Association between PD-L1 inhibitor, tumor site and adverse events of potential immune etiology within the US FDA adverse event reporting system

Abstract

Objective: To analyze tumor- and treatment-related factors that might impact the development of certain adverse events (AEs) of potential immune etiology among patients receiving PD-L1 inhibitors. Methods: The FDA Adverse Event Reporting System (FAERS) was accessed, and AE reports related to the use of PD-L1 inhibitors were reviewed. Associations between treatment, tumor type and occurrence of AEs of special interest were analyzed through multivariable logistic regression analysis. Results: A total of 80,304 AE reports were included in the current analysis. Diagnosis with lung cancer was associated with a higher probability of pneumonitis; diagnosis with melanoma was associated with a higher probability of hepatitis, hypophysitis/hypopituitarism and uveitis; and diagnosis with genitourinary cancers was associated with a higher probability of nephritis, adrenal insufficiency and myocarditis. Conclusion:  Within this cohort limited to AEs reported to the FAERS, there is an association between different AEs of special interest, agent(s) used and tumor(s) treated.