Taxotere® Plus Herceptin® Reduces Risk of Recurrence in Early Breast Cancer
According to interim analysis of the BCIRG 006 clinical trial, the addition of Herceptin® (trastuzumab) to Taxotere® (docetaxel) plus carboplatin (Paraplatin®) significantly reduces the risk of a cancer recurrence compared to chemotherapy alone in women with early HER2-positive breast cancer. Furthermore, the treatment combination of Herceptin and Taxotere/carboplatin does not increase the risk of heart complications.
Breast cancer is diagnosed in over 200,000 women annually in the US alone. The disease is responsible for approximately 40,000 deaths every year. Early breast cancer refers to cancer that has not spread to distant sites in the body. Breast cancer at this stage is often treated with surgery, chemotherapy, radiation therapy, hormone therapy, and/or biologic therapy.
The human epidermal growth factor receptor-2 (HER-2) is a protein that is part of a biologic pathway within a cell. The pathway is involved in cellular growth and replication. Approximately 30% of breast cancers overexpress HER-2 (HER2-positive). This results in uncontrolled replication of the cancer cell.
Herceptin is a monoclonal antibody (or protein) that is designed to bind to the HER-2 protein. The binding results in the prevention or reduction of replication of the cancer cell. Herceptin is currently approved as a single agent for the treatment of HER2-positive metastatic breast cancer in patients who have received prior chemotherapy. It is also approved in combination with the chemotherapy agent Taxol® (paclitaxel) in HER2-positive metastatic breast cancer in patients who have not received prior chemotherapy.
Results recently presented at the 2005 annual meeting of the American Society of Clinical Oncology (ASCO) have indicated that the addition of Herceptin to chemotherapy improves survival in patients with early-stage breast cancer. One concern with the combination of Herceptin and the commonly used chemotherapy agents referred to as anthracyclines is the small, yet severe risk of developing heart complications. Since the chemotherapy agent Taxotere is not associated with increased risks of heart complications, researchers conducted a large, phase III clinical trial to evaluate the combination of Herceptin and Taxotere without an anthracycline in the treatment of early breast cancer.
The BCIRG 006 trial included more than 3,000 patients with HER2-positive, early-stage breast cancer. Patients were treated with one of the following three treatment regimens and were directly compared:
- Doxorubicin (anthracycline), cyclophosphamide, Taxotere (AC-T)
- Doxorubicin, cyclophosphamide, Taxotere, Herceptin (AC-TH)
- Taxotere, carboplatin, Herceptin (TCH)
Patients in the two groups treated with Herceptin had an over 50% reduction in the risk of a cancer recurrence. Patients treated with chemotherapy only (AC-T) experienced only a 39% reduced risk of a cancer recurrence. Heart complications did not increase with the addition of Herceptin to Taxotere/carboplatin compared to chemotherapy only (AC-T); only 1.2% of patients experienced these complications in each treatment group. Conversely, 2.3% of patients treated with Herceptin plus the anthracycline-containing chemotherapy regimen (AC-TH) had heart complications. Longer follow-up is necessary to determine differences in overall survival.
The researchers concluded that the treatment combination consisting of Herceptin, Taxotere, and carboplatin significantly reduces the risk of a cancer recurrence in women with HER2-positive early breast cancer without increasing the risk of heart complications when compared to chemotherapy alone. Patients with early HER2-positive breast cancer may wish to speak with their physician regarding their individual risks and benefits of participating in a clinical trial further evaluating treatment including Herceptin and Taxotere.
Reference: Sanofi-Aventis. Interim analysis of phase III study shows TAXOTERE® (docetaxel)- based chemotherapy regimens combined with HERCEPTIN® (trastuzumab) significantly improved disease free survival in early-stage HER2-positive breast cancer. Available at: http://en.sanofi-aventis.com/press/p_press_2005.asp. Accessed September 2005.
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