Lai, Q; Vitale, A; Iesari, S; Finkenstedt, A; Mennini, G; Onali, S; Hoppe-Lotichius, M; ... European Hepatocellular Cancer Liver Transplant Study Group, .; + view all Lai, Q; Vitale, A; Iesari, S; Finkenstedt, A; Mennini, G; Onali, S; Hoppe-Lotichius, M; Manzia, TM; Nicolini, D; Avolio, AW; Mrzljak, A; Kocman, B; Agnes, S; Vivarelli, M; Tisone, G; Otto, G; Tsochatzis, E; Rossi, M; Viveiros, A; Ciccarelli, O; Cillo, U; Lerut, J; European Hepatocellular Cancer Liver Transplant Study Group, .; - view fewer (2019) The intention‐to‐treat effect of bridging treatments in the setting of Milan Criteria‐IN patients waiting for liver transplantation. Liver Transplantation , 25 (7) pp. 1022-1033. 10.1002/lt.25492.

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Abstract

In patients with hepatocellular cancer (HCC) meeting the Milan Criteria (MC), the benefit of loco-regional treatments (LRT) in the context of liver transplantation (LT) is still debated. Initial biases in the selection between treated and untreated patients have yielded conflicting reported results. The study aimed to identify, using a competing-risk analysis, risk factors for HCC-dependent LT failure, defined as pre-transplant tumor-related de-listing or post-transplant recurrence. The study was registered at http://www.ClinicalTrials.gov (ID:NCT03723304). In order to offset the initial limitations of the investigated population, an inverse probability of treatment weighting (IPTW) analysis was used: 1,083 MC-IN cases (no-LRT=182; LRT=901) were balanced using eight variables: age, gender, MELD value, HCV status, HBV status, largest lesion diameter, number of nodules, and alpha-fetoprotein (AFP). All the covariates were available at the first referral. After the IPTW, a pseudo-population of 2,019 patients listed for LT was analyzed, comparing two homogeneous groups of untreated (N=1,077) and LRT-treated (N=942) patients. Tumor progression after LRT was the most important independent risk factor for HCC-dependent failure (sub-hazard ratio=5.62; p<0.001). Other independent risk factors were major tumor diameter, AFP, MELD, patient age, male gender and period of waiting-list registration. One single LRT was protective compared with no treatment (SHR=0.51; p<0.001). The positive effect was still observed when two to three treatments were performed (SHR=0.66; p=0.02), but it was lost in case of four or more LRT (SHR=0.80; p=0.27). CONCLUSION: In MC-IN patients, up to three LRT are beneficial about intention-to-treat LT success, with a 49 to 34% reduction in failure risk compared to untreated patients. This benefit is lost if more LRT are required. Poor response to LRT is associated with a higher risk for HCC-dependent transplant failure. This article is protected by copyright. All rights reserved.

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