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1. Landscape of alcohol-related hepatocellular carcinoma in the last 15 years highlights the need to expand surveillance programs

Author

Nicola Reggidori, Laura Bucci, Valentina Santi, Benedetta Stefanini, Lorenzo Lani, Davide Rampoldi, Giorgia Ghittoni, Fabio Farinati, Alberto Masotto, Bernardo Stefanini, Andrea Mega, Elisabetta Biasini, Francesco Giuseppe Foschi, Gianluca Svegliati-Baroni, Angelo Sangiovanni, Claudia Campani, Giovanni Raimondo, Gianpaolo Vidili, Antonio Gasbarrini, Ciro Celsa, Mariella Di Marco, Edoardo G. Giannini, Rodolfo Sacco, Maurizia Rossana Brunetto, Francesco Azzaroli, Donatella Magalotti, Filomena Morisco, Gian Ludovico Rapaccini, Gerardo Nardone, Alessandro Vitale, Franco Trevisani, Maurizio Biselli, Paolo Caraceni, Annagiulia Gramenzi, Francesca Benevento, Alessandro Granito, Luca Muratori, Fabio Piscaglia, Francesco Tovoli, Gloria Allegrini, Calogero Cammà, Giuseppe Cabibbo, Carmelo Marco Giacchetto, Paolo Giuffrida, Maria Vittoria Grassini, Mauro Grova, Gabriele Rancatore, Caterina Stornello, Valentina Adotti, Tancredi Li Cavoli, Fabio Marra, Martina Rosi, Vittoria Bevilacqua, Alberto Borghi, Lucia Napoli, Fabio Conti, G.L. Frassineti, Maria Teresa Migliano, Nicoletta de Matthaeis, Francesca Romana Ponziani, Gabriele Missale, Andrea Olivani, Mario Capasso, Valentina Cossiga, Maria Guarino, Ester Marina Cela, Antonio Facciorusso, Camilla Graziosi, Valentina Lauria, Giorgio Pelecca, Marta Schirripa, Fabrizio Chegai, Armando Raso, Alessio Bozzi, Maria Stella Franzè, Carlo Saitta, Assunta Sauchella, Elton Dajti, Federico Ravaioli, Maria Corina Plaz Torres, Giulia Pieri, Filippo Oliveri, Gabriele Ricco, Veronica Romagnoli, Alessandro Inno, Fabiana Marchetti, Pietro Coccoli, Antonio Malerba, Alberta Cappelli, Rita Golfieri, Cristina Mosconi, and Matteo Renzulli

Subjects
Hepatocellular carcinoma, Alcohol abuse, ITA.LI.CA staging system, Metabolic dysfunction-associated fatty liver disease, Surveillance programs, Oesophageal varices, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background & Aims: Alcohol abuse and metabolic disorders are leading causes of hepatocellular carcinoma (HCC) worldwide. Alcohol-related aetiology is associated with a worse prognosis compared with viral agents, because of the lower percentage of patients diagnosed with HCC under routine surveillance and a higher burden of comorbidity in alcohol abusers. This study aimed to describe the evolving clinical scenario of alcohol-related HCC over 15 years (2006–2020) in Italy. Methods: Data from the Italian Liver Cancer (ITA.LI.CA) registry were used: 1,391 patients were allocated to three groups based on the year of HCC diagnosis (2006–2010; 2011–2015; 2016–2020). Patient characteristics, HCC treatment, and overall survival were compared among groups. Survival predictors were also investigated. Results: Approximately 80% of alcohol-related HCCs were classified as cases of metabolic dysfunction-associated fatty liver disease. Throughout the quinquennia,

Published
2023
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2. Potential feasibility of atezolizumab-bevacizumab therapy in patients with hepatocellular carcinoma treated with tyrosine-kinase inhibitors

Author

Benedetta Stefanini, Laura Bucci, Valentina Santi, Nicola Reggidori, Davide Rampoldi, Lorenzo Lani, Alessandro Granito, Angelo Sangiovanni, Giuseppe Cabibbo, Fabio Farinati, Claudia Campani, Francesco Giuseppe Foschi, Gianluca Svegliati-Baroni, Giovanni Raimondo, Antonio Gasbarrini, Andrea Mega, Elisabetta Biasini, Rodolfo Sacco, Filomena Morisco, Eugenio Caturelli, Gianpaolo Vidili, Francesco Azzaroli, Edoardo G. Giannini, Gian Ludovico Rapaccini, Maurizia Rossana Brunetto, Alberto Masotto, Gerardo Nardone, Mariella Di Marco, Donatella Magalotti, Franco Trevisani, Maurizio Biselli, Paolo Caraceni, Annagiulia Gramenzi, Francesco Tovoli, Luca Muratori, Francesca Benevento, Gloria Allegrini, Calogero Cammà, Ciro Celsa, Paolo Giuffrida, Caterina Stornello, Mauro Grova, Carmelo Marco Giacchetto, Gabriele Rancatore, Maria Vittoria Grassini, Valentina Adotti, Stefano Gitto, Fabio Marra, Martina Rosi, Vittoria Bevilacqua, Alberto Borghi, Andrea Casadei Gardini, Fabio Conti, Anna Chiara Dall'Aglio, Giorgio Ercolani, Federica Mirici, Nicoletta de Matthaeis, Francesca Romana Ponziani, Gabriele Missale, Andrea Olivani, Maria Guarino, Valentina Cossiga, Mario Capasso, Ester Marina Cela, Antonio Facciorusso, Valentina Lauria, Giorgia Ghittoni, Giorgio Pelecca, Fabrizio Chegai, Fabio Coratella, Mariano Ortenzi, Serena Dell'Isola, Maria Stella Franzè, Carlo Saitta, Assunta Sauchella, Elton Dajti, Federico Ravaioli, Giulia Pieri, Maria Corina Plaz Torres, Filippo Oliveri, Gabriele Ricco, Veronica Romagnoli, Alessandro Inno, Fabiana Marchetti, Pietro Coccoli, Antonio Malerba, Alberta Cappelli, Rita Golfieri, Cristina Mosconi, null Matteo Renzulli, Stefanini, B., Bucci, L., Santi, V., Reggidori, N., Rampoldi, D., Lani, L., Granito, A., Sangiovanni, A., Cabibbo, G., Farinati, F., Campani, C., Foschi, F. G., Svegliati-Baroni, G., Raimondo, G., Gasbarrini, A., Mega, A., Biasini, E., Sacco, R., Morisco, F., Caturelli, E., Vidili, G., Azzaroli, F., Giannini, E. G., Rapaccini, G. L., Brunetto, M. R., Masotto, A., Nardone, G., Di Marco, M., Magalotti, D., Trevisani, F., Biselli, M., Caraceni, P., Gramenzi, A., Tovoli, F., Muratori, L., Benevento, F., Allegrini, G., Camma, C., Celsa, C., Giuffrida, P., Stornello, C., Grova, M., Giacchetto, C. M., Rancatore, G., Grassini, M. V., Adotti, V., Gitto, S., Marra, F., Rosi, M., Bevilacqua, V., Borghi, A., Gardini, A. C., Conti, F., Dall'Aglio, A. C., Ercolani, G., Mirici, F., de Matthaeis, N., Ponziani, F. R., Missale, G., Olivani, A., Guarino, M., Cossiga, V., Capasso, M., Cela, E. M., Facciorusso, A., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Dell'Isola, S., Franze, M. S., Saitta, C., Sauchella, A., Dajti, E., Ravaioli, F., Pieri, G., Torres, M. C. P., Oliveri, F., Ricco, G., Romagnoli, V., Inno, A., Marchetti, F., Coccoli, P., Malerba, A., Cappelli, A., Golfieri, R., Mosconi, C., Matteo, Renzulli, Stefanini, Benedetta, Bucci, Laura, Santi, Valentina, Reggidori, Nicola, Rampoldi, Davide, Lani, Lorenzo, Granito, Alessandro, Sangiovanni, Angelo, Cabibbo, Giuseppe, Farinati, Fabio, Campani, Claudia, Foschi, Francesco Giuseppe, Svegliati-Baroni, Gianluca, Raimondo, Giovanni, Gasbarrini, Antonio, Mega, Andrea, Biasini, Elisabetta, Sacco, Rodolfo, Morisco, Filomena, Caturelli, Eugenio, Vidili, Gianpaolo, Azzaroli, Francesco, Giannini, Edoardo G, Rapaccini, Gian Ludovico, Brunetto, Maurizia Rossana, Masotto, Alberto, Nardone, Gerardo, Di Marco, Mariella, Magalotti, Donatella, and Trevisani, Franco

