CMF + radiotherapy in the primary treatment of operable breast cancer: preliminary results of a phase II pilot study

BACKGROUND AND OBJECTIVES: Chemotherapy and radiotherapy have been investigated in several studies about their role in primary (neoadjuvant) treatment before surgery in breast cancer. We proposed a pilot study to evaluate a primary scheme of alternate radio-chemotherapy in the treatment of operable (T2- small T3) breast cancer. METHODS: 14 patients were recruited. Cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) were administered on days 1 and 8, every 4 wk, for two cycles. Radiotherapy was administered during the 3rd and 4th wk (5 d/wk) after the beginning of chemotherapy. The patients were operated on within 24 wk. All the patients received four additional cycles of chemotherapy within 1 mo after surgery. RESULTS: We observed: 1 (8.3%) complete remission (CR), 8 (66.7%) partial remission (PR), 3 (25%) stationary disease (SD); no progressive disease was observed. Modified radical mastectomy was performed on 7 patients (58.3%). Conservative surgery was performed on 5 cases (41.7%). No major complications were observed. No patient has shown local or distant recurrence. CONCLUSIONS: This study shows the feasibility of a primary chemoradiotherapy treatment for breast cancer. But to evaluate the impact of this therapy on overall survival and recurrence risk and its possible introduction in clinical practice, we need larger series and longer follow-up.