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1. Neoangiogenesis-related genes are hallmarks of fast-growing hepatocellular carcinomas and worst survival. Results from a prospective study

Author

Mariagrazia Del Buono, Paola Loria, Teresa Pollicino, Stefano Colopi, Elena Bertolini, Guido Marzocchi, Stefano Ballestri, Cristian Caporali, Calogero Cammà, Barbara Lei, Aimilia Karampatou, Gianluigi Giannelli, Fabiola Milosa, Erica Villa, Giuseppe Cabibbo, Marco Enea, Elena Turola, Rosina Maria Critelli, Umberto Cillo, Giorgio Enrico Gerunda, Patrizia Pontisso, Nicola De Maria, María L. Martínez-Chantar, Paola Todesca, Luisa Losi, Livia Maccio, Filippo Schepis, Villa E., Critelli R., Lei B., Marzocchi G., Camma C., Giannelli G., Pontisso P., Cabibbo G., Enea M., Colopi S., Caporali C., Pollicino T., Milosa F., Karampatou A., Todesca P., Bertolini E., Maccio L., Martinez-Chantar M.L., Turola E., Dal Buono M., De Maria N., Ballestri S., Schepis F., Loria P., Gerunda G.E., Losi L., and Cillo U.

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, Time Factors, Carcinoma, Hepatocellular, Time Factor, Microarray, Hepatocellular carcinoma, molecular carcinogenesis, Gastroenterology, liver imaging, HEPATOCELLULAR CARCINOMA, LIVER IMAGING, MOLECULAR CARCINOGENESIS, MOLECULAR ONCOLOGY, Aged, Aged, 80 and over, Disease Progression, Female, Humans, Liver Neoplasms, Middle Aged, Neovascularization, Pathologic, Prospective Studies, Survival Rate, Tumor Burden, Medicine (all), 03 medical and health sciences, molecular oncology, 0302 clinical medicine, Hepatocellular carcinoma, liver imaging, molecular carcinogenesis, molecular oncology, Internal medicine, medicine, Carcinoma, Doubling time, Prospective cohort study, Survival rate, business.industry, Proportional hazards model, medicine.disease, Prospective Studie, 030104 developmental biology, Quartile, Liver Neoplasm, 030220 oncology & carcinogenesis, business, Human
Abstract

Objective The biological heterogeneity of hepatocellular carcinoma (HCC) makes prognosis difficult. We translate the results of a genome-wide high-throughput analysis into a tool that accurately predicts at presentation tumour growth and survival of patients with HCC.Design Ultrasound surveillance identified HCC in 78 (training set) and 54 (validation set) consecutive patients with cirrhosis. Patients underwent two CT scans 6 weeks apart (no treatment in-between) to determine tumour volumes (V-0 and V-1) and calculate HCC doubling time. Baseline-paired HCC and surrounding tissue biopsies for microarray study (Agilent Whole Human Genome Oligo Microarrays) were also obtained. Predictors of survival were assessed by multivariate Cox model.Results Calculated tumour doubling times ranged from 30 to 621 days (mean, 107 +/- 91 days; median, 83 days) and were divided into quartiles: = 111 days (n= 19). Median survival according to doubling time was significantly lower for the first quartile versus the others (11 vs 41 months, 42, and 47 months, respectively) (p< 0.0001). A five-gene transcriptomic hepatic signature including angiopoietin-2 (ANGPT2), delta-like ligand 4 (DLL4), neuropilin (NRP)/tolloid (TLL)-like 2 (NETO2), endothelial cell-specific molecule-1 (ESM1), and nuclear receptor subfamily 4, group A, member 1 (NR4A1) was found to accurately identify rapidly growing HCCs of the first quartile (ROC AUC: 0.961; 95% CI 0.919 to 1.000; p< 0.0001) and to be an independent factor for mortality (HR: 3.987; 95% CI 1.941 to 8.193, p< 0.0001).Conclusions The hepatic five-gene signature was able to predict HCC growth in individual patient and the consequent risk of death. This implies a role of this molecular tool in the future therapeutic management of patients with HCC.

