Comparative analysis of patients transplanted due to hepatocellular carcinoma. Are there survival differences between those who meet the Milan criteria and those who exceed them?

Abstract

Introduction and aim

The Milan criteria have been the subject of discussion in recent years due to their restrictive nature. Expansion of the criteria and the use of locoregional therapies to downstage patients and increase the number of transplant candidates have been proposed. Our study analyzed the results of patients that underwent transplant due to hepatocellular carcinoma, comparing those that met the Milan criteria and those that exceeded them.

Materials and methods

A retrospective, observational, single-center study was conducted on liver transplantations due to hepatocellular carcinoma, within the time frame of 2010−2021. Demographic and clinical variables, overall survival, and disease-free survival were analyzed. The Student’s t test or Mann–Whitney U test were applied for the quantitative variables and the Fisher’s exact test for the categorical variables. The survival function was estimated through the Kaplan–Meier method and the log-rank test was applied for comparing the groups.

Results

Of the 96 transplanted patients, 78 met the Milan criteria and 18 exceeded them. Patients that did not meet the Milan criteria had a higher number of nodules (1.6 vs. 3.5 nodules; p = 0.000), larger main lesions (24.38 vs. 38.55 mm; p = 0.000), a higher bilobar hepatocellular carcinoma rate (21.79% vs. 72.22%, p = 0.000), and higher tumor burden. There were no significant differences regarding overall survival, but there was a lower rate of disease-free survival in the group exceeding the criteria.

Conclusion

Downstaged patients that received locoregional therapies had lower disease-free survival rates than patients that met the Milan criteria, but there were no significant differences regarding overall survival.