JUNE 30, 2007
VOLUME 4 NO. 12

ADVANCES in MEDICINE

Liver cancer med first to boost survival

Sorafenib now first line treatment for patients with advanced disease


Liver cancer backgrounder

Causes: Hepatocellular carcinoma (HCC) is usually brought on by chronic liver disease or viral infections, namely Hepatitis B or C.

Diagnosis: There are hardly any symptoms in the early stages. "It's a question of 'if you think of it, you'll find it'," says Dr Sherman. "Diagnosis is made by radiology, it doesn't necessarily require a biopsy."

Mortality: HCC is the third most common cause of cancer death worldwide. Most patients die within a year of diagnosis.

Prevalence: In North America, HCC accounts for less than 1% of all cancers, while in Africa, Southeast Asia and China, it can be almost half of all cancers. "In the Western world, where all these studies are initiated, liver cancer has not been perceived as a major problem," Dr Sherman says. "That's changing now, because it is more frequent than before."

At long last, a treatment for advanced liver cancer that actually works. Sorafenib, a drug indicated for kidney cancer, bumps up survival rates of patients with advanced hepatocellular carcinoma (HCC) by 44%, according to a study in the June 20 supplement of the Journal of Clinical Oncology. That translates to an extra three months to live, not bad considering there's currently no effective treatment for this unfortunate population. The results were so positive that the trial was stopped early so the placebo controls could receive the medication.

FIRST IN LINE
"The kind of patients included in the sorafenib study have only experimental treatment available to them," explains Dr Morris Sherman, HCC specialist at the Toronto General Hospital and head of the Canadian Liver Foundation Medical Advisory Committee. "There's no effective treatment available at this stage of the disease." Chemotherapy isn't a viable option as it's only effective early on in the disease.

The Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) trial, which was also presented at the American Society of Clinical Oncologists meeting on June 4 in Chicago, included 602 patients at the advanced stage of the disease.

There's a striking delay in disease progression with sorafenib, according to lead author Dr Josep Llovet of the Hospital Clinic of Barcelona. This establishes it as a first-line treatment for these patients, he concludes.

ONE-TWO PUNCH
The drug has a double action effect on liver cancer cells. Targeting malignant cells, it inhibits tumour cell growth and suppresses vascularization of the tumour. The only major side effects observed were diarrhea and hand-foot skin reactions.

"There have been only two large scale studies so far for liver cancer," says Dr Sherman. "The first drug was safe to test in patients with advanced liver cancer, but not effective. Sorafenib is the first drug that didn't have any major liver-related side effects and produced positive results."

In fact, the most widely used drug at the moment, doxorubicin, has only one trial to back it up and is known to produce fatal complications.

GOLD STANDARD
Dr Llovet believes his study will set the standard for future liver cancer clinical trials. There's even a suggestion that sorafenib may be studied in patients with more compromised liver function, given its relative safety.

The drug is being tested for potential benefits in other types of cancers, but one major issue remains: the cost. While currently an accepted treatment for kidney cancer and expected to be shortly approved for liver cancer, how well it is reaching those most in need of it is another matter entirely.

"It costs $70,000 for one year of treatment," notes Dr Sherman with some alarm. "Even if it is approved, it may not be covered. So far it's not covered for kidney cancer. The improvement in survival is not huge, so it may not be considered worth it to fund the drug for three extra months of life."

 

 

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