Evidence map›Paper›PMID 39007060›Full record

ArticleEClinicalMedicine2024

Characterization of second primary malignancies post CAR T-cell therapy: real-world insights from the two global pharmacovigilance databases of FAERS and VigiBase.

Junyi Shen, Rong Hu, Anqi Lin, Aimin Jiang, Bufu Tang, Zaoqu Liu, Quan Cheng, Kai Miao, Jian Zhang, Peng Luo

Abstract read
In one paragraph

Article in EClinicalMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. [The risk and management strategies for second primary tumor after CAR-T cell therapy].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026
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  10. Sex and age disparities in goserelin safety: a global pharmacovigilance study.Naunyn-Schmiedeberg's archives of pharmacology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Junyi ShenDepartment of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, 510282, China.
Rong HuDepartment of Pharmacy, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, 510623, China.
Anqi LinDepartment of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, 510282, China.
Aimin JiangDepartment of Urology, Changhai Hospital, Naval Medical University (Second Military Medical University), Shanghai, China.
Bufu TangDepartment of Radiation Oncology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
Zaoqu LiuInstitute of Basic Medical Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, 100730, China.
Quan ChengDepartment of Neurosurgery, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Kai MiaoCancer Centre and Institute of Translational Medicine, Faculty of Health Sciences, University of Macau, Macau SAR, 999078, China.
Jian ZhangDepartment of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, 510282, China.
Peng LuoDepartment of Oncology, Zhujiang Hospital, Southern Medical University, Guangzhou, 510282, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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).

Indexed as

CAR-TFAERSMyelodysplastic syndromesSecond primary malignancyT-cell lymphomaVigiBase

Identifiers

PMID39007060
PMCPMC11245995

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.