title: Single agent epirubicin as first line chemotherapy for metastatic breast cancer patients.
abstract: 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 < or = 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 < or = 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.
authors.affiliation: U. O. Oncologia Medica, Dipartimento di Oncologia Ospedale S. Chiara, Pisa, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Michelotti
authors.forename: M
authors.initials: M
authors.lastname: Venturini
authors.forename: C
authors.initials: C
authors.lastname: Tibaldi
authors.forename: C
authors.initials: C
authors.lastname: Bengala
authors.forename: L
authors.initials: L
authors.lastname: Gallo
authors.forename: F
authors.initials: F
authors.lastname: Carnino
authors.forename: L
authors.initials: L
authors.lastname: Del Mastro
authors.forename: R
authors.initials: R
authors.lastname: Lionetto
authors.forename: E
authors.initials: E
authors.lastname: Montanaro
authors.forename: R
authors.initials: R
authors.lastname: Rosso
authors.forename: P
authors.initials: P
authors.lastname: Conte
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002317:Cardiovascular Agents / Q000008:administration & dosage; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006333:Heart Failure / Q000139:chemically induced; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D011929:Razoxane / Q000008:administration & dosage; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000139:chemically induced
chemical_list: D000903:Antibiotics, Antineoplastic; D002317:Cardiovascular Agents; D015251:Epirubicin; D011929:Razoxane