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- Dokumenttyp:
- Clinical Trial; Clinical Trial, Phase I; Journal Article; Multicenter Study
- Autor(en):
- Untch, M; Himsl, I; Kahlert, S; Lueck, HJ; Eidtmann, H; du Bois, A; Meerpohl, HG; Thomssen, C; Harbeck, N; Jackisch, C; Kreienberg, R; Emons, G; Wallwiener, D; Wiese, W; Schaller, G; Kuhn, W; Muscholl, M; Pauschinger, M; Langer, B
- Titel:
- Anthracycline and trastuzumab in breast cancer treatment.
- Abstract:
- 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.
- Zeitschriftentitel:
- Oncology (Williston Park)
- Jahr:
- 2004
- Band / Volume:
- 18
- Heft / Issue:
- 14 Suppl 1
- Seitenangaben Beitrag:
- 59-64
- Sprache:
- eng
- PubMed:
- http://view.ncbi.nlm.nih.gov/pubmed/15685838
- Print-ISSN:
- 0890-9091
- TUM Einrichtung:
- Frauenklinik und Poliklinik
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