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Taxotere(R)-Based Chemotherapy Significantly Improved Overall Survival Compared With Standard Anthracycline-Based Chemotherapy in Early Stage Breast Cancer
Date:12/13/2007

foundation of breast cancer chemotherapy for more than 30 years.

"The investigational Taxotere(R) combination significantly increased the percentage of women living with no signs of cancer at seven years, as compared to the anthracycline combination," said Dr. Jones.

US Oncology Adjuvant Trial 9735 Protocol

USO Adjuvant Trial 9735 was designed primarily to evaluate disease-free survival among women with node-positive and node-negative early breast cancer. Node-positive indicates that the cancer has spread to the lymph nodes under the arm, while node-negative breast cancer means that the lymph nodes are clear of cancer. Secondary endpoints included overall survival and safety. The investigators also explored the efficacy and safety of the treatments based on the age of patients and the biologic characteristics of their tumors.

All patients taking part in the study had received surgery for Stage I-III invasive breast cancer, meaning that the cancer was either localized to the breast or had spread to the lymph nodes under the adjacent arm.

A total of 1016 patients were randomized between June 1997 and December 1999; 48% of patients had node-negative disease and 16% were age 65 years or older. After surgery, patients were randomized to receive four cycles of either standard-dose of anthracycline doxorubicin 60 mg/m2 and cyclophosphamide 600/mg/m2 (n=510) or Taxotere(R) 75 mg/m2 and cyclophosphamide 600mg/m2 (n=506), administered by intravenous infusion every three weeks. After chemotherapy was completed, patients were treated with radiation therapy if indicated. Patients with hormone receptor positive disease also received hormonal therapy (tamoxifen).

In the TC group, there were 88 DFS events (17%) and 58 deaths (12%). The AC group had 118 DFS events (23%) and 84 deaths (17%). Exploratory analyses showed benefit of TC irrespective of age, hormonal status or Her2 status.

Grade 3-4 neutropenia occurred in 60% of younger (<
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SOURCE sanofi-aventis
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