Drug combination approved for advanced breast cancer

FDA Consumer, Jan-Feb, 2002

Two drugs already on the market to treat breast cancer have been approved by the FDA to be used in combination for an even greater effect in treating advanced cases of the disease.

Xeloda (capecitabine), an oral cancer therapy, and Taxotere (docetaxel), an intravenous drug, can now be used together to treat advanced cancer that has progressed after being treated with an anthracycline-containing therapy, such as Adriamycin (doxorubicin). Doctors limit anthracycline-containing treatments to life-threatening situations.

The FDA approved the drug combination in September after a study of 511 cancer patients demonstrated improvements in overall response rates, lengths of time before the disease worsened, and survival rates.

Xeloda and Taxotere individually are associated with side effects such as gastrointestinal symptoms, nausea, vomiting, and painful inflammation of the mouth. People with breast cancer also should be aware of these side effects when taking the newly approved drug combination. If side effects occur, it may be necessary to reduce the dose, or to interrupt or discontinue treatment.

In addition, Xeloda has a significant drug interaction with oral coumarin-derivative anticoagulant therapy, which can cause serious bleeding complications. The FDA urges people receiving Xeloda and a coumarin-derivative, such as Coumadin, to have their anticoagulant response monitored frequently. The agency also says that dosages of the drugs may have to be modified for people who have impaired kidney function.

Xeloda is manufactured by Roche Laboratories Inc., Nutley, N.J. Taxotere is marketed by Aventis Pharmaceuticals Inc., Bridgewater, N.J.