| アブストラクト | BACKGROUND: The FDA's alerts regarding the T-cell lymphoma risk post CAR-T therapy has garnered global attention, yet a comprehensive profile of second primary malignancies (SPMs) following CAR-T treatment is lacking. METHODS: We extracted adverse event reports of hematological malignancies (HMs) patients with clearly definable SPMs from the FAERS and VigiBase databases (2017-2023). Disproportionality analysis using reporting odds ratio (ROR) and adjusted ROR was performed to assess associations between SPMs and CAR-T therapy. Time-to-onset analysis explored factors affecting SPM manifestation. FINDINGS: SPMs post CAR T-cell therapy include HMs and solid tumors. T-cell lymphoma and myelodysplastic syndromes were consistently identified as positive signals across the overall and subgroup analyses. Hematological SPMs showed earlier onset with increasing annual incidence post CAR-T therapy, whereas solid tumors exhibit delayed manifestation. SPMs in CAR-T recipients had significantly earlier onset than non-recipients. Furthermore, age-specific characteristics reveal earlier SPM manifestations in pediatric, adolescent, and young adult populations compared to older populations post CAR-T therapy. INTERPRETATION: The current SPM profile highlights the necessity of long-term safety monitoring for all CAR-T recipients given the observed yearly increase of SPMs. Customizing long-term SPM screening across different age groups may enhance early detection and intervention strategies, ultimately improving patient outcomes in the follow-up of CAR-T recipients. FUNDING: This work was supported by grants from the Natural Science Foundation of Guangdong Province (2018A030313846 and 2021A1515012593), the Science and Technology Planning Project of Guangdong Province (2019A030317020), the National Natural Science Foundation of China (81802257, 81871859, 81772457, 82172750, 82172811, and 82260546), the Guangdong Basic and Applied Basic Research Foundation (Guangdong-Guangzhou Joint Funds) (2022A1515111212), and the Science and Technology Program of Guangzhou (2023A04J1257). |
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| 投稿者 | Shen, Junyi; Hu, Rong; Lin, Anqi; Jiang, Aimin; Tang, Bufu; Liu, Zaoqu; Cheng, Quan; Miao, Kai; Zhang, Jian; Luo, Peng |
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| 組織名 | Department of Oncology, Zhujiang Hospital, Southern Medical University,;Guangzhou, 510282, China.;Department of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou;Medical University, Guangzhou, 510623, China.;Department of Urology, Changhai Hospital, Naval Medical University (Second;Military Medical University), Shanghai, China.;Department of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai,;200032, China.;Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences and;Peking Union Medical College, Beijing, 100730, China.;Department of Neurosurgery, Xiangya Hospital, Central South University, Changsha,;Hunan, China.;National Clinical Research Center for Geriatric Disorders, Xiangya Hospital,;Central South University, Changsha, China.;Cancer Centre and Institute of Translational Medicine, Faculty of Health;Sciences, University of Macau, Macau SAR, 999078, China.;MoE Frontiers Science Center for Precision Oncology, University of Macau, Macau;SAR, 999078, China. |
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