Clinical phase II evaluation of the combination therapy with Docetaxel andEpidoxorubicin in the neoadjuvant, cytostatic treatment on patients with primary breast cancer (T1-4, N0-2, M0)

Background: Preoperative (neo-adjuvant) chemotherapy is very effective in d ownstaging primary tumors and moreover is able to prevent advancing metasta tic growth early in the course of the disease. Methods: We report on 38 patients with a median age of 54 years (range, 33- 70 years) suffering from biopsy-proven breast cancer (T1-T4). Mastectomy ha d been considered the treatment of choice in all cases. The patients receiv ed 194 cycles of chemotherapy with docetaxel (75 mg/m(2)) and epidoxorubici n (75 mg/m2) on day 1, every 21 days, together with 30 million IU of G-CSF from days 3 to 10. Three to 8 cycles (median 5 cycles) of the treatment wer e administered until best response was achieved on mammography and clinical assessment. Results: The neo-adjuvant chemotherapy was well tolerated and all patients completed the treatment regimen on an out-patient basis. During 194 cycles we observed leukopenia WHO grade IV only at one occasion (0.5%). WHO-grade III toxicity consisted of leukopenia (0.5%), diarrhoea (2%), and stomatitis (0,5%). Response to treatment was present in 85%, with 4 patients (11%) ex periencing a pathological complete response (pCR) of the invasive tumor (TO : n = 2, DCIS: n = 2) and 28 patients (74%) showing a partial pathological response. In 21 patients (52%) a breast- conserving surgical procedure was possible. Summary: We conclude that neo-adjuvant treatment of primary breast cancer w ith docetaxel and epidoxorubicin is safe and effective. By applying more ch emotherapy cycles preoperatively it might even be possible to raise the rat e of pCR and prolong survival.