Published
2015
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2. Treatment of hepatitis C recurrence is less successful in female than in male liver transplant recipients

Author

Giannelli, V, Giusto, M, Farcomeni, A, Ponziani, F, Pompili, M, Viganò, R, Iemmolo, R, Donato, M, Rendina, M, Toniutto, P, Pasulo, L, Morelli, M, De Martin, E, Miglioresi, L, DI PAOLO, D, Fagiuoli, S, Merli, M, Belli, L, Gerunda, G, Montalti, R, Di Benedetto, F, De Ruvo, N, Rigamonti, C, Colombo, M, Rossi, G, Fornasiere, E, Di Leo, A, Castellaneta, N, Lupo, L, Nemeo, V, Bringiotti, R, Zappimbulso, M, Vero, V, Colpani, M, Cescon, M, Bertuzzo, V, Pinna, A, Visco Comandini, U, Antonucci, G, Ettorre, G, Burra, P, Senzolo, M, Ginanni, C, Mennini, G, Rossi, M, Angelico, M, Tisone, G, Gasbarrini, A, Giannelli, V, Giusto, M, Farcomeni, A, Ponziani, F, Pompili, M, Viganò, R, Iemmolo, R, Donato, M, Rendina, M, Toniutto, P, Pasulo, L, Morelli, M, De Martin, E, Miglioresi, L, Di Paolo, D, Fagiuoli, S, Merli, M, Giannelli, Valerio, Giusto, Michela, Farcomeni, Alessio, Ponziani, Francesca R, Pompili, Maurizio, Viganò, Raffaella, Iemmolo, Rosa Maria, Donato, Maria F, Rendina, Maria, Toniutto, Pierluigi, Pasulo, Luisa, Morelli, Maria Cristina, De Martin, Eleonora, Miglioresi, Lucia, Di Paolo, Daniele, Fagiuoli, Stefano, Merli, Manuela, Montalti, Roberto, Giannelli V., Giusto M., Farcomeni A., Ponziani F.R., Pompili M., Viganò R., Iemmolo R.M., Donato M.F., Rendina M., Toniutto P., Pasulo L., Morelli M.C., De Martin E., Miglioresi L., Di Paolo D., Fagiuoli S., Merli M., Belli L., Gerunda G.E., Montalti R., Di Benedetto F., De Ruvo N., Rigamonti C., Colombo M., Rossi G., Fornasiere E., Di Leo A., Castellaneta N.M., Lupo L., Nemeo V., Bringiotti R., Zappimbulso M., Vero V., Colpani M., Cescon M., Bertuzzo V., Pinna A.D., Visco-Comandini U., Antonucci G., Ettorre G.M., Burra P., Senzolo M., Ginanni C.S., Mennini G., Rossi M., Angelico M., Tisone G., and Gasbarrini A.

Subjects
Adult, Male, antiviral treatment, Sex Factor, Hepacivirus, Polyethylene Glycol, Antiviral Agents, Settore MED/01 - Statistica Medica, Polyethylene Glycols, Sex Factors, INTERFERON THERAPY, Retrospective Studie, Recurrence, Ribavirin, gender, Humans, adherence, HCV, liver transplant, hepatitis c, Aged, Retrospective Studies, Antiviral Agent, Settore MED/12 - Gastroenterologia, Hepaciviru, liver transplantation, Settore MED/09 - MEDICINA INTERNA, HCV recurrence, liver transplantation, virus diseases, HEPATITIS C VIRUS, Interferon-alpha, Hepatitis C, Chronic, Middle Aged, Viral Load, hcv, hepatitis c virus, digestive system diseases, Liver Transplantation, Treatment Outcome, Patient Compliance, RNA, Viral, Female, HCV recurrence, Human
Abstract

