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Downstaging of hepatocellular cancer before liver transplant: long-term outcome compared to tumors within Milan criteria.

ABSTRACT: We report on the long-term intention-to-treat (ITT) outcome of 118 patients with hepatocellular carcinoma (HCC) undergoing downstaging to within Milan/United Network for Organ Sharing T2 criteria before liver transplantation (LT) since 2002 and compare the results with 488 patients listed for LT with HCC meeting T2 criteria at listing in the same period. The downstaging subgroups include 1 lesion >5 and ?8 cm (n?=?43), 2 or 3 lesions at least one >3 and ?5 cm with total tumor diameter ?8 cm (n?=?61), or 4-5 lesions each ?3 cm with total tumor diameter ?8 cm (n?=?14). In the downstaging group, 64 patients (54.2%) had received LT and 5 (7.5%) developed HCC recurrence. Two of the five patients with HCC recurrence had 4-5 tumors at presentation. The 1- and 2-year cumulative probabilities for dropout (competing risk) were 24.1% and 34.2% in the downstaging group versus 20.3% and 25.6% in the T2 group (P?=?0.04). Kaplan-Meier's 5-year post-transplant survival and recurrence-free probabilities were 77.8% and 90.8%, respectively, in the downstaging group versus 81% and 88%, respectively, in the T2 group (P?=?0.69 and P?=?0.66, respectively). The 5-year ITT survival was 56.1% in the downstaging group versus 63.3% in the T2 group (P?=?0.29). Factors predicting dropout in the downstaging group included pretreatment alpha-fetoprotein ?1,000 ng/mL (multivariate hazard ratio [HR]: 2.42; P?=?0.02) and Child's B versus Child's A cirrhosis (multivariate HR: 2.19; P?=?0.04).Successful downstaging of HCC to within T2 criteria was associated with a low rate of HCC recurrence and excellent post-transplant survival, comparable to those meeting T2 criteria without downstaging. Owing to the small number of patients with 4-5 tumors, further investigations are needed to confirm the efficacy of downstaging in this subgroup.

SUBMITTER: Yao FY

PROVIDER: S-EPMC4809192 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

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Downstaging of hepatocellular cancer before liver transplant: long-term outcome compared to tumors within Milan criteria.

Yao Francis Y FY Mehta Neil N Flemming Jennifer J Dodge Jennifer J Hameed Bilal B Fix Oren O Hirose Ryutaro R Fidelman Nicholas N Kerlan Robert K RK Roberts John P JP

Hepatology (Baltimore, Md.) 20150320 6

<h4>Unlabelled</h4>We report on the long-term intention-to-treat (ITT) outcome of 118 patients with hepatocellular carcinoma (HCC) undergoing downstaging to within Milan/United Network for Organ Sharing T2 criteria before liver transplantation (LT) since 2002 and compare the results with 488 patients listed for LT with HCC meeting T2 criteria at listing in the same period. The downstaging subgroups include 1 lesion >5 and ≤8 cm (n = 43), 2 or 3 lesions at least one >3 and ≤5 cm with total tumor ...[more]

