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

In order to better explore the toxicity and the activity of high dose epiru bicin (120 mg/m(2), 3 weeks) we analyzed a population of 127 metastatic bre ast cancer patients, treated in a randomized clinical trial conducted to ev aluate the cardioprotective effect of dexrazoxane against epirubicin induce d cardiotoxicity. All the patients had a diagnosis of metastatic breast can cer, an ECOG performance status less than or equal to 2 and normal hematolo gic, renal, hepatic and cardiac function. No prior adjuvant chemotherapy in cluding anthracycline was allowed. Epirubicin was given at the dose of 120 mg/m(2) i.v. bolus every 3 weeks. One hundred twenty five patients were eva luable for toxicity and response. Seventeen patients (11%) had a complete r esponse and 47 patients (37%) a partial response, for an overall response r ate of 48%. The median progression free and overall survivals were 8.3 mont hs and 18.3 months, respectively. Grade 3 and 4 leukopenia were observed in 8% and 7% of the patients, respectively. The most frequent nonhematologica l grade 3 toxicities were alopecia (87%), nausea and vomiting (16%), and mu cositis (8%). Cardiotoxicity, defined as occurrence of congestive heart fai lure, decrease in resting left ventricular ejection fraction (L-VEF) to les s than or equal to 45%, or 20 EF units decrease from baseline L-VEF, was ob served in 19% of the patients, after a median cumulative dose of epirubicin of 720 mg/m(2) (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 bef ore treatment.