According to results recently presented at the 38th Annual Meeting of the American Society of Clinical Oncology, the chemotherapy combination consisting of Gemzar® (gemcitabine) plus paclitaxel (Taxol®) appears promising as initial therapy for metastatic breast cancer.
Approximately 200,000 new cases of breast cancer are diagnosed annually in the United States. Patients with locally advanced breast cancer have cancer that has spread to nearby lymph nodes or the chest wall. Patients with metastatic breast cancer have cancer that has spread to distant sites in the body. Although a large proportion of patients with early-stage breast cancer are considered curable with standard therapies, patients with breast cancer that have metastatic disease are often not treated with curative intent. Research has been focused on improving survival and/or quality of life for patients with advanced breast cancer, including new chemotherapy combinations.
Recently, two clinical trials were conducted to evaluate the effectiveness of the chemotherapy combination Gemzar® plus paclitaxel as initial therapy in the treatment of metastatic breast cancer. In one trial, researchers from France treated 36 patients with metastatic breast cancer or locally advanced breast cancer with Gemzar® and paclitaxel. No patient had received prior chemotherapy for metastatic cancer. Following therapy, approximately 42% of patients had an anti-cancer response rate, with two patients achieving a complete disappearance of cancer, 13 patients achieving a partial disappearance of cancer and seven achieving a stabilization of their cancer. The average duration of response was 344 days and the average time to cancer progression was approximately 7.5 months. The most common side effects were low levels of white blood cells and hair loss. However, agents that promote white blood cell growth, such as Neulasta™, were not used in this trial and may help prevent and/or reduce the severity of low white blood cell levels caused by Gemzar® and paclitaxel.
The second clinical trial was conducted by researchers in Argentina and involved 42 patients with metastatic breast cancer. No patient had received prior therapy for metastatic disease, however, 27 patients had prior chemotherapy for earlier-stage breast cancer. Following therapy with Gemzar® and paclitaxel, 14.3% of patients achieved a complete disappearance of cancer, 40.7% achieved a partial disappearance of cancer and 26.2% achieved a stabilization in their cancer. The average duration of response was 19 months and the average time to cancer progression was approximately 9 months. One year following therapy, 65% of patients were still alive. The most common side effects in this trial were also low white blood cell levels, low platelet levels and inflammation of mucous membranes.
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The results from both of these clinical trials indicate that Gemzar® and paclitaxel is an effective treatment regimen for initial therapy of metastatic breast cancer. Further clinical trials are warranted directly comparing Gemzar® and paclitaxel to other chemotherapy combinations. Patients with metastatic breast cancer may wish to speak with their physician about the risks and benefits of Gemzar® and paclitaxel or participation in a clinical trial evaluating other promising therapies. Two sources of information regarding clinical trials include the National Cancer Institute ( cancer.gov) and www.eCancerTrials.com. eCancerTrials.com also provides personalized clinical trial searches on behalf of patients.
1.Genot J, Tubiana-Hulin M, Tubiana-Mathieu N, et al. Gemcitabine and paclitaxel in metastatic breast cancer: a phase II study in the first line setting. Proceedings from the 38th Annual Meeting of the American Society of Clinical Oncology. 2002;21:abstract 2002.
2.Delfino C, Caccia G, Riva L, et al. Gemcitabine plus paclitaxel administered as first-line chemotherapy for patients with advanced breast cancer. Proceedings from the 38th Annual Meeting of the American Society of Clinical Oncology. 2002;21:abstract 2025.
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