Adjuvant TAC may improve survival in women with node-negative breast cancer

Martin M. N Engl J Med. 2010;363:2200-2210.

Issue: December 25, 2010

Women with high-risk node-negative breast cancer who were treated with docetaxel, doxorubicin and cyclophosphamide were approximately 30% more likely to be alive and disease-free at follow-up than women treated with fluorouracil, doxorubicin and cyclophosphamide, according to study results.

The trial was conducted at 55 sites in Germany, Poland and Spain between June 1999 and March 2003; 49 of the participating sites were in Spain.

The aim was to determine the value of taxanes for the treatment of axillary node-negative breast cancer in 1,060 women. Eligible women also had at least one high risk factor for recurrence as defined by the 1998 St. Gallen criteria.

There were 539 women randomly assigned docetaxel, doxorubicin and cyclophosphamide (TAC) and 521 women assigned fluorouracil, doxorubicin and cyclophosphamide (FAC) every 3 weeks for six cycles after surgery, according to the results.

DFS after at least 5 years of follow-up was the primary outcome measure. OS and toxicity were secondary endpoints.

The median duration of follow-up was 77 months. At this time point, 87.8% of patients in the TAC group and 81.8% of women in the FAC group were alive and disease-free. This amounted to a 32% reduction in the risk of recurrence associated with TAC (HR=0.68; 95% CI, 0.49-0.93).

The benefit remained consistent when hormone receptor status, menopausal status and number of high risk factors were taken into account.

The survival rate was 95.2% in the TAC group and 93.5% in the FAC group, which the researchers said was a nonsignificant 24% difference (HR=0.76; 95% CI, 0.45-1.26). The overall mortality rate was 5.7%, with 26 deaths in the TAC group and 34 deaths in the FAC group.

Grade 3 or 4 adverse events occurred in 28.2% of TAC patients and 17% of FAC patients (P<.001). Serious events occurred in 22.4% of TAC patients and 4.2% of FAC patients. Primary prophylaxis with granulocyte colony–stimulating factors was linked to reductions in toxicity when provided with TAC.

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