A phase II trial of high dose epirubicin in patients with advanced breast carcinoma

Kathy D. Miller, Nikhil Munshi, David Loesch, Lawrence H. Einhorn, George W. Sledge

Research output: Contribution to journalArticle

4 Scopus citations


BACKGROUND. Anthracyclines are among the most active drugs in the treatment of breast carcinoma and exhibit a steep dose-response curve in vitro. This trial was performed to determine the efficacy and toxicity of epirubicin in the treatment of patients with advanced breast carcinoma when administered as a single agent in maximal doses. METHODS. Patients with chemotherapy-naive American Joint Committee on Cancer/International Union Against Cancer Stage IIIB or IV breast carcinoma received epirubicin, 180 mg/m2, intravenously every 3 weeks for a maximum of 8 cycles of therapy, Hematopoietic growth factors and cardioprotective agents were not used routinely. RESULTS. Twenty-seven patients were entered in the study. Although NCl/CTC criteria Grade 4 neutropenia occurred in 96% of patients, epirubicin was administered at 83.1% of the planned dose intensity. The median fall in left ventricular ejection fraction was 10%; clinical cardiac toxicity was observed in 3 patients. Objective responses were observed in 21 patients, including 6 complete responses. CONCLUSIONS. High dose epirubicin was found to result in substantial hematologic toxicity but was highly active in the treatment of patients with advanced breast carcinoma.

Original languageEnglish (US)
Pages (from-to)375-380
Number of pages6
Issue number2
StatePublished - Jan 15 2000



  • Anthracycline
  • Breast carcinoma
  • Chemotherapy
  • Dose intensity
  • Epirubicin
  • Metastatic

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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