Safety of Continuing Trastuzumab Despite Mild Cardiotoxicity A Phase I Trial
Safety of Continuing Trastuzumab Despite Mild Cardiotoxicity A Phase I Trial
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DOI：
10.1016/j.jaccao.2019.06.004
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发表时间：
2019-09-01
影响因子：
11.1
通讯作者：
Dhesy-Thind, Sukhbinder
中科院分区：
文献类型：
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作者：
Leong, Darryl P.;Cosman, Tammy;Dhesy-Thind, Sukhbinder
目的：本研究旨在评估持续曲妥珠单抗治疗发生轻度心脏毒性的人表皮生长因子受体阳性乳腺癌患者的安全性。心脏毒性是曲妥珠单抗最常见的剂量限制性毒性。目前的治疗标准是停药曲妥珠单抗，这可能导致更糟糕的癌症结果。目前尚不清楚尽管有轻微的心脏毒性，继续使用曲妥珠单抗是否安全。方法：如果左室射血分数（LVEF）在40%和正常下限之间，或者从基线下降>= 15%，则患者有资格参加这项I期前瞻性单臂试验。参与者在心脏肿瘤学诊所接受血管紧张素转换酶（ACE）抑制剂和/或β受体阻滞剂治疗，并进行临床随访和连续超声心动图随访1年。主要终点是心脏剂量限制性毒性，定义为心血管死亡（LVEF）
OBJECTIVES This study sought to evaluate the safety of continuing trastuzumab in patients with human epidermal growth factor receptor-positive breast cancer who developed mild cardiotoxicity.BACKGROUND Cardiotoxicity is the most common dose-limiting toxicity associated with trastuzumab. Current standard of care is discontinuation of trastuzumab, which can lead to worse cancer outcomes. It is unknown whether it is safe to continue trastuzumab despite mild cardiotoxicity.METHODS Patients were eligible for this phase I, prospective, single-arm trial if left ventricular ejection fraction (LVEF) was between 40% and the lower limit of normal or if it fell >= 15% from baseline. Participants were treated with angiotensin-converting enzyme (ACE) inhibitors and/or beta-blockers in a cardio-oncology clinic and were followed clinically and with serial echocardiograms for 1 year. The primary outcome was cardiac dose-limiting toxicity, defined as cardiovascular death, LVEF