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June 8, 2007:
The findings of a clinical trial in the United
States has put forward a drug that is likely to
become the first effective treatment for liver
cancer, one of the most common and deadliest
cancers in the world.
In a large clinical trial, the drug called Nexavar
extended the lives of patients by almost three
months, or 44%. While that is far from a cure,
experts say that it represents a breakthrough
after years of efforts to find a drug that works.
The findings of the clinical trial were presented
by doctors at the meeting of the American Society
of Clinical Oncology in Chicago, the United
States. Incidentally, the incidence of liver
cancer has been rising in the United States.
Dr Josep M Llovet, one of the principal
investigators in the trial, said: “We did not have
anything for these patients; now we have an
effective drug that prolongs survival.”
Nexavar, also known as sorafenib, was developed by
Onyx Pharmaceuticals, a California-based
biotechnology company, and Bayer, the German
pharmaceutical firm. The companies said they would
apply this summer for regulatory approval to sell
Nexavar as a treatment for liver cancer.
The drug is already approved as a treatment for
kidney cancer, which means that doctors are
allowed to prescribe it “off label” for patients
with liver cancer.
In the trial, patients who received Nexavar lived
a median of 10.7 months, compared with 7.9 months
for those who received a placebo. The main side
effects were diarrhea and a painful syndrome in
the hands and feet.
The trial involved 602 patients with
hepatocellular carcinoma, the most common form of
liver cancer by far. Experts said the results
would not apply to other forms of liver cancer or
to cancers that originated elsewhere, such as in
the lung or breast, and then spread to the liver.
An improvement of survival of 2.8 months is
considered significant for cancer drugs, given the
difficulty of treating the disease. However, there
has been rising concern among doctors, patients
and insurers about the cost of adding a few months
to life. Nexavar, like many other new cancer
drugs, is expensive – costing $4,500 a month.
Most cases of liver cancer occur in people who
already have cirrhosis of the liver, a scarring of
the organ that in turn can be caused by hepatitis
B or hepatitis C, alcohol abuse, or obesity.
Worldwide, there are about 600,000 new cases of
liver cancer a year, making liver cancer one of
the most common cancers and cancer deaths
globally.
If liver cancer is diagnosed when the tumor is
confined to a small area of the liver, it can
often be treated by surgically removing part of
the liver. Liver transplants can cure the disease,
though there is a shortage of donor organs. There
are also some other localised treatments, like one
that involves inserting particles into the liver
artery to cut off the flow of blood to the tumor.
Nexavar is one of a new generation of biotech
drugs that has started to transform cancer
treatment. Taken in doses of four pills a day, the
drug blocks both the blood supply to the tumor and
also proteins in cancer cells that spur tumor
growth.
However, outside experts say that though the drug
represents a promising advance, the patients in
the trial had fairly healthy livers.
BY OUR PHARMA CORRESPONDENT
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