It has been recently suggested that the risk of graft loss after liver transplantation (LT) may increase in female HCV patients. The aim of the study was to examine gender differences in HCV therapy tolerance and outcome in LT patients treated for HCV recurrence. A retrospective study was conducted on liver recipients with HCV recurrence, who were given antiviral therapy from 2001 to 2009 in 12 transplant centers in Italy. Sustained virological response (SVR), adherence-to-therapy, and side effects were evaluated. A multivariate logistic regression model was used after adjusting for possible confounders. The data regarding 342 treated patients were analyzed. SVR was reported in 38.8% of patients. At baseline, male and female did not differ in HCV viral load, histology, or rate of diabetes. SVR was lower in females than in males (29.5% vs. 42.1%; P=0.03). Adherence-to-therapy was also lower in females than in males 43.4% vs. 23.8%; P=0.001); anemia was the main reason for lower adherence. In a multivariate analysis in patients Genotype1, female gender (P

Published
2012

3. Balancing donor and recipient risk factors in liver transplantation: the value of D-MELD with particular reference to HCV recipients

Author

Avolio, A, Cillo, U, Salizzoni, M, DE CARLIS, LUCIANO GREGORIO, Colledan, M, Gerunda, G, Mazzaferro, V, Tisone, G, Romagnoli, R, Caccamo, L, Rossi, M, Vitale, A, Cucchetti, A, Lupo, L, Gruttadauria, S, Nicolotti, N, Burra, P, Gasbarrini, A, Agnes, S, Lirosi, M, Miele, L, Pompili, M, Siciliano, M, Perilli, V, Gaspari, R, Castagneto, M, Lupo, F, Tandoi, F, De Carlis, L, Mangoni, I, Belli, L, Pinna, A, Cescon, M, Gridelli, B, Li Petri, S, Volpes, R, Pinelli, D, Fagiuoli, S, Montalti, R, Regalia, E, Rossi, G, Antonelli, B, Berloco, P, Lai, Q, Risaliti, A, Nicolini, D, Valente, U, Gelli, M, Morelli, N, Zamboni, F, Tondolo, V, Ettorre, G, Vennarecci, G, Bresadola, F, Baccarani, U, Toniutto, P, Manzia, T, Anselmo, A, Angelico, M, Calise, F, Scuderi, V, Romano, M, Rendina, M, Barone, M, Cuomo, O, Perrella, A, Santaniello, W, Donataccio, M, Dalle Ore, G, De Ville De Goyet, J, Monti, L, De Waure, C., Avolio A.W., Cillo U., Salizzoni M., De Carlis L., Colledan M., Gerunda G.E., Mazzaferro V., Tisone G., Romagnoli R., Caccamo L., Rossi M., Vitale A., Cucchetti A., Lupo L., Gruttadauria S., Nicolotti N., Burra P., Gasbarrini A., Agnes S., Lirosi M.C., Miele L., Pompili M., Siciliano M., Perilli V., Gaspari R., Castagneto M., Tandoi F., Mangoni I., Belli L., Pinna A.D., Cescon M., Gridelli B., Li Petri S., Volpes R., Pinelli D., Fagiuoli S., Montalti R., Regalia E., Rossi G., Antonelli B., Berloco P., Lai Q., Risaliti A., Nicolini D., Valente U., Gelli M., Morelli N., Zamboni F., Tondolo V., Brotzu G., Ettorre G.M., Vennarecci G., Bresadola F., Baccarani U., Toniutto P.L., Manzia T., Anselmo A., Angelico M., Calise F., Scuderi V., Romano M., Rendina M., Barone M., Cuomo O., Perrella A., Santaniello W., Donataccio M., Dalle Ore G., de Ville de J., Monti L., Avolio, A W, Cillo, U, Salizzoni, M, De Carlis, L, Colledan, M, Gerunda, G E, Mazzaferro, Mariapia, Tisone, G, Romagnoli, R, Caccamo, L, Rossi, M, Vitale, A, Cucchetti, A, Lupo, L, Gruttadauria, S, Nicolotti, N, Burra, P, Gasbarrini, A, Agnes, S, Montalti, Roberto, Avolio, A, DE CARLIS, L, Gerunda, G, Mazzaferro, V, Lirosi, M, Miele, L, Pompili, M, Siciliano, M, Perilli, V, Gaspari, R, Castagneto, M, Lupo, F, Tandoi, F, Mangoni, I, Belli, L, Pinna, A, Cescon, M, Gridelli, B, Li Petri, S, Volpes, R, Pinelli, D, Fagiuoli, S, Montalti, R, Regalia, E, Rossi, G, Antonelli, B, Berloco, P, Lai, Q, Risaliti, A, Nicolini, D, Valente, U, Gelli, M, Morelli, N, Zamboni, F, Tondolo, V, Ettorre, G, Vennarecci, G, Bresadola, F, Baccarani, U, Toniutto, P, Manzia, T, Anselmo, A, Angelico, M, Calise, F, Scuderi, V, Romano, M, Rendina, M, Barone, M, Cuomo, O, Perrella, A, Santaniello, W, Donataccio, M, Dalle Ore, G, De Ville De Goyet, J, Monti, L, and De Waure, C

