The June 15th issue of the Journal of Clinical Oncology features a phase III clinical study about the use of Roche’s Xeloda® (capecitabine), an oral chemotherapy, in combination with Aventis’ Taxotere® (docetaxel) for Injection Concentrate, given by infusion, for the treatment of metastatic breast cancer.
The U.S. Food and Drug Administration recently approved the use of Xeloda in combination with Taxotere for the treatment of metastatic breast cancer based on the data from this phase III trial. The results of this phase III study demonstrate that the combination of Xeloda and Taxotere provides a statistically significant survival benefit compared to Taxotere monotherapy (median 14.5 months vs. 11.5 months, log rank p= 0.0126).
The survival advantage is a 23 percent less risk of death with Xeloda and Taxotere in combination compared to Taxotere alone (Hazard Ratio=0.775). In addition, the study also shows a statistically significant superior objective tumor response of 42 percent for patients treated with the combination of Xeloda + Taxotere, compared to Taxotere monotherapy (30 percent, p=0.006).
Time to disease progression is significantly longer for patients treated with Xeloda+Taxotere: median 6.1 months vs. 4.2 months with Taxotere alone (p=0.0001, Hazard Ratio=0.652), which translates into a 35 percent risk reduction for tumor progression in patients treated with Xeloda+Taxotere compared to Taxotere alone.
“We believe that the survival advantage of the combination of Xeloda+Taxotere may benefit many patients with metastatic breast cancer,” said Georges Gemayel, Vice President, National Specialty Care Business Operation, at Roche.
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