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Taxotere compared with Taxol in metastatic breast cancer clinical trial.
2004 JAN 1 - (NewsRx.com & NewsRx.net) -- In a clinical trial, women treated with Taxotere (docetaxel) Injection Concentrate had a statistically significant improvement in overall survival and time to disease progression compared with those who were treated with Taxol (paclitaxel) for locally advanced or metastatic breast cancer after prior failure of chemotherapy.
Importantly, despite an increased incidence of certain toxicities, there was no difference in quality of life scores between the treatment groups over time, according to a study presented at the 26th Annual San Antonio Breast Cancer Symposium. Taxotere and Taxol are in a class of drugs known as taxanes that are used extensively to treat women with metastatic breast cancer.
"Maintaining or improving the quality of life of patients is just one of several goals that we set out to achieve when choosing a therapy for metastatic breast cancer," said Stephen E. Jones, MD, medical director of U.S. Oncology Research, director of breast cancer research at the Baylor-Sammons Cancer Center in Dallas, Texas, and an investigator of this study.
"The significance of this data is reflected in the fact that women who received Taxotere not only lived longer than those who received Taxol, but there was no statistically significant difference in their quality of life scores over time with Taxotere."
This phase III, randomized study is the first to directly compare Taxotere and Taxol in locally advanced or metastatic breast cancer after prior failure of chemotherapy. The multi-center study accrued 449 women who were randomized to receive either Taxotere 100 mg/m[superscript]2 (1 hour infusion) or Taxol 175 mg/m[superscript]2 (3 hour infusion) every 3 weeks.
Treatment with study medications was continued until progression of disease, unmanageable toxicity or until the patient decided to terminate treatment.
The primary endpoint of this study was the rate of overall response (tumor shrinkage). The secondary endpoints included time to disease progression (time without the cancer growing), overall survival and quality of life. In the "intent to treat" population, the study found that women receiving Taxotere significantly improved their overall survival by 41% (median 15.4 months vs 12.7 months) over those treated with Taxol.
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