Review of docetaxel/doxorubicin combination in metastatic breast cancer.

Docetaxel (Taxotere) and doxorubicin (Adriamycin) have each demonstrated significant activity in metastatic breast cancer. Thus, the combination of docetaxel and doxorubicin has been evaluated in phase I trials to establish the dose-limiting toxicity, maximum tolerated dose, recommended dose for future phase II and III studies, and toxicity profile of the two agents used in combination. Results from phase I trials in patients with metastatic breast cancer indicate that the docetaxel/doxorubicin combination is well tolerated. The recommended dose for the combination regimen is either 50 mg/m2 of doxorubicin followed by 75 mg/m2 of docetaxel or 60 mg/m2 of both drugs, without granulocyte colony-stimulating factor (G-CSF) support. Febrile neutropenia complicated by grade 3 infection was the dose-limiting effect at the maximum tolerated dose. The response rate at this dose level was 90%. Based on the preliminary results of phase I studies, further phase II and III studies of a docetaxel/doxorubicin combination regimen are warranted.