News from Breast Cancer Week of June 23, 2002/ Vol. 2 No. 25

Study: Xeloda and Taxotere Provide Longer Survival Time

 

The chemotherapy drug Xeloda in combination with Taxotere is the first treatment combination to show a significantly longer survival time for patients with advanced breast cancer, according to data reported in the Journal of Clinical Oncology.

The U.S. Food and Drug Administration recently approved the drug combination for the treatment of metastataic breast cancer based on the data from this study.

The phase III clinical study analyzed Xeloda (capecitabine), an oral chemotherapy, in combination with Taxotere (docetaxel), given by infusion, in the treatment of metastatic breast cancer.

The study included 511 patients with locally advanced or metastatic breast cancer. The study evaluated overall survival time, time to disease progression and tumor response rate.

The results of the study show that the combination therapy provides a statistically significant survival benefit compared to therapy with Taxotere alone. The survival benefit is a 23 percent less risk of death with Xeloda and Taxotere in combination.

The study also showed a statistically significant superior tumor response of 42 percent for women treated with the drug combination compared to 30 percent with Taxotere alone. Time to disease progression was significantly longer for patients treated with Xeloda and Taxotere (average 6.1 months) compared to Taxotere alone (average 4.2 months), which translates into a 35 percent risk reduction for tumor progression in patients treatment with the combination therapy compared to Taxotere alone.

"The combination of Xeloda and Taxotere is a major advancement in treating women with metastatic breast cancer, due in large part to the significant survival advantage observed with the combination," said Dr. Joyce O'Shaughnessy, Co-Director of breast cancer research at Baylor-Sammons Cancer Center and US Oncology.

"This represents a crucial development, as improvements in patient survival are the bottom line, and the data from this study show early and consistent benefits for women treated with Xeloda and Taxotere, including survival, overall response rates and time to disease progression," O'Shaughnessy said.

Other sources: Hoffmann-La Roche