The impact of Milan criteria on liver transplantation for hepatocellular carcinoma: first 15 years' experience of the Hungarian Liver Transplant Program.

In addition to hepatitis C, hepatocellular carcinoma. is a leading indication for orthotopic liver transplantation (OLT). The indications for OLT in HCC remains a topic of debate. The successful Milan criteria are still accepted as the gold standard to select candidates with a good chance for long-term survival. The Hungarian Liver Transplant Program launched in 1995 reached 45 OLT/year in 2010. Among 412 first OLTs, there were 49 cases of a malignant tumor, including 41 among which the indication was the tumor. Of the 412 patients, 154 (37.4%) were hepatitic C virus (HCV) positive, including 29 with HCC and 23 cases in which HCC was the indication itself. Half of the HCC patients were within the Milan criteria; 50% exceeded the criteria. We observed a solitary HCC in 36% of cases: 2 foci in 18%; 3 in 7%, 4 in 14%, and ≥5 in 25%. Only 12 patients underwent a "down-staging" treatment before OLT: 8 radiofrequency ablation (RFA) and 4 transarterial chemoembolization (TACE). Cumulative 1-, 3-, and 5-year patient survivals were 62%, 54%, and 43%, respectively in HCC/HCV-positive patients and they were 74%, 67%, and 61% among non-HCC HCV-positive subjects. The cumulative HCC patient survival rates of 64%, 64%, and 53% among Milan criteria were superior to those of 57%, 40%, and 27% among subjects exceeding the Milan criteria (P=.01). Pre-OLT "down-staging" treatment increased the 1-year patient survival from 64% to 70%; however, it did not affect the long-term results. Among items of the Milan criteria tumor size had less impact on outcomes then number of foci. The majority of cases who exceeded the Milan criteria had been transplanted before 2003. Our results suggested that the Milan criteria should be applied for the selection of candidates in order to promise good survival after OLT for HCC.