Subjects
Atezolizumab-bevacizumab, Clinical Trials as Topic, Antineoplastic Combined Chemotherapy Protocol, Carcinoma, Hepatocellular, Systemic therapy, Hepatology, Hepatocellular carcinoma, Tirosin-kinase inhibitor, Liver Neoplasms, Gastroenterology, Bevacizumab, Feasibility Studie, Tyrosine, Human
Abstract

Background: The combination of atezolizumab-bevacizumab has been proven to be superior to sorafenib for the treatment of unresectable hepatocellular carcinoma not amenable to locoregional treatments, be-coming the standard of care of systemic therapy.Aim: This study aimed at assessing real-world feasibility of atezolizumab-bevacizumab in patients treated with tyrosine-kinase inhibitors.Methods: Among 1447 patients treated with tyrosine-kinase inhibitors from January 2010 to December 2020, we assessed the percentage of those potentially eligible to atezolizumab-bevacizumab (according to IMbrave-150 trial criteria), and the overall survival of eligible and non-eligible patients.Results: 422 (29%) patients were qualified for atezolizumab-bevacizumab therapy. The main exclusion causes were Child-Pugh class and Performance Status. Adopting the more permissive inclusion criteria of SHARP trial, 535 patients became eligible. The median overall survival of tyrosine-kinase inhibitors patients was 14.9 months, longer in eligible patients than in their counterpart due to better baseline liver function and oncological features.Conclusion: Real-world data indicate that less than one-third of hepatocellular carcinoma patients treated with tyrosine-kinase inhibitors are potentially eligible to atezolizumab-bevacizumab according to the reg-istration trial criteria. These patients have a longer survival than the non-eligible ones. If the selection criteria of atezolizumab-bevacizumab trial are maintained in clinical practice, tyrosine-kinase inhibitors will remain the most used systemic therapy for hepatocellular carcinoma patients.(c) 2022 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Published
2022

3. Economic Evaluation of Different Organizational Models for the Management of Patients with Hepatitis C

Author

Stefano Fagiuoli, Luisa Pasulo, Franco Maggiolo, Rosaria Spinella, Paolo Del Poggio, Roberto Boldizzoni, Mariella Di Marco, Alessandro Aronica, Chiara Benedetti, Paolo Correale, Chiara Garavaglia, and Carlo Nicora

Subjects
hepatitis c, italy, models, organizational, antiviral agents, daa, hcv, hub & spoke, center of excellence, Medicine (General), R5-920
Abstract

BACKGROUND: Access to Directly Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) treatment in Italy was initially restricted to severe patients. In 2017, AIFA expanded access to all patients, to achieve elimination by 2030. AIM: To investigate the impact of different hospitals’ organizational models on elimination timing, treatment capacity and direct costs. METHODS: Most Regional healthcare systems in Italy deploy a Center of Excellence (CoE) organizational model, where patients are referred to a single major hospital in the area, which is the only one that can prescribe and deliver DAAs. The study was conducted at Bergamo’s (Lombardy, Italy) Papa Giovanni XXIII hospital (PG-23), which deploys a Hub&Spoke model: the Hub (PG-23) prescribes and delivers DAAs while Spokes (four smaller hospitals) can only prescribe them. The study compares the two models (CoE vs. H&S). Patient journey and workloads were mapped and quantified through interviews with hospital stakeholders. Cost data were collected through the hospital’s IT system; the sample comprised 2,277 HCV patients, over one year. RESULTS: The study calculated the average cost to treat HCV patients (~ € 1,470 per patient). Key cost drivers are lab tests (60%) and specialist visits (30%). Over one year, H&S can treat 68% more patients than CoE. As deferred patients absorb up to 40% of total costs, the “Optimized” model was designed by streamlining specialists’ visits and involving general practitioners during follow-up. “Optimized” model increases treatment capacity and reduces costs of deferred patients by 72% vs CoE. CONCLUSION: The study demonstrates the importance of organizational models in efficiently achieving 2030 elimination.

Published
2019
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4. Development and Validation of a New Prognostic System for Patients with Hepatocellular Carcinoma.

Author

Fabio Farinati, Alessandro Vitale, Gaya Spolverato, Timothy M Pawlik, Teh-la Huo, Yun-Hsuan Lee, Anna Chiara Frigo, Anna Giacomin, Edoardo G Giannini, Francesca Ciccarese, Fabio Piscaglia, Gian Lodovico Rapaccini, Mariella Di Marco, Eugenio Caturelli, Marco Zoli, Franco Borzio, Giuseppe Cabibbo, Martina Felder, Rodolfo Sacco, Filomena Morisco, Elisabetta Biasini, Francesco Giuseppe Foschi, Antonio Gasbarrini, Gianluca Svegliati Baroni, Roberto Virdone, Alberto Masotto, Franco Trevisani, Umberto Cillo, and ITA.LI.CA study group

