免疫检查点和血管内皮生长因子抑制剂联合试验中的心血管资格标准和不良事件报告

IF 12 1区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Stephen Rankin MBChB , Benjamin Elyan MBChB , Robert Jones MBChB, PhD , Balaji Venugopal MBBS, MD , Patrick B. Mark MBChB, PhD , Jennifer S. Lees MA, PhD , Mark C. Petrie MBChB , Ninian N. Lang MBChB, PhD
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引用次数: 0

摘要

背景免疫检查点抑制剂(ICIs)和血管内皮生长因子抑制剂(VEGFIs)的联合疗法改善了癌症治疗效果,并得到越来越多的应用。本研究旨在评估 ICI 和 VEGFI 联合疗法试验中心血管资格标准、基线特征和心血管不良事件的定义和报告的一致性和清晰度。评估了试验出版物中的心血管资格标准和基线心血管特征报告,还检查了心血管不良事件的定义和报告标准。结果纳入了17项试验(N = 10,313; 发表于2018-2022年)。15项试验有多个心血管排除标准。没有主要试验出版物报告基线心血管特征。13项试验排除了既往患有心力衰竭、心肌梗死、高血压或中风的患者。心血管疾病的定义存在异质性。15项试验中,当心血管不良事件发生率≥5%至25%时,报告了 "1至4级 "心血管不良事件。所有试验都记录了高血压事件,但其他心血管事件的报告并不一致。结论 ICI 和 VEGFI 联合试验在心血管排除标准、基线特征报告和心血管不良事件报告方面存在异质性。这限制了对这些联合用药相关事件的发生率和严重程度的最佳理解。应该对这些要素进行更好的标准化。(新型全身性抗癌疗法血管内皮生长因子信号通路抑制剂单独或与免疫检查点抑制剂联合用药试验中肾病和心血管疾病患者的排除和代表性;CRD42022337942)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Cardiovascular Eligibility Criteria and Adverse Event Reporting in Combined Immune Checkpoint and VEGF Inhibitor Trials

Background

Combination therapy with immune checkpoint inhibitors (ICIs) and vascular endothelial growth factor inhibitors (VEGFIs) has improved cancer outcomes and is increasingly used. These drug classes are associated with cardiovascular toxicities when used alone, but heterogeneity in trial design and reporting may limit knowledge of toxicities in patients receiving these in combination.

Objectives

The aim of this study was to assess consistency and clarity in definitions and reporting of cardiovascular eligibility criteria, baseline characteristics, and cardiovascular adverse events in ICI and VEGFI combination trials.

Methods

A scoping review was conducted of phase 2 to 4 randomized controlled trials of ICI and VEGFI combination therapy for solid tumors. Trial cardiovascular eligibility criteria and baseline cardiovascular characteristic reporting in trial publications was assessed, and cardiovascular adverse event definitions and reporting criteria were also examined.

Results

Seventeen trials (N = 10,313; published 2018-2022) were included. There were multiple cardiovascular exclusion criteria in 15 trials. No primary trial publication reported baseline cardiovascular characteristics. Thirteen trials excluded patients with prior heart failure, myocardial infarction, hypertension, or stroke. There was heterogeneity in defining cardiovascular conditions. “Grade 1 to 4” cardiovascular adverse events were reported when incidence was ≥5% to 25% in 15 trials. Incident hypertension was recorded in all trials, but other cardiovascular events were not consistently reported. No trial specifically noted the absence of cardiovascular events.

Conclusions

In ICI and VEGFI combination trials, there is heterogeneity in cardiovascular exclusion criteria, reporting of baseline characteristics, and reporting of cardiovascular adverse events. This limits an optimal understanding of the incidence and severity of events relating to these combinations. Better standardization of these elements should be pursued. (Exclusions and Representation of Patients With Kidney Disease and Cardiovascular Disease in Drug Trials of the Novel Systemic Anti-Cancer Therapies VEGF-Signalling Pathway Inhibitors Alone or in Combination With Immune Checkpoint Inhibitors; CRD42022337942)

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来源期刊
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.
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