Study eyes liver transplantation after Region 5 UNOS downstaging

Liver transplantation of selected patients with hepatocellular carcinoma (HCC) is an accepted indication and associated with excellent outcomes. Until recently, criteria for liver transplantation were based on the Milan criteria that only took size and number of tumors under consideration. In this multicenter study, patients who were outside of Milan criteria were successfully downstaged to within Milan criteria with locoregional therapy and subsequently transplanted with excellent outcomes. Salient features included the following. 1) Six months waiting after the first treatment and 3 months after downstaging was required to ensure that the tumor stage remained within Milan criteria. 2) Any specific type of locoregional therapy was allowed. 3) Downstaging was possible in a majority of patients after a single treatment. 4) Patients with alpha-fetoprotein greater than 1000 ng/mL (approximately 10%) as well as presence of substantial decompensated liver disease (approximately 40%) did not have favorable outcomes. 4) On multivariable analysis, tumor biology was a stronger predictor of poor outcomes than was stage of liver disease.

The study is important because it supports incorporating tumor biology (regression on subsequent imaging, low AFP versus high AFP) and concomitant liver disease status (Child A versus Child B/C) in addition to size and number of tumors (Milan criteria) for identifying a further slice of patients with HCC who may benefit from transplant. Indeed, downstaging protocols are now part of the Organ Procurement and Transplantation Network MELD exception pathway for liver transplantation of HCC patients in the United States, as long as locoregional therapy results in successful downstaging and the AFP (if elevated) decreases to below 500 ng/mL.

Sumeet K. Asrani, MD, MSc, is associate professor in medicine and hepatologist at Baylor University Medical Center, and medical director of the Center for Advanced Liver Disease, Dallas. He has no conflicts of interest.