Subjects
Medicine
Abstract

Prognostic assessment in patients with hepatocellular carcinoma (HCC) remains controversial. Using the Italian Liver Cancer (ITA.LI.CA) database as a training set, we sought to develop and validate a new prognostic system for patients with HCC.Prospective collected databases from Italy (training cohort, n = 3,628; internal validation cohort, n = 1,555) and Taiwan (external validation cohort, n = 2,651) were used to develop the ITA.LI.CA prognostic system. We first defined ITA.LI.CA stages (0, A, B1, B2, B3, C) using only tumor characteristics (largest tumor diameter, number of nodules, intra- and extrahepatic macroscopic vascular invasion, extrahepatic metastases). A parametric multivariable survival model was then used to calculate the relative prognostic value of ITA.LI.CA tumor stage, Eastern Cooperative Oncology Group (ECOG) performance status, Child-Pugh score (CPS), and alpha-fetoprotein (AFP) in predicting individual survival. Based on the model results, an ITA.LI.CA integrated prognostic score (from 0 to 13 points) was constructed, and its prognostic power compared with that of other integrated systems (BCLC, HKLC, MESIAH, CLIP, JIS). Median follow-up was 58 mo for Italian patients (interquartile range, 26-106 mo) and 39 mo for Taiwanese patients (interquartile range, 12-61 mo). The ITA.LI.CA integrated prognostic score showed optimal discrimination and calibration abilities in Italian patients. Observed median survival in the training and internal validation sets was 57 and 61 mo, respectively, in quartile 1 (ITA.LI.CA score ≤ 1), 43 and 38 mo in quartile 2 (ITA.LI.CA score 2-3), 23 and 23 mo in quartile 3 (ITA.LI.CA score 4-5), and 9 and 8 mo in quartile 4 (ITA.LI.CA score > 5). Observed and predicted median survival in the training and internal validation sets largely coincided. Although observed and predicted survival estimations were significantly lower (log-rank test, p < 0.001) in Italian than in Taiwanese patients, the ITA.LI.CA score maintained very high discrimination and calibration features also in the external validation cohort. The concordance index (C index) of the ITA.LI.CA score in the internal and external validation cohorts was 0.71 and 0.78, respectively. The ITA.LI.CA score's prognostic ability was significantly better (p < 0.001) than that of BCLC stage (respective C indexes of 0.64 and 0.73), CLIP score (0.68 and 0.75), JIS stage (0.67 and 0.70), MESIAH score (0.69 and 0.77), and HKLC stage (0.68 and 0.75). The main limitations of this study are its retrospective nature and the intrinsically significant differences between the Taiwanese and Italian groups.The ITA.LI.CA prognostic system includes both a tumor staging-stratifying patients with HCC into six main stages (0, A, B1, B2, B3, and C)-and a prognostic score-integrating ITA.LI.CA tumor staging, CPS, ECOG performance status, and AFP. The ITA.LI.CA prognostic system shows a strong ability to predict individual survival in European and Asian populations.

Published
2016
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5. Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Author

Alessandra Brocchieri, Marta Borghi, Angelo Pan, Mariella Di Marco, Silvia Colombo, Chiara Molteni, Natalia Terreni, Paolo Poggio, Alberto Colombo, De Silvestri Annalisa, Riccardo Centenaro, Luisa Pasulo, Paolo Viganò, Maria Cristina Vinci, Marie Graciella Pigozzi, Stefano Fagiuoli, Pietro Lampertico, Sergio Lazzaroni, Sherrie Bhoori, Massimo Zuin, Franco Noventa, Alessio Aghemo, Barbara Menzaghi, Andrea Lombardi, Franco Maggiolo, I. Fanetti, Alessia Giorgini, Massimo Puoti, Emanuela Messina, Paolo Grossi, Roberta D'Ambrosio, Pietro Invernizzi, Monia Mendeni, Daniele Bella, E. Dionigi, Ombretta Spinelli, Maria Teresa Taddei, Pietro Pozzoni, Antonella d'Arminio Monforte, Elisabetta Buscarini, Angiola Spinetti, Serena Zaltron, D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, and Fagiuoli, S

Subjects
Male, Sustained Virologic Response, Sofosbuvir, Hepacivirus, Kidney, urologic and male genital diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, MED/12 - GASTROENTEROLOGIA, eGFR, Aged, 80 and over, Hepatitis C, Middle Aged, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Glomerular Filtration Rate, Cohort study, medicine.drug, Adult, medicine.medical_specialty, SVR, Genotype, Renal function, CKD, Antiviral Agents, Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Renal Insufficiency, Chronic, Aged, Retrospective Studies, Hepatology, business.industry, Ribavirin, Retrospective cohort study, Hepatitis C, Chronic, medicine.disease, Logistic Models, chemistry, business, Kidney disease
Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Published
2020

6. Epidemiological trends and trajectories of MAFLD-associated hepatocellular carcinoma 2002-2033: The ITA.LI.CA database

Author

Alessandro, Vitale, Gianluca, Svegliati-Baroni, Alessio, Ortolani, Monica, Cucco, Giulio V, Dalla Riva, Edoardo G, Giannini, Fabio, Piscaglia, Gianludovico, Rapaccini, Mariella, Di Marco, Eugenio, Caturelli, Marco, Zoli, Rodolfo, Sacco, Giuseppe, Cabibbo, Fabio, Marra, Andrea, Mega, Filomena, Morisco, Antonio, Gasbarrini, Francesco Giuseppe, Foschi, Gabriele, Missale, Alberto, Masotto, Gerardo, Nardone, Giovanni, Raimondo, Francesco, Azzaroli, Gianpaolo, Vidili, Filippo, Oliveri, Filippo, Pelizzaro, Rafael, Ramirez Morales, Umberto, Cillo, Franco, Trevisani, Luca, Miele, Giulio, Marchesini, Fabio, Farinati, Alessandro, Di Bucchianico, Vitale, A., Svegliati-Baroni, G., Ortolani, A., Cucco, M., Dalla Riva, G. V., Giannini, E. G., Piscaglia, F., Rapaccini, G., Di Marco, M., Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, A., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Pelizzaro, F., Ramirez Morales, R., Cillo, U., Trevisani, F., Miele, L., Marchesini, G., Farinati, F., Alessandro Vitale, Gianluca Svegliati-Baroni, Alessio Ortolani, Monica Cucco, Giulio V Dalla Riva, Edoardo G Giannini, Fabio Piscaglia, Gianludovico Rapaccini, Mariella Di Marco, Eugenio Caturelli, Marco Zoli, Rodolfo Sacco, Giuseppe Cabibbo, Fabio Marra, Andrea Mega, Filomena Morisco, Antonio Gasbarrini, Francesco Giuseppe Foschi, Gabriele Missale, Alberto Masotto, Gerardo Nardone, Giovanni Raimondo, Francesco Azzaroli, Gianpaolo Vidili, Filippo Oliveri, Filippo Pelizzaro, Rafael Ramirez Morales, Umberto Cillo, Franco Trevisani, Luca Miele, Giulio Marchesini, Fabio Farinati, Vitale, Alessandro, Svegliati-Baroni, Gianluca, Ortolani, Alessio, Cucco, Monica, Dalla Riva, Giulio V, Giannini, Edoardo G, Piscaglia, Fabio, Rapaccini, Gianludovico, Di Marco, Mariella, Caturelli, Eugenio, Zoli, Marco, Sacco, Rodolfo, Cabibbo, Giuseppe, Marra, Fabio, Mega, Andrea, Morisco, Filomena, Gasbarrini, Antonio, Foschi, Francesco Giuseppe, Missale, Gabriele, Masotto, Alberto, Nardone, Gerardo, Raimondo, Giovanni, Azzaroli, Francesco, Vidili, Gianpaolo, Oliveri, Filippo, Pelizzaro, Filippo, Ramirez Morales, Rafael, Cillo, Umberto, Trevisani, Franco, Miele, Luca, Marchesini, Giulio, and Farinati, Fabio

