An adjuvant regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC) is effective for women with high-risk, node-negative as well as node-positive breast cancer, according to a study by the Spanish Breast Cancer Research Group.
The taxane-based regimen has proved superior to fluorouracil, doxorubicin, and cyclophosphamide (FAC) in women with node-positive breast cancer, but its value in node-negative disease had not been determined.
Miguel MartÍn, MD, PhD, of the Hospital General Universitario, Madrid, Spain, and his associates randomized 1060 women with axillary-node–negative breast cancer who were at high risk for recurrence to treatment with either TAC or FAC after surgery.
At a median follow-up of 77 months, women in the TAC group had a 32% lower risk of disease recurrence: 87.8% were alive and disease free compared with 81.8% in the FAC group. The benefit of TAC was consistent regardless of hormone-receptor status, menopausal status, or number of high-risk factors, including age, tumor size, and histologic grade.
Survival rates in the two groups were not significantly different, but the number of events was small. Grade 3 or 4 adverse events were more common, however with TAC than with FAC (28.2% vs 17.0%). Primary prophylaxis with granulocyte colony-stimulating factor reduced the acute toxicities of TAC.