Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer

Marc P. Bonaca; Ninian N. Lang; Alice Chen; Laleh Amiri-Kordestani; Leslie Lipka; Michal Zwiewka; Colette Strnadova; Sigrid Klaar; Susan Dent; Tijana Krnjeta Janicijevic; Joerg Herrmann; Ana Barac; Rudolf A. de Boer; Anita Deswal; Morten Schou; Tomas G. Neilan; Peter van der Meer; Javid Moslehi; Lavanya Kondapalli; Bonnie Ky; Teresa Lopez Fernandez; R. Frank Cornell; Thomas W. Flaig; Judith Hsia; Elad Sharon; Evandro de Azambuja; Jonathan Seltzer; James L. Januzzi; Mark C. Petrie

doi:10.1016/j.jaccao.2024.09.014

Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer

Marc P. Bonaca^*, Ninian N. Lang, Alice Chen, Laleh Amiri-Kordestani, Leslie Lipka, Michal Zwiewka, Colette Strnadova, Sigrid Klaar, Susan Dent, Tijana Krnjeta Janicijevic, Joerg Herrmann, Ana Barac, Rudolf A. de Boer, Anita Deswal, Morten Schou, Tomas G. Neilan, Peter van der Meer, Javid Moslehi, Lavanya Kondapalli, Bonnie KyTeresa Lopez Fernandez, R. Frank Cornell, Thomas W. Flaig, Judith Hsia, Elad Sharon, Evandro de Azambuja, Jonathan Seltzer, James L. Januzzi, Mark C. Petrie

^*Corresponding author for this work

Cardiovascular Centre (CVC)

Research output: Contribution to journal › Review article › peer-review

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Abstract

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.

Original language	English
Pages (from-to)	83-95
Number of pages	13
Journal	Jacc: cardiooncology
Volume	7
Issue number	2
DOIs	https://doi.org/10.1016/j.jaccao.2024.09.014
Publication status	Published - Feb-2025

Keywords

adverse events
cardiotoxicity
chemotherapy
heart failure
immunotherapy
outcomes
reporting
targeted therapy

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Cardiovascular Safety in Oncology Clinical TrialsFinal publisher's version, 2.66 MBLicence: CC BY-NC-ND

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Bonaca, M. P., Lang, N. N., Chen, A., Amiri-Kordestani, L., Lipka, L., Zwiewka, M., Strnadova, C., Klaar, S., Dent, S., Janicijevic, T. K., Herrmann, J., Barac, A., de Boer, R. A., Deswal, A., Schou, M., Neilan, T. G., van der Meer, P., Moslehi, J., Kondapalli, L., ... Petrie, M. C. (2025). Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer. Jacc: cardiooncology, 7(2), 83-95. https://doi.org/10.1016/j.jaccao.2024.09.014

@article{22ea73df48924e9cb82543feb0332519,

title = "Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer",

abstract = "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.",

keywords = "adverse events, cardiotoxicity, chemotherapy, heart failure, immunotherapy, outcomes, reporting, targeted therapy",

author = "Bonaca, {Marc P.} and Lang, {Ninian N.} and Alice Chen and Laleh Amiri-Kordestani and Leslie Lipka and Michal Zwiewka and Colette Strnadova and Sigrid Klaar and Susan Dent and Janicijevic, {Tijana Krnjeta} and Joerg Herrmann and Ana Barac and {de Boer}, {Rudolf A.} and Anita Deswal and Morten Schou and Neilan, {Tomas G.} and {van der Meer}, Peter and Javid Moslehi and Lavanya Kondapalli and Bonnie Ky and Fernandez, {Teresa Lopez} and Cornell, {R. Frank} and Flaig, {Thomas W.} and Judith Hsia and Elad Sharon and {de Azambuja}, Evandro and Jonathan Seltzer and Januzzi, {James L.} and Petrie, {Mark C.}",

note = "Publisher Copyright: {\textcopyright} 2025",

year = "2025",

month = feb,

doi = "10.1016/j.jaccao.2024.09.014",

language = "English",

volume = "7",

pages = "83--95",

journal = "Jacc: cardiooncology",

issn = "2666-0873",

publisher = "Elsevier",

number = "2",

}

Bonaca, MP, Lang, NN, Chen, A, Amiri-Kordestani, L, Lipka, L, Zwiewka, M, Strnadova, C, Klaar, S, Dent, S, Janicijevic, TK, Herrmann, J, Barac, A, de Boer, RA, Deswal, A, Schou, M, Neilan, TG, van der Meer, P, Moslehi, J, Kondapalli, L, Ky, B, Fernandez, TL, Cornell, RF, Flaig, TW, Hsia, J, Sharon, E, de Azambuja, E, Seltzer, J, Januzzi, JL & Petrie, MC 2025, 'Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer', Jacc: cardiooncology, vol. 7, no. 2, pp. 83-95. https://doi.org/10.1016/j.jaccao.2024.09.014

TY - JOUR

T1 - Cardiovascular Safety in Oncology Clinical Trials

T2 - JACC: CardioOncology Primer

AU - Bonaca, Marc P.

AU - Lang, Ninian N.

AU - Chen, Alice

AU - Amiri-Kordestani, Laleh

AU - Lipka, Leslie

AU - Zwiewka, Michal

AU - Strnadova, Colette

AU - Klaar, Sigrid

AU - Dent, Susan

AU - Janicijevic, Tijana Krnjeta

AU - Herrmann, Joerg

AU - Barac, Ana

AU - de Boer, Rudolf A.

AU - Deswal, Anita

AU - Schou, Morten

AU - Neilan, Tomas G.

AU - van der Meer, Peter

AU - Moslehi, Javid

AU - Kondapalli, Lavanya

AU - Ky, Bonnie

AU - Fernandez, Teresa Lopez

AU - Cornell, R. Frank

AU - Flaig, Thomas W.

AU - Hsia, Judith

AU - Sharon, Elad

AU - de Azambuja, Evandro

AU - Seltzer, Jonathan

AU - Januzzi, James L.

AU - Petrie, Mark C.

PY - 2025/2

Y1 - 2025/2

N2 - 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.

AB - 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.

KW - adverse events

KW - cardiotoxicity

KW - chemotherapy

KW - heart failure

KW - immunotherapy

KW - outcomes

KW - reporting

KW - targeted therapy

UR - http://www.scopus.com/inward/record.url?scp=85215206546&partnerID=8YFLogxK

U2 - 10.1016/j.jaccao.2024.09.014

DO - 10.1016/j.jaccao.2024.09.014

M3 - Review article

AN - SCOPUS:85215206546

SN - 2666-0873

VL - 7

SP - 83

EP - 95

JO - Jacc: cardiooncology

JF - Jacc: cardiooncology

IS - 2

ER -

Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer

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