Subjects
Male, Settore MED/12 - Gastroenterologia, Carcinoma, Hepatocellular, Liver Neoplasms, nonalcoholic steatohepatitis, Gastroenterology, hepatocellular carcinoma, digestive system diseases, Non-alcoholic Fatty Liver Disease, Risk Factors, Humans, neoplasms
Abstract

BackgroundMetabolic dysfunction-associated fatty liver disease (MAFLD) represents a new inclusive definition of the whole spectrum of liver diseases associated to metabolic disorders. The main objective of this study was to compare patients with MAFLD and non-MAFLD with hepatocellular carcinoma (HCC) included in a nationally representative cohort.MethodsWe analysed 6882 consecutive patients with HCC enrolled from 2002 to 2019 by 23 Italian Liver Cancer centres to compare epidemiological and future trends in three subgroups: pure, single aetiology MAFLD (S-MAFLD); mixed aetiology MAFLD (metabolic and others, M-MAFLD); and non-MAFLD HCC.ResultsMAFLD was diagnosed in the majority of patients with HCC (68.4%). The proportion of both total MAFLD and S-MAFLD HCC significantly increased over time (from 50.4% and 3.6% in 2002–2003, to 77.3% and 28.9% in 2018–2019, respectively, pConclusionsThe prevalence of MAFLD HCC in Italy is rapidly increasing to cover the majority of patients with HCC. Despite a less favourable cancer stage at diagnosis, patients with MAFLD HCC have a lower risk of HCC-related death, suggesting reduced cancer aggressiveness.

Published
2021

7. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort

Author

Sergio Lazzaroni, Paolo Grossi, Chiara Molteni, Maria Grazia Valsecchi, Pietro Lampertico, Luca Valenti, Alessio Aghemo, Alessia Giorgini, Antonella d'Arminio Monforte, Roberta D'Ambrosio, Federico Gatti, Omar Giglio, Daniele Bella, Davide Paolo Bernasconi, Giuseppe Lapadula, Sherrie Bhoori, Hamid Hasson, Monica Schiavini, Elisa Colella, Roberto Boldizzoni, A. Ciaccio, Simona Landonio, Andrea Capretti, Maria Cristina Vinci, Giuliano Rizzardini, Barbara Menzaghi, Elisabetta Degasperi, Caterina Uberti-Foppa, Chiara Baiguera, Andrea Lombardi, Gianpiero Aimo, Layla Pagnucco, Paolo Perini, Giuliana Cologni, Natalia Terreni, Paolo Bonfanti, Mauro Viganò, Paolo Viganò, Alessandro Soria, Roberto Rossotti, Massimo Puoti, Ombretta Spinelli, Canio Carriero, Silvia Polo, Guglielmo Marco Migliorino, Silvia Colombo, Riccardo Centenaro, Luisa Pasulo, Anna De Bona, E. Dionigi, Paolo Poggio, Franco Noventa, Isabella Carderi, Angelo Pan, Angiola Spinetti, Mariella Di Marco, Cecilia Liani, Stefano Fagiuoli, Marie Graciella Pigozzi, Marco Fava, Massimo Graffeo, Maria Grazia Rumi, Alberto Colombo, Soria, A., Fava, M., Bernasconi, D. P., Lapadula, G., Colella, E., Valsecchi, M. G., Migliorino, G. M., D'Ambrosio, R., Landonio, S., Schiavini, M., Spinetti, A., Carriero, C., Degasperi, E., Cologni, G., Gatti, F., Vigano, P., Hasson, H., Uberti-Foppa, C., Pasulo, L., Baiguera, C., Rossotti, R., Vinci, M., Puoti, M., Giorgini, A., Menzaghi, B., Lombardi, A., Pan, A., Aghemo, A., Grossi, P. A., Boldizzoni, R., Colombo, S., Vigano, M., Rumi, M. G., Del Poggio, P., Valenti, L., Giglio, O., De Bona, A., d'Arminio Monforte, A., Colombo, A., Spinelli, O., Pigozzi, M. G., Molteni, C., Bonfanti, P., Terreni, N., Perini, P., Capretti, A., Bella, D., Liani, C., Polo, S., Aimo, G., Pagnucco, L., Bhoori, S., Centenaro, R., Graffeo, M., Ciaccio, A., Dionigi, E., Lazzaroni, S., Carderi, I., Di Marco, M., Rizzardini, G., Noventa, F., Lampertico, P., Fagiuoli, S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, and Fagiuoli, S

Subjects
Male, medicine.medical_specialty, Daclatasvir, Genotype, Sofosbuvir, ribavirin, pibrentasvir, daclatasvir, genotype 3, glecaprevir, Hepatitis C, sofosbuvir, sustained virological response, velpatasvir, Hepacivirus, Antiviral Agents, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Ribavirin, medicine, Humans, Univariate analysis, Hepatology, business.industry, Glecaprevir, Hepatitis C, Chronic, medicine.disease, Pibrentasvir, Regimen, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods: Sustained virological response 12weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression. Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF+DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF+DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P=.065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P=.007) and lower median pretreatment Log10HCV-RNA (5.87 vs 6.20, P=.001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF+DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12. Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF+DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.

Published
2020

8. Economic Evaluation of Different Organizational Models for the Management of Patients with Hepatitis C

Author

Chiara Garavaglia, Stefano Fagiuoli, Paolo Poggio, Alessandro Aronica, Rosaria Spinella, Mariella Di Marco, Franco Maggiolo, Carlo Nicora, Roberto Boldizzoni, Paolo Correale, Luisa Pasulo, and Chiara Benedetti

Subjects
lcsh:R5-920, medicine.medical_specialty, Hepatitis C, Italy, Models, Organizational, Antiviral Agents, DAA, HCV, Hub & Spoke, Center of Excellence, models, organizational, Total cost, business.industry, Center of excellence, hub & spoke, medicine.disease, Indirect costs, Cost driver, Expanded access, italy, antiviral agents, Economic evaluation, Emergency medicine, hcv, medicine, center of excellence, hepatitis c, lcsh:Medicine (General), business, daa, Average cost
Abstract

