Cardiovascular Safety Assessment in Cancer Drug Development
The development of cardiovascular toxicity attributable to anticancer drugs is a pivotal event that is associated with cardiovascular morbidity as well as with worse cancer‐specific and overall outcomes. Although broad consensus exists regarding the importance of cardiovascular safety assessment in...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-12-01
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| Series: | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| Subjects: | |
| Online Access: | https://www.ahajournals.org/doi/10.1161/JAHA.121.024033 |
| _version_ | 1797945425751179264 |
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| author | Ohad Oren Tomas G. Neilan Michael G. Fradley Deepak L. Bhatt |
| author_facet | Ohad Oren Tomas G. Neilan Michael G. Fradley Deepak L. Bhatt |
| author_sort | Ohad Oren |
| collection | DOAJ |
| description | The development of cardiovascular toxicity attributable to anticancer drugs is a pivotal event that is associated with cardiovascular morbidity as well as with worse cancer‐specific and overall outcomes. Although broad consensus exists regarding the importance of cardiovascular safety assessment in cancer drug development, real‐world data suggest that cardiovascular events are significantly underestimated in oncology trials. This drug safety discrepancy has profound implications on drug development decisions, risk‐benefit evaluation, formulation of surveillance and prevention protocols, and survivorship. In this article, we review the contemporary cardiovascular safety evaluation of new pharmaceuticals in hematology and oncology, spanning from in vitro pharmacodynamic testing to randomized clinical trials. We argue that cardiovascular safety assessment of anticancer drugs should be reformed and propose practical strategies, including development and validation of preclinical assays, expansion of oncology trial eligibility, incorporation of cardiovascular end points in early‐phase studies, and design of longitudinal multi‐institutional cardiotoxicity registries. |
| first_indexed | 2024-04-10T20:54:56Z |
| format | Article |
| id | doaj.art-bc74c2800d4947429856c23add84edec |
| institution | Directory Open Access Journal |
| issn | 2047-9980 |
| language | English |
| last_indexed | 2024-04-10T20:54:56Z |
| publishDate | 2021-12-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease |
| spelling | doaj.art-bc74c2800d4947429856c23add84edec2023-01-23T07:23:59ZengWileyJournal of the American Heart Association: Cardiovascular and Cerebrovascular Disease2047-99802021-12-01102410.1161/JAHA.121.024033Cardiovascular Safety Assessment in Cancer Drug DevelopmentOhad Oren0Tomas G. Neilan1Michael G. Fradley2Deepak L. Bhatt3Division of Cardiology Massachusetts General Hospital and Harvard Medical School Boston MACardio‐Oncology Program Division of Cardiology Massachusetts General Hospital and Harvard Medical School Boston MACardio‐Oncology Center of Excellence Division of Cardiology Department of Medicine Perelman School of Medicine at the University of Pennsylvania Philadelphia PABrigham and Women’s Hospital Heart & Vascular Center and Harvard Medical School Boston MAThe development of cardiovascular toxicity attributable to anticancer drugs is a pivotal event that is associated with cardiovascular morbidity as well as with worse cancer‐specific and overall outcomes. Although broad consensus exists regarding the importance of cardiovascular safety assessment in cancer drug development, real‐world data suggest that cardiovascular events are significantly underestimated in oncology trials. This drug safety discrepancy has profound implications on drug development decisions, risk‐benefit evaluation, formulation of surveillance and prevention protocols, and survivorship. In this article, we review the contemporary cardiovascular safety evaluation of new pharmaceuticals in hematology and oncology, spanning from in vitro pharmacodynamic testing to randomized clinical trials. We argue that cardiovascular safety assessment of anticancer drugs should be reformed and propose practical strategies, including development and validation of preclinical assays, expansion of oncology trial eligibility, incorporation of cardiovascular end points in early‐phase studies, and design of longitudinal multi‐institutional cardiotoxicity registries.https://www.ahajournals.org/doi/10.1161/JAHA.121.024033antineoplastic agentscardiotoxicitycardiovascular safetyconsensusrandomized controlled trials |
| spellingShingle | Ohad Oren Tomas G. Neilan Michael G. Fradley Deepak L. Bhatt Cardiovascular Safety Assessment in Cancer Drug Development Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease antineoplastic agents cardiotoxicity cardiovascular safety consensus randomized controlled trials |
| title | Cardiovascular Safety Assessment in Cancer Drug Development |
| title_full | Cardiovascular Safety Assessment in Cancer Drug Development |
| title_fullStr | Cardiovascular Safety Assessment in Cancer Drug Development |
| title_full_unstemmed | Cardiovascular Safety Assessment in Cancer Drug Development |
| title_short | Cardiovascular Safety Assessment in Cancer Drug Development |
| title_sort | cardiovascular safety assessment in cancer drug development |
| topic | antineoplastic agents cardiotoxicity cardiovascular safety consensus randomized controlled trials |
| url | https://www.ahajournals.org/doi/10.1161/JAHA.121.024033 |
| work_keys_str_mv | AT ohadoren cardiovascularsafetyassessmentincancerdrugdevelopment AT tomasgneilan cardiovascularsafetyassessmentincancerdrugdevelopment AT michaelgfradley cardiovascularsafetyassessmentincancerdrugdevelopment AT deepaklbhatt cardiovascularsafetyassessmentincancerdrugdevelopment |