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Percutaneous Contrast Echocardiography-guided Intramyocardial Injection and Cell Delivery in a Large Preclinical Model
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Cardiovascular Safety in Oncology Clinical Trials: JACC: CardioOncology Primer

Marc P Bonaca1, Ninian N Lang2, Alice Chen3

  • 1CPC Clinical Research, Cardiology & Vascular medicine, University of Colorado Anschutz Medical School, Aurora, Colorado, USA.

JACC. Cardiooncology
|February 19, 2025
PubMed

Insights

Novel cancer treatments improve outcomes but can cause cardiovascular toxicities. This primer recommends improved methods for detecting and reporting these adverse events in oncology trials.

Area of Science:

  • Cardiovascular research
  • Oncology
  • Clinical trial safety

Background:

  • Novel cancer therapies offer improved outcomes but pose risks of cardiovascular toxicities.
  • Current clinical trial safety evaluations have limitations in detecting cardiovascular risks.
  • Enhanced methods are needed to improve the power and specificity of cardiovascular safety assessments.

Purpose of the Study:

  • To provide recommendations for improving the collection and reporting of cardiovascular safety signals in oncology trials.
  • To enhance the understanding of potential cardiovascular toxicities associated with cancer therapies.

Main Methods:

  • Convened a stakeholder think tank with representation from academia, industry, and regulators.
  • Formed two working groups: one on consensus definitions for adverse events, the other on methods for cardiovascular event ascertainment and adjudication.

Main Results:

  • The think tank focused on improving the Common Terminology Criteria for Adverse Events (CTCAE) for cardiovascular disease definitions.
  • Methods for ascertaining and adjudicating cardiovascular events in cancer trials were considered.

Conclusions:

  • Improved collection and reporting of cardiovascular safety data are crucial for oncology trials.
  • Standardizing definitions and ascertainment methods will enhance the understanding and management of cancer therapy-related cardiovascular toxicities.
Keywords:
adverse eventscardiotoxicitychemotherapyheart failureimmunotherapyoutcomesreportingtargeted therapy

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