BACKGROUND: Access to Directly Acting Antivirals (DAAs) for Hepatitis C Virus (HCV) treatment in Italy was initially restricted to severe patients. In 2017, AIFA expanded access to all patients, to achieve elimination by 2030.AIM: To investigate the impact of different hospitals’ organizational models on elimination timing, treatment capacity and direct costs.METHODS: Most Regional healthcare systems in Italy deploy a Center of Excellence (CoE) organizational model, where patients are referred to a single major hospital in the area, which is the only one that can prescribe and deliver DAAs. The study was conducted at Bergamo’s (Lombardy, Italy) Papa Giovanni XXIII hospital (PG-23), which deploys a Hub&Spoke model: the Hub (PG-23) prescribes and delivers DAAs while Spokes (four smaller hospitals) can only prescribe them. The study compares the two models (CoE vs. H&S). Patient journey and workloads were mapped and quantified through interviews with hospital stakeholders. Cost data were collected through the hospital’s IT system; the sample comprised 2,277 HCV patients, over one year.RESULTS: The study calculated the average cost to treat HCV patients (~ € 1,470 per patient). Key cost drivers are lab tests (60%) and specialist visits (30%). Over one year, H&S can treat 68% more patients than CoE. As deferred patients absorb up to 40% of total costs, the “Optimized” model was designed by streamlining specialists’ visits and involving general practitioners during follow-up. “Optimized” model increases treatment capacity and reduces costs of deferred patients by 72% vs CoE.CONCLUSION: The study demonstrates the importance of organizational models in efficiently achieving 2030 elimination.

Published
2019

9. A meta-analysis of single HCV-untreated arm of studies evaluating outcomes after curative treatments of HCV-related hepatocellular carcinoma

Author

Cabibbo, Giuseppe, Petta, Salvatore, Barbã ra, Marco, Missale, Gabriele, Virdone, Roberto, Caturelli, Eugenio, Piscaglia, Fabio, Morisco, Filomena, Colecchia, Antonio, Farinati, Fabio, Giannini, Edoardo, Trevisani, Franco, Craxã¬, Antonio, Colombo, Massimo, Cammã , Calogero, Bucci, Laura, Zoli, Marco, Garuti, Francesca, Lenzi, Barbara, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Benvegnã¹, Luisa, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Mariella Di Marco Claudia, Vavassori, Elena, Roselli, Paola, Dell’Isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Attardo, Simona, Rossi, Margherita, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Felder, Martina, Mega, Andrea, Gasbarrini, Antonio, Pompili, Maurizio, Rinninella, Emanuele, Sacco, Rodolfo, Mismas, Valeria, Foschi, Francesco Giuseppe, Dall’Aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Olivani, Andrea, Biasini, Elisabetta, Nardone, Gerardo, Guarino, Maria, Svegliati-Baroni, Gialuca, Ortolani, Alessio, Masotto, Alberto, Marchetti, Fabiana, Valerio, Matteo, Marra, Fabio, Aburas, Sami, Inghilesi, Andrea L, Cappelli, Alberta, Golfieri, Rita, Mosconi, MARIA CRISTINA, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Benvegnu', Luisa, Cabibbo, Giuseppe, Petta, Salvatore, Barbàra, Marco, Missale, Gabriele, Virdone, Roberto, Caturelli, Eugenio, Piscaglia, Fabio, Morisco, Filomena, Colecchia, Antonio, Farinati, Fabio, Giannini, Edoardo, Trevisani, Franco, Craxì, Antonio, Colombo, Massimo, Cammà, Calogero, Nardone, GERARDO ANTONIO PIO, Cabibbo, G., Petta, S., Barbara, M., Missale, G., Virdone, R., Caturelli, E., Piscaglia, F., Morisco, F., Colecchia, A., Farinati, F., Giannini, E., Trevisani, F., Craxi, A., Colombo, M., Camma, C., Bucci, L., Zoli, M., Garuti, F., Lenzi, B., Biselli, M., Caraceni, P., Cucchetti, A., Gramenzi, A., Granito, A., Magalotti, D., Serra, C., Negrini, G., Napoli, L., Salvatore, V., Benevento, F., Benvegnu, L., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Moscatelli, A., Pellegatta, G., Picciotto, A., Savarino, V., Ciccarese, F., Del Poggio, P., Olmi, S., de Matthaeis, N., Balsamo, M. D. M. C., Vavassori, E., Roselli, P., Dell'Isola, S., Ialungo, A. M., Rastrelli, E., Attardo, S., Rossi, M., Costantino, A., Affronti, A., Affronti, M., Mascari, M., Felder, M., Mega, A., Gasbarrini, A., Pompili, M., Rinninella, E., Sacco, R., Mismas, V., Foschi, F. G., Dall'Aglio, A. C., Feletti, V., Lanzi, A., Cappa, F. M., Neri, E., Stefanini, G. F., Tamberi, S., Olivani, A., Biasini, E., Nardone, G., Guarino, M., Svegliati-Baroni, G., Ortolani, A., Masotto, A., Marchetti, F., Valerio, M., Marra, F., Aburas, S., Inghilesi, A. L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Coccoli, P., Zamparelli, M. S., Barbã ra, Marco, Craxã¬, Antonio, Cammã , Calogero, Bucci, Laura, Zoli, Marco, Garuti, Francesca, Lenzi, Barbara, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Benvegnã¹, Luisa, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Mariella Di Marco Claudia, Vavassori, Elena, Roselli, Paola, Dellâ isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Attardo, Simona, Rossi, Margherita, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Felder, Martina, Mega, Andrea, Gasbarrini, Antonio, Pompili, Maurizio, Rinninella, Emanuele, Sacco, Rodolfo, Mismas, Valeria, Foschi, Francesco Giuseppe, Dallâ aglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Federica Mirici, Cappa, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Olivani, Andrea, Biasini, Elisabetta, Nardone, Gerardo, Guarino, Maria, Svegliati-Baroni, Gialuca, Ortolani, Alessio, Masotto, Alberto, Marchetti, Fabiana, Valerio, Matteo, Marra, Fabio, Aburas, Sami, Inghilesi, Andrea L, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Coccoli, Piero, Zamparelli, Marco Sanduzzi, Camma', C., Benvegnã¹, L., Balsamo, M., Dell’Isola, S., Ialungo, A., Foschi, F., Dall’Aglio, A., Cappa, F., Stefanini, G., Inghilesi, A., and Zamparelli, M.

Subjects
Oncology, medicine.medical_specialty, Carcinoma, Hepatocellular, recurrence, Hepatitis C virus, medicine.medical_treatment, medicine.disease_cause, survival, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Adjuvant therapy, hepatocellular carcinoma, prognosis, recurrences, Humans, Survival analysis, Hepatology, business.industry, Liver Neoplasms, medicine.disease, Hepatitis C, 030220 oncology & carcinogenesis, Meta-analysis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Neoplasm Recurrence, Local, business, Adjuvant, prognosi
Abstract

Background & Aims: Determining risk for recurrence or survival after curative resection or ablation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) is important for stratifying patients according to expected outcomes in future studies of adjuvant therapy in the era of direct-acting antivirals (DAAs). The aims of this meta-analysis were to estimate the recurrence and survival probabilities of HCV-related early HCC following complete response after potentially curative treatment and to identify predictors of recurrence and survival. Methods: Studies reporting time-dependent outcomes (HCC recurrence or death) after potentially curative treatment of HCV-related early HCC were identified in MEDLINE through May 2016. Data on patient populations and outcomes were extracted from each study by three independent observers and combined using a distribution-free summary survival curve. Primary outcomes were actuarial probabilities of recurrence and survival. Results: Eleven studies met the inclusion criteria. Pooled estimates of actuarial recurrence rates were 7.4% at 6months and 47.0% at 2years. Pooled estimates of actuarial survival rates were 79.8% at 3years and 58.6% at 5years. Heterogeneity among studies was highly significant for all outcomes. By univariate meta-regression analyses, lower serum albumin, randomized controlled trial study design and follow-up were independently associated with higher recurrence risk, whereas tumour size and alpha-foetoprotein levels were associated with higher mortality. Conclusions: This meta-analysis showed that recurrence risk and survival are extremely variable in patients with successfully treated HCV-related HCC, providing a useful benchmark for indirect comparisons of the benefits of DAAs and for a correct design of randomized controlled trials in the adjuvant setting.

