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Sorafenib offers hope
in the battle for liver cancer survival
Sorafenib offers hope in the battle for liver cancer
survival
The outlook for
hepatocellular
carcinoma (HCC) sufferers is bleak - current medication has a five-year
survival rate for those with liver cancer of less than 5% in the developed
world and even lower in developing countries. However, patients in trials of a
new drug called Sorafenib have seen their survival times double.
Sorafenib offers hope in the battle for liver cancer
survival
Sorafenib offers hope in the battle for
liver cancer survival
(Published 17th December 2004)
The
outlook for hepatocellular
carcinoma (HCC) sufferers is bleak - current medication has a five-year
survival rate for those with liver cancer of less than 5% in the developed
world and even lower in developing countries. However, patients in trials of a
new drug called Sorafenib have seen their survival times double. Datamonitor's
Dr Lorna Fern investigates...
Liver cancer is
currently the fifth most common cancer in the world, responsible for about one
million cases and half a million deaths globally every year. HCC is a tumor of
the liver that arises from focal scarring points in cirrhotic liver tissue, and
its global incidence is on the increase, concurrent with a global increase in
the number of cases of viral hepatitis and of alcoholic cirrhosis in developed
countries.
Some specialists have described it as a 'waiting epidemic'.
In the US alone there has been a three-fold increase in the incidence of HCC
over the last decade. Similar trends have been seen in four other
pharmaceutical markets including the United Kingdom, France and
Canada.
Bleak outlook
Furthermore, opinion leaders predict
that the full effect of hepatitis B (HBV)
vaccination programs will not be felt for another 10-15 years. There is no
hepatitis C (HCV) vaccine and the effect of blood screening programs introduced
in the 1990s will not curb the rising incidence of HCV-related HCC for at least
two decades.
The effects of binge drinking on the increasing incidence
of HCC remains to be seen. However, today's binge drinking culture has already
been linked to an increase in liver cirrhosis in developed countries, and thus
may in turn increase the numbers of HCC cases. Studies have found that liver
cirrhosis is becoming a major public health concern in the UK, and it is
affecting men and women at younger ages than ever seen before. Datamonitor
predicts the incidence of HCC will continue to increase resulting in a large,
clinically underserved patient population.
The treatment of
liver cancer
presents a formidable challenge to physicians as it frequently presents in the
setting of liver cirrhosis. HCC is often described as two diseases in one - a
virulent malignant disorder arising in the setting of chronic liver disease.
Between 70-90% of HCC patients will have liver cirrhosis at the time of
diagnosis.
The problem in patients with liver cirrhosis is that the
cirrhosis itself severely compromises liver function. This increases the
toxicity of anticancer drugs as the pivotal role that the liver plays in their
detoxification and removal is diminished. Indeed it is often the condition of
the remaining liver that dictates the final treatment options.
HCC
patients not only require effective agents to treat the tumor, but there is
also significant unmet need for drugs that will stabilize and treat the
underlying liver disease. Surgical resection of the primary tumor or liver
transplantation are the only potentially curative options for HCC patients.
However, because it is complicated by underlying liver cirrhosis, only 10% of
patients are eligible for surgery.
Current chemotherapy agents only
offer a modest response rate of up to 20% at best, with no significant benefit
to the overall survival rate.
New therapies to capitalize on unmet
need
Any new therapy for HCC will gain rapid up take if it shows
even a modest increase in efficacy or reduction in toxicity over current
regimes. Bayer's Sorafenib has shown potential in early trials to double
patient survival time through its novel mechanism of action that cuts off blood
supply to the cancer cells.
The demonstrated increase in survival time
with Sorafenib is significant in HCC patients as current therapeutic options
offer a modest four months survival with considerable toxicity. For HCC
patients Sorafenib doubles this survival time to approximately 9 months, and,
although this could be described as only a minor improvement for HCC patients,
Sorafenib's favorable toxicity profile makes this drug even more appealing,
Furthermore the additional time gained for patients to spend with their
families and loved ones is invaluable.
Although this is exciting data it
needs to be confirmed in larger trials, which are planned. Assuming trials with
Sorafenib continue to go well, Datamonitor expects it to hit the US market in
2006.
In the meantime, Eximias Pharmaceutical's Thymitaq and Amgen's T67
are the only agents currently in phase III trials for HCC, however, opinion
leaders predict that while these agents provide alternatives to current therapy
options they would be unlikely to provide significant improvement in survival
for HCC patients. There is optimism that innovative-targeted therapies, which
target pathways critical to cancer cell survival, such as Sorafenib, hold
promise for HCC patients. Well designed controlled trials of these agents in
HCC patients are warranted.
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