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Updated: Oct 9, 2025
Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Cardiovascular Safety Assessment in Cancer Drug Development
Ohad Oren1, Tomas G Neilan2, Michael G Fradley3
1Division of Cardiology Massachusetts General Hospital and Harvard Medical School Boston MA.
Abstract:
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.
Insights
Anticancer drug cardiotoxicity is underestimated in trials, impacting patient outcomes. Reforming cardiovascular safety assessments with new strategies is crucial for better drug development and patient care.
Area of Science:
- Oncology
- Cardiology
- Drug Safety
Background:
- Cardiovascular toxicity from anticancer drugs leads to significant morbidity and mortality.
- Current oncology trials often underestimate cardiovascular events, creating a drug safety discrepancy.
- This discrepancy affects drug development, risk-benefit analysis, and patient survivorship.
Purpose of the Study:
- To review current cardiovascular safety evaluations for new oncology drugs.
- To highlight the underestimation of cardiovascular events in clinical trials.
- To propose reforms and practical strategies for improved cardiotoxicity assessment.
Main Methods:
- Review of contemporary cardiovascular safety evaluation methods for anticancer drugs.
- Analysis spanning in vitro pharmacodynamic testing to randomized clinical trials.
- Examination of real-world data and its implications.
Main Results:
- Cardiovascular events associated with anticancer drugs are significantly underestimated in oncology trials.
- This underestimation has profound implications for drug development and patient management.
- Existing evaluation methods may not adequately capture cardiotoxicity risks.
Conclusions:
- Cardiovascular safety assessment for anticancer drugs requires significant reform.
- Proposed strategies include improved preclinical assays, expanded trial eligibility, and integrated cardiovascular endpoints.
- Longitudinal registries are essential for comprehensive cardiotoxicity monitoring.
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