Introduction: Hepatitis often occurs after the initiation of immune checkpoint inhibitor (ICI) treatment. The time and grade of hepatitis after ICI initiates and the prognostic role of immune-related hepatitis in patients with advanced hepatocellular carcinoma (aHCC) remains unclear.
Methods: In this real-world analysis, we enrolled aHCC patients receiving ICIs, documented the highest level of liver enzymes during/after ICIs, and analyzed the survival impact of different hepatitis patterns.
Results: One hundred and ninety-three aHCC patients receiving ICIs were recruited. During ICIs, 88.6% of all patients experienced aspartate transaminase (AST) elevations (Grade III/IV: 7.8%). For alanine transaminase (ALT), 81.3% had elevated levels (Grade III/IV: 3.6%), and 41.5% of patients had elevated bilirubin levels (Grade 3/4: 6.7%). The median AST, ALT, and total bilirubin values significantly increased after ICI treatment initiated (all p < 0.001) and similarly, after excluding progressive disease ( p = 0.014, p = 0.002, p < 0.001). The median time of hepatitis occurrence is from the 4.0 th –15.9 th weeks. Multivariate analysis showed that patterns of liver enzyme change of AST and total bilirubin in patients receiving ICIs significantly correlate to overall survival (OS, p = 0.009 and 0.001, respectively). After ICI termination, patients with late elevated bilirubin ( p = 0.003) and AST ( p = 0.005) would indicate poor survival.
Discussion/ Conclusion: Hepatitis patterns in patients with aHCC under ICI therapy can predict OS. Close monitoring of hepatitis could help to promptly predict the outcomes of patients receiving ICIs.