Expanded criteria for liver transplantation in patients with hepatocellular carcinoma: A report from the International Registry of Hepatic Tumors in Liver Transplantation

Hepatocellular carcinoma (HCC) is a common indication for liver transplantation (LT). Currently, deceased donor LT is approved by the United Network for Organ Sharing for patients with HCC who meet the Milan criteria of a single tumor up to 5 cm or up to 3 tumors up to 3 cm as determined by imaging studies. We analyzed data in the International Registry of Hepatic Tumor:3 in Liver Transplantation from 1,206 patients with HCC. Tumor size and number were determined by gross pathologic,examination. Kaplan-Meier recurrence-free survival in patients with a single tumor <= 5 cm or 2-3 lesions all <= 3 cm in diameter was 84.7% at 1 year and 61.8% at 5 years. Overall, patients whose tumor or tumors exceeded these limits had worse survival 67.20% at 1 year and 42.8% at 5 years, P < 0.001); however, not all patients in this group did poorly. Patients with 2-4 tumors <= 5 cm or single lesions <= 6 cm had recurrence-free survival equivalent to patients with a single tumor of 3.1-5.0 cm or 2-3 lesions all <= 3 cm in diameter. These data suggest that current criteria for selecting tumor patients for LT may be too restrictive and could be expanded.