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The Food and Drug Administration (FDA) recently approved the chemotherapy agent Gemzar®(gemcitabine), in combination with paclitaxel, as first-line therapy for metastatic breast cancer, offering patients with this disease a new and effective treatment option.

Breast cancer is the most common cancer diagnosed in women in the United States, claiming the lives of approximately U.S. 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 chemotherapy agent paclitaxel (Taxol®).

The specific FDA indication for Gemzar® is for use with the chemotherapy agent paclitaxel in women who have stopped responding to prior anthracycline-based chemotherapy for treatment of earlier-stage breast cancer. The clinical trial from which this indication was based included women with metastatic breast cancer who were treated with either Gemzar® plus paclitaxel, or paclitaxel alone. These women had already been treated for earlier-stage breast cancer with anthracycline-based regimens, or other regimens if they were not able to tolerate anthracyclines. The time to cancer progression was significantly greater in the group of patients treated with Gemzar® plus paclitaxel (5.2 months), compared to paclitaxel alone (2.9 months). Overall survival data will be presented at the upcoming meeting of the American Society of Clinical Oncology in June 2004.

Patients who have been diagnosed with metastatic breast cancer following a recurrence may wish to speak with their physician regarding the risks and benefits of treatment with Gemzar®.

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Reference: Lilly Oncology. FDA Grants Approval for Lilly’s Gemzar in Combination with Taxol as First-Line Treatment for Metastatic Breast Cancer. Available at: [ Accessed May 2004.]( Accessed May 2004.)

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