To evaluate the clinical and pathologic response and toxicity of cyclophosphamide and epirubicin and fluorouracil as neoadjuvant chemotherapy in the treatment of breast cancer, and observe the long-term effect.

From January 2001 to June 2006, 89 patients confirmed breast cancer by core needle biopsy were enrolled onto this clinical trial and treated with neoadjuvant chemotherapy,the regimen containing cyclophosphamide 600 mg/m² (day 1) and epirubicin 100 mg/m² (day 1) and 5-fluorouracil 500 mg/m² (day 1) (FEC100) was administered every 3 weeks for 4 cycles before local treatment.

The clinical overall response was 80.5%. cCR was 19.1%(17/89), cPR was 61.8%(55/89), SD was 19.1%(17/89), and no case was PD. Pathological complete response (pCR) was found in 16 cases (18.0%). Leukopenia with grade 3 and 4 occurred in 26 patients. Febrile leukopenia occurred in 3 patients. Nausea and vomitting with grade 3 occurred in 12 patients(13.5%). 71 cases had grade 3 alopecia(79.8%). There was no congestive heart failure. At a median follow-up of 37 months, the overall survival rate(OS)was 86.6% and the disease free survival rate(DFS)was 81.7%. The rates of OS and DFS for patients with a pCR were both 93.7%.

The FEC100 regimen is a very active and well-tolerated regimen in the neoadjuvant chemotherapy for breast cancer.