Abstract
Sirolimus (SRL) has been reported to benefit patients undergoing liver transplantation (LT) for hepatocellular carcinoma (HCC). This study aimed to compare SRL with tacrolimus (TAC) in living-donor LT (LDLT) recipients beyond the Milan criteria. This study was initially designed to enrol 45 recipients who underwent LDLT for HCC beyond the Milan criteria. At 1 month after LT, the patients were randomly assigned to either SRL or TAC-based treatment, with both groups receiving mycophenolate mofetil. The primary outcome was three-year recurrence-free survival (RFS) and the secondary outcome was overall survival (OS). A total of 42 patients completed the study. HCC recurrence occurred in 8 of 22 (36.4%) patients in the SRL group and in 5 of 22 (25%) patients in the TAC group. No differences in RFS and OS were found between the two groups in simple comparison. The type of immunosuppressant remained a nonsignificant factor for recurrence in multivariate analysis; however, SRL significantly prolonged OS (TAC hazard ratio: 15 [1.3–172.85], p = 0.03) after adjusting for alpha-fetoprotein and positron emission tomography standardised uptake value ratio (tumour/background liver). In conclusion, SRL does not decrease HCC recurrence but prolongs OS after LDLT for HCC beyond the Milan criteria.
Highlights
Liver transplantation (LT) is an outstanding treatment option for patients with hepatocellular carcinoma (HCC)
HCC beyond the Milan criteria accounts for 30–40% of living-donor LT (LDLT) for HCC cases at Seoul National University Hospital
The expansion of indications for LDLT inevitably results in a higher tumour recurrence rate [14]
Summary
Liver transplantation (LT) is an outstanding treatment option for patients with hepatocellular carcinoma (HCC). Complete resection of the tumour and underlying oncogenic cirrhotic liver provides superior oncologic outcomes. Several morphological selection criteria for LT, including the Milan criteria and the University of California San Francisco (UCSF) criteria, have been proposed because patients with tumour recurrence after LT show a poor prognosis. Some patients beyond these criteria have shown good outcomes, thereby expanding the indications of LT, especially in living-donor LT (LDLT) [1]. Biological criteria including alpha-fetoprotein (AFP) and protein induced by vitamin K absence/antagonist (PIVKA)-II levels, positron emission tomography (PET) positivity, and treatment response to locoregional therapy can be used to select optimal LT candidates outside the conventional morphological criteria [2,3]. Expansion of the conventional selection criteria for LT recipients inevitably leads to an increased rate of tumour recurrence. Treatments to reduce the risk of recurrence, while prolonging survival rates, are needed
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