Fight Against Liver Cancer Gains New Ammunition
< Jun.
06, 2007 > -- Researchers have announced
the first drug to make major inroads against liver
cancer, one of the more aggressive types of cancer.
Nexavar® (sorafenib
tosylate), made by Bayer, gave patients with advanced
liver
cancer 44 percent more time to live, compared to
patients who did not receive the drug, according
to results presented earlier this week at the annual
meeting of the American Society
of Clinical Oncology (ASCO), in Chicago.
In fact, results of a major clinical
trial with Nexavar were so successful that the trial
was halted early, the researchers say.
"This is the first systemic therapy
to prolong survival in [liver cancer] patients," says
Dr. Joseph Llovet, lead author of the study and director
of research in liver cancer at Mount Sinai School
of Medicine in New York City. "This is a new reference
standard for systemic therapy of [liver cancer] patients
after 30 years of research and more than 100 randomized
controlled trials performed."
Dr. Len Lichtenfeld, deputy chief
medical officer of the American
Cancer Society, adds, "This is going to change
the standard of practice."
Liver cancer is the third leading
cause of cancer death in the world and often causes
death within a year of diagnosis. About 40 percent
of liver cancers (up to 80 percent in Asia and sub-Saharan
Africa) are diagnosed at an advanced stage, in part
because it advances so rapidly.
Surgery is sometimes possible,
and radiation and chemotherapy can also be options.
But until now, there has been no systemic treatment,
meaning a medication that enters the bloodstream.
"There is no established standard
of care for liver cancer even though it is one of
the leading causes of death," says Dr. A. William
Blackstock, professor of radiation oncology at Wake
Forest University in Winston-Salem, North Carolina.
Nexavar, which is taken in tablet
form, is already approved in the US for treating
advanced kidney cancer. It is also being studied
for various other cancers; results of some of those
studies were presented at the ASCO meeting
this week.
In this study, 602 patients with
advanced liver cancer were randomly assigned to receive
either 400 milligrams of Nexavar twice a day or a
placebo for six months.
Patients receiving the drug lived
a median of 10.7 months, compared with only 7.9 months
for those on a placebo. Time to cancer progression
was 5.5 months in the Nexavar group, versus only
2.8 months in the placebo group. The findings were
so positive that the study was terminated early.
"We recommended ending the trial
early because of survival advantages favoring the
sorafenib [Nexavar] group," says Dr. Llovet.
Side effects were similar in the
two groups, the most common being diarrhea, skin
reactions, fatigue, and bleeding.
"Sorafenib was well tolerated
with manageable side effects," Dr. Llovet says.
Until now, patients suffering
from liver cancer in an initial phase have benefited
from procedures like resection, transplantation,
or ablation. Unfortunately, more than 60 percent
of cases of liver cancer are detected in an advanced
phase, making chemoembolization the only available
treatment.
Chemoembolization is a method
of delivering highly-concentrated chemotherapy directly
into a tumor, through a catheter (a long, thin, hollow
tube) that is inserted into a blood vessel leading
to the tumor.
Chemoembolization can only be
applied to 15 percent of liver cancer patients, and
until recently, there was no other effective treatment
for the rest of patients.
Sorafenib blocks a cellular cycle
signal pathway, preventing not only the proliferation
of tumor cells but also the formation of blood vessels
supporting the tumor. Therefore, it delays tumor
progression and, as a consequence, improves survival.
This implies a hopeful change
for patients, since until now, treatments tried to
eradicate the disease. New agents such as sorafenib
work to slow disease progression. If new drugs or
combinations of drugs inhibit cancer progression,
then it will allow those with cancer to live longer,
according to the researchers.
Always consult your physician
for more information.
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The IRB includes physicians, other
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