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From the Food and Drug Administration
November 7, 2001

New Combination Therapy for Advanced Breast Cancer

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JAMA. 2001;286(17):2085. doi:10.1001/jama.286.17.2085

The FDA has approved capecitabine (Xeloda, Hoffman LaRoche Inc, Nutley, NJ) combined with docetaxel (Taxotere, Aventis Pharmaceuticals, Parsippany, NJ) for treating patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

The combination therapy was approved on the basis of an open-label randomized trial in 75 centers worldwide. Participants were 511 patients with metastatic breast cancer resistant to or recurring or relapsing during or after anthracycline-containing therapy. In the combination arm, 225 patients were randomized to receive Xeloda, 1250 mg/m2 twice daily for 14 days followed by 1 week without treatment, and Taxotere, 75 mg/m2 as a 1-hour intravenous infusion, given in 3-week cycles. In the monotherapy arm, 256 patients received Taxotere, 100 mg/m2 as a 1-hour intravenous infusion, administered in 3-week cycles. The mean duration of treatment was 129 days in the combination arm and 98 days in the monotherapy arm. The combination therapy resulted in significant improvement in median days to disease progression (186 vs 128; hazard ratio, 0.65; P<.001) overall survival (442 vs 352; hazard ratio, 0.78; P = .01), and response rate (32% vs 22%; P = .009), compared with Taxotere alone.

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