Rankin, Stephen and Elyan, Benjamin and Jones, Robert and Venugopal, Balaji and Mark, Patrick B. and Lees, Jennifer S. and Petrie, Mark C. and Lang, Ninian N. (2024) Cardiovascular eligibility criteria and adverse event reporting in combined immune checkpoint and VEGF inhibitors trials. JACC: CardioOncology, 6 (2). pp. 267-279. ISSN 2666-0873
AI Summary:
A scoping review was conducted of phase 2 to 4 randomized controlled trials of ICI and VEGFI combination therapy for solid tumors. The review found heterogeneity in cardiovascular exclusion criteria, reporting of baseline characteristics, and reporting of cardiovascular adverse events.AI Topics:
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)
Rankin, Stephen
Author
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair J. and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2025) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients. Clinical Science, 139 (1). pp. 29-41. ISSN 0143-5221
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2024) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients using 18F-FDG positron emission tomography. bioRxiv.
Rankin, Stephen and Elyan, Benjamin and Jones, Robert and Venugopal, Balaji and Mark, Patrick B. and Lees, Jennifer S. and Petrie, Mark C. and Lang, Ninian N. (2024) Cardiovascular eligibility criteria and adverse event reporting in combined immune checkpoint and VEGF inhibitors trials. JACC: CardioOncology, 6 (2). pp. 267-279. ISSN 2666-0873
See full publications listElyan, Benjamin
Author
Elyan, Benjamin M.P. and Tan, Beatrix and Lambourg, Emilie and McAllister, David A. and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. and Bell, Samira (2025) Incidence of cancer in people with CKD not requiring kidney replacement therapy: a systematic review and meta-analysis. Clinical Kidney Journal, 18 (5): sfaf084. ISSN 2048-8505
Elyan, Benjamin M.P. and Sullivan, Michael K. and Hedley, James and De La Mata, Nicole and Webster, Angela C. and Venugopal, Balaji and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. (2024) The impact of VEGF signalling pathway inhibitors and/or immune checkpoint inhibitors on kidney function over time: a single centre retrospective analysis. BJC Reports, 2: 57. ISSN 2731-9377
Rankin, Stephen and Elyan, Benjamin and Jones, Robert and Venugopal, Balaji and Mark, Patrick B. and Lees, Jennifer S. and Petrie, Mark C. and Lang, Ninian N. (2024) Cardiovascular eligibility criteria and adverse event reporting in combined immune checkpoint and VEGF inhibitors trials. JACC: CardioOncology, 6 (2). pp. 267-279. ISSN 2666-0873
See full publications listJones, Robert
Author
Elyan, Benjamin M.P. and Tan, Beatrix and Lambourg, Emilie and McAllister, David A. and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. and Bell, Samira (2025) Incidence of cancer in people with CKD not requiring kidney replacement therapy: a systematic review and meta-analysis. Clinical Kidney Journal, 18 (5): sfaf084. ISSN 2048-8505
Elyan, Benjamin M.P. and Sullivan, Michael K. and Hedley, James and De La Mata, Nicole and Webster, Angela C. and Venugopal, Balaji and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. (2024) The impact of VEGF signalling pathway inhibitors and/or immune checkpoint inhibitors on kidney function over time: a single centre retrospective analysis. BJC Reports, 2: 57. ISSN 2731-9377
Rescigno, Pasquale and Porta, Nuria and Finneran, Laura and Riisnaes, Ruth and Figueiredo, Ines and Carreira, Suzanne and Flohr, Penny and Miranda, Susana and Bertan, Claudia and Ferreira, Ana and Crespo, Mateus and Rodrigues, Daniel Nava and Gurel, Bora and Nobes, Jenny and Crabb, Simon and Malik, Zafar and Ralph, Christy and McGovern, Ursula and Hoskin, Peter and Jones, Robert J. and Birtle, Alison and Gale, Joanna and Sankey, Peter and Jain, Suneil and McLaren, Duncan and Chadwick, Eliot and Espinasse, Aude and Hall, Emma and de Bono, Johann (2024) Capivasertib in combination with enzalutamide for metastatic castration resistant prostate cancer after docetaxel and abiraterone: Results from the randomized phase II RE-AKT trial. European Journal of Cancer, 205: 114103. ISSN 0959-8049
See full publications listVenugopal, Balaji
Author
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair J. and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2025) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients. Clinical Science, 139 (1). pp. 29-41. ISSN 0143-5221
Elyan, Benjamin M.P. and Sullivan, Michael K. and Hedley, James and De La Mata, Nicole and Webster, Angela C. and Venugopal, Balaji and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. (2024) The impact of VEGF signalling pathway inhibitors and/or immune checkpoint inhibitors on kidney function over time: a single centre retrospective analysis. BJC Reports, 2: 57. ISSN 2731-9377
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2024) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients using 18F-FDG positron emission tomography. bioRxiv.
See full publications listMark, Patrick B.
