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Study Results Show Taxotere(R) Improves Survival With Comparable Quality Of Life
Compared With Taxol(R) in Women With Metastatic Breast Cancer
- First Head-to-Head Study of Its Kind Compares Two of Most Widely Used
Chemotherapies -
SAN ANTONIO, Dec. 4 /PRNewswire/ -- In a clinical trial, women treated with
Taxotere(R) (docetaxel) Injection Concentrate had a statistically significant
improvement in overall survival and time to disease progression compared to
those who were treated with Taxol(R)(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 today at the 26th Annual San Antonio Breast Cancer Symposium.
Taxotere(R) and Taxol(R) 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, M.D., Medical Director of U.S. Oncology
Research, Director of Breast Cancer Research at the Baylor- Sammons Cancer
Center in Dallas, TX and an investigator of this study. "The significance of
this data is reflected in the fact that women who received Taxotere(R) not only
lived longer than those who received Taxol(R), but there was no statistically
significant difference in their quality of life scores over time with
Taxotere(R)."
Study Results and Protocol
This phase III, randomized study is the first to directly compare Taxotere(R)
and Taxol(R) 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(R) 100mg/m2 (1 hour infusion) or Taxol(R) 175 mg/m2
(3 hour infusion) every three 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(R)
significantly improved their overall survival by 41 percent (median 15.4 months
vs. 12.7 months), p=0.03 over those treated with Taxol(R). In addition, women
receiving Taxotere(R) experienced a significant 62 percent improvement in time
to disease progression (median 5.7 months vs. 3.6 months), p