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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
7
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pubmed:dateCreated |
2004-4-19
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pubmed:abstractText |
This prospective, parallel-group, dose-escalation study evaluated the cardiac safety of trastuzumab (Herceptin) plus epirubicin/cyclophosphamide (EC) in women with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer (MBC) and determined an epirubicin dose for further evaluation. HER2-positive patients received standard-dose trastuzumab plus epirubicin (60 or 90 mg/m(2))/cyclophosphamide (600 mg/m(2)) 3-weekly (EC60+H, n=26; EC90+H, n=25), for four to six cycles; 23 HER2-negative patients received EC alone (90/600 mg/m(2)) 3-weekly for six cycles (EC90). All patients underwent thorough cardiac evaluation. Two EC90+H-treated patients experienced symptomatic congestive heart failure 4.5 and 6 months after the end of chemotherapy. One EC60+H-treated patient experienced an asymptomatic decrease in left ventricular ejection fraction (LVEF) to <50% 6 months after the end of chemotherapy. No such events occurred in control patients. Asymptomatic LVEF decreases of >10% points were detected in 12 (48%), 14 (56%) and 5 (24%) patients treated with EC60+H, EC90+H, and EC90. Objective response rates with EC60+H and EC90+H were >60%, and 26% for EC90 alone. These results indicate that trastuzumab may be combined with EC with manageable cardiotoxicity and promising efficacy.
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pubmed:language |
eng
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pubmed:journal |
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pubmed:citationSubset |
IM
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pubmed:chemical |
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pubmed:status |
MEDLINE
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pubmed:month |
May
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pubmed:issn |
0959-8049
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pubmed:author |
pubmed-author:BlohmerJ-UJU,
pubmed-author:EbertAA,
pubmed-author:EidtmannHH,
pubmed-author:EmonsGG,
pubmed-author:HöffkenKK,
pubmed-author:HarbeckNN,
pubmed-author:HeilmanVV,
pubmed-author:JackischCC,
pubmed-author:KuhnWW,
pubmed-author:LückH JHJ,
pubmed-author:LangerBB,
pubmed-author:MeerpohlH GHG,
pubmed-author:MuschollMM,
pubmed-author:PauschingerMM,
pubmed-author:ReichardtPP,
pubmed-author:ThomssenChCh,
pubmed-author:UntchMM,
pubmed-author:WallwienerDD,
pubmed-author:WieseWW,
pubmed-author:du BoisAA
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pubmed:issnType |
Print
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pubmed:volume |
40
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
988-97
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pubmed:dateRevised |
2011-11-17
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pubmed:meshHeading |
pubmed-meshheading:15093573-Adult,
pubmed-meshheading:15093573-Aged,
pubmed-meshheading:15093573-Antibodies, Monoclonal,
pubmed-meshheading:15093573-Antibodies, Monoclonal, Humanized,
pubmed-meshheading:15093573-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:15093573-Breast Neoplasms,
pubmed-meshheading:15093573-Cyclophosphamide,
pubmed-meshheading:15093573-Dose-Response Relationship, Drug,
pubmed-meshheading:15093573-Epirubicin,
pubmed-meshheading:15093573-Female,
pubmed-meshheading:15093573-Genes, erbB-2,
pubmed-meshheading:15093573-Heart Diseases,
pubmed-meshheading:15093573-Humans,
pubmed-meshheading:15093573-Maximum Tolerated Dose,
pubmed-meshheading:15093573-Middle Aged,
pubmed-meshheading:15093573-Neoplasm Metastasis,
pubmed-meshheading:15093573-Prospective Studies
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pubmed:year |
2004
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pubmed:articleTitle |
Cardiac safety of trastuzumab in combination with epirubicin and cyclophosphamide in women with metastatic breast cancer: results of a phase I trial.
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pubmed:affiliation |
Klinik und Poliklinik für Geburtshilfe und Frauenheilkunde, Ludwig-Maximilians-Universität, München, Germany.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Comparative Study,
Multicenter Study,
Clinical Trial, Phase I
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