[OT] Liver Cancer Pill Extends Lives

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Liver Cancer Pill Extends Lives

Nexavar Hailed as Breakthrough in Treatment of Advanced Liver Cancer

By Charlene Laino

WebMD Medical News

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 p 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. 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. p M. Llovet, MD, Mount Sinai School of Medicine,

New York; University of Barcelona, Spain. A. Blackstock, MD, Wake Forest

University School of Medicine, Winston-Salem, N.C. World Health Organization.

s Hopkins Liver Cancer Center.

http://www.webmd.com/cancer/news/20070604/liver-cancer-pill-extends-lives?ecd=wn\

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