PMID: 25689978

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Project description:Background & aimsGood outcomes after liver transplantation (LT) have been reported after successfully downstaging to Milan criteria in more advanced hepatocellular carcinoma (HCC). We aimed to compare post-LT outcomes in patients receiving locoregional therapies (LRT) before LT according to Milan criteria and University of California San Francisco downstaging (UCSF-DS) protocol and 'all-comers'.MethodsThis multicentre cohort study included patients who received any LRT before LT from Europe and Latin America (2000-2018). We excluded patients with alpha-foetoprotein (AFP) above 1,000 ng/ml. Competing risk regression analysis for HCC recurrence was conducted, estimating subdistribution hazard ratios (SHRs) and corresponding 95% CIs.ResultsFrom 2,441 LT patients, 70.1% received LRT before LT (n = 1,711). Of these, 80.6% were within Milan, 12.0% within UCSF-DS, and 7.4% all-comers. Successful downstaging was achieved in 45.2% (CI 34.8-55.8) and 38.2% (CI 25.4-52.3) of the UCSF-DS group and all-comers, respectively. The risk of recurrence was higher for all-comers (SHR 6.01 [p <0.0001]) and not significantly higher for the UCSF-DS group (SHR 1.60 [p = 0.32]), compared with patients remaining within Milan. The all-comers presented more frequent features of aggressive HCC and higher tumour burden at explant. Among the UCSF-DS group, an AFP value of ≤20 ng/ml at listing was associated with lower recurrence (SHR 2.01 [p = 0.006]) and better survival. However, recurrence was still significantly high irrespective of AFP ≤20 ng/ml in all-comers.ConclusionsPatients within the UCSF-DS protocol at listing have similar post-transplant outcomes compared with those within Milan when successfully downstaged. Meanwhile, all-comers have a higher recurrence and inferior survival irrespective of response to LRT. Additionally, in the UCSF-DS group, an ALP of ≤20 ng/ml might be a novel tool to optimise selection of candidates for LT.Clinical trial numberThis study was registered as part of an open public registry (NCT03775863).Lay summaryPatients with more extended HCC (within the UCSF-DS protocol) successfully downstaged to the conventional Milan criteria do not have a higher recurrence rate after LT compared with the group remaining in the Milan criteria from listing to transplantation. Moreover, in the UCSF-DS patient group, an ALP value equal to or below 20 ng/ml at listing might be a novel tool to further optimise selection of candidates for LT.

Project description:BackgroundIntrahepatic distant recurrence (IDR) is a significant problem for patients who have undergone radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC). The objective of the study was to investigate risk factors and to predict outcomes of recurrent IDR within Milan criteria after complete RFA for primary early-stage HCC.MethodThis retrospective study reviewed 449 patients with intrahepatic distant recurrent HCC after complete RFA for early-stage HCC. After excluding 100 patients who were beyond Milan criteria, with incomplete lab data, or had follow-up less than three months, a total of 349 patient cases were compiled and their baseline characteristics, further treatment modalities after tumor recurrence and survival were analyzed.ResultsAfter a median follow-up of 36.2 months, 92 patients had expired. The majority of patients were male (59.9%) with a median age of 64.3 years (range:38-88). The cumulative 5-year overall survival (OS) rates after treatment for recurrent HCC was 67.2%. On multivariate analysis, end-stage renal disease(Hazard ratio (H.R.) = 2.33, p = 0.021), m-ALBI grade 2a (H.R. = 2.86, p = 0.003) and m-ALBI grades 2b or 3 (H.R. = 2.30, p = 0.009), APRI greater than 1 (H.R. = 1.92, p = 0.036) and 2nd recurrence occurring within 1 year (H.R. = 2.69, p<0.001) were significantly associated with worse survival. The cumulative 5-year 2nd recurrence rate was 87.4%. On multivariate analysis, male gender (H.R. = 1.47, p = 0.01), age greater than 65 years (H.R. = 1.72, p<0.001), an alpha fetoprotein level greater than 20ng/ml (H.R. = 1.41, p = 0.016), surgical treatment for recurrent HCC (H.R. = 0.25, p = 0.007), tumor number greater than 1 (H.R. = 1.35, p = 0.046), and IDR developing within 2 years (H.R. = 1.67, p = 0.001) were prognostic factors for 2nd recurrence.ConclusionOur study suggested that presence of end-stage renal disease, m-ALBI grades 2 and 3, APRI >1 and time to 2nd HCC recurrence were all associated with overall survival while the 2nd HCC recurrence was associated with male gender, age ≥65 years, α-fetoprotein level >20 ng/mL, non-surgical therapy, time to IDR, and tumor number> 1.

Dataset Information

Downstaging of hepatocellular cancer before liver transplant: long-term outcome compared to tumors within Milan criteria.

Publications

Downstaging of hepatocellular cancer before liver transplant: long-term outcome compared to tumors within Milan criteria.

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