Published
2017

10. Determinants of alpha-fetoprotein levels in patients with hepatocellular carcinoma: Implications for its clinical use

Author

Edoardo G. Giannini, Francesco Giuseppe Foschi, Marco Zoli, Mariella Di Marco, Rodolfo Sacco, Roberto Virdone, Gabriele Missale, Gian Lodovico Rapaccini, Giorgio Sammito, Filomena Morisco, Eugenio Caturelli, Franco Borzio, Fabio Farinati, Martina Felder, Giuseppe Cabibbo, Franco Trevisani, Gianluca Svegliati Baroni, A. Pecorelli, Francesca Ciccarese, and Antonio Gasbarrini

Subjects
Cancer Research, Pathology, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Cancer, Odds ratio, Hepatitis C, medicine.disease, Chronic liver disease, Gastroenterology, digestive system diseases, Oncology, Hepatocellular carcinoma, Internal medicine, medicine, Biomarker (medicine), business, Liver function tests, Liver cancer, neoplasms
Abstract

BACKGROUND α-Fetoprotein (AFP) is a biomarker commonly used in the management of patients with hepatocellular carcinoma (HCC), although the possible determinants of its serum levels in these patients have not been adequately explored. For this study, the authors evaluated the relevance of demographic, clinical, and oncologic factors to the presence of elevated AFP levels in large cohort of patients with HCC. METHODS In 4123 patients with HCC who were managed by the Italian Liver Cancer Group, AFP levels were assessed along with their association with demographic, biochemical, clinical, and oncologic characteristics. Patients were subdivided according to the presence of elevated AFP (ie, >10 ng/mL). RESULTS AFP levels were elevated in 62.4% of patients with HCC. Multivariate logistic regression analysis indicated that being a woman (odds ratio [OR], 1.497; 95% confidence interval [95%CI], 1.250-1.793; P 2 cm (OR, 1.346; 95% CI, 1.135-2.596; P = .001), multinodular HCC (OR, 1.641; 95% CI, 1.403-1.920; P

Published
2014

11. THU-180-Treatment of genotype 3 HCV infection in the large real-life 'Navigatore Lombardia' multicentre cohort: Results from three different regimens

Author

Maria Grazia Rumi, Mauro Viganò, Alberto Colombo, Sherrie Bhoori, Antonella d'Arminio Monforte, Riccardo Centenaro, Luisa Pasulo, Sergio Lazzaroni, Alessandro Soria, Andrea Capretti, Maria Cristina Vinci, Pietro Lampertico, Gianpiero Aimo, Chiara Molteni, Andrea Lombardi, Alessio Aghemo, Silvia Polo, Alessia Giorgini, Federico Gatti, Paola Brambilla, Elisabetta Degasperi, E. Dionigi, Anna Spolti, Paolo Bonfanti, Anna De Bona, Luca Valenti, Stefania Salpietro, Marta Borghi, Esther Merlini, Natalia Terreni, Giuliano Rizzardini, Valentina Grasso, Paolo Viganò, Sara Gritti, Paolo Grossi, Roberta D'Ambrosio, Simona Landonio, Alessandra Gambaro, Daniele Bella, Massimo Puoti, Ombretta Spinelli, Caterina Uberti-Foppa, Angelo Pan, Monica Schiavini, Mariella Di Marco, Paolo Poggio, Barbara Menzaghi, Canio Carriero, Hamid Hasson, Elisa Colella, Roberto Boldizzoni, Nunzia Bottalico, Stefano Fagiuoli, Angiola Spinetti, Cecilia Liani, Giuseppe Lapadula, Guido Colloredo Mels, Massimo Graffeo, Franco Noventa, Luciana Scabeni, Roberta Soffredini, Roberto Gulminetti, Marie Graciella Pigozzi, and Isabella Carderi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Diabetes mellitus, Cohort, Genotype, Medicine, business, medicine.disease
Published
2019

12. Influence of clinically significant portal hypertension on survival after hepatic resection for hepatocellular carcinoma in cirrhotic patients

Author

Edoardo G. Giannini, Vincenzo Savarino, Fabio Farinati, Francesca Ciccarese, Gianludovico Rapaccini, Mariella Di Marco, Luisa Benvegnu, Franco Borzio, Eugenio Caturelli, Maria Chiaramonte, The Italian Liver Cancer group [. . ., Virginia Erroi, Donatella Magalotti, Sabina Olmi, Emanuela Giampalma, Rita Golfieri, DOMENICALI, MARCO, ZOLI, MARCO, TREVISANI, FRANCO, BERNARDI, MAURO, BISELLI, MAURIZIO, CASSINI, ROMINA, CARACENI, PAOLO, CUCCHETTI, ALESSANDRO, GRAMENZI, ANNAGIULIA, RAVAIOLI, MATTEO, BALSAMO, CLAUDIA, MOSCONI, CRISTINA, RENZULLI, MATTEO, ROSELLI, PAMELA, RISSO, DAVIDE, BOSCO, GIOVANNA, Edoardo G. Giannini, Vincenzo Savarino, Fabio Farinati, Francesca Ciccarese, Gianludovico Rapaccini, Mariella Di Marco, Luisa Benvegnu, Marco Zoli, Franco Borzio, Eugenio Caturelli, Maria Chiaramonte, Franco Trevisani, The Italian Liver Cancer (ITA.LI.CA) group [.., Mauro Bernardi, Maurizio Biselli, Romina Cassini, Paolo Caraceni, Alessandro Cucchetti, Virginia Erroi, Annagiulia Gramenzi, Donatella Magalotti, Matteo Ravaioli, Sabina Olmi, Claudia Balsamo, Emanuela Giampalma, Rita Golfieri, Cristina Mosconi, Matteo Renzulli, Pamela Roselli, Davide Risso, Giovanna Bosco, ]., Giannini, E. G., Savarino, V., Farinati, F., Ciccarese, F., Rapaccini, G., Marco, M. D., Benvegnu, L., Zoli, M., Borzio, F., Caturelli, E., Chiaramonte, M., Trevisani, F, Olmi, S, and on behalf of Italian Liver Cancer, (ITA. LI. CA) group.

