TABLE 2.

UNOS Down‐Staging Criteria

Inclusion Criteria

HCC exceeding Milan criteria but meeting one of the following: Single lesion 5.1‐8 cm 2‐3 lesions each ≤ 5 cm with the sum of the maximal tumor diameters ≤ 8 cm 4‐5 lesions each ≤ 3 cm with the sum of the maximal tumor diameters ≤ 8 cm Plus absence of vascular invasion or extrahepatic disease based on cross‐sectional imaging

Criteria for Successful Down‐Staging

Residual tumor size and diameter within Milan criteria (1 lesion ≤ 5 cm, 2‐3 lesions ≤ 3 cm) Only viable tumor(s) are considered; tumor diameter measurements should not include the area of necrosis from tumor‐directed therapy If there is more than one area of residual tumor enhancement, then the diameter of the entire lesion should be counted toward the overall tumor burden

Criteria for Down‐Staging Failure and Exclusion From LT

Progression of tumor(s) to beyond inclusion/eligibility criteria for down‐staging (as defined earlier) Tumor invasion of a major hepatic vessel based on cross‐sectional imaging Lymph node involvement by tumor or extrahepatic spread of tumor Infiltrative tumor growth pattern Per current UNOS policy, if AFP ≥ 1000 ng/mL, then transplant cannot be undertaken unless AFP level decreases to <500 ng/mL with LRT

Timing of LT in Relation to Down‐Staging

There should be a minimum observation period of 3 months of disease stability from successful down‐staging to LT Per current UNOS policy, patient must remain within Milan criteria for 6 months after successful down‐staging before receiving MELD exception points