Yu Anthony F, Dang Chau T, Moskowitz Chaya S, Mishra Meza Akriti, DeFusco Patricia, Oligino Eric, Chen Carol L, Sanford Rachel, Drullinsky Pamela, Bromberg Jacqueline, Wong Serena, Modi Shanu, Jorgensen Justine, Oeffinger Kevin C, Steingart Richard M, Liu Jennifer E
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA; Department of Medicine, Weill Cornell Medical College, New York, New York, USA.
JACC CardioOncol. 2025 Jun;7(4):430-441. doi: 10.1016/j.jaccao.2025.05.006.
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.
This study evaluated the cardiac safety of reduced CTRCD surveillance performed every 6 months during non-anthracycline HER2-targeted treatment.
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.
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).
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.
尽管越来越多地使用与癌症治疗相关心脏功能障碍（CTRCD）风险较低的更安全方案，但仍建议每3个月进行一次超声心动图检查，以监测接受HER2靶向治疗的患者中的CTRCD。
本研究评估了在非蒽环类HER2靶向治疗期间每6个月进行一次减少的CTRCD监测的心脏安全性。
这项非随机临床试验纳入了190例接受非蒽环类HER2靶向治疗的HER2阳性乳腺癌患者。每6个月通过超声心动图进行CTRCD监测。主要排除标准为既往蒽环类药物暴露史、严重心血管疾病和未控制的高血压。主要结局是心脏事件发生率，定义为1年内发生心力衰竭或心血管死亡。次要结局包括从基线到6个月和1年时左心室射血分数（LVEF）的变化、无症状CTRCD的发生率、HER2靶向治疗中断的发生率以及减少心脏监测的可行性。
中位年龄为52岁（四分位间距：45 - 60岁）；174例（91.6%）为I - III期疾病，所有患者均接受基于曲妥珠单抗的方案治疗。心血管危险因素包括高血压（20.0%）和糖尿病（4.2%），基线时平均左心室射血分数为63.6±标准误0.3%。中位随访17.5个月（四分位间距：16.3 - 18.9个月），发生0例（0%；单侧97.5%置信区间：0% - 1.9%）心脏事件。1例患者发生无症状CTRCD（0.5%；95%置信区间：0.01% - 2.9%），但在暂时中断治疗后恢复治疗。每6个月进行减少的CTRCD监测计划的依从性为73.2%（意向性分析）和79.9%（符合方案分析）。
对于CTRCD风险较低的患者，每6个月进行一次减少的CTRCD监测是安全可行的，并且可能是在非蒽环类HER2靶向治疗方案期间可考虑的一种合适策略。
