Gemzar ® plus Paclitaxel Improves Survival in Advanced Breast Cancer
According to results presented at the 40th annual meeting of the American Society of Clinical Oncology (ASCO), the chemotherapy combination consisting of Gemzar ® (gemcitabine) and paclitaxel (Taxol ®) improves anti-cancer responses, time to cancer progression and survival at one year compared to paclitaxel alone in the treatment of metastatic breast cancer. Gemzar ® in combination with paclitaxel was recently approved by the FDA for the initial treatment of metastatic breast cancer.
Breast cancer is the most common cancer diagnosed in women in the United States, claiming the lives of approximately 40,000 women annually. Although treatment for patients with early-stage breast cancer (or cancer that has not spread from its site of origin) results in high cure rates, some patients ultimately experience a recurrence and spread of their cancer. Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body, often invading vital organs. Survival for patients with metastatic breast cancer is poor, with the average survival time from diagnosis of this advanced stage of cancer being 18 to 30 months. Patients whose cancer has recurred following previous therapy and has developed into metastatic breast cancer are often treated with the chemotherapy agent paclitaxel.
The recent trial involved 529 patients with metastatic breast cancer who were treated with either Gemzar ®/paclitaxel or paclitaxel alone and were directly compared. Patients had received prior treatment with anthracyclines (doxorubicin or epirubicin) for earlier-stage disease and had experienced disease progression. Anti-cancer response rates were 40.8% for patients treated with Gemzar ®/paclitaxel, compared to only 22.1% for those treated with paclitaxel alone. The average overall survival was 18.5 months for patients treated with Gemzar ®/paclitaxel, compared with 15.8 months for those treated with paclitaxel alone. At one year, patients treated with Gemzar ®/paclitaxel had a significantly improved survival rate (70.7%) compared to those treated with paclitaxel alone (60.9%).
The researchers concluded that the chemotherapy combination consisting of Gemzar ® plus paclitaxel is superior to paclitaxel alone in the treatment of metastatic breast cancer. Furthermore, the presenters at ASCO stated that the Gemzar ®/paclitaxel regimen was very well tolerated and is associated with fewer side effects than some single-agent therapies for breast cancer. They also stated that clinical trials evaluating Gemzar ®/paclitaxel are warranted for earlier stage breast cancer. Patients diagnosed with breast cancer who will undergo chemotherapy may wish to speak with their physician about the risks and benefits of Gemzar ®/paclitaxel or the participation in a clinical trial further evaluating Gemzar ® regimens or novel therapeutic approaches. 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 by cancerconsultants.com.
Reference: Albain K, Nag S, Calderillo-Ruiz G, et al. Global phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel (T) as frontline therapy for metastatic breast cancer (MBC): First report of overall survival. Proceedings from the 40th annual meeting of the American Society of Clinical Oncology. New Orleans, LA. 2004. Abstract #510.
These results indicate that the addition of Femara ® following 5 years of tamoxifen significantly reduces the risk of death and cancer recurrence in women with breast cancer, with node-positive patients gaining the greatest survival benefit. Clinical trials are ongoing to determine the optimal timing and sequencing of aromatase inhibitors and tamoxifen in the treatment of hormone-positive breast cancer. Postmenopausal patients with hormone-positive breast cancer may wish to speak with their physician about the risks and benefits of continued Femara ® following tamoxifen in their treatment regimen, or the participation in a clinical trial further evaluating the role of aromatase inhibitors. 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 at cancerconsultants.com.
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2. Goss P, Ingle J, Martino S, et al. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. The New England Journal of Medicine. Early publication available at: www.nejm.org. October 9, 2003.
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