# Liver transplantation for small hepatocellular carcinomas in patients with cirrhosis (the Milan criteria)

Source: https://onco.cc/key-papers/paper-mazzaferro-milan-criteria-nejm-1996/  
OnCo record `paper-mazzaferro-milan-criteria-nejm-1996` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

This study showed that liver transplantation cures most patients with cirrhosis whose liver cancer is limited to one tumour up to 5 cm or up to three tumours each up to 3 cm, the Milan criteria that have governed transplant selection ever since.

## Summary

Prospective cohort of 48 patients with cirrhosis and unresectable hepatocellular carcinoma meeting size criteria (single tumour 5 cm or less, or up to three tumours each 3 cm or less) who underwent liver transplantation.

Four-year overall survival was 75 percent and recurrence-free survival 83 percent, with 85 percent overall survival among the 35 patients whose explants confirmed the criteria, compared with poor historical results in unselected patients.

## Fields

- Kind: Key paper
- Last checked: 2026-09-17
- Journal: New England Journal of Medicine
- Year: 1996
- DOI: 10.1056/NEJM199603143341104
- Authors: Mazzaferro V, Regalia E, Doci R, et al.
- Findings: Four-year overall survival 75 percent; recurrence-free survival 83 percent.; 85 percent four-year survival when explant pathology confirmed the criteria.
- What it means: The Milan criteria remain the global standard for transplant eligibility in hepatocellular carcinoma, with downstaging protocols extending access to patients just outside them.
- Caveats: Small single-centre series; expanded criteria (UCSF, up-to-seven) have since been proposed.

## Sources

- N Engl J Med 1996: https://doi.org/10.1056/NEJM199603143341104
- PubMed: https://pubmed.ncbi.nlm.nih.gov/8594428/

## Connected records

- cancers: [Early hepatocellular carcinoma (BCLC 0 and A)](https://onco.cc/cancers/hcc-early/)
- journals: [New England Journal of Medicine](https://onco.cc/journals/nejm/)

---
JSON: https://onco.cc/api/v1/entities/paper-mazzaferro-milan-criteria-nejm-1996.json