Expert opinion on drug safety · 2025
Pancreatic adverse events induced by immune checkpoint inhibitors: a real-world observational study.
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Zhan Mei, Long Qinran, He Jinhan, Huang Litao, Liu Ran, Wu Bin, Xu Ting
Аннотация
BACKGROUND: Immune checkpoint inhibitor (ICI)-induced pancreatic adverse events (AEs) are rare occurrences that are poorly documented in the literature.
RESEARCH DESIGN AND METHODS: We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs.
RESULTS: The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90-67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12-26.82], p = 0.036), lung cancer (OR 2.62; [95% CI, 1.09-6.34], p = 0.032), younger patients (OR 0.97; [95% CI, 0.94-0.99], p = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], p = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs.
CONCLUSIONS: This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn identifier is ChiCTR2300075974.
RESEARCH DESIGN AND METHODS: We conducted a retrospective review of patients who had ICI up to June 2023. Patient follow-up was extended until death or to May 2024. The primary outcome was the incidence of severe ICI-related pancreatic AEs. Logistic regression was used to investigate the associations between clinical characteristics and severe ICI-related pancreatic AEs.
RESULTS: The study included 7,840 participants who received ICI. The study population was predominantly male (74.50%), with a median age of 59.20 years [IQR 51.90-67.70 years]. Among them, 49 patients (0.63%) developed severe ICI-related pancreatic AEs. Logistic regression revealed that pancreatic cancer (OR 5.47; [95% CI, 1.12-26.82], p = 0.036), lung cancer (OR 2.62; [95% CI, 1.09-6.34], p = 0.032), younger patients (OR 0.97; [95% CI, 0.94-0.99], p = 0.015), and using PD-L1 inhibitor (OR 3.09, [95% CI 1.46 to 6.52], p = 0.003) were associated with a higher risk of severe ICI-related pancreatic AEs.
CONCLUSIONS: This study demonstrated that most ICI-related pancreatic AEs were asymptomatic. Primary tumor type, age, and ICI type may be predictive factors for severe ICI-related pancreatic AEs.
CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn identifier is ChiCTR2300075974.