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.

First of its Kind for Liver Cancer Treatment

"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.

One Medication Treats Multiple Cancer Types

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.

Medication Delays Cancer Progression

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.

More About Clinical Trials

Clinical trials are studies, managed by government agencies, educational institutions, private not-for-profit organizations, or commercial businesses, to develop, produce, and evaluate the effectiveness of new treatments and therapies for diseases.

According to the National Cancer Institute (NCI), there are different types of cancer clinical trials, including:

• prevention trials designed to keep cancer from developing in people who have not previously had cancer.

• prevention trials designed to prevent a new type of cancer from developing in people who have had cancer.

• early detection trials to find cancer, especially in its early stages.

• treatment trials to test new therapies in people who have cancer.

• quality of life studies to improve comfort and quality of life for people who have cancer.

• behavioral studies to evaluate ways of modifying cancer-causing behaviors, such as tobacco use.

• genetic studies to address how genetic makeup affects detection, diagnosis, and treatment of cancer.

Large cancer centers, university hospitals, local medical centers, or physician offices may all be included in managing clinical trials. There may be only one or two locations involved in a particular study, or hundreds around the country.

Each protocol in a trial defines specific characteristics, called eligibility criteria, that participants should have in order to participate in the study. Characteristics may include type of disease and its stage, as well as the participant's age and general health.

Eligibility criteria help assure that the study results answer the research question and identify who will benefit in the future from the approach being studied.

There are several procedures in place, as part of the protocols, to protect the safety of the people who participate. Informed consent is a process designed to protect potential participants through detailed description of important facts about a specific clinical trial. Two groups that oversee the safety procedures are the:

• organization that sponsors the study (for example, the National Cancer Institute)

• Institutional Review Board (IRB) that oversees clinical research in the healthcare institution. The IRB includes physicians, other healthcare providers, consumers, and sometimes members of the clergy, who do not have any personal interest in the results of the study. As neutral reviewers, they ensure that the study is conducted fairly and that participants are not likely to be harmed.

Always consult your physician for more information.