BIRMINGHAM, United KingdomAt 48 months' follow-up, adjuvant treatment of early breast cancer with epirubicin (Ellence) plus CMF showed significantly improved relapse-free and overall survival, compared with CMF alone, according to combined results of two large randomized studies. Christopher J. Poole, MD, of the University of Birmingham, and his colleagues reported the results in the New England Journal of Medicine (355:1851-1862, 2006).
The two trials included 2,391 women with early breast cancer. In the NEAT study (National Epirubicin Adjuvant Trial), 2,021 patients received four cycles of epirubicin followed by four cycles of "classic" CMF (cyclophosphamide, methotrexate, fluorouracil) or six cycles of CMF alone. In the BR9601 trial, 370 patients received four cycles of epirubicin followed by four cycles of modified classic CMF (all three drugs given once every 3 weeks) or eight cycles of CMF alone.
Combined results showed significantly higher 2-year relapse-free survival with epirubicin (91% vs 85% for CMF alone); 5-year relapse-free survival (76% vs 69%); 2-year overall survival (95% vs 92%); and 5-year overall survival (82% vs 75%) (P < .001 for all comparisons). The hazard ratios favored epirubicin for relapse or death without relapse (0.69, P < .001) and death from any cause (0.67, P < .001). "The results for overall and relapse-free survival in NEAT were similar to those in BR9601," Dr. Poole noted.
Other independent prognostic factors, including nodal status, tumor grade, tumor size, ER status, and the presence or absence of vascular or lymphatic invasion, did not significantly interact with the effect of epirubicin plus CMF.
Dr. Poole reported that although the overall incidence of adverse effects was significantly higher with epirubicin, they "did not significantly affect the delivered dose intensity or the quality of life."
Shared Decision-Making Process Essential
MARK N. LEVINE, MD, and TIMOTHY WHELAN, BM, BCh In a New England Journal of Medicine editorial, Drs. Levine and Whelan, of McMaster University and the Juravinski Cancer Centre, Hamilton, Ontario, had little criticism of the NEAT/BR9601 trial, noting only that the report did not include the number of patients in each group who received adjuvant radiation therapy or tamoxifen during follow-up.
The thrust of their editorial was the need for tailored therapy, since "the magnitude of the benefit [of adjuvant chemotherapy] is modest, and many patients have to be treated to benefit a few."