Aim: Liver transplantation (LT) for hepatocellular carcinoma (HCC)beyond the Milan criteria is still controversial. We investigated whether a policy of selective tumor down staging (DS) and patient prioritization based on clinical predictors might help improve the results of LT for non-Milan patients. Materials and methods: In January 1997 we set up a prospective trial on LT ± tumor down staging for consenting, adult patients affected with nodular-type HCC. Patients were down staged with either TACE, PEI, and/or RFA in the presence of: centrally-sited nodule(s), alpha-feto-protein serum levels ≥ 200 ng/ml, tumor grading ≥ G3, wait list times ≥ 3 months, and ineffective down staging while on wait list. Within the same UNOS status category patients were prioritized as follows: HCC > non-HCC; outside Milan > within Milan; centrally-sited > peripheral nodule(s), serum AFP levels, time on wait list, and ineffective > effective DS. Objective measures were: total patients enrolled; drop out rate; transplant rate; post-transplant recurrence rate, overall and disease-free survival rates. Data were analyzed within one year of last enrolment on an intent-to-treat basis. Results: Until October 2004 a total of 198 patients (125 Milan; 73 non-Milan) were enrolled in the current trial and 161 (81.3%) were transplanted at a median of 139 days within wait listing (112 Milan; 49 non-Milan). One, 5, and 8-year patients’ survival rates (Kaplan-Meier) were 88.6%, 82.7%, and 74.5%, respectively. When censoring for unrelated deaths, 1, 5 and 8-year survival rates were 98.9%, 89.3%, and 89.3% in Milan patients versus 95.6%, 85.9% and 85.9% in non-Milan patients (Cox regression p = 0.4). One, 5, and 8-year disease-free survival rates were 97%, 87.5%, and 87.5% in Milan patients versus 90.7%, 67%, and 67% in non-Milan patients (Cox regression p = 0.02). Conclusions: A policy of tumor down staging in association with patient prioritization based on clinical predictors may provide favorable results for HCC patients beyond the Milan criteria.
Liver transplantation for non-Milan HCC patients
De Simone P;Filipponi F
2006-01-01
Abstract
Aim: Liver transplantation (LT) for hepatocellular carcinoma (HCC)beyond the Milan criteria is still controversial. We investigated whether a policy of selective tumor down staging (DS) and patient prioritization based on clinical predictors might help improve the results of LT for non-Milan patients. Materials and methods: In January 1997 we set up a prospective trial on LT ± tumor down staging for consenting, adult patients affected with nodular-type HCC. Patients were down staged with either TACE, PEI, and/or RFA in the presence of: centrally-sited nodule(s), alpha-feto-protein serum levels ≥ 200 ng/ml, tumor grading ≥ G3, wait list times ≥ 3 months, and ineffective down staging while on wait list. Within the same UNOS status category patients were prioritized as follows: HCC > non-HCC; outside Milan > within Milan; centrally-sited > peripheral nodule(s), serum AFP levels, time on wait list, and ineffective > effective DS. Objective measures were: total patients enrolled; drop out rate; transplant rate; post-transplant recurrence rate, overall and disease-free survival rates. Data were analyzed within one year of last enrolment on an intent-to-treat basis. Results: Until October 2004 a total of 198 patients (125 Milan; 73 non-Milan) were enrolled in the current trial and 161 (81.3%) were transplanted at a median of 139 days within wait listing (112 Milan; 49 non-Milan). One, 5, and 8-year patients’ survival rates (Kaplan-Meier) were 88.6%, 82.7%, and 74.5%, respectively. When censoring for unrelated deaths, 1, 5 and 8-year survival rates were 98.9%, 89.3%, and 89.3% in Milan patients versus 95.6%, 85.9% and 85.9% in non-Milan patients (Cox regression p = 0.4). One, 5, and 8-year disease-free survival rates were 97%, 87.5%, and 87.5% in Milan patients versus 90.7%, 67%, and 67% in non-Milan patients (Cox regression p = 0.02). Conclusions: A policy of tumor down staging in association with patient prioritization based on clinical predictors may provide favorable results for HCC patients beyond the Milan criteria.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
