Hematological toxicity of anti-tumor antibody-drug conjugates: A retrospective pharmacovigilance study using the FDA adverse event reporting system
ADCs are significantly associated with increased reporting of hematotoxicity. A novel hematotoxicity signal that was not disclosed in the drug specifications was observed. The most prominent hematotoxicity AE signals were cytopenia related to inotuzumab ozogamicin (IO), polatuzumab vedotin (PV), loncastuximab tesirine (LT), and tisotumab vedotin (TV); febrile bone marrow aplasia related togemtuzumab ozogamicin (GO), BV, and SG; and myelosuppression related to BV, trastuzumab emtansine (TE), andenfortumab vedotin (EV). Our findings need to be validated by large-scale prospective studies.
Authors
- Yang‐Yi Chen (ORCID: https://orcid.org/0000-0002-8488-635X)
- Mei Rao (ORCID: https://orcid.org/0009-0007-5417-9340)
- Hong Chen (ORCID: https://orcid.org/0009-0009-2906-5514)
- Xiaohui Wu (ORCID: https://orcid.org/0000-0003-0228-4070)
- Chunmei Chen (ORCID: https://orcid.org/0009-0000-2912-0856)
- Lihua Wu
- Huiying Wang
Institutions
- Fujian Medical University (CN)
- Longyan University (CN)
- First Affiliated Hospital of Fujian Medical University (CN)
Publication Details
- Journal
- PLoS ONE
- Published
- 2025-10-27
- DOI
- https://doi.org/10.1371/journal.pone.0334513
- Primary Topic
- HER2/EGFR in Cancer Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00