Irreversible cardiotoxicity induced by trastuzumab: a systematic review based on a pharmacovigilance case report.

Víctor E Lechuga-Noa, L Yesenia Rodríguez-Tanta, Tania Del Pilar Solis-Yucra, Efraín Cesar Rojo Rosales
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Abstract

Irreversible cardiotoxicity (IC) induced by trastuzumab (TZB) is a rare but serious adverse event. As a result, its characteristics and the specific factors related to exposure remain poorly understood. This study aims to synthesize and evaluate the existing evidence on IC. We presented a pharmacovigilance case of long-term IC and conducted a systematic review (SR) of the clinical manifestations of cases reported worldwide. We reported the case using the CARE guidelines checklist and assessed the causality using the modified Algorithm of Karch and Lasagna. Following PRISMA guidelines, we conducted the SR using defined terms in PubMed, Embase, Scopus, and Web of Science from inception until June 2023. This SR included five case reports, including the pharmacovigilance case reported by us. While patients exhibited different severe clinical characteristics, receiving TZB at a 6 mg/kg dose was consistent. Despite varying treatment durations, the median time of IC diagnosis was 10 months, and the average difference between the basal and the final left ventricular ejection fraction was roughly 30%. According to the modified Karch and Lasagna algorithm, all cases were ranged from possible to probable. While TZB is generally considered a reversible cardiotoxic antineoplastic, clinicians and regulators must be aware of the potential IC risk with long-term manifestations. Vigilant cardiac monitoring and further research are crucial to better understanding and managing this serious adverse event.

曲妥珠单抗诱导的不可逆心脏毒性:基于药物警戒病例报告的系统评价。
曲妥珠单抗(TZB)诱导的不可逆心脏毒性(IC)是一种罕见但严重的不良事件。因此,其特征和与暴露有关的具体因素仍然知之甚少。本研究旨在综合和评价现有的IC证据。我们提出了一个长期IC的药物警戒病例,并对世界范围内报告的病例的临床表现进行了系统回顾(SR)。我们使用CARE指南清单报告病例,并使用改进的Karch和Lasagna算法评估因果关系。按照PRISMA的指导方针,我们使用PubMed, Embase, Scopus和Web of Science中的定义术语从成立到2023年6月进行了SR。该报告包括5例病例报告,其中包括我们报告的药物警戒病例。虽然患者表现出不同的严重临床特征,但接受6 mg/kg剂量的TZB是一致的。尽管治疗时间不同,但IC诊断的中位时间为10个月,基础和最终左室射血分数的平均差异约为30%。根据改进的Karch和Lasagna算法,所有病例的范围从可能到可能。虽然TZB通常被认为是一种可逆的心脏毒性抗肿瘤药物,但临床医生和监管机构必须意识到长期表现的潜在IC风险。警惕的心脏监测和进一步的研究对于更好地理解和管理这一严重不良事件至关重要。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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CiteScore
0.40
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