In a clinical trial, women treated with Taxotere (docetaxel) had a statistically significant improvement in overall survival and time to disease progression compared to 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 today 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 US 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 100mg/m2 (1 hour infusion) or Taxol 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 (tumour 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 per cent (median 15.4 months vs. 12.7 months), p= 0.03 over those treated with Taxol. In addition, women receiving Taxotere experienced a significant 62 per cent improvement in time to disease progression (median 5.7 months vs. 3.6 months), p<0.0001 as compared to Taxol. Overall response rates were higher for Taxotere (32.0 per cent) compared to TaxolÒ (25.0 percent, p=0.10).

Quality of life scores were similar between treatment arms over time despite an increased incidence of grade 3/4 toxicities, including neutropenia (decrease in white blood cells which help fight infection), fever, diarrhea and edema (fluid retention) in women who received Taxotere. Quality of life was assessed using the Functional Assessment of Cancer Therapy questionnaire which is specific to breast cancer (modified FACT-B). The questionnaire is designed to assess quality of life including the emotional, functional, physical and social well being of patients. The women completed the questionnaire prior to treatment, after cycle 4 and at the end of the treatment.

"Results of large, randomized phase III trials directly comparing one treatment to another are essential to determine the best treatment options for patients battling metastatic breast cancer," said Michael L Meyers, senior director, Oncology Medical Affairs, Aventis. "The results of this very important trial add to the already large body of clinical evidence that shows that Taxotere is the most active taxane in the treatment of metastatic breast cancer."