Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer
. (2006) Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer. New England Journal of Medicine, Vol.355 (No.18). pp. 1851-1862. ISSN 0028-4793
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Official URL: http://dx.doi.org/10.1056/NEJMoa052084
The National Epirubicin Adjuvant Trial (NEAT) and the BR9601 trial examined the
efficacy of anthracyclines in the adjuvant treatment of early breast cancer.
In NEAT, we compared four cycles of epirubicin followed by four cycles of cyclophosphamide,
methotrexate, and fluorouracil (CMF) with six cycles of CMF alone. In the
BR9601 trial, we compared four cycles of epirubicin followed by four cycles of CMF,
with eight cycles of CMF alone every 3 weeks. The primary end points were relapsefree
and overall survival. The secondary end points were adverse effects, dose intensity,
and quality of life.
The two trials included 2391 women with early breast cancer; the median follow-up
was 48 months. Relapse-free and overall survival rates were significantly higher in the
epirubicin–CMF groups than in the CMF-alone groups (2-year relapse-free survival,
91% vs. 85%; 5-year relapse-free survival, 76% vs. 69%; 2-year overall survival, 95% vs.
92%; 5-year overall survival, 82% vs. 75%; P<0.001 by the log-rank test for all comparisons).
Hazard ratios for relapse (or death without relapse) (0.69; 95% confidence
interval [CI], 0.58 to 0.82; P<0.001) and death from any cause (0.67; 95% CI, 0.55 to
0.82; P<0.001) favored epirubicin plus CMF over CMF alone. Independent prognostic
factors were nodal status, tumor grade, tumor size, and estrogen-receptor status
(P<0.001 for all four factors) and the presence or absence of vascular or lymphatic
invasion (P = 0.01). These factors did not significantly interact with the effect of epirubicin
plus CMF. The overall incidence of adverse effects was significantly higher
with epirubicin plus CMF than with CMF alone but did not significantly affect the
delivered-dose intensity or the quality of life.
Epirubicin plus CMF is superior to CMF alone as adjuvant treatment for early breast
cancer. (ClinicalTrials.gov number, NCT00003577.)
|Item Type:||Journal Article|
|Subjects:||R Medicine > R Medicine (General)
R Medicine > RS Pharmacy and materia medica
|Divisions:||Faculty of Medicine > Warwick Medical School|
|Library of Congress Subject Headings (LCSH):||Anthrcyclines -- Testing, Breast cancer, Drugs testing|
|Journal or Publication Title:||New England Journal of Medicine|
|Publisher:||Massachusetts Medical Society Publisher|
|Official Date:||2 November 2006|
|Page Range:||pp. 1851-1862|
|Access rights to Published version:||Open Access|
|Description:||Final version (as published).|
Early Breast Cancer Trialists' Collaborative Group. (1992). Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy: 133 randomised trials involving 31,000 recurrences and 24,000 deaths among 75,000 women. Lancet, 339, pp. 71-85.
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