Abstract P1-11-21: Effectiveness Analysis of Neoadjuvant Treatment by Using 4FE100C vs 6FE100C in Patients with Advanced Breast Cancer

Abstract

Objective: To detect the difference in the effectiveness of 6 FE100C as neoadjuvant chemotherapy (NCT) vs 4 FE100C and set the duration. Method. Forty-eight consecutive cases per group from January 2003 to December 2007 were registered. Patients received cyclophosphamide 500 mg/m2, epirubicin 100 mg/m2 and 5-fluorouracil 500 mg/m2 (FE100C) with 4 or 6 cycles every 21 days. They were followed by surgery and radiotherapy. Results In the analysis, the number of the largest cycle was a predictor in clinical response. Theobjective complete clinical and partial response (cCR+cPR) was 62.5% and 87.5% with 4 FE100C and 6 FE100C respectively (p <0.003); the clinical benefit was better with six FE100C with a complete response rate (cCR) of 35.4% (CI 95%: 22% −48%, n=17). The distribution of best complete pathologic response (CPR) for 6 FE100C was significantly better than for 4 FE100C (20.8% vs.12.5%, p = 0.044). The most clinically important difference in gastrointestinal toxicity caused by 6 FE100C was the effect of mild to moderate vomiting (52.4% vs. 39% for 4 FE100C, p = 0.001); the severe leukopenia (2.43% vs. 1.56%, p= 0.401) and moderate anemia (2.08% vs. 0.52%, p = 0.142) for 6 FE100C and 4 FE100C respectively. There was no significant difference between regimens. The toxicity of the nausea, alopecia and hematologic toxicity in the effect of peripheral leukocyte count and platelet presented no significant difference between regimens. The moderate anemia was rescued with blood transfusion and severe leukopenia with filgastrim. There was no cardio toxicity, thrombocytopenia or other serious events. Conclusion: Both regimens were similar for the incidence of gastric toxicity and hematologic toxicity. The scheme of six FE100C was well tolerated in patients with LABC. It was confirmed a significant improvement in the pCR and cCR with intensified epirubicin dose (100mg/m2) for 6 cycles without granulocyte colony-stimulating factor. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-11-21.