Improved outcome from substituting methotrexate with epirubicin: results from a randomised comparison of CMF versus CEF in patients with primary breast cancer

Bent Ejlertsen, Henning T Mouridsen, Maj-Britt Jensen, Jørn Andersen, Søren Cold, Per Edlund, Marianne Ewertz, Brita B Jensen, Claus Kamby, Bo Nordenskjold, Jonas Bergh

61 Citationer (Scopus)

Abstract

We compared the efficacy of CEF (cyclophosphamide, epirubicin, and fluorouracil) against CMF (cyclophosphamide, methotrexate, and fluorouracil) in moderate or high risk breast cancer patients. We randomly assigned 1224 patients with completely resected unilateral breast cancer to receive nine cycles of three-weekly intravenous CMF or CEF. Patients were encouraged to take part in a parallel trial comparing oral pamidronate 150 mg twice daily for 4 years versus control (data not shown). Substitution of methotrexate with epirubicin significantly reduced the unadjusted hazard for disease-free survival (DFS) by 16% (hazard ratio 0.84; 95% CI; 0.71-0.99) and for overall survival by 21% (hazard ratio 0.79; 95% CI; 0.66-0.94). The risk of secondary leukaemia and congestive heart failure was similar in the two groups. Overall CEF was superior over CMF in terms of DFS and OS in patients with operable breast cancer without subsequent increase in late toxicities.

OriginalsprogEngelsk
TidsskriftEuropean journal of cancer (Oxford, England : 1990)
Vol/bind43
Udgave nummer5
Sider (fra-til)877-84
Antal sider8
ISSN0959-8049
DOI
StatusUdgivet - mar. 2007
Udgivet eksterntJa

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