The Evolving Design of NIH-Funded Cardio-Oncology Studies to Address Cancer Treatment-Related Cardiovascular Toxicity

JACC. CardioOncology

Eileen Dimond, RN, MS¹  Bishow Adhikari, PhD²  Joseph M. Unger, PhD, MS³  Bonnie Ky, MD, MSCE⁴  Lori M. Minasian, MD⁵  Carol Fabian, MD⁵  Myrtle Davis, DVM, PhD, ATS⁵  Karen M. Mustian, PhD, MPH⁶  Pamela S. Douglas, MD⁷  Steven Lipshultz, MD⁸  Richard Fagerstrom, PhD⁹  W. Gregory Hundley, MD^1,10  Justin Floyd, DO^1,11  Eric J. Chow, MD, MPH^1,12  Saro H. Armenian, DO, MPH^1,13 

[1] Address for correspondence: Dr. Lori Minasian, Division of Cancer Prevention, National Cancer Institute, 9609 Medical Center Drive, 5E-342, MSC-9784, Bethesda, Maryland 20892.;Bristol-Myers Squibb Pharmaceutical Candidate Optimization, Princeton, New Jersey;Cancer Care Specialists of Illinois, Heartland NCORP, Swansea, Illinois;City of Hope Comprehensive Cancer Center, Department of Population Sciences, Duarte, California;Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland;Duke University School of Medicine, Duke Clinical Research Institute, Durham, North Carolina;Fred Hutchinson Cancer Research Center, Public Health Sciences Division, SWOG Statistics and Data Management Center, Seattle, Washington;Fred Hutchinson Cancer Research Center, Public Health Sciences and Clinical Research Divisions, Department of Pediatrics, University of Washington, Seattle, Washington;National Heart, Lung, and Blood Institute (NHLBI), Division of Cardiovascular Sciences, Bethesda, Maryland;University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Kaleida Health, John R. Oishei Children’s Hospital, UBMD Pediatrics, Buffalo, New York;University of Kansas Medical Center Cancer Center Westwood, Kansas;University of Rochester Medical Center, Wilmot Cancer Institute, Rochester, New York;Virginia Commonwealth University, VCU Pauley Heart Center, Richmond, Virginia;

关键词: adverse events;    anthracyclines;    cancer;    cardioprotection;    cardiotoxicity;    chemotherapy;   

DOI  :  

来源: DOAJ

【 摘 要 】

Cardiovascular (CV) toxicity from cancer therapy is a significant and growing concern. Conventional oncology clinical trial designs focused solely on cancer treatment efficacy have not provided sufficient information on both CV risk factors and outcomes. Similarly, traditional CV trials evaluating standard interventions typically exclude cancer patients, particularly those actively receiving cancer therapy. Neither trial type simultaneously evaluates the balance between CV toxicity and cancer outcomes; however, there is increasing collaboration among oncologists and cardiologists to design new cardio-oncology trials that address this important need. In this review, we detail 5 ongoing, oncology-based trials with integrated CV endpoints. Key design features include: 1) a careful assessment of CV risk factors and disease before, during, and after cancer therapy with standardized collection of clinical imaging, functional, and biomarker data; 2) an introduction of cardioprotective interventions at various timepoints in cancer therapy; 3) a balance of the risk of subclinical CV injury with the need for ongoing cancer treatment; and 4) an understanding of the time profile for development of clinically apparent CV toxicity. Additional critical priorities in cardio-oncology clinical research include harmonization of data collection and definitions for all physician- and patient-reported exposures and outcomes.

【 授权许可】

Unknown