Cardiac Safety of Reduced Cardiotoxicity Surveillance During HER2-Targeted Therapy.

BACKGROUND

Echocardiograms are recommended every 3 months to monitor for cancer therapy-related cardiac dysfunction (CTRCD) among patients treated with HER2-targeted therapy, despite increasing use of safer regimens associated with low CTRCD risk.

OBJECTIVES

This study evaluated the cardiac safety of reduced CTRCD surveillance performed every 6 months during non-anthracycline HER2-targeted treatment.

METHODS

This non-randomized clinical trial enrolled 190 patients with HER2-positive breast cancer treated with non-anthracycline HER2-targeted therapy. CTRCD surveillance by means of echocardiography was performed every 6 months. Key exclusion criteria were previous anthracycline exposure, significant cardiovascular disease, and uncontrolled hypertension. The primary outcome was the cardiac event rate, defined by heart failure or cardiovascular death at 1 year. Secondary outcomes included change in LVEF from baseline to 6 months and 1 year, incidence of asymptomatic CTRCD, incidence of HER2-targeted treatment interruption, and feasibility of reduced cardiac surveillance.

RESULTS

The median age was 52 years (Q1-Q3: 45-60 years); 174 (91.6%) had stage I-III disease, and all were treated with a trastuzumab-based regimen. Cardiovascular risk factors included hypertension (20.0%) and diabetes (4.2%), and the mean left ventricular ejection fraction at baseline was 63.6 ± SE 0.3%. There were 0 (0%; 1-sided 97.5% CI: 0%-1.9%) cardiac events with a median follow-up of 17.5 months (Q1-Q3: 16.3-18.9 months). One patient developed asymptomatic CTRCD (0.5%; 95% CI: 0.01%-2.9%) but resumed therapy after a temporary treatment interruption. Adherence to the reduced CTRCD surveillance schedule every 6 months was 73.2% (intention-to-treat) and 79.9% (per-protocol).

CONCLUSIONS

Reduced CTRCD surveillance every 6 months is safe and feasible for patients at low risk for CTRCD and may be an appropriate strategy to consider during non-anthracycline HER2-targeted treatment regimens.