Epirubicin plus low dose trastuzumab in HER2 positive metastatic breast cancer

Purpose This phase II study, evaluated theactivity and cardiotoxicity of first-line epirubicin plus lowdosetrastuzumab (LD-T) in patients with HER2 positiveMBC. Methods Patients received epirubicin 90 mg/sqmevery 3 weeks plus weekly LD-T (2 mg/kg loading dose,then 1 mg/kg). After 6/8 cycles of epirubicin, single agenttrastuzumab was continued. Cardiotoxicity was defined assigns or symptoms of congestive heart failure (CHF), orC15% decline in LVEF without symptoms, or \15%LVEF decline to less than 50%, without symptoms. ResultsForty-five patients were enrolled. Twenty-three receivedprior adjuvant anthracyclines. Overall response rate was61.4%. The median time to progression was 7.4 monthsand the median survival was 32.8 months. Two (4.5%)patients developed CHF. Conclusions Epirubicin plusLD-T is an active regimen, however, the relatively highrate of cardiotoxicity together with the availability of lesscardiotoxic and active trastuzumab-containing combinationsprecludes further evaluation of this regimen.