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Epirubicin and cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy for early breast cancer

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Poole, Christopher J., Earl, Helena M., Hiller, Louise, Dunn, Janet A., Bathers, Sarah, Grieve, Robert J., Spooner, David A., Agrawal, Rajiv K., Brunt, A. Murray, O’Reilly, Susan M. et al.

. (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

Abstract

Background
The National Epirubicin Adjuvant Trial (NEAT) and the BR9601 trial examined the
efficacy of anthracyclines in the adjuvant treatment of early breast cancer.
Methods
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.
Results
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.
Conclusions
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

ISSN:

0028-4793

Official Date:

2 November 2006

Dates:

Date	Event
2 November 2006	Published

Volume:

Vol.355

Number:

No.18

Page Range:

pp. 1851-1862

Identification Number:

10.1056/NEJMoa052084

Status:

Peer Reviewed

Access rights to Published version:

Open Access

Description:

Final version (as published).

References:

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