Exploring tumor lysis syndrome linked to immune checkpoint inhibitors: insights from the FAERS pharmacovigilance database

The increasing use of immune checkpoint inhibitors (ICIs) has raised concerns about immune-related adverse events (irAEs), including tumor lysis syndrome(TLS), traditionally linked to cytotoxic chemotherapy. This study investigates the association between ICIs and TLS, analyzing clinical characteristics, treatment regimens, and outcomes. ICIs-associated TLS cases reported in the FDA Adverse Event Reporting System (FAERS) from Q1 2011 to Q1 2024 were analyzed. Disproportionality analysis and Weibull shape parameter (WSP) modeling were used to assess reporting trends and onset patterns. Among 364 TLS cases, anti-PD-1 were most frequently implicated (n = 210), followed by anti-PD-L1 (n = 109) and anti-CTLA-4 (n = 45). Combination therapies accounted for 61.0% of cases, with distinct disease distributions: dual ICIs in melanoma (36.36%), ICIs plus chemotherapy in lung cancer (47.37%), and ICIs plus antiangiogenic therapy in hepatocellular carcinoma (59.14%). The median onset time was 9 days (IQR: 3-23.75), with WSP analysis indicating an early failure pattern (β = 0.75, 95% CI: 0.66-0.85). ICIs are significantly associated with TLS, particularly in combination regimens, necessitating early risk identification and close monitoring. Given the rising use of ICIs, proactive management and ongoing pharmacovigilance are essential to mitigate severe outcomes.