Risk Signal Mining for Adverse Events of Pembrolizumab in Gynecological Cancer Patients
HOU Yifang
YU Weijiang
LI Jiawen
LUO Yanlin
Abstract：Objective To explore the adverse events(AE)risk signals of pembrolizumab in gynecologic cancer patients,and to provide reference for improving the efficacy of this drug in treating gynecological cancer patients.Methods AE reports of gynecological cancer patients with pembrolizumab were collected from the US Food and Drug Administration adverse event reporting system database from the third quarter of 2014 to the second quarter of 2024.AEs were standardized according to the preferred term(PT)in the International Medical Terminology Dictionary.The AE risk signals of pembrolizumab were explored using the reporting odds ratio(ROR)method.The risk signal was defined as that the number of reports ≥3 and the lower limit of the 95％confidence interval of the ROR＞1.Results A total of 4 117 AE reports with pembrolizumab in gynecological cancer patients were obtained,including 3 097 serious AEs(75.22％).Among 3 097 serious AEs,598 cases were death(14.53％),150 cases were life-threatening(3.64％).A total of 255 positive PTs were detected by ROR method.The top 5 PTs in the number of AE reports were malignant neoplasm progression,hypertension,diarrhea,hypothyroidism,and malaise.The top 5 PTs in signal intensity were tumor pseudoprogression(ROR=189.97),hypothyroidism(ROR=161.13),hyperthyroidism(ROR=129.11),hepatic disorder(ROR=103.95),and tumor hyperprogression(ROR=75.89).A total of 52 of the 255 positive PTs were not recorded in the label.Among them,the PTs with higher number of AE reports were palmar-plantar erythrodysaesthesia syndrome,proteinuria,dysphonia,heart failure,myelosuppressionand,gallbladder/bile duct disease,septic shock,cerebral infarction,etc.The PTs with stronger signal intensity of AE reports were tumor hyperprogression(ROR=75.89),panniculitis(ROR=60.71),strabismus(ROR=30.35),cholangitis(ROR=26.57),hepatic encephalopathy(ROR=10.12),etc.Conclusion Malignant neoplasm progression,hypertension,thyroid dysfunction are the AEs that need to be monitored during the use of pembrolizumab in gynecologic cancer patients.Fifty-two PTs that are not recorded in the drug instruction,such as heart failure and myelosuppression,need to be noticed.
Keywords：immune checkpoint inhibitorsadverse drug reaction reporting systemdata miningpembrolizumab
Publication Date：2025-09-28
Online Publishing Date：2026-09-12(First online date of this platform, not the publication date of the document)
Pages：6( 3268-3273 )