Cardiovascular Safety in Oncology Clinical Trials JACC: CardioOncology Primer

被引：3

作者：

Bonaca, Marc P. ^{[1
]}

Lang, Ninian N. ^{[2
]}

Chen, Alice ^{[3
]}

Amiri-Kordestani, Laleh ^{[4
,5
]}

Lipka, Leslie ^{[6
]}

Zwiewka, Michal ^{[7
]}

Strnadova, Colette ^{[8
]}

Klaar, Sigrid ^{[9
]}

Dent, Susan ^{[10
]}

Janicijevic, Tijana Krnjeta ^{[11
]}

Herrmann, Joerg ^{[12
]}

Barac, Ana ^{[13
,14
]}

Boer, Rudolf A. de ^{[15
]}

Deswal, Anita ^{[16
]}

Schou, Morten ^{[17
]}

Neilan, Tomas G. ^{[18
]}

van der Meer, Peter ^{[19
]}

Moslehi, Javid ^{[20
,21
]}

Kondapalli, Lavanya ^{[22
]}

Ky, Bonnie ^{[23
]}

Fernandez, Teresa Lopez ^{[24
,25
]}

Cornell, R. Frank ^{[26
]}

Flaig, Thomas W. ^{[27
]}

Hsia, Judith

Sharon, Elad ^{[27
]}

de Azambuja, Evandro ^{[28
,29
]}

Seltzer, Jonathan ^{[30
]}

Januzzi, James L. ^{[31
,32
]}

Petrie, Mark C. ^{[33
]}

机构：

[1] Univ Colorado, CPC Clin Res Cardiol & Vasc Med, Anschutz Med Sch, Aurora, CO USA

[2] Univ Glasgow, Sch Cardiovasc & Metab Hlth, Glasgow City, Scotland

[3] NCI, Div Canc Treatment & Diag, Bethesda, MD USA

[4] US FDA, Ctr Drug Evaluat & Res CDER, Silver Spring, MD USA

[5] US FDA, Oncol Ctr Excellence OCE, Silver Spring, MD USA

[6] Merck & Co Inc, Rahway, NJ USA

[7] Paul Ehrlich Inst, Bundesinst Impfstoffe & Biomed Arzneimittel, FederalInst Vaccines & Biomed, Langen, Germany

[8] Hlth Canada, Ottawa, ON, Canada

[9] NDA Grp, Upplands Vasby, Sweden

[10] Duke Univ, Duke Canc Inst, Durham, NC USA

[11] F Hoffmann La Roche Ltd, Basel, Switzerland

[12] Mayo Clin, Dept Cardiovasc Med, Rochester, MN USA

[13] lInova Schar Canc Inst, Annandale, VA USA

[14] Inova Heart & Vasc Inst, Annandale, VA USA

[15] Erasmus MC, Cardiovasc Inst, Thorax Ctr, Dept Cardiol, Rotterdam, Netherlands

[16] Univ Texas MD Anderson Canc Ctr, Dept Cardiol, Houston, TX USA

[17] Univ Copenhagen, Herlev Gentofte Hosp, Herlev Gentofte, Denmark

[18] Harvard Med Sch, Massachusetts Gen Hosp, Dept Med, Cardiooncol Program, Boston, MA USA

[19] Univ Groningen, Univ Med Ctr Groningen, Dept Cardiol, Groningen, Netherlands

[20] Univ Calif San Francisco, Div Cardiol, Sect Cardiooncol & Immunol, San Francisco, CA USA

[21] Univ Calif San Francisco, Cardiovasc Res Inst, San Francisco, CA USA

[22] Univ Colorado, Sch Med, Aurora, South Africa

[23] Univ Penn, Thalheimer Ctr Cardiooncol, Perelman Sch Med, Philadelphia, PA USA

[24] La Paz Univ Hosp, Inst Hlth Res, Cardiol Dept, Madrid, Spain

[25] Quiron Pozuelo Univ Hosp, Cardiol Dept, Madrid, Spain

[26] AbbVie Inc, N Chicago, IL USA

[27] Dana Farber Canc Inst, Boston, MA USA

[28] Inst Jules Bordet, Brussels, Belgium

[29] Univ Libre Bruxelles LUB, Brussels, Belgium

[30] Sandpiper Res, Narberth, PA USA

[31] Harvard Med Sch, Massachusetts Gen Hosp, Cardiol Div, Boston, MA USA

[32] Baim Inst Clin Res, Heart Failure & Biomarker Trials, Boston, MA USA

[33] Univ Glasgow, Glasgow, Scotland

来源：

JACC: CARDIOONCOLOGY | 2025年 / 7卷 / 02期

关键词：

adverse events; cardiotoxicity; chemotherapy; heart failure; immunotherapy; outcomes; reporting; targeted therapy; CANCER; ASSOCIATION; MYOCARDITIS; EVENTS;

D O I：

10.1016/j.jaccao.2024.09.014

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. (JACC CardioOncol. 2025;7:83-95) (c) 2025 Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

引用

页码：83 / 95

页数：13

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