Subjects
Graft Rejection, Male, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, Hepacivirus, Liver transplantation, Gastroenterology, Liver disease, Postoperative Complications, Retrospective Studie, UNSUSTAINABLE MATCH, Models, Risk Factors, Immunology and Allergy, Health Status Indicators, Age Factor, PROGNOSTIC INDICES, Pharmacology (medical), Health Status Indicator, D-MELD, Liver Transplantation, liver transplantation, Hazard ratio, Graft Survival, donor-recipient match, outcome, prognosis, risk factors, Age Factors, Trapianto epatico, Hepatitis C, Hepatitis B, Statistical, Middle Aged, Prognosis, Tissue Donors, Survival Rate, Italy, HCV, Female, Human, Adult, medicine.medical_specialty, Prognosi, Donor Selection, End Stage Liver Disease, Young Adult, Internal medicine, medicine, Humans, fattori di rischio, Aged, Retrospective Studies, Transplantation, Hepaciviru, Models, Statistical, business.industry, Donor selection, Risk Factor, Settore MED/09 - MEDICINA INTERNA, Odds ratio, medicine.disease, Settore MED/18, Surgery, body regions, Postoperative Complication, business
Abstract

Donor-recipient match is a matter of debate in liver transplantation. D-MELD (donor age × recipient biochemical model for end-stage liver disease [MELD]) and other factors were analyzed on a national Italian database recording 5946 liver transplants. Primary endpoint was to determine factors predictive of 3-year patient survival. D-MELD cutoff predictive of 5-year patient survival 1628). At 3 years, the odds ratio (OR) for death was 2.03 (95% confidence interval [CI], 1.44-2.85) in D-MELD class C versus B. The OR was 0.40 (95% CI, 0.24-0.66) in class A versus class B. Other predictors were hepatitis C virus (HCV; OR = 1.42; 95% CI, 1.11-1.81), hepatitis B virus (HBV; OR = 0.69; 95% CI, 0.51-0.93), retransplant (OR = 1.82; 95% CI, 1.16-2.87) and low-volume center (OR = 1.48; 95% CI, 1.11-1.99). Cox regressions up to 90 months confirmed results. The hazard ratio was 1.97 (95% CI, 1.59-2.43) for D-MELD class C versus class B and 0.42 (95% CI, 0.29-0.60) for D-MELD class A versus class B. Recipient age, HCV, HBV and retransplant were also significant. The 5yrsPS

Published
2011

4. Long-term follow-up and outcome of liver transplantation from anti-hepatitis C virus-positive donors: A European multicentric case-control study

