, it can be treated early.

Additionally, Roberts pointed out that sorafenib is quite expensive, averaging more than $5,000 a month for treatment. The drug is currently approved in the United States for the treatment of a form of advanced kidney cancer.

The study was supported by Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals, makers of Nexavar.

More information

The U.S. National Cancer Institute has more information on liver cancer.

SOURCES: Jordi Bruix, M.D., head, Barcelona Clinic Liver Cancer group, and senior consultant, Liver Unit, Hospital Clinic of Barcelona, University of Barcelona, Spain; Josep Maria Llovet, M.D., director, research in liver cancer, Mount Sinai School of Medicine, New York City, and professor, Barcelona Clinic Liver Cancer Group, Barcelona, Spain; Lewis Roberts, M.B., Ph.D., associate professor, medicine, and director, hepatobiliary neoplasia clinic, Mayo Clinic, Rochester, Minn.; July 24, 2008, New England Journal of Medicine
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