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

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 ni...

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Veröffentlicht in:European journal of cancer (1990) 2007-03, Vol.43 (5), p.877-884
Hauptverfasser: Ejlertsen, Bent, Mouridsen, Henning T, Jensen, Maj-Britt, Andersen, Jørn, Cold, Søren, Edlund, Per, Ewertz, Marianne, Jensen, Brita B, Kamby, Claus, Nordenskjold, Bo, Bergh, Jonas
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container_end_page 884
container_issue 5
container_start_page 877
container_title European journal of cancer (1990)
container_volume 43
creator Ejlertsen, Bent
Mouridsen, Henning T
Jensen, Maj-Britt
Andersen, Jørn
Cold, Søren
Edlund, Per
Ewertz, Marianne
Jensen, Brita B
Kamby, Claus
Nordenskjold, Bo
Bergh, Jonas
description 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.
doi_str_mv 10.1016/j.ejca.2007.01.009
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subjects Adult
Aged
Antineoplastic combined chemotherapy protocols
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Antineoplastic Combined Chemotherapy Protocols/administration & dosage/therapeutic use
Biological and medical sciences
Breast neoplasms
Breast Neoplasms - drug therapy
Cyclophosphamide
Cyclophosphamide - administration & dosage
Cytarabine - administration & dosage
Epirubicin
Epirubicin - administration & dosage
Female
Fluorouracil
Fluorouracil - administration & dosage
Hematology, Oncology and Palliative Medicine
Humans
Medical sciences
MEDICIN
Medicin och hälsovetenskap
MEDICINE
Methotrexate
Methotrexate - administration & dosage
Middle Aged
Pharmacology. Drug treatments
Proportional hazards models
Randomised controlled trials
Survival analysis
Treatment Outcome
Tumors
title Improved outcome from substituting methotrexate with epirubicin: Results from a randomised comparison of CMF versus CEF in patients with primary breast cancer
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