Capecitabine and docetaxel in advanced breast cancer: analyses of a phase III comparative trial.

A recent phase III trial demonstrated that the combination of capecitabine (Xeloda) and docetaxel (Taxotere) significantly improved objective tumor response rate, time to disease progression, and overall survival compared with single-agent docetaxel in anthracycline-pretreated patients with advanced breast cancer. Early separation of survival curves suggests that combined treatment prevented early mortality seen with single-agent docetaxel and, thus, that the capecitabine/docetaxel combination may be more beneficial than sequential treatment in some patients in this setting. Dose reduction of the combination (eg, to capecitabine at 950 mg/m2) did not reduce effectiveness of treatment and was associated with reduced toxicity; study of the combination in the adjuvant setting has been initiated with a lower capecitabine starting dose. Poststudy treatment with capecitabine in patients in the docetaxel-alone group was associated with significantly improved survival compared with poststudy treatment with all other cytotoxic agents, suggesting that some patients may benefit from sequential therapy with docetaxel and capecitabine. No difference in reduction of riskfor death was seen according to whether combined treatment was given as first-, second-, or third-line therapy. The capecitabine/docetaxel combination appears to influence the natural history of metastatic breast cancer in a significant manner; it remains to be determined whether the benefits of the combination reflect additive or synergistic effects and whether greater benefit may be derived from sequential or combined treatment in overall populations or patient subgroups.