Comparison of Docetaxel, Doxorubicin and Cyclophosphamide (TAC) with 5-Fluorouracil, Doxorubicin and Cyclophosphamide (FAC) Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer: A Phase III Clinical Trial

The present study aimed to compare the rates of complete clinical and pathologic response to docetaxel, doxorubicin and cyclophosphamide (TAC) vs. 5-fluorouracil, doxorubicin and cyclophosphamide (FAC) as neoadjuvant chemotherapy in women with locally advanced breast cancer. One hundred women with pathologically confirmed newly diagnosed locally advanced (T3-T4 or N2-N3) breast cancer were randomly assigned to receive a median of four cycles of either 5-fluorouracil (600 mg/m2), doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) every three weeks or docetaxel (75 mg/m2), doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every three weeks followed by modified radical mastectomy. Complete clinical and pathologic response rates and toxicity were the primary and secondary outcome measures of the study. Median age for all patients was 43.4 years (range 25-63 years). Patients in the TAC arm achieved a higher clinical (16%) response rate than those in the FAC arm (4%, P=0.046). The pathologic response rate was also higher in the TAC arm compared to the FAC arm [TAC (20%) vs. FAC (6%), P=0.037]. Estrogen receptor- negative status correlated with a higher clinical [TAC (19%) vs. FAC (4%), P=0.032] and pathologic [TAC (23%) vs. FAC (4%), P=0.011)] response rate in both arms. All patients generally tolerated treatment well, and treatment-related toxicities were manageable. Combined treatment with TAC led to higher rates of complete clinical and pathologic response with acceptable toxicity compared to FAC in patients with locally advanced breast cancer. However, further follow-up is needed to translate this response into improvements in survival.