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Background: The increasing incidence of cancer highlights the need for better understanding of the toxic effects of chemotherapy. The extent and nature of the clinical-based investigation of chemotherapy-induced cardiac dysfunction is unknown.
Methods: We used clinicaltrials.gov to collect data about clinical studies of cardiotoxicity in breast cancer. Information about each study's objective, definition of cardiac dysfunction and primary/secondary end-points was analysed.
Results: 29 studies, published between 1997 and 2016, were found. The total number of patients was 3,550 (mean 167.2). Of all studies, 10 (35.7%) investigated strategies to improve early diagnosis, 8 (28.5%) focused on preventive measures, 8 (28.5%) on predictive tools, and 5 (17.8%) on treatment. 16 studies (57.1%) defined cardiac dysfunction as abnormalities in LVEF, 4 (14.2%) used cardiac MRI signal abnormalities and the rest relied on “NCI toxicity criteria”, “heart-related side effects” or “cardiotoxicity”. As their primary outcome measure, 21 studies (75%) specified a radiographic end-point (LVEF by TTE, MUGA or MRI), 12 (42.8%) had clinical end-points, 3 (10.7%) had biochemical parameters and the rest mentioned “cardiac toxicity” as primary end-point. Compared with earlier studies, those initiated after 2006 had significantly larger percentage of patients participating in predictive (0.37 versus 0.01; p<0.0001) and diagnostic studies (0.19 versus 0.003; p<0.0001); studies conducted during the same time period had significantly lower number of patients involved in investigations of preventive (0.37 versus 0.62; p<0.0001) and therapeutic (0.006 versus 0.6; p<0.0001) strategies, compared with those done before 2006.
Conclusions: Significant variability exists in the definition of cardiac dysfunction used in clinical trials, raising the need for more uniform criteria. In addition, less than one half of the studies had a clinical end-outcome, representing a challenge to the clinical implications of those studies. Importantly, in recent years more attention has been given to diagnostic and/or predictive tools and less to developing strategies that would change the natural history of the cardiac disease.
Poster Hall, Hall C
Friday, March 17, 2017, 10:00 a.m.-10:45 a.m.
Session Title: Making Progress in Understanding Heart Failure
Abstract Category: 13. Heart Failure and Cardiomyopathies: Clinical
Presentation Number: 1123-290
- 2017 American College of Cardiology Foundation