Herceptin trastuzumab: Postmarketing study data

Researchers at Vall d'Hebron University Hospital reported data from an analysis of medical records from 45 patients ages 70-92 with HER2-overexpressing breast cancer who had received >=1 dose of Herceptin showing that the drug increased the incidence of heart problems, especially in women with a history of heart disease and/or diabetes. Specifically, 8 patients experienced asymptomatic cardiotoxicity, defined as an absolute drop of >=10% in left ventricular ejection fraction (LVEF) with a final LVEF of <50% or any absolute drop of >20%, and 4 patients developed symptomatic congestive heart failure (CHF). All 8 patients with asymptomatic cardiac events recovered completely after discontinuing Herceptin. Furthermore, patients were significantly more likely to develop asymptomatic or symptomatic cardiac events during treatment with Herceptin if they presented with a history of diabetes (33.3% vs. 6.1%, p=0.01) or cardiac disease (33% vs. 9.1%, p=0.017) compared to patients without each respective risk factor. Data were published in Annals of Oncology. ...