Orthotopic liver transplantation (OLT) indication for hepatocellular carcinoma (HCC) is currently based on the Milan criteria. The University of California, San Francisco (UCSF) group recently proposed an expansion of the selection criteria according to tumors characteristics on the explanted liver. This study: 1) assessed the validity of these criteria in an independent large series and 2) tested for the usefulness of these criteria when applied to pre-OLT tumor evaluation. Between 1985 and 1998, 479 patients were listed for liver transplantation (LT) for HCC and 467 were transplanted. According to pre-OLT (imaging at date of listing) or post-OLT (explanted liver) tumor characteristics, patients were retrospectively classified according to both the Milan and UCSF criteria. The 5-yr survival statistics were assessed by the Kaplan-Meier method and compared by the log-rank test. Pre-OLT UCSF criteria were analyzed according to an intention-to-treat principle. Based on the pre-OLT evaluation, 279 patients were Milanϩ, 44 patients were UCSFϩ but MilanϪ (subgroup of patients that might benefit from the expansion), and 145 patients were UCSFϪ and MilanϪ. With a short median waiting time of 4 months, 5-yr survival was 60.1 Ϯ 3.0%, 45.6 Ϯ 7.8%, and 34.7 Ϯ 4.0%, respectively (P Ͻ 0.001). The 5-yr survival was arithmetically lower in UCSFϩ MilanϪ patients compared to Milanϩ but this difference was not significant (P ϭ 0.10). Based on pathological features of the explanted liver, 5-yr survival was 70.4 Ϯ 3.4%, 63.6 Ϯ 7.8%, and 34.1 Ϯ 3.1%, in Milanϩ patients (n ϭ 184), UCSFϩ MilanϪ patients (n ϭ 39), and UCSFϪ MilanϪ patients (n ϭ 238), respectively (P Ͻ 0.001). However, the 5-yr survival did not differ between Milanϩ and UCSFϩ MilanϪ patients (P ϭ 0.33). In conclusion, these results show that when applied to pre-OLT evaluation, the UCSF criteria are associated with a 5-yr survival below 50%. Their applicability is therefore limited, despite similar survival rates compared to the Milan criteria, when the explanted liver is taken into account.

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