ABSTRACT
This trial compared six cycles of fluorouracil, doxorubicin, and cyclophosphamide [FAC] with a sequential regimen of three cycles of FAC followed by three cycles of docetaxel [FAC-D] as adjuvant treatment for women with node-positive, hormone-receptor negative breast cancer. Eighty-five patients with node-positive, hormone receptor negative breast cancer women were randomly assigned to either FAC every 21 days for six cycles, or three cycles of FAC followed by three cycles of docetaxel [FAC-D], both given every 21 days. Radiotherapy was performed after the 6 cycles of chemotherapy. The primary end-point was disease-free survival. Median follow-up was 44 months, disease-free survival was 60.5% with FAC, and 78.5% with FAC-D, demonstrating 47% reduction in the risk of relapse. The high risk of an event was found during the first 2 years. Overall-survival rates were 69.8% with FAC and 81% for FAC-D, demonstrating 33% reduction in the risk of death. The incidence of neutropenia and parasethia, were higher in the sequential arm of the study [p- 0.03, 0.017, respectively]. Though non-significant difference, incidence of amenorrhea was higher in the FAC group [p=0.06]. Sequential adjuvant chemotherapy with FAC followed by docetaxel resulted in significant improvement in disease-free survival but no significant improvement in overall-survival in node-positive, hormone-receptor negative breast cancer patients and has an acceptable toxicity