Author
Elyan, Benjamin M.P. and Tan, Beatrix and Lambourg, Emilie and McAllister, David A. and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. and Bell, Samira (2025) Incidence of cancer in people with CKD not requiring kidney replacement therapy: a systematic review and meta-analysis. Clinical Kidney Journal, 18 (5): sfaf084. ISSN 2048-8505
Elyan, Benjamin M.P. and Sullivan, Michael K. and Hedley, James and De La Mata, Nicole and Webster, Angela C. and Venugopal, Balaji and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. (2024) The impact of VEGF signalling pathway inhibitors and/or immune checkpoint inhibitors on kidney function over time: a single centre retrospective analysis. BJC Reports, 2: 57. ISSN 2731-9377
Rankin, Stephen and Elyan, Benjamin and Jones, Robert and Venugopal, Balaji and Mark, Patrick B. and Lees, Jennifer S. and Petrie, Mark C. and Lang, Ninian N. (2024) Cardiovascular eligibility criteria and adverse event reporting in combined immune checkpoint and VEGF inhibitors trials. JACC: CardioOncology, 6 (2). pp. 267-279. ISSN 2666-0873
See full publications listLees, Jennifer S.
Author
Elyan, Benjamin M.P. and Tan, Beatrix and Lambourg, Emilie and McAllister, David A. and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. and Bell, Samira (2025) Incidence of cancer in people with CKD not requiring kidney replacement therapy: a systematic review and meta-analysis. Clinical Kidney Journal, 18 (5): sfaf084. ISSN 2048-8505
Elyan, Benjamin M.P. and Sullivan, Michael K. and Hedley, James and De La Mata, Nicole and Webster, Angela C. and Venugopal, Balaji and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. (2024) The impact of VEGF signalling pathway inhibitors and/or immune checkpoint inhibitors on kidney function over time: a single centre retrospective analysis. BJC Reports, 2: 57. ISSN 2731-9377
Rankin, Stephen and Elyan, Benjamin and Jones, Robert and Venugopal, Balaji and Mark, Patrick B. and Lees, Jennifer S. and Petrie, Mark C. and Lang, Ninian N. (2024) Cardiovascular eligibility criteria and adverse event reporting in combined immune checkpoint and VEGF inhibitors trials. JACC: CardioOncology, 6 (2). pp. 267-279. ISSN 2666-0873
See full publications listPetrie, Mark C.
Author
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair J. and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2025) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients. Clinical Science, 139 (1). pp. 29-41. ISSN 0143-5221
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2024) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients using 18F-FDG positron emission tomography. bioRxiv.
Rankin, Stephen and Elyan, Benjamin and Jones, Robert and Venugopal, Balaji and Mark, Patrick B. and Lees, Jennifer S. and Petrie, Mark C. and Lang, Ninian N. (2024) Cardiovascular eligibility criteria and adverse event reporting in combined immune checkpoint and VEGF inhibitors trials. JACC: CardioOncology, 6 (2). pp. 267-279. ISSN 2666-0873
See full publications listLang, Ninian N.
Author
Elyan, Benjamin M.P. and Tan, Beatrix and Lambourg, Emilie and McAllister, David A. and Jones, Rob J. and Lang, Ninian N. and Mark, Patrick B. and Lees, Jennifer S. and Bell, Samira (2025) Incidence of cancer in people with CKD not requiring kidney replacement therapy: a systematic review and meta-analysis. Clinical Kidney Journal, 18 (5): sfaf084. ISSN 2048-8505
Elbassioni, Ali Ali Mohamed and Raheem, Anmar A. and Song, Jian and Johnston, Alexander S. and Trivett, Cara and Lin, Hong and Zhang, Haobo and Bradley, Ashley and Higgins, Erin and Mooney, Leanne and Koay, Yen Chin and O'Toole, Dylan and Herzyk, Pawel and Nixon, Colin and Blyth, Karen and O'Sullivan, John F. and Lang, Ninian N. and Berry, Colin and Braun, Thomas and Schiattarella, Gabriele G. and Giacca, Mauro and McBride, Martin W. and Nicklin, Stuart A. and Cameron, Ewan R. and Loughrey, Christopher M. and MacDonald, Eilidh A. (2025) Targeting Runx1 protects against heart failure with preserved ejection fraction. bioRxiv.
Rankin, Stephen and Fountain, Caitlin and Gemmell, Alastair J. and Quinn, Daire and Henderson, Alasdair and McClure, John and Small, Sandy and Venugopal, Balaji and McKay, Pamela and Slomka, Piotr J. and Colville, David and Petrie, Mark C. and Meléndez, Giselle C. and Lang, Ninian N. (2025) Arterial effects of anthracycline: structural and inflammatory assessments in non-human primates and lymphoma patients. Clinical Science, 139 (1). pp. 29-41. ISSN 0143-5221
See full publications listAvailable under License Creative Commons Attribution.
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