Which is More Effective; Docetaxel, Doxorubicin and Cyclophosphamide Or 5-Fluorouracil, Doxorubicin and Cyclophosphamide in Adjuvant Treatment of Early Stage Node Positive Breast Cancer?

Background The aim of this study is to compare the efficacy and the safety of docetaxel, doxorubicin and cyclophosphamide (TAC) with 5-fluorouracil, doxorubicin and cyclophosphamide (FAC) as adjuvant treatment for early stage node positive breast cancer patients. Methods Sixty patients with pathologically confirmed early stage node-positive breast cancer were randomly assigned to receive six cycles of eitherdocetaxel (75mg/m), doxorubicin (50mg/m) and cyclophosphamide (500mg/m) every three weeks or 5-fluorouracil (500mg/m), doxorubicin (50mg/m) and cyclophosphamide (500mg/m) every three weeks as adjuvant treatment. The two chemotherapy regimens were compared in term of disease free survival (DFS) and overall survival (OS). Results At a median follow-up of 30 month, the median estimated rate of DFS for patients in the TAC group was 24 month compared to 20 month for patients in the FAC group which was statistically significant (95 % confidence interval [CI], 0.49 to 7.17, P less than0.04). In terms of OS, no significant difference between the two treatment groups, the median estimated rate of OS in the TAC arm was 25 month compared to 24 month in the FAC arm ( CI, 2.84 to 5.27, P= 0.522). No significant difference in DFS as regardingthe prognostic factors as number of involved axillary lymph nodes (p=0.485), menopausal status (P=0.684), hormone-receptor status (P=0.795) and HER2/neustatus (P=0.509). The incidence of grade 2-3 anemia was higher in the TAC group than in the FAC group (23.3 % versus 13.3 %, Pless than0.04). As regarding neutropenia, it occurred more frequently in the TAC group (13.3 % versus 6.7 %, Pless than0.04). The incidence of grade 3 febrile neutropenia in the TAC group was 10 % versus 3.3 % in the FAC group (P=0.372). Conclusion Incorporation of docetaxel in the adjuvant treatment of early node-positive breast cancer patients improves the DFS with tolerable toxicity compared to FAC regimen. However, further follow-up is needed to demonstrate its effect on the OS.