Study demonstrates improved survival in women with metastatic breast cancer

Copenhagen, Denmark September 24, 2003 Today at the European Cancer Conference (ECCO) annual meeting, results from a randomized, Phase III study were presented which demonstrated that women with metastatic breast cancer who were treated with Taxotere (docetaxel) Injection Concentrate had a statistically significant improvement in overall survival and time to disease progression compared to those who were treated with paclitaxel. Both these agents are in a class of drugs knows as taxanes that are used extensively to treat women with metastatic breast cancer.

The multi-center study included 449 women who were randomized to either Taxotere 100mg/m2 (1 hour infusion) or paclitaxel 175 mg/m2 (3 hour infusion) every three weeks. Treatment was continued until progression of disease, unmanageable toxicity or intercurrent illness occurred, or until the patient decided to terminate treatment for any other reason. Eligibility criteria included: bi-dimensionally measurable metastatic breast cancer, having failed either one prior anthracycline-based regimen as first-line therapy for metastatic breast cancer or disease progression during or within 12 months of completing anthracycline-based adjuvant or neoadjuvant chemotherapy.

"While Taxotere is already the most widely used chemotherapy agent in the treatment of women with metastatic breast cancer, this trial offers more hope to women with breast cancer and has significance in treatment decisions," said Peter Ravdin, M.D., Ph.D., an Associate Professor of Oncology at the University of Texas Health Science Center at San Antonio and Principal Investigator of the study. "Taxanes have been proven to be a leading class of agents across a wide range of cancers. This trial is an important comparison of the taxanes that may influence future research and treatment strategies."

The primary endpoint of this study was the rate of overall response (tumor shrinkage). The secondary endpoints included time to

Contact: Arleen Goldenberg
Cohn & Wolfe

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