Author

Michele Valmasoni, Mario Spaggiari, Roberto Montalti, Roberto Ballarin, Nicola De Ruvo, Giorgio Enrico Gerunda, Nicola Cautero, Alessandro Cucchetti, Fabrizio Di Benedetto, Silvio Nadalin, Cristina Longo, Umberto Cillo, Antonio Daniele Pinna, Roberto Troisi, Patrizia Burra, Ballarin, R., Cucchetti, A., Spaggiari, M., Montalti, R., Di Benedetto, F., Nadalin, S., Troisi, R.I., Valmasoni, M., Longo, C., De Ruvo, N., Cautero, N., Cillo, U., Pinna, A.D., Burra, P., Gerunda, G.E., Ballarin, Roberto, Cucchetti, Alessandro, Spaggiari, Mario, Montalti, Roberto, Di Benedetto, Fabrizio, Nadalin, Silvio, Troisi, Roberto Ivan, Valmasoni, Michele, Longo, Cristina, De Ruvo, Nicola, Cautero, Nicola, Cillo, Umberto, Pinna, Antonio Daniele, Burra, Patrizia, and Gerunda, Giorgio Enrico

Subjects
Male, Graft outcome, Cirrhosis, Marginal graft, medicine.medical_treatment, Liver transplantation, medicine.disease_cause, Gastroenterology, Adult, Aged, Case-Control Studies, Female, Follow-Up Studies, Graft Survival, Hepatitis C Antibodies, blood, Humans, Liver Transplantation, mortality, Male, Middle Aged, RNA, Viral, analysis, Recurrence, Survival Rate, Tissue Donors, Treatment Outcome, Genotyping, Hepatitis C recurrence, Matched pair analysis, Viral hepatitis posttransplantation, Recurrence, education.field_of_study, medicine.diagnostic_test, Graft Survival, Hepatitis C, Middle Aged, Tissue Donors, Survival Rate, Treatment Outcome, Liver biopsy, RNA, Viral, Female, Case-Control Studie, Human, Adult, medicine.medical_specialty, Hepatitis C virus, Population, Follow-Up Studie, Internal medicine, medicine, Humans, education, Survival rate, Aged, Transplantation, business.industry, Hepatitis C Antibodies, medicine.disease, Surgery, Liver Transplantation, Case-Control Studies, business, Hepatitis C Antibodie, Follow-Up Studies
Abstract

Background. The growing prevalence of hepatitis C virus (HCV) infection in the general population has resulted in an increased frequency of potential organ donors that carry the virus. Given the significant disparity between organ supply and demand for transplantation, it becomes essential to consider whether livers from anti-HCV-positive donors may be considered suitable for transplantation. Methods. Based on a multicenter European database, 694 patients with HCV-related cirrhosis underwent liver transplantation and 11% of them received the graft from anti-HCV-positive donors. Of this group, we selected 63 patients (study group) and, after a 1:1 case-control approach, compared them with 63 patients that received an anti-HCV-negative donor graft (control group). Only grafts with preperfusion liver biopsy results with a fibrosis score of not more than 1 were used for transplantation. Results. Patients who received anti-HCV-positive grafts had a cumulative survival rate of 83.6% and 61.7% at 1 and 5 years, respectively, vs. 95.1% and 68.2% for the control group. In comparing overall patient and graft survival, there was no statistically significant difference between the two groups (P = 0.22 and 0.11). Recurrence of hepatitis C tended to be more rapid in the group of patients who received anti-HCV-positive grafts, although it did not reach statistical significance (P = 0.07). Conclusions. We do not recommend the indiscriminate use of anti-HCV-positive donors, especially if HCV-RNA positive, as the use of this kind of graft could be linked to an advanced stage of fibrosis, the main risk factor we observed for earlier hepatitis C recurrence.

Published
2011

5. Predicting survival after liver transplantation in patients with hepatocellular carcinoma beyond the Milan criteria: a retrospective, exploratory analysis

