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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacology of Anti-Cancer Drugs
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1434231
This article is part of the Research Topic Drug Discovery in Cancer Research: Success Stories and Open Challenges View all 17 articles

CAR-T Therapy Pulmonary Adverse Event Profile: A pharmacovigilance study based on FAERS database (2017 to 2023)

Provisionally accepted
Jing Shi Jing Shi 1,2Xinya Liu Xinya Liu 2*Yun Jiang Yun Jiang 2,3*Mengjiao Gao Mengjiao Gao 2*Jian Yu Jian Yu 1*Yuanming Zhang Yuanming Zhang 2*Li Wu Li Wu 1*
  • 1 Tumor Hospital of Xinjiang Medical University, Ürümqi, China
  • 2 Xinjiang Medical University, Ürümqi, Xinjiang Uyghur Region, China
  • 3 Fifth Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang Uyghur Region, China

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

    Background: Chimeric antigen receptor T-cell (CAR-T) therapy, a rapidly emerging treatment for cancer that has gained momentum since its approval by the FDA in 2017, involves the genetic engineering of patients' T cells to target tumors. Although significant therapeutic benefits have been observed, life-threatening adverse pulmonary events have been reported. Methods: Using SAS 9.4 with MedDRA 26.1, we retrospectively analyzed data from the Food and Drug Administration's Adverse Event Reporting System (FAERS) database, covering the period from 2017 to 2023. The analysis included the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayes Geometric Mean (EBGM) to assess the association between CAR-T cell therapy and adverse pulmonary events (PAEs). Results: The FAERS database recorded 9,400 adverse events (AEs) pertaining to CAR-T therapies, of which 940 (10%) were PAEs. Among these CAR-T cell-related AEs, hypoxia was the most frequently reported (344 cases), followed by respiratory failure (127 cases). Notably, different CAR-T cell treatments demonstrated varying degrees of association with PAEs. Specifically, Tisa-cel was associated with severe events including respiratory failure and hypoxia, whereas Axi-cel was strongly correlated with both hypoxia and tachypnea. Additionally, other CAR-T therapies, namely Brexu-cel, Liso-cel, Ide-cel, and Cilta-cel, have also been linked to distinct PAEs. Notably, the majority of these PAEs occurred within the first 30 days post-treatment. The fatality rates varied among the different CAR-T therapies, with Tisa-cel exhibiting the highest fatality rate (43.6%), followed by Ide-cel (18.8%). Conclusion: This study comprehensively analyzed the PAEs reported in the FAERS database among recipients of CAR-T cell therapy, revealing conditions such as hypoxia, respiratory failure, pleural effusion, and atelectasis. These CAR-T cell therapy-associated events are clinically significant and merit the attention of clinicians and researchers.

    Keywords: chimeric antigen receptor T cells, CAR T cell therapy, FAERS database, Real-world study, pharmacovigilance analysis, pulmonary adverse events

    Received: 17 May 2024; Accepted: 30 Jul 2024.

    Copyright: © 2024 Shi, Liu, Jiang, Gao, Yu, Zhang and Wu. 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:
    Xinya Liu, Xinjiang Medical University, Ürümqi, Xinjiang Uyghur Region, China
    Yun Jiang, Xinjiang Medical University, Ürümqi, Xinjiang Uyghur Region, China
    Mengjiao Gao, Xinjiang Medical University, Ürümqi, Xinjiang Uyghur Region, China
    Jian Yu, Tumor Hospital of Xinjiang Medical University, Ürümqi, China
    Yuanming Zhang, Xinjiang Medical University, Ürümqi, Xinjiang Uyghur Region, China
    Li Wu, Tumor Hospital of Xinjiang Medical University, Ürümqi, China

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