O-39 clinical characteristics and outcome of drug-induced liver injury due to antineoplastic and biological agents

Introduction and Objectives: Idiosyncratic drug-induced liver injury (DILI) caused by antineoplastic and biological agents is an emerging clinical burden in oncologic patients. However, clinical characteristics of DILI due to these drugs remain poorly understood. This study aimed to assess the clinical presentation and outcome of DILI caused by antineoplastic and biological agents in patients enrolled in the prospective Spanish and Latin American DILI registries. Materials and Methods: Information from well-vetted DILI cases caused by antineoplastic and biological agents enrolled in the Spanish DILI Registry (n=38) and the LATINDILI Network (n=33) since their establishment in 2022 was retrieved. Demographics, clinical characteristics, laboratory findings and outcome were analyzed through descriptive statistics. Results: Overall, DILI patients were aged 61±17 years, with Latin American patients slightly younger than Spanish cases (64 vs. 56; p=0.053) and were predominantly men (66%). Novel therapies such as Protein Kinase Inhibitors represented 14% of cases, while Immune Checkpoint Inhibitors caused 6% of DILI cases. Hepatocellular damage predominated (79%), while 12% had a cholestatic injury. Nearly 70% of patients developed jaundice, and 49% were hospitalized. Alanine and aspartate aminotransferase were highly increased (median values 13 and 11 times above the upper limit of normal (ULN), respectively), while alkaline phosphatase showed modest elevations (1.3 times ULN). Total bilirubin was elevated by a median of 3.7-fold ULN. Most of the patients coursed with a moderate injury (46%), and 15% developed severe liver damage. Four Spanish cases, and one from Latin America, had liver-related death (p=0.018). There were no chronic DILI cases, and 71% of patients resolved spontaneously. Conclusions: DILI, due to antineoplastic and biological agents, was more common in men, caused a hepatocellular injury, and usually coursed as a moderate-to-severe liver injury. Latin American cases were slightly younger, while the mortality rate was higher among Spanish DILI patients.