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ORIGINAL RESEARCH article

Front. Immunol.
Sec. Cancer Immunity and Immunotherapy
Volume 16 - 2025 | doi: 10.3389/fimmu.2025.1499143
This article is part of the Research Topic Adverse and Toxic Effects of Childhood Cancer Treatments - Volume II View all 6 articles

Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS

Provisionally accepted
Wen Gao Wen Gao 1*Ganggang Wang Ganggang Wang 2Lin Su Lin Su 1*Yanjun Liu Yanjun Liu 1*Xiaohan Yang Xiaohan Yang 1*Yi Li Yi Li 1*Qi Mei Qi Mei 3*
  • 1 Fourth People’s Hospital of Jinan, Jinan, China
  • 2 Shanxi Bethune Hospital, Shanxi Medical University, Taiyuan, Shanxi Province, China
  • 3 Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei Province, China

The final, formatted version of the article will be published soon.

    Background:The advent of tisagenlecleucel has been a major advance in the pharmacological treatment of relapsed/refractory B-cell acute lymphoblastic leukemia in children and adolescents.However, further research is required to better define its safety profile.Objectives: To determine the cardiovascular toxicity of tisagenlecleucel in children and adolescents.Methods: The US Food and Drug Administration's Adverse Event Reporting System was searched to identify cardiovascular adverse events (CVAEs) related to tisagenlecleucel in pediatric patients up to the age of 18 years.Results: The median time to onset of tisagenlecleucel-associated CVAEs was shorter than that of tisagenlecleucel-associated non-CVAEs (3 days [interquartile range (IQR) 1, 6] vs. 7 days [IQR 2, 54]). The median time to onset was longer in patients with fatal CVAEs than in those with non-fatal CVAEs (4 days [IQR 1, 12.5] vs. 2 days [IQR 1, 4]). The most frequently reported CVAEs were mitral valve disease, hypotension, and capillary leak syndrome. Patients who developed shock had the highest mortality rate (66.67%). Concomitant use of medication for a neurological disorder was an independent risk factor for CVAEs, and concomitant use of medication for a respiratory disease was an independent risk factor for fatal CVAEs. Most CVAEs were associated with cytokine release syndrome, and older patients had a more favorable prognosis.Conclusions: Children and adolescents who receive tisagenlecleucel should be closely monitored for CVAEs, particularly during the first week of treatment.

    Keywords: tisagenlecleucel, adverse event reporting system, Data Mining, Cardiovascular adverse event, Child

    Received: 20 Sep 2024; Accepted: 02 Jan 2025.

    Copyright: © 2025 Gao, Wang, Su, Liu, Yang, Li and Mei. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Wen Gao, Fourth People’s Hospital of Jinan, Jinan, China
    Lin Su, Fourth People’s Hospital of Jinan, Jinan, China
    Yanjun Liu, Fourth People’s Hospital of Jinan, Jinan, China
    Xiaohan Yang, Fourth People’s Hospital of Jinan, Jinan, China
    Yi Li, Fourth People’s Hospital of Jinan, Jinan, China
    Qi Mei, Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, Hubei Province, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.