Author

Mazzaferro, V, Llovet, Jm, Miceli, R, Bhoori, S, Schiavo, M, Mariani, L, Camerini, T, Roayaie, S, Schwartz, Me, Grazi, Gl, Adam, R, Neuhaus, P, Salizzoni, M, Bruix, J, Forner, A, De Carlis, L, Cillo, U, Burroughs, Ak, Troisi, R, Rossi, M, Gerunda, Ge, Lerut, J, Belghiti, J, Boin, I, Gugenheim, J, Rochling, F, Van Hoek, B, Majno, P, Graziadei, I, Vogel, W, Lucidi, V, de Hemptinne, B, Leopardi, L, Cotsoglou, C, Iannelli, A, Staccini, A, Koenigsrainer, A, Steurer, W, Cautero, N, Risaliti, A, Lupo, L, Colledan, M, De Giorgio, M, Fagiuoli, S, Pinna, Ad, Ravaioli, M, Battiston, C, Coppa, J, Regalia, E, Romito, R, Giacomoni, A, Mangoni, J, Maggi, U, Rossi, G, Masetti, M, Montalti, R, Calise, F, Cuomo, O, Scuderi, E, Bridda, A, Vitale, A, Tisone, G, Berloco, P, Paraluppi, G, Patrono, D, Adani, Gl, Baccarani, U, Lorenzin, D, Zieniewicz, K, Ribeiro, V, Soderdahl, G, Giostra, E, Mentha, G, Morel, P, Marelli, L, Patch, D, Muiesan, P, Heaton, N, Schwartz, M, Rossaro, L, Khatri, V, Hsieh, Cb., Mazzaferro, V, Llovet, J, Miceli, R, Bhoori, S, Schiavo, M, Mariani, L, Camerini, T, Roayaie, S, Schwartz, M, Grazi, G, Adam, R, Neuhaus, P, Salizzoni, M, Bruix, J, Forner, A, De Carlis, L, Cillo, U, Burroughs, A, Troisi, R, Rossi, M, Gerunda, G, Lerut, J, Belghiti, J, Boin, I, Gugenheim, J, Rochling, F, Van Hoek, B, Majno, P, Colledan, M, Fagiuoli, S, Mazzaferro V., Llovet J.M., Miceli R., Bhoori S., Schiavo M., Mariani L., Camerini T., Roayaie S., Schwartz M.E., Grazi G.L., Adam R., Neuhaus P., Salizzoni M., Bruix J., Forner A., De Carlis L., Cillo U., Burroughs A.K., Troisi R., Rossi M., Gerunda G.E., Lerut J., Belghiti J., Boin I., Gugenheim J., Rochling F., Van Hoek B., Majno P., Graziadei I., Vogel W., Lucidi V., de Hemptinne B., Leopardi L., Cotsoglou C., Iannelli A., Staccini A., Koenigsrainer A., Steurer W., Cautero N., Risaliti A., Lupo L., Colledan M., De Giorgio M., Fagiuoli S., Pinna A.D., Ravaioli M., Battiston C., Coppa J., Regalia E., Romito R., Giacomoni A., Mangoni J., Maggi U., Rossi G., Masetti M., Montalti R., Calise F., Cuomo O., Scuderi E., Bridda A., Vitale A., Tisone G., Berloco P., Paraluppi G., Patrono D., Adani G.L., Baccarani U, Lorenzin D, Zieniewicz K, Ribeiro V, Soderdahl G., Giostra E., Mentha G., Morel P., Marelli L., Patch D., Muiesan P., Heaton N., Rossaro L., Khatri V., Hsieh C.B., Mazzaferro, Vincenzo, Llovet, Josep M, Miceli, Rosalba, Bhoori, Sherrie, Schiavo, Marcello, Mariani, Luigi, Camerini, Tiziana, Roayaie, Sasan, Schwartz, Myron E, Grazi, Gian Luca, Adam, René, Neuhaus, Peter, Salizzoni, Mauro, Bruix, Jordi, Forner, Alejandro, De Carlis, Luciano, Cillo, Umberto, Burroughs, Andrew K, Troisi, Roberto, Rossi, Massimo, Gerunda, Giorgio E, Lerut, Jan, Belghiti, Jacque, Boin, Ilka, Gugenheim, Jean, Rochling, Fedja, Van Hoek, Bart, and Majno, Pietro

