Adding the anthracycline epirubicin to cyclophosphamide, methotrexate, and fluorouracil (CMF) is superior to CMF alone as adjuvant therapy for early breast cancer, regardless of estrogen-receptor status, tumor grade, or patient age.
The conclusion comes from two trials—The National Epirubicin Adjuvant Trial and the BR9601 trial—involving a total of 2,391 women with early breast cancer. After a median follow-up of 48 months, 2-year and 5-year relapse-free survival rates and 2-year and 5-year overall survival rates were significantly higher in the epirubicin group than in the CMF-alone group (91% vs. 85%; 76% vs. 69%; 95% vs. 92%; 82% vs. 75%, respectively; P<0.001). In addition, hazard ratios for relapse (or death without relapse) (0.69) and for death from any cause (0.67) were significant (P<0.001 for both).
While significantly more adverse effects occurred in the epirubicin group than in the CMF-alone group, they did not affect delivered dose intensity or quality of life.
Poole CJ, Earl HM, Hiller L, et al. Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. N Engl J Med. 2006;355:1851-1862.