肿瘤临床试验中的心血管安全性

IF 12 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Jacc: Cardiooncology Pub Date : 2025-02-01 DOI:10.1016/j.jaccao.2024.09.014

Marc P. Bonaca MD, MPH , Ninian N. Lang MBChB, PhD , Alice Chen MD , Laleh Amiri-Kordestani MD , Leslie Lipka MD, PhD , Michal Zwiewka MD , Colette Strnadova PhD , Sigrid Klaar MD, PhD , Susan Dent MD , Tijana Krnjeta Janicijevic PharmD, PhD , Joerg Herrmann MD , Ana Barac MD, PhD , Rudolf A. de Boer MD , Anita Deswal MD, MBBS, MPH , Morten Schou MD , Tomas G. Neilan MD, MPH , Peter van der Meer MD , Javid Moslehi MD , Lavanya Kondapalli MD , Bonnie Ky MD, MSCE , Mark C. Petrie MD

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引用次数: 0

摘要

新疗法的发展改善了癌症的预后，但可能导致心血管毒性。传统的临床试验安全性评估方法在检测心血管危险信号方面存在局限性。我们需要提高心血管安全性的能力和特异性的机制。然而，其影响包括成本增加和开发速度减慢。心血管安全研究联盟促进了与学术界、工业界和监管机构代表的利益相关者讨论。成立了一个智囊团，目的是为改进肿瘤试验中心血管安全信号的收集和报告提供建议。成立了两个工作组。第一个重点是将心血管疾病的共识定义纳入肿瘤试验报告中使用的不良事件通用术语标准。第二组考虑确定和判定癌症试验中心血管事件的方法。本引物的首要目的是提高对癌症治疗潜在心血管毒性的理解。

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Cardiovascular Safety in Oncology Clinical Trials

The development of novel treatments has improved cancer outcomes but may result in cardiovascular toxicities. Traditional approaches to clinical trial safety evaluation have limitations in their ability to detect signals of cardiovascular risk. Mechanisms to increase power and specificity to clarify cardiovascular safety are required. However, implications include increased costs and slower development. The Cardiovascular Safety Research Consortium facilitated stakeholder discussions with representation from academia, industry, and regulators. A think tank was assembled with the aim of providing recommendations for improved collection and reporting of cardiovascular safety signals in oncology trials. Two working groups were formed. The first focuses on incorporation of consensus definitions of cardiovascular disease into the Common Terminology Criteria for Adverse Events used in oncology trial reporting. The second group considers methods for ascertainment and adjudication of cardiovascular events in cancer trials. The overarching aim of this primer is to improve understanding of the potential cardiovascular toxicities of cancer therapies.

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来源期刊

Jacc: Cardiooncology Multiple-

CiteScore

12.50

自引率

6.30%

发文量

106

期刊介绍： JACC: CardioOncology is a specialized journal that belongs to the esteemed Journal of the American College of Cardiology (JACC) family. Its purpose is to enhance cardiovascular care for cancer patients by publishing high-quality, innovative scientific research and sharing evidence-based knowledge. The journal aims to revolutionize the field of cardio-oncology and actively involve and educate professionals in both cardiovascular and oncology fields. It covers a wide range of topics including pre-clinical, translational, and clinical research, as well as best practices in cardio-oncology. Key areas of focus include understanding disease mechanisms, utilizing in vitro and in vivo models, exploring novel and traditional therapeutics (across Phase I-IV trials), studying epidemiology, employing precision medicine, and investigating primary and secondary prevention. Amyloidosis, cardiovascular risk factors, heart failure, and vascular disease are some examples of the disease states that are of particular interest to the journal. However, it welcomes research on other relevant conditions as well.