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Cardiac Safety Of Trastuzumab In Combination With Epirubicin And Cyclophosphamide In Women With Metastatic Breast Cancer: Results Of A Phase I Trial.

M. Untch, H. Eidtmann, A. Du Bois, H. G. Meerpohl, C. Thomssen, A. Ebert, N. Harbeck, C. Jackisch, V. Heilman, G. Emons, D. Wallwiener, W. Wiese, J. Blohmer, K. Hoeffken, W. Kuhn, P. Reichardt, M. Muscholl, M. Pauschinger, B. Langer, H. Lueck
Published 2004 · Medicine

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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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