Pathological complete response rates comparing 3 versus 6 cycles of epidoxorubicin and docetaxel in the neoadjuvant setting of patients with stage II and III breast cancer

We conducted a prospective randomized study to compare the results of 3 cycles of epidoxorubicin/docetaxel to 6 cycles of epidoxorubicin/docetaxel prior to surgery in breast cancer patients with clinical stages II and III. Forty-five patients eligible for neoadjuvant chemotherapy were randomly assigned to receive either 3 (group 1) or 6 (group 2) cycles of epidoxorubicin/docetaxel prior to surgery. Chemotherapy consisted of epidoxorubicin 75 mg/m(2) and docetaxel 75 mg/m(2) on day 1 in 3-week cycles. The primary endpoint was the pathological complete response (pCR) rate; secondary endpoints were the rates of breast-conserving surgery and the axillary lymph node status in both groups. A pCR occurred in 10% (two of 20) in Group 1 and in 36% (nine of 25) in Group 2, which was statistically significant (p = 0.045). Breast-conserving surgery could be performed in 70% (14 of 20) in Group 1 and in 76% (19 of 25) in Group 2 (p = 0.065). Axillary lymph node status was negative in 45% (nine of 20) in Group 1 and 52% (13 of 25) in Group 2 (p = 0.86). We conclude that 6 cycles of pre-operative epidoxorubicin/docetaxel versus 3 cycles of pre-operative epidoxorubicin/docetaxel significantly increases the pCR rates for breast cancer patients.