Taxotere® Approved for Early Breast Cancer

Taxotere® Approved for Early Breast Cancer

The United States Food and Drug Administration (FDA) has approved the chemotherapy agent Taxotere®(docetaxel) for the treatment of early breast cancer. The specific indication includes Taxotere® to be used in combination with Adriamycin® (doxorubicin) and Cytoxan® (cyclophosphamide), referred to as TAC, following surgery in women with breast cancer that has spread to their lymph nodes.

Breast cancer is diagnosed in over 200,000 women annually in the United States alone, and is the second leading cause of cancer deaths in women. When diagnosed and treated in early stages, prior to distant spread in the body, cure rates remain high with standard therapeutic approaches. Standard treatment for women with breast cancer that has only spread to nearby lymph nodes typically includes surgery, chemotherapy, radiation therapy and/or hormone therapy. Researchers continue to evaluate newer chemotherapy agents and/or combinations to improve cure rates as well as minimize side effects for patients with early stage breast cancer.

Taxotere® is a chemotherapy agent that is already approved for the treatment of advanced breast cancer, lung cancer and prostate cancer, and continues to be evaluated in various stages and types of cancers in clinical trials. The trial that prompted the approval of Taxotere® for early breast cancer included nearly 1,500 women with early breast cancer that has spread to axillary (under the arm) lymph nodes. Following surgery to remove the cancer, patients were treated with either TAC or a commonly used chemotherapy regimen referred to as FAC (5-fluorouracil, Adriamycin® and Cytoxan®). At approximately 55 months follow-up, the risk of a cancer recurrence was reduced by 26% in the patients treated with TAC, compared to FAC. In addition, survival was improved for women treated with TAC, compared to FAC, and further survival data will be revealed at a longer follow-up. TAC was associated with higher rates of low levels of white blood cells than FAC, but was generally well tolerated.

Patients with early breast cancer that has spread to nearby lymph nodes who are to undergo chemotherapy following surgery may wish to speak with their physician about the risks and benefits of treatment including TAC.

Reference: Aventis.

FDA Approves Taxotere® for the Treatment of Women with Early Stage Breast Cancer. Available at:

Accessed August 2004.

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