ArticlePloS one2025
Hematological toxicity of anti-tumor antibody-drug conjugates: A retrospective pharmacovigilance study using the FDA adverse event reporting system.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Multi-target-directed drugs: new additions in 2025 and post-marketing safety surveillance of drugs marketed in 2022-2024.Pharmacological reports : PR · 2026Review
- Infectious Complications of Antibody-Drug Conjugates: A Review of Safety Data from FDA-Approved Agents.Current oncology reports · 2026Review
- Toxicities of Antibody-Drug Conjugates in Breast Cancer: From Mechanistic Insights to Clinical Management.Pharmaceutics · 2026Review
- Article
- Antibody-Drug Conjugates Reshape the Landscape of Cancer Therapy: Evolution, Challenges and Future Perspectives from the Concept of "Magic Bullet" to Clinical Application.Current oncology reports · 2026Review
- Haematological toxicity associated with antineoplastic drugs: a pharmacovigilance analysis based on the FDA adverse event reporting system database.Frontiers in immunology · 2026Article
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough antibody-drug conjugates (ADCs) have shown significant efficacy in cancer treatment, hematotoxicity remains a serious issue. This study aims to investigate the relationship between ADCs and hematological toxicity.
methodsOur study was conducted using data extracted from the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) from the third quarter of 2011 to the second quarter of 2024. We used four disproportionality analysis methods to measure risk signals. In addition, we analyzed the time-to-onset of hematotoxicity adverse events (AEs).
resultsA total of 4,803 cases of hematotoxicity AEs associated with ADCs were identified, the median age of patients was 60 years (IQR: 47-72). Different ADCs have different hematotoxicity profiles, among which brentuximab vedotin (BV) and sacituzumab govitecan (SG) were more likely to lead to serious outcomes. The median time-to-onset of hematotoxicity AEs was the shortest for SG at 12 days and the longest for trastuzumab deruxtecan (TG) at 22 days. The hospitalization and mortality rates with hematotoxicity AEs were 30.38% and 18.30%, respectively.
conclusionsADCs 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.
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