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Liver Transplantation for Patients With Hepatocellular Carcinoma: Long-Term Role of Downstaging

By: Lauren Harrison, MD, MS
Posted: Friday, September 30, 2022

For patients with hepatocellular carcinoma who were downstaged using the Milan criteria, the outcomes 10 years after liver transplantation were excellent, showing the clear utility of these criteria in liver transplantation decision-making. The Milan criteria state that patients who have single tumors smaller than 5 cm or three tumors each smaller than 3 cm with no microvascular invasion and no metastasis should undergo liver transplantation. Josep M. Llovet, MD, PhD, of the Icahn School of Medicine at Mount Sinai, New York, and his colleagues published their findings in JAMA Surgery.

“Our study represents a solid confirmation that [hepatocellular carcinoma] patients effectively downstaged to Milan criteria have an outstanding median survival of 10 years, thus providing the rationale to adopt this policy on a global basis,” said Dr. Llovet in a press release from Mount Sinai.

This retrospective cohort study analyzed data from 2,645 adults who underwent liver transplantation for hepatocellular carcinoma at five different centers between January 2001 and December 2015. There were 341 patients whose disease was downstaged to within the Milan criteria, 2,122 whose disease was always within the Milan criteria, and 182 patients whose disease was not downstaged. Researchers looked at several outcomes, including the difference in overall survival, the time to recurrence, and recurrence-free survival among the various groups.

The 10-year survival rate after liver transplantation was 52.1% in those whose disease was downstaged compared with 61.5% in those whose disease was always within the Milan criteria and 43.3% in those whose disease was not downstaged. The 10-year recurrence rates were 20.6%, 13.3%, and 41.1% in the three groups, respectively. Some of the factors associated with the failure of downstaging included tumor size larger than 7 cm at diagnosis (odds ratio [OR] = 2.62, P = .02) and having more than three tumors at the time of diagnosis (OR = 2.34, P = .01). Patients with recurrent hepatocellular carcinoma who were treated with surgery had improved 5-year survival rates when compared with patients who did not have surgery (31.6% vs. 7.3%, P < .001).

Disclosure: For a full list of authors’ disclosures, visit

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