According to results presented at the 40th annual meeting of the American Society of Clinical Oncology (ASCO), the addition of Herceptin® (trastuzumab) to chemotherapy prior to surgery significantly improves anti-cancer responses in patients with HER-2 positive breast cancer.
Breast cancer is diagnosed in approximately 250,000 individuals annually in the United States. Patients with early-stage breast cancer, or cancer that has not spread outside the breast to distant sites in the body, have a high cure rate with standard therapeutic approaches. Standard treatment for early breast cancer may include chemotherapy prior to surgery, referred to as neoadjuvant therapy. Neoadjuvant therapy reduces the size of the cancer, allowing for optimal chances of a complete surgical removal of the cancer with breast-sparing surgery, versus a mastectomy where the entire breast is removed. Studies are continuing to evaluate the effects of neoadjuvant therapy on long-term survival compared to adjuvant therapy in early breast cancer.
Herceptin® is a monoclonal antibody that is targeted against the human epidermal growth factor-2 (Her-2) pathway. The Her-2 pathway is associated with growth and replication of cancer cells. Some cancer cells overexpress Her-2, and are referred to as Her-2 positive. Herceptin® binds to distinct components of HER2-positive cells, and disrupts cellular replication. The addition of Herceptin® to chemotherapy had demonstrated improved outcomes, including survival, in patients with HER-2 positive metastatic breast cancer, and studies are ongoing to evaluate Herceptin® in different stages of the disease.
Researchers from the M.D. Anderson Cancer Center recently conducted a clinical trial to evaluate the addition of Herceptin® to chemotherapy as neoadjuvant therapy in patients with early breast cancer. This trial included 42 patients with HER-2 positive breast cancer. Approximately half of the patients were treated with Herceptin® plus chemotherapy (5-fluorouracil, epirubicin and cyclophosphamide), and approximately half of the patients were treated with the same chemotherapy regimen only prior to surgery for early breast cancer. Following neoadjuvant therapy, 67% of patients treated with Herceptin®/chemotherapy, compared to only 25% of patients treated with chemotherapy alone had no detectable cancer. Treatment was well tolerated. The trial’s Data Monitoring Committee stopped the trial early due to the superiority and tolerability of the addition of Herceptin® to chemotherapy in this group of patients. Longer follow-up is needed to determine long-term survival benefits.
The researchers concluded that the addition of Herceptin® to chemotherapy as neoadjuvant therapy in Her-2 positive breast cancer significantly improves anti-cancer responses and is well tolerated. The researchers at M.D. Anderson have adopted this treatment regimen as the standard treatment for this group of patients. Patients with early, Her2-positive breast cancer may wish to speak with their physician about the risks and benefits of neoadjuvant therapy including Herceptin® or the participation in a clinical trial evaluating novel therapeutic options. Two sources of information regarding ongoing clinical trials include the National Cancer Institute (cancer.gov) and www.cancerconsultants.com. Personalized clinical trial searches are also performed on behalf of patients at cancerconsultants.com
Reference: A. U. Buzdar, K. Hunt, T. Smith, et al. Significantly higher pathological complete remission (PCR) rate following neoadjuvant therapy with trastuzumab (H), paclitaxel (P), and anthracycline-containing chemotherapy (CT): Initial results of a randomized trial in operable breast cancer (BC) with HER/2 positive disease. Proceedings from the 40th annual meeting of the American Society of Clinical Oncology. New Orleans, LA. June 2004. Abstract #520.
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