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Biomarker-guided cardioprotection for patients treated with anthracyclines: a randomized clinical trial.

Title: Biomarker-guided cardioprotection for patients treated with anthracyclines: a randomized clinical trial.
Authors: Xia, Congying; Smith, Amanda M.; Lefebvre, Bénédicte; Jamal, Faizi A.; Armenian, Saro H.; Koropeckyj-Cox, Daniel; Zhang, Liyong; Liu, Peter P.; Landsburg, Daniel; Clark, Amy S.; Shah, Payal D.; Hubbard, Rebecca A.; Huang, Anran; Golec, Sophia; Hewitt, Maureen; Wilcox, Nicholas S.; Chen, Zhen; Rethy, Leah; Jung, Wonyoung; Ko, Kyunga; Narayan, Vivek; Martei, Yehoda M.; Lang, Ninian N.; Januzzi, James L.; Felker, G. Michael; Ky, Bonnie
Publisher Information: American Medical Association
Publication Year: 2025
Collection: University of Glasgow: Enlighten - Publications
Description: There are gaps in the understanding of the clinical actionability of cardiovascular biomarkers for risk stratification during cardiotoxic chemotherapy. To gain insights into an N-terminal pro-B-type natriuretic peptide (NT-proBNP)-guided approach for cardioprotection in patients with breast cancer or lymphoma treated with anthracyclines and quantify the feasibility, tolerability, and exploratory efficacy of an NT-proBNP-guided strategy compared with usual care. The NT-proBNP guide, a multicenter, randomized (stratified 1:1 by cancer type) clinical trial, included 100 participants with breast cancer or lymphoma initiating anthracyclines from March 18, 2021, to October 20, 2023, who were followed up for 12 months. Study participants in the NT-proBNP-guided arm had biomarker concentrations measured prior to anthracycline initiation (baseline), at each cycle, and at 3, 6, 9, and 12 months. An elevated NT-proBNP concentration triggered the initiation or titration of neurohormonal therapy. Participants in the usual care arm received routine care without prospective monitoring of NT-proBNP concentrations. The primary outcomes were feasibility and safety of the NT-proBNP-guided approach. Feasibility was defined by recruitment, retention, and medication compliance rates. Safety outcomes were assessed according to the Common Terminology Criteria for Adverse Events, version 5.0, at each visit. Exploratory outcomes included differences in blinded, centrally quantified echocardiographic measures and NT-proBNP concentrations between the 2 arms. Analysis was performed on an intention-to-treat approach. Across 100 participants (mean [SD] age, 52.2 [14.4] years; 86 women [86.0%]), 74 (74.0%) had breast cancer and 26 (26.0%) had lymphoma. At 12 months, the retention rate was 92.7% (89 of 96). In the NT-proBNP-guided arm, 27 participants had NT-proBNP elevations, with a median time from baseline to first elevation of 14 days (IQR, 0-76 days), and a median time between the first NT-proBNP elevation and neurohormonal therapy ...
Document Type: article in journal/newspaper
File Description: text
Language: English
Relation: https://eprints.gla.ac.uk/374522/1/374522.pdf; Xia, C. et al. (2025) Biomarker-guided cardioprotection for patients treated with anthracyclines: a randomized clinical trial. JAMA Network Open , 8(12), e2546201. (doi:10.1001/jamanetworkopen.2025.46201 ) (PMID:41335439) (PMCID:PMC12676363)
DOI: 10.1001/jamanetworkopen.2025.46201
Availability: https://eprints.gla.ac.uk/374522/; https://eprints.gla.ac.uk/374522/1/374522.pdf; https://doi.org/10.1001/jamanetworkopen.2025.46201
Rights: cc_by_4
Accession Number: edsbas.AE196376
Database: BASE