CAR-T细胞治疗后相关第二原发恶性肿瘤的临床特征与全程管理

doi:10.19803/j.1672-8629.20250457

摘要/Abstract

摘要： 目的研究CAR-T细胞治疗后相关第二原发恶性肿瘤（SPM）和全程化管理实践。方法提取CAR-T细胞治疗后SPM病例并针对CAR-T细胞治疗后SPM的流行病学、机制进行综述并讨论CAR-T细胞治疗后的SPM的全程化管理策略。结果 CAR-T细胞治疗相关SPM风险经初步分析介于3%~8%。CAR-T细胞治疗后SPM的发生风险并非源于单一因素,其病因具有多源性特征,风险因素包括血液前驱病变如意义未明克隆性造血、CAR-T细胞治疗引发的过度炎症反应、多线治疗的致癌性等。开展以三级预防为基础的全程化管理可有效减少SPM风险。结论 CAR-T细胞治疗对原发肿瘤的临床获益显著超越继发恶性肿瘤SPM的潜在风险,临床药师参与CAR-T细胞治疗全过程,医药协同构建三级预防体系,开展SPM的识别、分析、报告、随访的药学服务,并将CAR-T细胞治疗全程化管理纳入数据驱动的持续质量改进,对于CAR-T细胞治疗的全程化管理安全、有效地开展有重要临床意义。

关键词: CAR-T细胞治疗, 第二原发恶性肿瘤, 急性髓系白血病, 血液肿瘤, 实体肿瘤, 全程化管理

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

中图分类号:

R979
R994.11

张颢, 吴雪婷, 贺淑娇, 王怡然. CAR-T细胞治疗后相关第二原发恶性肿瘤的临床特征与全程管理[J]. 中国药物警戒, 2025, 22(9): 1012-1017.

ZHANG Hao, WU Xueting, HE Shujiao, WANG Yiran. Clinical Features and Integrated Care Pathway for Second Primary Malignancies after CAR-T Cell Therapy[J]. Chinese Journal of Pharmacovigilance, 2025, 22(9): 1012-1017.

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