Biweekly gemcitabine, doxorubicin, and paclitaxel as first-line treatment in metastatic breast cancer

In a single-center, open, phase II trial, we assessed the toxicity and acti vity of a triple combination therapy-doxorubicin at 30 mg/m(2) (day I), pac litaxel (Taxol) at 135 mg/m(2) (day 2), and gemcitabine (Gemzar) at 2,500 m g/m2 (day 2 after paclitaxel)-administered biweekly in a 28-day cycle for s ix cycles. This was given as first-line treatment in 41 patients with metas tatic breast cancer. Granulocyte colony-stimulating factor was used in 27 p atients to permit maintenance of dose density. Hematologic toxicity was mod erate. Nonhematologic adverse events were generally mild. The objective res ponse rate was 82.9% (34/41) with 18 patients (43.9%) achieving complete re sponse and 16 (38%) achieving partial response; progressive disease was obs erved in 4 patients (9.8%). Responses were observed at all metastatic sites , including complete responses in lung liver, bone, and soft tissue. Median duration of response was 14.1 months and median time to progression was 13 .9 months. Median survival was 26.2 months. The biweekly combination of gem citabine, doxorubicin, and paclitaxel is safe and highly active as first-li ne treatment in metastatic breast cancer.