Immune Checkpoint Inhibitors for Recurrent Hepatocellular Carcinoma After Liver Transplantation: Safety Under an Immunosuppression-Preserving Strategy

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Abstract
BACKGROUND Immune checkpoint inhibitors (ICIs) are widely used as first-line combination therapies for many cancers. However, ICIs are associated with an increased risk of graft rejection in patients requiring liver transplants, and the tumor response rate has yet to be determined. MATERIAL AND METHODS This retrospective study included liver transplant recipients who received ICIs for recurrent hepatocellular carcinoma. During ICI therapy, baseline immunosuppressant doses were maintained, with low-dose steroid treatments added when clinically indicated. RESULTS A total of 25 patients were included, with 12 receiving ICIs as first-line therapy, and 13 as second-line therapy. The median progression-free survival (PFS) was 4.93 months (95% CI, 2.33-28.63) and 7.20 months (3.80-32.47), respectively. One patient (4.0%) developed grade 2 hepatitis, and 2 (8%) experienced grade 3 gastrointestinal bleeding. Concurrent steroid use was associated with fewer immune-related adverse events (0% vs 30%, P=0.052) but showed a trend toward shorter PFS (HR=2.30, P=0.071). Two patients (8%) achieved complete remission, and 4 (16%) maintained disease control for more than 1 year. In multivariable analysis, recurrence within 1 year after transplantation was the only significant prognostic factor for PFS (HR=2.98, P=0.043). CONCLUSIONS Our findings suggest that ICIs can be administered after liver transplantation without reducing baseline immunosuppressant doses, potentially minimizing the risk of fatal allograft rejection while still allowing antitumor activity. These results should be interpreted cautiously, and larger studies are needed to define the safe and appropriate use of ICIs in this population.

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