ArticleInternational journal of surgery (London, England)2026
Mapping adverse events and monitoring priorities for trastuzumab deruxtecan use in metastatic breast cancer.
Article in International journal of surgery (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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15 authors.
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Abstract
introductionMetastatic breast cancer (MBC) remains a major clinical challenge despite recent advances in HER2-targeted therapies such as trastuzumab deruxtecan (T-DXd). While clinical trials have demonstrated its efficacy, concerns about treatment-emergent toxicities persist, highlighting the need for real-world pharmacovigilance to capture a broader spectrum of adverse events (AEs).
methodsWe analyzed reports from the US FDA Adverse Event Reporting System (FAERS, 2004-2024), including trastuzumab deruxtecan reports recorded since its market introduction in 2019. Disproportionality analyses were performed to identify potential AE signals. Time-to-onset distributions were assessed, and a clinical prioritization score was developed to rank AEs based on signal strength, frequency, mortality, and classification as important or designated medical events.
resultsDisproportionality analyses revealed significant AE signals associated with T-DXd across multiple organ systems, including injury and procedural complications, respiratory, gastrointestinal, and social circumstances. Time-to-onset analysis revealed substantial heterogeneity in the timing of T-DXd-associated AEs. Early-onset events included dyspnea and eye disorders, whereas cardiac and nervous system toxicities showed delayed onset. Among twelve high-priority AEs, peritonitis received the highest priority scores (scores = 11). Interstitial lung disease demonstrated the most prominent disproportionality signal. Several other pulmonary-related events, including pneumonitis, pulmonary fibrosis, and pulmonary toxicity, also ranked as high priority.
conclusionThis study highlights respiratory and gastrointestinal toxicities as major risks associated with T-DXd in metastatic breast cancer. Careful monitoring, early intervention, and patient education are essential to balance benefits and risks, while future research should focus on molecular mechanisms to enable precision medicine.
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