Taxotere (Docetaxel)

Taxotere has been approved as a treatment for subjects who have locally advanced or metastatic (spreading) breast cancer, which has progressed during anthracycline-based therapy or has relapsed during anthracycline-based adjuvant therapy. Approximately two out of three breast cancer subjects treated with chemotherapy in the United States receive anthracyclines at some point in the treatment of their disease.

Anthracycline-based chemotherapy is commonly used by oncologists as initial therapy for metastatic disease and as adjuvant chemotherapy administered in conjunction with surgery to prevent disease recurrence. In subjects with advanced disease, their cancer will eventually become resistant and stop responding to the treatment.

Unlike other chemotherapeutic agents, Taxotere can be administered outside the hospital.

The approved outpatient regimen for Taxotere is 60 to 100 mg/m2 administered intravenously for one hour every three weeks. Other currently used chemotherapy agents may require hospitalization due to much longer infusion times.

As of June 1998, Taxotere is approved for first-line treatment of metastatic breast cancer in subjects whose disease has recurred despite adjuvant therapy.

In worldwide phase II clinical trials, Taxotere demonstrated the highest tumor response rates ever reported for a single agent in this subject population.

Taxotere has been studied extensively in clinical trials involving thousands of subjects worldwide, including the United States, Canada, Japan, and Europe. Additional clinical trials are ongoing to investigate the potential use of Taxotere to treat other tumor types.

Side effects have been shown to be predictable and manageable. They include hair loss, reduced white blood cell count, skin rash, fluid retention, hypersensitivity, nausea, and diarrhea.

Taxotere is a new chemical entity that inhibits cancer cell growth, which depends on the formation of an internal cellular skeleton made up of elements called microtubules. During the cell development cycle, microtubules first assemble and then disassemble, permitting cancer cells to divide and thus allow tumor growth. Taxotere essentially freezes the cancer cell's internal skeleton by promoting the assembly and blocking the disassembly of microtubules. This action prohibits cancer cell division, which causes cell death.

In the United States, breast cancer is the most common form of cancer in women. Each year 183,000 new cases are diagnosed and nearly 45,000 subjects die. Although many women are treated successfully initially, about 50% of breast cancer subjects will eventually relapse or recur. When this happens, the cancer often metastasizes or spreads beyond the breast to other parts of the body, such as the liver or bone. For women between the ages of 40 and 55, metastatic breast cancer is the leading cause of death.