The Food and Drug Administration has approved the chemotherapy drug Taxotere (docetaxel) for men with advanced prostate cancer that is not responding to hormone therapy. The drug is to be given with the steroid prednisone. Taxotere has already been approved to treat breast and lung cancer.

The approval is particularly important because Taxotere is the first chemotherapy drug shown to improve the survival of men in the advanced stage of this disease.

"Patients need as many effective treatment options as possible and Taxotere, in combination with prednisone, offers hope to certain patients who have not responded to other treatments," said acting FDA commissioner Lester M. Crawford, PhD, in a statement.

Until now, chemotherapy given to prostate cancer patients was primarily intended to slow the growth of the cancer and reduce pain from metastasis; no studies had shown that chemotherapy helped men live longer. For this reason it has been reserved for men who have failed all other treatments (radiation, surgery, or hormone therapy).

The FDA based its decision on a study of more than 1,000 patients. The Taxotere-prednisone combination increased survival by more than 2 months, when compared to standard chemotherapy. Details of the trial will be presented next week at a national cancer conference.

The most common side effects of the Taxotere regimen were nausea, hair loss and bone marrow suppression. Some men also experienced fluid retention and tingling in the arms and legs.