Postmarketing safety of [ 177 Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system DOI
Yan Zhao, Na Wang, Zhaoqi Zhang

и другие.

Expert Opinion on Drug Safety, Год журнала: 2025, Номер unknown

Опубликована: Фев. 11, 2025

[177Lu]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 not systemically evaluated. Adverse event reports for were retrieved from April 2022 June 2024 The Food and Drug Administration Event Reporting System (FAERS) database. Disproportionality analysis was conducted by four algorithms: reporting odds ratio (ROR), proportional (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) Bayesian Confidence Propagation Neural Network (BCPNN). Subgroup analysis, time-to-onset sensitivity also employed. 384,2712 adverse retrieved, which 870 associated with in patients. We identified known events (fatigue/asthenia, anemia, thrombocytopenia nausea) discovered specified on label (loss libido, hydronephrosis, supraventricular tachycardia, tumor lysis syndrome, flare). revealed high-risk signals included stomatitis, pneumonia, leukopenia, sepsis patients aged over 85. median onset time 55 days (interquartile range 24-124 days). findings provide insights into valuable references clinical applications mCRPC.

Язык: Английский

Improving the Accuracy of Bone-Scintigraphy Imaging Analysis Using the Skeletal Count Index: A Study Based on Human Trial Data DOI Creative Commons
Ryosuke Miki,

Tatsuya Tsuchitani,

Yoshiyuki Takahashi

и другие.

Radiation, Год журнала: 2025, Номер 5(1), С. 5 - 5

Опубликована: Янв. 17, 2025

The image quality index for whole-body bone scintigraphy has traditionally relied on the total count (Total-C) with a threshold of ≥1.5 million counts (MC). However, Total-C measurements are susceptible to variability owing urine retention. This study aimed develop skeletal (Skel-C)-based index, focusing exclusively regions, improve accuracy analysis in scintigraphy. To determine optimal Skel-C-based threshold, Skel-C thresholds were set at 0.9, 1.0, 1.1, and 1.2 MC, 1.75, 2.0, 2.25 MC. Patients then categorized based whether their values above or below these thresholds. group including all cases was defined as 1.5 high group. Sensitivity specificity calculated each group, receiver operating characteristic analyses statistical evaluations conducted. program < 0.9 MC significantly lower than that ≥ groups. decrease evident only not identified levels. These findings highlight importance achieving suggest alone is insufficient reliable assessment.

Язык: Английский

Процитировано

1

Postmarketing safety of [ 177 Lu]Lu-PSMA-617 radioligand therapy for prostate cancer: a disproportionality analysis of the FDA adverse event reporting system DOI
Yan Zhao, Na Wang, Zhaoqi Zhang

и другие.

Expert Opinion on Drug Safety, Год журнала: 2025, Номер unknown

Опубликована: Фев. 11, 2025

[177Lu]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 not systemically evaluated. Adverse event reports for were retrieved from April 2022 June 2024 The Food and Drug Administration Event Reporting System (FAERS) database. Disproportionality analysis was conducted by four algorithms: reporting odds ratio (ROR), proportional (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) Bayesian Confidence Propagation Neural Network (BCPNN). Subgroup analysis, time-to-onset sensitivity also employed. 384,2712 adverse retrieved, which 870 associated with in patients. We identified known events (fatigue/asthenia, anemia, thrombocytopenia nausea) discovered specified on label (loss libido, hydronephrosis, supraventricular tachycardia, tumor lysis syndrome, flare). revealed high-risk signals included stomatitis, pneumonia, leukopenia, sepsis patients aged over 85. median onset time 55 days (interquartile range 24-124 days). findings provide insights into valuable references clinical applications mCRPC.

Язык: Английский

Процитировано

0