Nexavar Hailed as Breakthrough in Treatment of Advanced Liver Cancer
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Reviewed By Louise Chang, MD
June 4, 2007 (Chicago) -- After more than 30 years of research and hundreds of studies, a pill has been shown to extend the lives of people with liver cancer, the third leading cause of cancer death worldwide.
In a study of more than 600 people with advanced liver cancer, those given the drug Nexavar lived nearly three months longer than those given a placebo.
Though three months may not sound like much, doctors say the drug represents a breakthrough that will become the standard of care for people with advanced liver cancer.
Researcher Josep M. Llovet, MD, a liver cancer specialist at both Mount Sinai School of Medicine in New York, and the University of Barcelona in Spain, says that doctors have nothing to offer people whose liver cancers are diagnosed at an advanced stage. In the U.S. and Europe, 40% of liver cancers are diagnosed at a late stage; elsewhere in the world, the figure stands at 70%.
"Now for the first time we have a drug that works in this population," he tells WebMD.
Study Halted Prematurely
Llovet notes that over the past few decades, tests of dozens of other new drugs have failed. In contrast, the results of the study were so striking that the study was halted prematurely so that all participants could be offered Nexavar.
"This is the first time a treatment has ever been shown to offer this kind of survival advantage to these patients," says A. William Blackstock, MD, a cancer doctor at Wake Forest University School of Medicine in Winston-Salem, N.C.
He says that typically, people diagnosed with advanced liver cancer have only months to live.
Since Nexavar is already approved for use in the treatment for kidney cancer, doctors are likely to prescribe it "off label" to people with liver cancer while awaiting the FDA to formally approve it for that use, he says.
Blackstock moderated a news briefing at which the findings were released at the annual meeting of the American Society of Clinical Oncology.
Nexavar Well Tolerated
In the study, people with advanced liver cancer were randomly assigned to receive either Nexavar or placebo twice a day.
Those who took Nexavar lived a median of 10.7 months, compared with 7.9 months for those on placebo.
Put another way, people on Nexavar have a 44% improvement in survival over those on placebo, Llovet says.
The drug also delayed progression of the cancer: 5.5 months vs. 2.8 months for placebo.
Nexavar was very safe, with the most common side effect being diarrhea and fatigue, he says.
"Part of the excitement of this drug is that is a very well-tolerated agent," Blackstock says.
Though the price tag is high -- about $5,000 a month -- he says he doubts that will be a barrier due to a dearth of other options.
Llovet adds that already, some insurance companies are picking up the cost of the drug in individual cases.
A targeted therapy, Nexavar attacks the tumor on multiple fronts, starving it of its blood supply, interfering with cell signaling that spurs tumor growth and preventing cell division.
Globally, 560,000 people get liver cancer each year, with 595,000 people a year dying from it.
In the U.S.,19,000 new cases and nearly 17,000 deaths are expected this year. Rates are on the rise because of an increase in the number of people infected with hepatitis C, one of the leading causes of liver cancer, Llovet says.
SOURCES: 43rd Annual Meeting of the American Society of Clinical Oncology, Chicago, June 1-5, 2007. Josep M. Llovet, MD, Mount Sinai School of Medicine, New York; University of Barcelona, Spain. A. William Blackstock, MD, Wake Forest University School of Medicine, Winston-Salem, N.C. World Health Organization. Johns Hopkins Liver Cancer Center.
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