Tang Xue-Miao, Chen Hao, Liu Yu, Huang Bin-Lian, Zhang Xiu-Quan, Yuan Jian-Mei, He Xia
Department of Ultrasound and Electrocardiogram Department of Clinical Laboratory Department of Radiation Oncology Department of Nursing, Sun Yat-Sen University Cancer Center State Key Laboratory of Oncology in Southern China Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Medicine (Baltimore). 2017 Jan;96(3):e5946. doi: 10.1097/MD.0000000000005946.
The cardiac safety of cetuximab, particularly as single approach, has not been investigated extensively. This trial was designed to evaluate the cardiac safety of cetuximab as salvage monotherapy in Chinese chemotherapy-refractory metastatic colorectal cancer (mCRC) patients.Cetuximab was administrated at an initial dose of 400 mg/mon day 1 (week 1), followed by a maintenance dose of 250 mg/m on day 1 of each 7-day cycle. Electrocardiograph (ECG), routine laboratory tests, and troponin I (TNI) Ultra were performed at baseline, during, and after the cetuximab therapy. The incidence of abnormal ECGs, elevated TNI Ultra, cardiac events, and noncardiac events were recorded and analyzed.TNI Ultra+ was found in 20 patients (32.3%) during the cetuximab therapy.TNI Ultra+ occurred more frequently in patients with more than 3 organs affected and accepted fourth or above lines of chemotherapy. The most frequent abnormal ECG was ST depression in 24 (38.7%) patients. The elevated TNI Ultra and abnormal ECGs could recover after the cetuximab therapy. The most of cardiac adverse events were mild and transient and the noncardiac adverse events were also consistent with the known safety profile for cetuximab.Cetuximab showed its cardiac safety as a single agent for chemotherapy-refractory mCRC patients. And TNI Ultra and ECG could be sensitive and convenient approaches for the surveillance of adverse events.
西妥昔单抗的心脏安全性,尤其是作为单一治疗方法时,尚未得到广泛研究。本试验旨在评估西妥昔单抗作为挽救性单药疗法,用于中国化疗难治性转移性结直肠癌(mCRC)患者的心脏安全性。西妥昔单抗在第1天(第1周)的初始剂量为400mg/m²,随后在每个7天周期的第1天给予250mg/m²的维持剂量。在西妥昔单抗治疗前、治疗期间和治疗后进行心电图(ECG)、常规实验室检查和肌钙蛋白I(TNI)超敏检测。记录并分析异常心电图、TNI超敏升高、心脏事件和非心脏事件的发生率。在西妥昔单抗治疗期间,20例患者(32.3%)出现TNI超敏升高。TNI超敏升高在受影响器官超过3个且接受过四线或以上化疗的患者中更频繁出现。最常见的异常心电图是24例(38.7%)患者出现ST段压低。西妥昔单抗治疗后,TNI超敏升高和异常心电图可恢复。大多数心脏不良事件为轻度且短暂,非心脏不良事件也与西妥昔单抗已知的安全性特征一致。西妥昔单抗作为化疗难治性mCRC患者的单一药物显示出心脏安全性。并且TNI超敏检测和心电图可作为监测不良事件的敏感且便捷的方法。