Subjects
Thrombocytopaenia, Liver Cirrhosis, Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Cirrhosis, Survival, Hepatocellular carcinoma, Hepatic resection, Portal venous pressure, Hepatic venous pressure gradient, Portal hypertensive gastropathy, hepatic resection, Gastroenterology, Internal medicine, Hypertension, Portal, Hepatectomy, Humans, Medicine, HEPATOCELLULAR CARCINOMA, Portal hypertension, Aged, Retrospective Studies, Hepatology, Platelet Count, business.industry, Liver Neoplasms, portal hypertension, Middle Aged, Gastric varices, Prognosis, medicine.disease, Survival Analysis, digestive system diseases, Oesophageal varices, Italy, Surgery, Female, business, Liver cancer
Abstract

Background: The role of clinically significant portal hypertension on the prognosis of cirrhotic patients undergoing hepatic resection for hepatocellular carcinoma (HCC) is debated. Aims: In this study, our aim was to assess the role of clinically significant portal hypertension after hepatic resection for HCC in patients with cirrhosis. Methods: We assessed the prognostic role of the presence of clinically significant portal hypertension (oesophageal/gastric varices/portal hypertensive gastropathy or a platelet count 100 vs 86 months, P = 0.742). Conclusions: Presence of clinically significant portal hypertension has no influence on survival of patients with well-compensated cirrhosis undergoing hepatic resection for HCC. © 2013 John Wiley & Sons A/S.

Published
2013

13. 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

Author

Umberto Cillo, Roberto Virdone, Patrizia Burra, Maria Chiaramonte, Rodolfo Sacco, Francesco Giuseppe Foschi, Fabio Piscaglia, Mariella Di Marco, Franco Trevisani, Alessandro Vitale, Eugenio Caturelli, Gianluca Svegliati Baroni, Marco Zoli, Fabio Farinati, Filomena Morisco, Gian Lodovico Rapaccini, E.G. Giannini, Gabriele Missale, Franco Borzio, Martina Felder, Gaya Spolverato, Francesca Ciccarese, Giuseppe Cabibbo, Antonio Gasbarrini, Vitale, Alessandro, Farinati, Fabio, Burra, Patrizia, Trevisani, Franco, Giannini, Edoardo G., Ciccarese, Francesca, Piscaglia, Fabio, Rapaccini, Gian Lodovico, Di Marco, Mariella, Caturelli, Eugenio, Zoli, Marco, Borzio, Franco, Cabibbo, Giuseppe, Felder, Martina, Sacco, Rodolfo, Morisco, Filomena, Missale, Gabriele, Foschi, Francesco Giuseppe, Gasbarrini, Antonio, Svegliati Baroni, Gianluca, Virdone, Roberto, Chiaramonte, Maria, Spolverato, Gaya, Cillo, Umberto, and Giannini, Edoardo G

Subjects
Oncology, Male, Time Factors, Databases, Factual, medicine.medical_treatment, Cost-Benefit Analysis, Liver transplantation, Clinical endpoint, Liver Neoplasms, Surgery, Transplantation, Hepatology, Health Care Costs, hepatocellular carcinoma, Middle Aged, Markov Chains, Tumor Burden, Models, Economic, Treatment Outcome, Italy, Hepatocellular carcinoma, Female, Quality-Adjusted Life Years, alpha-Fetoproteins, Alpha-fetoprotein, Monte Carlo Method, medicine.medical_specialty, Carcinoma, Hepatocellular, Settore MED/12 - GASTROENTEROLOGIA, Decision Support Techniques, alpha-fetoprotein, Predictive Value of Tests, Internal medicine, medicine, Humans, neoplasms, Survival analysis, Aged, Proportional Hazards Models, Retrospective Studies, Proportional hazards model, business.industry, Patient Selection, Retrospective cohort study, medicine.disease, Survival Analysis, digestive system diseases, United States, Liver Transplantation, Multivariate Analysis, business
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. Liver Transpl 21:1250-1258, 2015. © 2015 AASLD.

Published
2015

14. Determinants of alpha-fetoprotein levels in patients with hepatocellular carcinoma: Implications for its clinical use

Author

Edoardo G, Giannini, Giorgio, Sammito, Fabio, Farinati, Francesca, Ciccarese, Anna, Pecorelli, Gian Lodovico, Rapaccini, Mariella, Di Marco, Eugenio, Caturelli, Marco, Zoli, Franco, Borzio, Giuseppe, Cabibbo, Martina, Felder, Antonio, Gasbarrini, Rodolfo, Sacco, Francesco Giuseppe, Foschi, Gabriele, Missale, Filomena, Morisco, Gianluca, Svegliati Baroni, Roberto, Virdone, Franco, Trevisani, Giannini, Edoardo G, Sammito, Giorgio, Farinati, Fabio, Ciccarese, Francesca, Pecorelli, Anna, Rapaccini, Gian Lodovico, Di Marco, Mariella, Caturelli, Eugenio, Zoli, Marco, Borzio, Franco, Cabibbo, Giuseppe, Felder, Martina, Gasbarrini, Antonio, Sacco, Rodolfo, Foschi, Francesco Giuseppe, Missale, Gabriele, Morisco, Filomena, Svegliati Baroni, Gianluca, Virdone, Roberto, and Trevisani, Franco

Subjects
Liver Cirrhosis, Adult, Male, Cancer Research, Carcinoma, Hepatocellular, Prognosi, alanine aminotransferase, Liver Cirrhosi, Sex Factor, Cohort Studies, Sex Factors, Liver Function Tests, Biomarkers, Tumor, Humans, alpha-Fetoprotein, neoplasms, Serum Albumin, Aged, Neoplasm Staging, Liver Function Test, Medicine (all), Liver Neoplasms, Alanine Transaminase, Bilirubin, Middle Aged, Prognosis, Hepatitis C, digestive system diseases, female, Italy, Oncology, Liver Neoplasm, Tumor Markers, Biological, alpha-Fetoproteins, Cohort Studie, cirrhosi, Human
Abstract

BACKGROUND: α-Fetoprotein (AFP) is a biomarker commonly used in the management of patients with hepatocellular carcinoma (HCC), although the possible determinants of its serum levels in these patients have not been adequately explored. For this study, the authors evaluated the relevance of demographic, clinical, and oncologic factors to the presence of elevated AFP levels in large cohort of patients with HCC. METHODS: In 4123 patients with HCC who were managed by the Italian Liver Cancer Group, AFP levels were assessed along with their association with demographic, biochemical, clinical, and oncologic characteristics. Patients were subdivided according to the presence of elevated AFP (ie, >10 ng/mL). RESULTS: AFP levels were elevated in 62.4% of patients with HCC. Multivariate logistic regression analysis indicated that being a woman (odds ratio [OR], 1.497; 95% confidence interval [95%CI], 1.250-1.793; P < .0001), the presence of cirrhosis (OR, 1.538; 95% CI, 1.050-2.254; P = .027), liver disease with viral etiology (OR, 1.900; 95% CI, 1.589-2.272; P < .0001), an elevated alanine aminotransferase level (OR, 1.878; 95% CI, 1.602-2.202; P < .0001), a low albumin level (OR, 1.301; 95% CI, 1.110-1.525; P = .012), an HCC tumor size >2 cm (OR, 1.346; 95% CI, 1.135-2.596; P = .001), multinodular HCC (OR, 1.641; 95% CI, 1.403-1.920; P < .0001), and the presence of vascular invasion (OR, 1.774; 95% CI, 1.361-2.311; P < .0001) were associated independently with elevated levels of AFP. Both the median AFP level and the proportion of patients who had elevated levels increased with decreasing degrees of HCC differentiation (P < .0001). CONCLUSIONS: Sex and features of chronic liver disease were identified as nontumor characteristics that influence serum AFP levels in patients with HCC. These findings should be taken into account as limitations in interpreting the oncologic meaning of this biomarker in clinical practice.