Subjects
Oncology, Adult, medicine.medical_specialty, Carcinoma, Hepatocellular, Adolescent, medicine.medical_treatment, education, Liver transplantation, Milan criteria, Retrospective Studie, Liver Neoplasms/mortality/*surgery, Internal medicine, Liver Transplantation, Carcinoma, medicine, Humans, HEPATOCELLULAR CARCINOMA, Child, Aged, Retrospective Studies, mortality/surgery, ddc:617, Proportional hazards model, business.industry, Hazard ratio, Liver Neoplasms, SELECTION CRITERIA, Retrospective cohort study, Hepatocellular, Middle Aged, medicine.disease, digestive system diseases, Surgery, Carcinoma, Hepatocellular/mortality/*surgery, Transplantation, Settore MED/18 - Chirurgia Generale, Liver Neoplasm, Hepatocellular carcinoma, Adolescent, Adult, Aged, Carcinoma, mortality/surgery, Child, Humans, Liver Neoplasms, mortality/surgery, Liver Transplantation, Middle Aged, Retrospective Studies, business, Human
Abstract

Background: Patients undergoing liver transplantation for hepatocellular carcinoma within the Milan criteria (single tumour ≤5 cm in size or ≤3 tumours each ≤3 cm in size, and no macrovascular invasion) have an excellent outcome. However, survival for patients with cancers that exceed these criteria remains unpredictable and access to transplantation is a balance of maximising patients' chances of cure and organ availability. The aim of this study was to explore the survival of patients with tumours that exceed the Milan criteria, to assess whether the criteria could be less restrictive, enabling more patients to qualify as transplant candidates, and to derive a prognostic model based on objective tumour characteristics, to see whether the Milan criteria could be expanded. Methods: Data on patients who underwent transplantation for hepatocellular carcinoma despite exceeding Milan criteria at different centres were recorded via a web-based survey completed by specialists from each centre. The survival of these patients was correlated retrospectively with the size of the largest tumour nodule, number of nodules, and presence or absence of microvascular invasion detected at pathology. Contoured multivariable regression Cox models produced survival estimates by means of different combinations of the covariates. The primary aim of this study was to derive a prognostic model of overall survival based on tumour characteristics, according to the main parameters used in the Tumour Node Metastasis classification. The secondary aim was the identification of a subgroup of patients with hepatocellular carcinoma exceeding the Milan criteria, who achieved a 5-year overall survival of at least 70%-ie, similar to the outcome expected for patients who meet the Milan criteria. Findings: Over a 10-month period, between June 25, 2006, and April 3, 2007, data for 1556 patients who underwent transplantation for hepatocellular carcinoma were entered on the database by 36 centres. 1112 patients had hepatocellular carcinoma exceeding Milan criteria and 444 patients had hepatocellular carcinoma shown not to exceed Milan criteria at post-transplant pathology review. In the group of patients with hepatocellular carcinomas exceeding the criteria, the median size of the largest nodule was 40 mm (range 4-200) and the median number of nodules was four (1-20). 454 of 1112 patients (41%) had microvascular invasion and, for those transplanted outside the Milan criteria, 5-year overall survival was 53·6% (95% CI 50·1-57·0), compared with 73·3% (68·2-77·7) for those that met the criteria. Hazard ratios (HR) associated with increasing values of size and number were 1·34 (1·25-1·44) and 1·51 (1·21-1·88), respectively. The effect was linear for size, whereas for number of tumours, the effect tended to plateau above three tumours. The effect of tumour size and number on survival was mediated by recurrence (b=0·08, SE=0·12, p=0·476). The presence of microvascular invasion doubled HRs in all scenarios. The 283 patients without microvascular invasion, but who fell within the Up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumour [in cm] and the number of tumours) achieved a 5-year overall survival of 71·2% (64·3-77·0). Interpretation: More patients with hepatocellular carcinoma could be candidates for transplantation if the current dual (yes/no) approach to candidacy, based on the strict Milan criteria, were replaced with a more precise estimation of survival contouring individual tumour characteristics and use of the up-to-seven criteria. Funding: Specific funding was not used to do this study. © 2009 Elsevier Ltd. All rights reserved

Published
2009

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