Mesothelioma Blog

More than one-third of all breast cancer patients are administered chemotherapy drugs that are not explicitly approved by the U.S. Food and Drug Administration (FDA) to treat the disease, according to a recent study conducted by M.D. Anderson.

Such a practice is relatively common among many illnesses, but it especially prevalent among breast cancer patients. Known as off-label drug use, doctors often prescribe drugs that are FDA-approved for the treatment of other conditions, but not breast cancer. The term “off-label” refers to the drug label report that is approved by the FDA. Such a report dictates approved doses and for which medical conditions the drug is considered a safe and effective treatment.

In terms of breast cancer, M.D. Anderson researchers found that 35 percent of women were treated with off-label chemotherapy drugs between the years of 1991 and 2002. This percentage was calculated by using the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) database. This database is considered the most extensive cancer registry in the United States, and represents 26 percent of the entire U.S. population.

All women in the study were aged 65 years or older. Researchers note that oncologists tend to treat older patients more conservatively. As such, the actual percentage of breast cancer patients using off-label medications may be higher than 35 percent.

The most prevalent off-label drug used to treat breast cancer was Navelbine® (used by 16 percent of all off-label breast cancer patients). Navelbine is a drug approved for the treatment of lung cancer. Gemzar® – a pancreatic cancer drug – was also a commonly prescribed off-label treatment.

Both chemo drugs have been shown to be effective in the treatment of breast cancer. However, clinical trials explicitly testing the safety and effectiveness of such drugs for use in breast cancer treatment have not been completed. Drugs that have been proven effective, but as of yet properly passed clinical trials, make up the majority of off-label drug cases.

However, some off-label drug use is considered hazardous or shows no signs of medical benefit. In fact, researchers found that seven percent of off-label breast cancer treatments were considered medically inappropriate.

Such off-label use raises controversy around the unrestricted use of FDA-approved drugs. Additionally, off-label use of chemo drugs is typically not approved by Medicare, Medicaid and insurance.

Resources: http://www.mdanderson.org/newsroom/cance…
 http://www.cancer.org/docroot/ETO/conten…