Published
2014

15. Estimation of lead-time bias and its impact on the outcome of surveillance for the early diagnosis of hepatocellular carcinoma

Author

Cucchetti A., Trevisani F., Pecorelli A., Erroi V., Farinati F., Ciccarese F., Rapaccini G. L., Di Marco M., Caturelli E., Giannini E. G., Zoli M., Borzio F., Cabibbo G., Felder M., Gasbarrini A., Sacco R., Foschi F. G., Missale G., Morisco F., Baroni G. S., Virdone R., Bernardi M., Pinna A. D., Bolondi L., Biselli M., Caraceni P., Garuti F., Gramenzi A., Lenzi B., Magalotti D., Piscaglia F., Serra C., Ravaioli M., Venerandi L., Del Poggio P., Olmi S., Balsamo C., Di Nolfo M. A., Vavassori E., Alberti A., Benvegnu L., Gatta A., Giacomin A., Vanin V., Pozzan C., Maddalo G., Giampalma E., Cappelli A., Golfieri R., Mosconi C., Renzulli M., Dell'Isola S., Ialungo A. M., Roselli P., Risso D., Marenco S., Sammito G., Bruzzone L., Bosco G., Grieco A., Pompili M., Rinninella E., Siciliano M., Chiaramonte M., Guarino M., Camma C., Maida M., Di Martino A., Barcellona M. R., Schiada L., Gemini S., Biasini E., Porro E., del Ricambio M., Mismas V., Vivaldi C., Cucchetti, A, Trevisani, F, Pecorelli, A, Erroi, V, Farinati, F, Ciccarese, F, Rapaccini, Gl, Di Marco, M, Caturelli, E, Giannini, Eg, Zoli, M, Borzio, F, Cabibbo, G, Felder, M, Gasbarrini, A, Sacco, R, Foschi, Fg, Missale, G, Morisco, Filomena, Baroni, G, Virdone, R, Bernardi, M, Pinna, Ad, Italian Liver Cancer, Group, Alessandro, Cucchetti, Franco, Trevisani, Anna, Pecorelli, Virginia, Erroi, Fabio, Farinati, Francesca, Ciccarese, Gian, Lodovico Rapaccini, Mariella Di, Marco, Eugenio, Caturelli, Edoardo, G. Giannini, Marco, Zoli, Franco, Borzio, Giuseppe, Cabibbo, Martina, Felder, Antonio, Gasbarrini, Rodolfo, Sacco, Francesco, Giuseppe Foschi, Gabriele, Missale, Filomena, Morisco, Gianluca, Svegliati Baroni, Roberto, Virdone, Mauro, Bernardi, Antonio D., Pinna, for the Italian Liver Cancer Group [.., Bolondi, Luigi, Maurizio, Biselli, Piscaglia, Fabio, ]., Cucchetti, A., Trevisani, F., Pecorelli, A., Erroi, V., Farinati, F., Ciccarese, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Giannini, E. G., Zoli, M., Borzio, F., Cabibbo, G., Felder, M., Gasbarrini, A., Sacco, R., Foschi, F. G., Missale, G., Morisco, F., Baroni, G. S., Virdone, R., Bernardi, M., Pinna, A. D., Bolondi, L., Biselli, M., Caraceni, P., Garuti, F., Gramenzi, A., Lenzi, B., Magalotti, D., Piscaglia, F., Serra, C., Ravaioli, M., Venerandi, L., Del Poggio, P., Olmi, S., Balsamo, C., Di Nolfo, M. A., Vavassori, E., Alberti, A., Benvegnu, L., Gatta, A., Giacomin, A., Vanin, V., Pozzan, C., Maddalo, G., Giampalma, E., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Dell'Isola, S., Ialungo, A. M., Roselli, P., Risso, D., Marenco, S., Sammito, G., Bruzzone, L., Bosco, G., Grieco, A., Pompili, M., Rinninella, E., Siciliano, M., Chiaramonte, M., Guarino, M., Camma, C., Maida, M., Di Martino, A., Barcellona, M. R., Schiada, L., Gemini, S., Biasini, E., Porro, E., del Ricambio, M., Mismas, V., and Vivaldi, C.

Subjects
Male, medicine.medical_specialty, Pediatrics, Carcinoma, Hepatocellular, Time Factors, Hepatocellular carcinoma, Settore MED/12 - GASTROENTEROLOGIA, Disease, Gastroenterology, Bias, Internal medicine, Overall survival, medicine, Humans, Early Detection of Cancer, Aged, Estimation, Surveillance, Hepatology, business.industry, Liver Neoplasms, medicine.disease, digestive system diseases, Lead time bias, Cirrhosis, Female, business, Lead-time bias, Follow-Up Studies
Abstract

Lead-time is the time by which diagnosis is anticipated by screening/surveillance with respect to the symptomatic detection of a disease. Any screening program, including surveillance for hepatocellular carcinoma (HCC), is subject to lead-time bias. Data regarding lead-time for HCC are lacking. Aims of the present study were to calculate lead-time and to assess its impact on the benefit obtainable from the surveillance of cirrhotic patients. Background & Aims: Lead-time is the time by which diagnosis is anticipated by screening/surveillance with respect to the symptomatic detection of a disease. Any screening program, including surveillance for hepatocellular carcinoma (HCC), is subject to lead-time bias. Data regarding lead-time for HCC are lacking. Aims of the present study were to calculate lead-time and to assess its impact on the benefit obtainable from the surveillance of cirrhotic patients. Methods: One-thousand three-hundred and eighty Child–Pugh class A/B patients from the ITA.LI.CA database, in whom HCC was detected during semiannual surveillance (n = 850), annual surveillance (n = 234) or when patients came when symptomatic (n = 296), were selected. Lead-time was estimated by means of appropriate formulas and Monte Carlo simulation, including 1000 patients for each arm. Results: The 5-year overall survival after HCC diagnosis was 32.7% in semiannually surveilled patients, 25.2% in annually surveilled patients, and 12.2% in symptomatic patients (p

Published
2014

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