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All subjects had normal left ventricular ejection fraction (LVEF greater than or equal to 55%) before starting trastuzumab therapy, according to study investigator Thomas Suter, MD, chief, inpatient services, department of cardiology, Swiss Cardiovascular Centre, University of Berne, University Hospital, Inselspital, Berne, Switzerland.

Overall, 4.3% of trastuzumab-treated patients discontinued therapy due to cardiac disorders. Rates of cardiac dysfunction (3.04% vs 0.53%), symptomatic CHF (2.15% vs 0.12%), and severe CHF (0.60% vs 0%) were all significantly higher in the trastuzumab arm compared with the observation arm.

There were no cardiac deaths in the trastuzumab arm, however, versus 1 in the observation arm.

Importantly, most patients who experienced a cardiac event had a recovered LVEF after a median of 189 days. This was also true among patients who developed severe CHF, of whom 80% were asymptomatic and 60% had a recovered LVEF after a median of 124 days.

More detailed analysis revealed a number of risk factors for cardiac endpoints, the researchers reported. Variables associated with a significantly increased risk included a lower LVEF at baseline, body mass index >25 m<SUP>2</SUP>. In addition, the cumulative dose of doxorubicin or epirubicin chemotherapy received was significantly higher among patients who experienced cardiotoxicity versus those who did not.

The researchers say that the considerable reduction in the risk of cancer recurrence with trastuzumab outweighs the low cumulative incidence of cardiotoxicity, including cardiac death and CHF.

"In the HERA trial, there was a low incidence of cardiac endpoints after a median follow-up of 12 months," they concluded. "Results suggest that cardiac dysfunction is mostly reversible within this observation period but longer follow up is needed."


[Presentation title: Cardiac Side Effects in the Herceptin Adjuvant (HERA) Trial. Abstract P110]
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