title: Utility-based criteria for selecting patients with hepatocellular carcinoma for liver transplantation: A multicenter cohort study using the alpha-fetoprotein model as a survival predictor.
abstract: The lifetime utility of liver transplantation (LT) in patients with hepatocellular carcinoma (HCC) is still controversial. The aim of this study was to ascertain when LT is cost-effective for HCC patients, with a view to proposing new transplant selection criteria. The study involved a real cohort of potentially transplantable Italian HCC patients (n = 2419 selected from the Italian Liver Cancer group database) who received nontransplant therapies. A non-LT survival analysis was conducted, the direct costs of therapies were calculated, and a Markov model was used to compute the cost utility of LT over non-LT therapies in Italian and US cost scenarios. Post-LT survival was calculated using the alpha-fetoprotein (AFP) model on the basis of AFP values and radiological size and number of nodules. The primary endpoint was the net health benefit (NHB), defined as LT survival benefit in quality-adjusted life years minus incremental costs (US $)/willingness to pay. The calculated median cost of non-LT therapies per patient was US $53,042 in Italy and US $62,827 in the United States. On Monte Carlo simulation, the NHB of LT was always positive for AFP model values ≤ 3 and always negative for values > 7 in both countries. A multivariate model showed that nontumor variables (patient's age, Child-Turcotte-Pugh [CTP] class, and alternative therapies) had the potential to shift the AFP model threshold of LT cost-ineffectiveness from 3 to 7. LT proved always cost-effective for HCC patients with AFP model values ≤ 3, whereas the cost-ineffectiveness threshold ranged between 3 and 7 using nontumor variables.
authors.affiliation: Dipartimento di Chirurgia Generale e Trapianto d'Organo, Unità di Chirurgia Epatobiliare e Trapianti Epatici, Università di Padova, Padova, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Vitale
authors.affiliation: Divisione di Gastroenterologia, Azienda Università di Padova, Padova, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Farinati
authors.affiliation: Divisione di Gastroenterologia, Azienda Università di Padova, Padova, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Burra
authors.affiliation: Unità di Semeiotica Medica, Dipartimento di Scienze Mediche e Chirurgiche, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Trevisani
authors.affiliation: Dipartimento di Medicina, Dipartimento di Scienze Mediche e Chirurgiche, Alma Mater Studiorum, Università di Bologna, Bologna, Italy.
authors.forename: Edoardo G
authors.initials: EG
authors.lastname: Giannini
authors.affiliation: Divisione di Chirurgia, Policlinico San Marco, Zingonia, Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Ciccarese
authors.affiliation: Divisione di Chirurgia, Policlinico San Marco, Zingonia, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Piscaglia
authors.affiliation: Unità di Medicina Interna e Gastroenterologia, Complesso Integrato Columbus, Università Cattolica di Roma, Roma, Italy.
authors.forename: Gian Lodovico
authors.initials: GL
authors.lastname: Rapaccini
authors.affiliation: Divisione di Medicina, Azienda Ospedaliera Bolognini, Seriate, Italy.
authors.forename: Mariella
authors.initials: M
authors.lastname: Di Marco
authors.affiliation: Unità Operativa di Gastroenterologia, Ospedale Belcolle, Viterbo, Italy.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Caturelli
authors.affiliation: Divisione di Chirurgia, Policlinico San Marco, Zingonia, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Zoli
authors.affiliation: Dipartimento di Medicina, Unità di Radiologia, Ospedale Fatebenefratelli, Milano, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Borzio
authors.affiliation: Dipartimento Biomedico di Medicina Interna e Specialistica, Unità di Gastroenterologia, Università di Palermo, Palermo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cabibbo
authors.affiliation: Ospedale Regionale di Bolzano, Unità di Gastroenterologia, Bolzano, Italy.
authors.forename: Martina
authors.initials: M
authors.lastname: Felder
authors.affiliation: Unità Operativa Gastroenterologia e Malattie del Ricambio, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Sacco
authors.affiliation: Dipartimento di Medicina Clinica e Chirurgia, Unità di Gastroenterologia, Università di Napoli Federico II, Napoli, Italy.
authors.forename: Filomena
authors.initials: F
authors.lastname: Morisco
authors.affiliation: Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero, Universitaria di Parma, Parma, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Missale
authors.affiliation: Dipartimento di Medicina Interna, Ospedale per gli Infermi di Faenza, Faenza, Italy.
authors.forename: Francesco Giuseppe
authors.initials: FG
authors.lastname: Foschi
authors.affiliation: Unità di Medicina Interna e Gastroenterologia, Policlinico Gemelli, Università Cattolica di Roma, Roma, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Gasbarrini
authors.affiliation: Clinica di Gastroenterologia, Università Politecnica delle Marche, Ancona, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Svegliati Baroni
authors.affiliation: Dipartimento Biomedico di Medicina Interna e Specialistica, Unità di Medicina Interna 2, Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Virdone
authors.affiliation: Unità di Gastroenterologia, Ospedale Sacro Cuore Don Calabria, Negrar, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Chiaramonte
authors.affiliation: Dipartimento di Chirurgia Generale e Trapianto d'Organo, Unità di Chirurgia Epatobiliare e Trapianti Epatici, Università di Padova, Padova, Italy.
authors.forename: Gaya
authors.initials: G
authors.lastname: Spolverato
authors.affiliation: Dipartimento di Chirurgia Generale e Trapianto d'Organo, Unità di Chirurgia Epatobiliare e Trapianti Epatici, Università di Padova, Padova, Italy.
authors.forename: Umberto
authors.initials: U
authors.lastname: Cillo
mesh_terms: D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000097:blood* / Q000191:economics / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D003362:Cost-Benefit Analysis; D016208:Databases, Factual; D003661:Decision Support Techniques; D005260:Female; D017048:Health Care Costs; D006801:Humans; D007558:Italy; D008113:Liver Neoplasms / Q000097:blood* / Q000191:economics / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D016031:Liver Transplantation / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D018803:Models, Economic; D009010:Monte Carlo Method; D015999:Multivariate Analysis; D018579:Patient Selection; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D019057:Quality-Adjusted Life Years; D012189:Retrospective Studies; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden; D014481:United States; D000509:alpha-Fetoproteins / Q000032:analysis*
chemical_list: C097353:AFP protein, human; D000509:alpha-Fetoproteins