| Autor: |
Hamid A; Department of Medicine University of Mississippi Medical Center Jackson MS., Anker MS; Department of Cardiology (CBF), Charité University Medicine Berlin Berlin Germany.; Berlin Institute of Health Center for Regenerative Therapies (BCRT) Berlin Germany.; DZHK (German Centre for Cardiovascular Research), partner site Berlin Berlin Germany., Ruckdeschel JC; Division of Hematology/Oncology, Department of Medicine, Cancer Center and Research Institute University of Mississippi Medical Center Jackson MS., Khan MS; Department of Medicine University of Mississippi Medical Center Jackson MS., Tharwani A; Department of Medicine Cleveland Clinic Foundation Cleveland OH., Oshunbade AA; Division of Cardiology, Department of Medicine University of Mississippi Medical Center Jackson MS., Kipchumba RK; Department of Medicine University of Mississippi Medical Center Jackson MS., Thigpen SC; Department of Medicine University of Mississippi Medical Center Jackson MS., Anker SD; Berlin Institute of Health Center for Regenerative Therapies (BCRT) Berlin Germany.; DZHK (German Centre for Cardiovascular Research), partner site Berlin Berlin Germany.; Department of Cardiology (CVK) Charité Universitätsmedizin Berlin Berlin Germany.; Berlin Institute of Health Center for Regenerative Therapies (BCRT) Charité Universitätsmedizin Berlin Germany.; German Centre for Cardiovascular Research (DZHK) partner site Berlin Charité Universitätsmedizin Berlin Germany., Fonarow GC; Division of Cardiology David Geffen School of Medicine at UCLA Los Angeles CA., Hall ME; Division of Cardiology, Department of Medicine University of Mississippi Medical Center Jackson MS., Butler J; Department of Medicine University of Mississippi Medical Center Jackson MS. |
| Jazyk: |
angličtina |
| Zdroj: |
Journal of the American Heart Association [J Am Heart Assoc] 2022 Aug 02; Vol. 11 (15), pp. e025206. Date of Electronic Publication: 2022 Jul 25. |
| DOI: |
10.1161/JAHA.121.025206 |
| Abstrakt: |
Background Several cancer therapies have been associated with cardiovascular harm in early-phase clinical trials. However, some cardiovascular harms do not manifest until later-phase trials. To limit interdisease variability, we focused on breast cancer. Thus, we assessed the reporting of cardiovascular safety monitoring and outcomes in phase 2 and 3 contemporary breast cancer clinical trials. Methods and Results We searched Embase and Medline records for phase 2 and 3 breast cancer pharmacotherapy trials. We examined exclusion criterion as a result of cardiovascular conditions, adverse cardiovascular event reporting, and cardiovascular safety assessment through cardiovascular imaging, ECG, troponin, or natriuretic peptides. Fisher's exact test was utilized to compare reporting. Fifty clinical trials were included in our study. Patients were excluded because of cardiovascular conditions in 42 (84%) trials. Heart failure was a frequent exclusion criterion (n=31; 62% trials). Adverse cardiovascular events were reported in 43 (86%) trials. Cardiovascular safety assessments were not reported in 23 (46%) trials, whereas natriuretic peptide and troponin assessments were not reported in any trial. Cardiovascular safety assessments were more frequently reported in industry-funded trials (69.2% versus 0.0%; P <0.001), and in trials administering targeted/immunotherapy agents compared with only hormonal/conventional chemotherapy (78.6% versus 22.7%, P <0.001). Conclusions Our findings demonstrate significant under-representation of patients with cardiovascular conditions or prevalent cardiovascular disease in contemporary later-phase breast cancer trials. Additionally, cardiovascular safety is not routinely monitored in these trials. Therefore, contemporary breast cancer clinical trials may possibly underestimate the cardiovascular risks of cancer pharmacotherapy agents for use in clinical practice. |
| Databáze: |
MEDLINE |
| Externí odkaz: |
|
Plný text