Sorafenib Superior to Placebo in Overall Survival for Primary Liver Cancer Patients: Presented at ASCO

The multi-kinase inhibitor sorafenib (Nexavar) is superior to placebo in overall survival among patients with primary liver disease, researcher reported here at the 43rd American Society of Clinical Oncology Annual Meeting (ASCO).

"After 30 years and 100 failed clinical trails, we now have something that works in these patients," said Joseph Llovet, MD, director of research, Mount Sinai School of Medicine, New York, New York, United States. "This is the first time we've had an effective systemic treatment for liver cancer."

Dr. Llovet said that when compared with placebo, patients who received sorafenib tablets lived an average of 10.7 months compared with 7.9 months for patients on placebo. Although modest, the 2.8 survival advantage for sorafenib was highly significant (P =.00058), he said.

He presenting the findings from the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) trial a late breaking study on June 4th.

Sorafenib, an oral tablet, is approved in the United States for treatment of kidney cancer, and is being tested in patients with other cancers as well.

About 19,000 people in the United States contract liver cancer each year and more than 16,000 people die of the disease each year, according to statistics from the American Cancer Society.

"This really is a big deal," said A. William Blackstock, MD, professor of radiation oncology, Wake Forest University, Winston-Salem, North Carolina, United States, who moderated a press briefing on the results of the trial.

"We really don't have anything to treat advanced liver cancer, and 40% of patients in the United States with liver cancer are diagnosed in an advanced state," Dr. Blackstock said. "This will give us a platform upon which we can perform clinical trials."

He said that conducting a placebo-controlled study would be nearly impossible in the United States because most patients would refuse to enter a trial in which one arm would contain sham medication.

With the ability to offer a medicine that can extend survival as a comparator drug, new medications can be tested against sorafenib and could lead to further improvements in survival.

"Because there are no therapies that significantly improve survival for the thousands of patients with liver cancer, these findings demonstrate the compelling study results of Nexavar as the new reference standard of care for the first-line treatment of hepatocellular cancer," Dr. Llovet said.

In their study, Dr. Llovet and colleagues recruited 602 patients -- 299 patients received 400 mg of sorafenib and 303 patients received placebo. The trial was truncated because early review indicated that patients were doing better with sorafenib than with placebo.

Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, commented, "We are looking at a true increment in survival."

"While primary liver cancer is not a huge disease concern in the United States, it is a serious problem worldwide. In the United States, its incidence is increasing," he added.

One of the advantages of sorafenib in the treatment of liver cancer is that the drug does not appear to cause a lot of toxicity, Dr. Lichtenfeld said. "In the study, the toxicity was similar to that of placebo," he noted.

Dr. Blackstock said he expects doctors who have patients with liver cancer to start using the drug as soon as possible. The question of whether the drug will be reimbursed by third party payers is in the air. He said the drug costs $5,000 a month.

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