The Bottom Line: The criteria for eligibility for transplantation were the presence of a tumor 5 cm or less in diameter in patients with single hepatocellular carcinomas (HCC) and no more than three tumor nodules, each 3 cm or less in diameter, in patients with multiple tumors.
References: Mazzaferro V., et al. “Liver transplantation for the treatment of small hepatocellular carcinomas in patients with cirrhosis.” New England Journal of Medicine 1996 Mar 14; 334(11): 693-699.
Mazzaferro V., et al. “Milan criteria in liver transplantation for hepatocellular carcinoma: An evidence-based analysis of 15 years of experience.” Liver Transplantation 2011 Oct; 17 (Suppl 2): S44-S57 .
Summary: The original prospective cohort study simply concluded that “liver transplantation is an effective treatment for small, unresectable hepatocellular carcinomas in patients with cirrhosis” (1996, p.693). Named for its origin in Milan, Italy, the Milan criteria (MC) have since become a standard practice of care in treatment of patients with HCC. Ever since their adoption in clinical practice, the MC have helped doctors to single out early-stage HCC as a prognostic category of cancer presentation that is amenable to curative treatments. After their implementation, the favorable posttransplant outcomes that were observed in cohort series were so convincing that the MC immediately became the standard of care for early HCC, and further validation by randomized controlled trials (RCTs) was prevented.