Real world experience with immune-checkpoint inhibitors (ICI) in hepatocellular carcinoma (HCC): 5-year single center analysis.

e16169 Background: The HIMALAYA and IMbrave150 trials introduced two groundbreaking ICI combinations for treating HCC, showing the potential to significantly improve outcomes compared to sorafenib (SOR). Our study aimed to evaluate the risk factors associated with poor outcomes in HCC patients treated with ICIs in real-world settings prior to the HIMALAYA era. Methods: In this retrospective, single-center study, patients with HCC receiving ICI from 1/2017 and 6/2023 at a tertiary academic medical center were evaluated. The patient's baseline characteristics (at the first dose of ICI) were extracted with details of immune-related adverse events (irAE) and survival outcomes. Overall survival (OS) and progression-free survival (PFS) were analyzed using multivariate (MVA) logistic regression. Results: A total of 51 patients with HCC received treatment (median age: 66 years; range: 40–86), predominantly males (83%) and Caucasians (85%). Child-Pugh Turcotte (CTP) score distribution was A- 53%, B- 36%, and C-11%. ICI was first-line systemic therapy in 38% and the rest had SOR, lenvatinib (LEN), regorafenib (REF), or ramucirumab (RM); 49% had locoregional therapies (LRTs); only 25% (n = 13) received atezolizumab and bevacizumab combination (BEV) and none of them received dual ICI therapy; 19% had irAE (all-grade). MVA predictors of OS are discussed in the table below. For PFS, two significant factors were low serum Albumin (hazard ratio (HR): - 0.3) and irAE incidence (HR: – 4.9). Stratification by median Albumin (≤3.3 vs. > 3 g/dL) showed lower albumin was linked to worse PFS (3 vs. 6.5 months (m), p = 0.002) and OS (12 vs. 23 m, p = 0.04). Conclusions: In our real-world experience, results underscore the importance of integrating liver function (Albumin levels), prior treatment history (LRT), and irAE monitoring into individualized treatment strategies for HCC patients receiving ICIs. Further prospective studies are warranted to validate these findings. MVA for OS in the study cohort. Factor p-value HR Gender, Male vs. Female 0.02 2.4 BEV combination 0.03 0.45 Trans arterial radioembolization 0.002 0.3 Ablation <0.001 0.07 Surgery 7.8 Total bilirubin 0.42 Albumin 0.36 irAE 0.04 2.16 Hepatitis 0.15 0.15 Alcohol use 0.2 0.2 Prior LEN vs. none 0.001 37 Prior SOR vs. none 0.02 0.48 Prior SOR + REF vs. none 0.4 Prior SOR + LEN vs. none 0.03 9.2 Prior SOR + LEN+ RM vs. none 0.5 Alpha-fetoprotein 0.2 Transarterial chemoembolization 0.8 Stereotactic radiation therapy 0.6 Ascites 0.2 Encephalopathy 0.3