Source: DGNews  |  Posted 8 years ago

By Charlene Laino

SAN ANTONIO, TX -- December 4, 2003 -- For women with metastatic breast cancer who have failed prior chemotherapy, docetaxel is associated with a significant improvement in overall survival and time to disease progression, when compared with paclitaxel, a Phase III randomised trial shows.

Despite an increase in certain toxicities, there was no difference in quality-of-life scores between the 2 groups, said Stephen E. Jones, MD, Medical Director of U.S. Oncology Research and Director of Breast Cancer Research, Baylor-Sammons Cancer Center, Dallas, Texas, United States. Dr. Jones presented the findings here on December 3rd at the 26th annual San Antonio Breast Cancer Symposium.

The trial -- the first to directly compare docetaxel and paclitaxel -- enrolled 449 women with metastatic breast cancer, who were randomised to receive either 100 mg/m2 of docetaxel as a 1-hour infusion or 175 mg/m2 of paclitaxel as a 3-hour infusion, every 3 weeks. The drugs were continued until progression of disease, unmanageable toxicity, or until the patient opted to terminate treatment.

In the intent-to-treat population, median survival was 15.4 months in the arm receiving docetaxel, compared with 12.7 months in the group receiving paclitaxel. This finding translated to 41% relative improvement in overall survival attributable to docetaxel, which was significant at the P = .03 level, Dr. Jones reported.

Also, time to disease progression was 5.7 months for women taking docetaxel, compared with 3.6 months for those on paclitaxel. This translated to a 62% improvement in time to disease progression (P < .0001).

Overall response rates were 32% in the docetaxel arm versus 25.0% in the paclitaxel arm (P = .10), the study showed.

There were more haematological toxicities with docetaxel therapy, Dr. Jones said, mainly Grade 3/4 neutropenia. Fifteen percent of the patients in the docetaxel arm suffered febrile neutropenia versus 2% of patients on paclitaxel.

Quality-of-life scores, however, as assessed by a modified Functional Assessment of Cancer Therapy questionnaire, were not significantly different between the 2 arms after 4 cycles of treatment, Dr. Jones reported.

Aventis Pharmaceuticals sponsored this trial.

[Study Title: Randomized Trial Comparing Docetaxel and Paclitaxel in Patients with Metastatic Breast Cancer. Abstract 10]