Abstract
Introduction: Current practice to only prioritize hepatocellular carcinoma (HCC) that fulfill the Milan criteria (IN<sub>MC</sub>) is changing, since it causes the exclusion of patients who could benefit from liver transplantation. To select patients outside MC (OUT<sub>MC</sub>) for transplantation, we implemented extended selection criteria without up-front morphometric restrictions containing surrogate parameters of tumor biology. Methods: OUT<sub>MC</sub> patients were considered without restrictions of morphometrics and received locoregional treatment after interdisciplinary consultation. Our dynamic selection criteria for OUT<sub>MC</sub> patients required (IN<sub>MUC</sub>): (1) treatment response over (2) at least 6 months and (3) alpha-fetoprotein ≤400 ng/mL over the entire evaluation period. Patients with IN<sub>MC</sub> tumors served as control and internal validation cohort. Results: 31 of 170 liver transplant candidates were OUT<sub>MC</sub>. Of these, 8 dropped out. The remaining 23 patients met the selection criteria and underwent transplantation. Recurrence-free survival was higher in patients transplanted IN<sub>MC</sub> compared to those OUT<sub>MC</sub> IN<sub>MUC</sub> (92.2% vs. 70.8%; p = 0.026) after 5 years of follow-up. Overall survival showed no significant difference (p = 0.552). With dynamic selection of transplant candidates, recurrence could also be predicted for the IN<sub>MC</sub> patients as internal validation cohort (c-index: 0.896; CI 0.588–0.981, p = 0.005). Conclusion: Dynamic selection criteria for the stratification of patients with OUT<sub>MC</sub> HCCs is feasible and allows for excellent long-term results and acceptable tumor recurrence rates comparable to IN<sub>MC</sub> patients.
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