Early cardiac toxicity is a risk associated with adjuvant chemotherapy plus trastuzumab. However, objective measures of cardiac function and health-related quality of life are lacking in long-term follow-up of patients who remain cancer free after completion of adjuvant treatment.

Patients in NSABP Protocol B-31 received anthracycline and taxane chemotherapy with or without trastuzumab for adjuvant treatment of node-positive, human epidermal growth factor receptor 2–positive early-stage breast cancer. A long-term follow-up assessment was undertaken for patients who were alive and disease free, which included measurement of left ventricular ejection fraction by multigated acquisition scan along with patient-reported outcomes using the Duke Activity Status Index (DASI), the Medical Outcomes Study questionnaire, and a review of current medications and comorbid conditions.

At a median follow-up of 8.8 years among eligible participants, five (4.5%) of 110 in the control group and 10 (3.4%) of 297 in the trastuzumab group had a > 10% decline in left ventricular ejection fraction from baseline to a value < 50%. Lower DASI scores correlated with age and use of medications for hypertension, cardiac conditions, diabetes, and hyperlipidemia, but not with whether patients had received trastuzumab.

In patients without underlying cardiac disease at baseline, the addition of trastuzumab to adjuvant anthracycline and taxane-based chemotherapy does not result in long-term worsening of cardiac function, cardiac symptoms, or health-related quality of life. The DASI questionnaire may provide a simple and useful tool for monitoring patient-reported changes that reflect cardiac function.

早期心脏毒性是辅助化疗加曲妥珠单抗相关的风险。然而，在完成辅助治疗后仍无癌症的患者的长期随访中，缺乏对心脏功能和健康相关生活质量的客观测量。

NSABP协议B-31中的患者接受蒽环类和紫杉类化学疗法联合或不联合曲妥珠单抗的治疗，以辅助治疗淋巴结阳性，人表皮生长因子受体2阳性的早期乳腺癌。对存活和无疾病的患者进行了长期随访评估，其中包括通过多次采集扫描测量左心室射血分数以及使用杜克活动状态指数（DASI），医学成果对患者报告的结果进行测量。研究问卷，并审查当前的药物和合并症。

在符合条件的参与者中位随访8.8年后，曲妥珠单抗组110例中有5（4.5％）占297％，曲妥珠单抗组中297例中有10例（3.4％）的左室射血分数从基线下降至值<50％。较低的DASI分数与年龄，高血压，心脏病，糖尿病和高脂血症的药物使用相关，但与患者是否接受曲妥珠单抗无关。

在基线时没有潜在心脏疾病的患者中，在辅助蒽环类和紫杉烷类化学疗法中添加曲妥珠单抗不会导致心脏功能，心脏症状或健康相关生活质量的长期恶化。DASI问卷可以为监测反映心脏功能的患者报告的变化提供一个简单而有用的工具。