Single agent epirubicin as first line chemotherapy for metastatic breast cancer patients

Andrea Michelotti, Marco Venturini, Carmelo Tibaldi, Carmelo Bengala, Luigi Gallo, Flavio Carnino, Lucia Del Mastro, Rita Lionetto, Elda Montanaro, Riccardo Rosso, Pierfranco Conte

Research output: Contribution to journalArticlepeer-review


In order to better explore the toxicity and the activity of high dose epirubicin (120 mg/m2, 3 weeks) we analyzed a population of 127 metastatic breast cancer patients, treated in a randomized clinical trial conducted to evaluate the cardioprotective effect of dexrazoxane against epirubicin induced cardiotoxicity. All the patients had a diagnosis of metastatic breast cancer, an ECOG performance status ≤ 2 and normal hematologic, renal, hepatic and cardiac function. No prior adjuvant chemotherapy including anthracycline was allowed. Epirubicin was given at the dose of 120 mg/m2 i.v. bolus every 3 weeks. One hundred twenty five patients were evaluable for toxicity and response. Seventeen patients (11%) had a complete response and 47 patients (37%) a partial response, for an overall response rate of 48%. The median progression free and overall survivals were 8.3 months and 18.3 months, respectively. Grade 3 and 4 leukopenia were observed in 8% and 7% of the patients, respectively. The most frequent nonhematological grade 3 toxicities were alopecia (87%), nausea and vomiting (16%), and mucositis (8%). Cardiotoxicity, defined as occurrence of congestive heart failure, decrease in resting left ventricular ejection fraction (L-VEF) to ≤ 45%, or 20 EF units decrease from baseline L-VEF, was observed in 19% of the patients, after a median cumulative dose of epirubicin of 720 mg/m2 (range 120-1440). This study confirms in a large series of patients the activity of high dose epirubicin; however, the high incidence of cardiotoxicity requires a careful evaluation of cardiac risk factors before treatment.

Original languageEnglish
Pages (from-to)133-139
Number of pages7
JournalBreast Cancer Research and Treatment
Issue number2
Publication statusPublished - 2000


  • Breast cancer
  • Epirubicin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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