Combined analysis of two phase II trials in patients with primary and advanced breast cancer with epidoxorubicin and docetaxel+granulocyte colony stimulating factor.

Anthracyclines and taxanes are to date the most active cytotoxic agents in the treatment of breast cancer, and a combination of these is therefore considered to result in the highest response rates in the neoadjuvant, as well as in palliative treatment. These two phase II studies aimed to evaluate the feasibility, toxicity and activity of a cytostatic regimen combining epidoxorubicin and docetaxel in outpatient patients suffering from breast cancer. In total, 104 consecutive patients were enrolled in these prospective clinical trials. The chemotherapeutic regimen consisted of epidoxorubicin [75 mg/m2 body surface area (BSA)] and docetaxel (75 mg/m2 BSA) on day 1 accompanied by the administration of granulocyte colony stimulating factor on days 3-10, repeated every 3 weeks (ED+G). Sixty-six patients received ED+G as neoadjuvant and 38 patients as palliative treatment, respectively. Patients received a total of 566 cycles (median: 6 cycles, range: 2-11 cycles) of this therapeutic regimen. Outpatient ED+G was well tolerated. A major response to preoperative ED+G could be demonstrated in 54 of 66 patients (82%) and in 22 of 38 palliative treated patients (58%). We conclude that outpatient ED+G is safe in the neoadjuvant and palliative treatment of patients suffering from breast cancer by showing a favorable side effect and activity profile. Thus, this regimen can be considered for further clinical trials.