TABLE 3.
Study | Design | Patients Within the Milan Criteria/Total Patients (n/N) | Follow-Up | Model Components | Proposed Model | Main Results | Level of Evidence* |
---|---|---|---|---|---|---|---|
Mazzaferro et al.29 (2009) | Multicenter, retrospective cohort | 1112/1556 | 53 months (median) | Largest size, number, and microvascular invasion | Up-to-7 criteria (largest size plus number) | 5-year overall survival: 71.2% (47.4% with microvascular invasion) | 2b/4 |
Chan et al.41 (2008) | Retrospective cohort with validation | Test cohort: —/116 Validation cohorts: 31 and 41 |
Test: 27 months Validation: 104 and 28 months (mean) |
Largest size (1 point), bilobar distribution (2 points), macrovascular invasion (3 points), and not well differentiated (−3 points) | PCRS | 5-year overall survival: 90% with PCRS ≤ 0, 65% with PCRS = 1 or 2, and 20% with PCRS ≥ 3 | 2b |
Parfitt et al.39 (2007) | Retrospective cohort | 50/75 | 8 years (mean) | Microvascular invasion, microsatellitosis, giant/bizarre cells, and largest size ≥ 3 cm | 3.5–4 points for each variable | Incidence of recurrence: <5% with 0–4 points, 40%–65% with 7–7.5 points, and >95% with 10.5–14.5 points | 2b/4 |
Iwatsuki et al.37 (2000) | Retrospective cohort | —/344 | 91 months (mean) | Bilobar distribution, largest size (>2 or 5 cm), and microvascular/ macrovascular invasion | Prognostic risk score (3.1–15.0 points for each variable) | 5-year disease-free survival: 100% with <7.5 points, 61% with ≤11.0 points, 40% with <15.0 points, and 5% with ≥15.0 points | 2b/4 |
Evidence level 2b is based on clinical decision rules (scoring systems), and evidence level 4 is based on a retrospective study of populations.