| アブストラクト | BACKGROUND: [(177)Lu]Lu-PSMA-617 (Pluvicto), a new radioligand therapy that targets prostate-specific membrane antigen (PSMA), has been approved to treat metastatic castration-resistant prostate cancer (mCRPC). However, the real-world safety profile of [(177)Lu]Lu-PSMA-617 has not been systemically evaluated. RESEARCH DESIGN AND METHODS: Adverse event reports for [(177)Lu]Lu-PSMA-617 were retrieved from April 2022 to June 2024 from The Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis was conducted by four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN). Subgroup analysis, time-to-onset and sensitivity analysis were also employed. RESULTS: 384,2712 adverse event reports were retrieved, of which 870 were associated with [(177)Lu]Lu-PSMA-617 in prostate cancer patients. We identified known adverse events (fatigue/asthenia, anemia, thrombocytopenia and nausea) and discovered adverse events not specified on the label (loss of libido, hydronephrosis, supraventricular tachycardia, tumor lysis syndrome, and tumor flare). Subgroup analysis revealed high-risk signals included stomatitis, pneumonia, leukopenia, and sepsis for patients aged over 85. The median onset time was 55 days (interquartile range 24-124 days). CONCLUSIONS: The findings provide new insights into the adverse events of [(177)Lu]Lu-PSMA-617 and valuable references for clinical applications of radioligand therapy for mCRPC. |
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| 組織名 | Department of Oncology, The Fourth Hospital of Hebei Medical University,;Shijiazhuang, China.;Department of Nuclear Medicine, The Fourth Hospital of Hebei Medical University,;Hebei Provincial Key Laboratory of Tumor Microenvironment and Drug Resistance, |
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