Postmarketing safety of [177Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system

被引:0
作者
Zhao, Yan [1 ]
Wang, Na [2 ,3 ]
Zhang, Zhaoqi [2 ,3 ]
Zhao, Xinming [2 ,3 ]
机构
[1] Fourth Hosp Hebei Med Univ, Dept Oncol, Shijiazhuang, Peoples R China
[2] Fourth Hosp Hebei Med Univ, Dept Nucl Med, 12 Jiankang Rd, Shijiazhuang 050011, Peoples R China
[3] Hebei Prov Key Lab Tumor Microenvironm & Drug Resi, Shijiazhuang, Peoples R China
关键词
Lu-177]Lu-PSMA-617; FAERS; adverse event; prostate cancer; radioligand therapy; TUMOR FLARE;
D O I
10.1080/14740338.2025.2466673
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Background [Lu-177]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 [Lu-177]Lu-PSMA-617 has not been systemically evaluated. Research design and methods Adverse event reports for [Lu-177]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 [Lu-177]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 [Lu-177]Lu-PSMA-617 and valuable references for clinical applications of radioligand therapy for mCRPC.
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