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rdf:type |
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lifeskim:mentions |
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pubmed:issue |
14 Suppl 14
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pubmed:dateCreated |
2005-2-2
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pubmed:abstractText |
This study was designed to evaluate the cardiac safety of the combined treatment of HER2-positive metastatic breast cancer patients with trastuzumab (Herceptin) plus epirubicin and cyclophosphamide (EC) in comparison with EC alone in HER2-negative metastatic breast cancer patients. Patients included those with metastatic breast cancer without any prior anti-HER2 treatment, anthracycline therapy, or any other chemotherapy for metastatic disease. This was a nonrandomized, prospective, dose-escalating, multicenter, open-label, phase I study in Germany. A control group of 23 patients received EC 90/600 mg/m2 3-weekly for six cycles (EC90 alone). A total of 26 HER2-positive patients were treated with trastuzumab, or H (2 mg/kg weekly after an initial loading dose of 4 mg/kg), and EC 60/600 mg/m2 3-weekly for six cycles (EC60+H); another 25 HER2-positive patients received H and EC 90/600 mg/m2 3-weekly for six cycles. Asymptomatic reductions in left ventricular ejection fraction (LVEF) of more than 10% points were detected in 12 patients (48%) treated with EC60+H and in 14 patients (56%) treated with EC90+H vs 6 patients (26%) in the EC90 alone cohort. LVEF decreases to <50% occurred in one patient in the EC60+H cohort and in two patients in the EC90+H cohort during the H monotherapy. No cardiac event occurred in the cohort with EC90 alone. The overall response rates for EC60+H and EC90+H were >60%, vs 26% for EC90 alone. The interim results of this study approve the cardiac safety of the combination of H with EC, with low risk of cardiac toxicity. The combination regimen revealed 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 |
http://linkedlifedata.com/resource/pubmed/chemical/Anthracyclines,
http://linkedlifedata.com/resource/pubmed/chemical/Antibiotics, Antineoplastic,
http://linkedlifedata.com/resource/pubmed/chemical/Antibodies, Monoclonal,
http://linkedlifedata.com/resource/pubmed/chemical/Antibodies, Monoclonal, Humanized,
http://linkedlifedata.com/resource/pubmed/chemical/Cyclophosphamide,
http://linkedlifedata.com/resource/pubmed/chemical/Epirubicin,
http://linkedlifedata.com/resource/pubmed/chemical/Receptor, erbB-2,
http://linkedlifedata.com/resource/pubmed/chemical/trastuzumab
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pubmed:status |
MEDLINE
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pubmed:month |
Dec
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pubmed:issn |
0890-9091
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pubmed:author |
pubmed-author:Du BoisAA,
pubmed-author:EidtmannHH,
pubmed-author:EmonsGG,
pubmed-author:HarbeckNN,
pubmed-author:HimslII,
pubmed-author:JackischCC,
pubmed-author:KahlertSS,
pubmed-author:KreienbergRR,
pubmed-author:KuhnWW,
pubmed-author:LangerBB,
pubmed-author:LueckH JHJ,
pubmed-author:MeerpohlH GHG,
pubmed-author:MuschollMM,
pubmed-author:PauschingerMM,
pubmed-author:SchallerGG,
pubmed-author:ThomssenCC,
pubmed-author:UntchMM,
pubmed-author:WallwienerDD,
pubmed-author:WieseWW
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pubmed:issnType |
Print
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pubmed:volume |
18
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
59-64
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pubmed:dateRevised |
2011-11-17
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pubmed:meshHeading |
pubmed-meshheading:15685838-Adult,
pubmed-meshheading:15685838-Aged,
pubmed-meshheading:15685838-Anthracyclines,
pubmed-meshheading:15685838-Antibiotics, Antineoplastic,
pubmed-meshheading:15685838-Antibodies, Monoclonal,
pubmed-meshheading:15685838-Antibodies, Monoclonal, Humanized,
pubmed-meshheading:15685838-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:15685838-Breast Neoplasms,
pubmed-meshheading:15685838-Cyclophosphamide,
pubmed-meshheading:15685838-Drug Administration Schedule,
pubmed-meshheading:15685838-Epirubicin,
pubmed-meshheading:15685838-Female,
pubmed-meshheading:15685838-Germany,
pubmed-meshheading:15685838-Heart Diseases,
pubmed-meshheading:15685838-Humans,
pubmed-meshheading:15685838-Middle Aged,
pubmed-meshheading:15685838-Prospective Studies,
pubmed-meshheading:15685838-Receptor, erbB-2,
pubmed-meshheading:15685838-Stroke Volume,
pubmed-meshheading:15685838-Time Factors,
pubmed-meshheading:15685838-Treatment Outcome
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pubmed:year |
2004
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pubmed:articleTitle |
Anthracycline and trastuzumab in breast cancer treatment.
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pubmed:affiliation |
Klinikum Grosshadern, Frauenklinik München, Ludwig-Maximilians-Universität, München, Germany. mwolf@med.uni-muenchen.de
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Multicenter Study,
Clinical Trial, Phase I
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