Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (9): 1012-1017.
DOI: 10.19803/j.1672-8629.20250457

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Clinical Features and Integrated Care Pathway for Second Primary Malignancies after CAR-T Cell Therapy

ZHANG Hao1, WU Xueting1, HE Shujiao2, WANG Yiran2,*   

  1. 1Department of Pharmacy, Shenzhen University General Hospital, Shenzhen Guangdong 518055, China;
    2Department of Hematology and Oncology, Shenzhen University General Hospital, Shenzhen Guangdong, 518055, China
  • Received:2025-07-11 Published:2025-09-22

Abstract: Objective To investigate related second primary malignancies (SPMs) and comprehensive management practices following Chimeric antigen receptor T (CAR-T) cell therapy. Methods The epidemiology and mechanism of SPM after CAR-T cell therapy were reviewed, and the whole process management strategy for SPMs after CAR-T cell therapy was discussed. Results The risk of SPMs associated with CAR-T cell therapy was found to range from 3% to 8%. Risk factors for SPMs after CAR-T cell therapy included hematological precursor lesions such as clonal hematopoiesis of uncertain significance, excessive inflammatory responses triggered by CAR-T cell therapy, and the carcinogenic potential of multiple lines of treatment. Clinical pharmacists could effectively reduce the risk via compr-ehensive management based on three-level prevention. Conclusion The clinical benefits of CAR-T cell therapy for primary tumors outweigh the potential risks associated with SPMs. It is essential for clinical pharmacists to intervene in the entire process of CAR-T cell therapy and collaboratively construct a three-level prevention system with healthcare providers that involves providing pharmaceutical services for the identification, analysis, reporting, and follow-up of SPMs and incorporating comprehensive management of CAR-T cell therapy into a data-driven continuous quality improvement approach, which is of clinical importance for the safe and effective administration of CAR-T cell therapy.

Key words: CAR-T Cell Therapy, Second Primary Malignancies, Acute Myeloid Leukemia, Hematologic Malignancies, Solid Tumors, Integrated Care Pathway

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