Bridging FDA Adverse Event Reporting System (FAERS) and Clinical Practice: Comprehensive Characterization of Immune...

Immune checkpoint inhibitors (ICIs) frequently cause severe adverse events (AEs) in elderly lung cancer patients due to age-related immune decline. This study combines pharmacovigilance analysis of the FDA Adverse Event Reporting System (FAERS) with real-world data to explore safety profiles in geriatric lung cancer patients.

AE reports for geriatric lung cancer patients (≥ 65 years) on FDA-approved ICIs from FAERS (Q3 2014-Q3 2024) were analyzed using the Reporting Odds Ratio. Single-center retrospective data was used for clinical contextualization.

A total of 16 062 AE reports were identified, along with 260 AE signals in the FAERS database. The median age of reports was 72 years, with a male predominance (70.8%). Median onset time was 50 days. Reports with fatal outcomes (not causally adjudicated) accounted for 27.6% of cases. The geriatric group had significantly higher odds of reported fatal outcomes compared to the non-elderly group (OR = 1.13, p < 0.001). Further analysis revealed elevated odds of fatal outcomes were associated with reports concerning male patients (OR = 1.46), those originating from Asian geographic regions (OR = 1.36), and anti-PD-1 recipients (OR = 1.22) (all p < 0.001) in geriatric patients. A complementary single-center cohort (n = 225) provided clinical context, identifying immune-mediated pneumonia (21.3%) as the most common AE, predominantly in males (89.6%) and anti - PD-1 users (93.8%).

A higher reported rate of fatal outcomes was observed in geriatric lung cancer patients, especially those reports pertaining to males, Asian regions, and recipients of anti-PD-1 therapy.