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- Document type:
- Clinical Trial; Clinical Trial, Phase I; Journal Article; Multicenter Study; Article
- Author(s):
- Untch, M; Eidtmann, H; du Bois, A; Meerpohl, HG; Thomssen, Ch; Ebert, A; Harbeck, N; Jackisch, C; Heilman, V; Emons, G; Wallwiener, D; Wiese, W; Blohmer, JU; Hoffken, K; Kuhn, W; Reichardt, P; Muscholl, M; Pauschinger, M; Langer, B; Luck, HJ
- Title:
- Cardiac safety of trastuzumab in combination with epirubicin and cyclophosphamide in women with metastatic breast cancer: results of a phase I trial.
- Abstract:
- 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.
- Journal title abbreviation:
- Eur J Cancer
- Year:
- 2004
- Journal volume:
- 40
- Journal issue:
- 7
- Pages contribution:
- 988-97
- Language:
- eng
- Fulltext / DOI:
- doi:10.1016/j.ejca.2004.01.011
- Pubmed ID:
- http://view.ncbi.nlm.nih.gov/pubmed/15093573
- Print-ISSN:
- 0959-8049
- TUM Institution:
- Frauenklinik und Poliklinik
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