Epirubicin and docetaxel as neoadjuvant treatment of locally advanced breast cancer: A phase II study

Aims and background. Neoadjuvant chemotherapy is the standard treatment for locally advanced breast cancer. The combination of anthracyclines and taxanes is considered the first choice chemotherapy in advanced breast cancer. We report here the overall results of a phase II study of epirubicin and docetaxel as neoadjuvant chemotherapy in advanced breast cancer. Patients and methods. Forty-five patients with locally advanced, nonmetastatic breast carcinoma were treated with epirubicin, 90 mg/m ², docetaxel, 75 mg/m ², intravenously, every 3 weeks for 4 cycles before and 4 cycles after surgery, followed by tamoxifen for 5 years if estrogen receptor positive and radiation therapy if indicated. Patient characteristics included amedian age of 45 years; pre/postmenopausal, 31/14 patients; T3-T4 in 33, N0/N1 in 12/33; ductal/lobular in 42/3; ER+ in 23; and HER2 overexpression in 23. Results. Clinical response included complete remission in 7 patients and partial remission in 27 (response rate, 75%). All 45 patients underwent surgery (quadrantectomy in 7). Histological examination of the breast and lymph nodes revealed no signs of disease in 3 patients and ductal carcinoma in situ only in 2. Twenty-five patients completed the chemotherapy program. G3-G4 toxicity included neutropenia in 39 patients. No other G3-4 toxicity nor toxic deaths occurred. Median relapse-free and overall survival were 35 and 56 months, respectively. Conclusions. The neoadjuvant treatment was active and well tolerated, but the incidence of pathologic complete remissions was relatively low.