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2. Personalised management of patients with hepatocellular carcinoma: a multiparametric therapeutic hierarchy concept

Author

Vitale, A, Cabibbo, G, Iavarone, M, Vigano, L, Pinato, D, Ponziani, F, Lai, Q, Casadei-Gardini, A, Celsa, C, Galati, G, Gambato, M, Crocetti, L, Renzulli, M, Giannini, E, Farinati, F, Trevisani, F, Cillo, U, Baccarani, U, Brancaccio, G, Cozzolongo, R, Cucchetti, A, De Matthaeis, N, Di Sandro, S, Famularo, S, Finotti, M, Foschi, F, Ghinolfi, D, Guarracino, M, Gruttadauria, S, Guarino, M, Kostandini, A, Lenci, I, Levi Sandri, G, Manzia, T, Marasco, G, Masarone, M, Mazzarelli, C, Melandro, F, Miele, L, Morisco, F, Nicolini, D, Pagano, D, Pelizzaro, F, Pieri, G, Piscaglia, F, Plaz Torres, M, Pravisani, R, Rendina, M, Romano, F, Russo, F, Sacco, R, Sangiovanni, A, Sposito, C, Tortora, R, Tovoli, F, Vigano, M, Violi, P, Vitale A., Cabibbo G., Iavarone M., Vigano L., Pinato D. J., Ponziani F. R., Lai Q., Casadei-Gardini A., Celsa C., Galati G., Gambato M., Crocetti L., Renzulli M., Giannini E. G., Farinati F., Trevisani F., Cillo U., Baccarani U., Brancaccio G., Cozzolongo R., Cucchetti A., De Matthaeis N., Di Sandro S., Famularo S., Finotti M., Foschi F. G., Ghinolfi D., Guarracino M., Gruttadauria S., Guarino M., Kostandini A., Lenci I., Levi Sandri G. B., Manzia T. M., Marasco G., Masarone M., Mazzarelli C., Melandro F., Miele L., Morisco F., Nicolini D., Pagano D., Pelizzaro F., Pieri G., Piscaglia F., Plaz Torres M. C., Pravisani R., Rendina M., Romano F., Russo F. P., Sacco R., Sangiovanni A., Sposito C., Tortora R., Tovoli F., Vigano M., Violi P., Vitale, A, Cabibbo, G, Iavarone, M, Vigano, L, Pinato, D, Ponziani, F, Lai, Q, Casadei-Gardini, A, Celsa, C, Galati, G, Gambato, M, Crocetti, L, Renzulli, M, Giannini, E, Farinati, F, Trevisani, F, Cillo, U, Baccarani, U, Brancaccio, G, Cozzolongo, R, Cucchetti, A, De Matthaeis, N, Di Sandro, S, Famularo, S, Finotti, M, Foschi, F, Ghinolfi, D, Guarracino, M, Gruttadauria, S, Guarino, M, Kostandini, A, Lenci, I, Levi Sandri, G, Manzia, T, Marasco, G, Masarone, M, Mazzarelli, C, Melandro, F, Miele, L, Morisco, F, Nicolini, D, Pagano, D, Pelizzaro, F, Pieri, G, Piscaglia, F, Plaz Torres, M, Pravisani, R, Rendina, M, Romano, F, Russo, F, Sacco, R, Sangiovanni, A, Sposito, C, Tortora, R, Tovoli, F, Vigano, M, Violi, P, Vitale A., Cabibbo G., Iavarone M., Vigano L., Pinato D. J., Ponziani F. R., Lai Q., Casadei-Gardini A., Celsa C., Galati G., Gambato M., Crocetti L., Renzulli M., Giannini E. G., Farinati F., Trevisani F., Cillo U., Baccarani U., Brancaccio G., Cozzolongo R., Cucchetti A., De Matthaeis N., Di Sandro S., Famularo S., Finotti M., Foschi F. G., Ghinolfi D., Guarracino M., Gruttadauria S., Guarino M., Kostandini A., Lenci I., Levi Sandri G. B., Manzia T. M., Marasco G., Masarone M., Mazzarelli C., Melandro F., Miele L., Morisco F., Nicolini D., Pagano D., Pelizzaro F., Pieri G., Piscaglia F., Plaz Torres M. C., Pravisani R., Rendina M., Romano F., Russo F. P., Sacco R., Sangiovanni A., Sposito C., Tortora R., Tovoli F., Vigano M., and Violi P.

Abstract

Advances in the surgical and systemic therapeutic landscape of hepatocellular carcinoma have increased the complexity of patient management. A dynamic adaptation of the available staging-based algorithms is required to allow flexible therapeutic allocation. In particular, real-world hepatocellular carcinoma management increasingly relies on factors independent of oncological staging, including patients’ frailty, comorbid burden, critical tumour location, multiple liver functional parameters, and specific technical contraindications impacting the delivery of treatment and resource availability. In this Policy Review we critically appraise how treatment allocation strictly based on pretreatment staging features has shifted towards a more personalised treatment approach, in which expert tumour boards assume a central role. We propose an evidence-based framework for hepatocellular carcinoma treatment based on the novel concept of multiparametric therapeutic hierarchy, in which different therapeutic options are ordered according to their survival benefit (ie, from surgery to systemic therapy). Moreover, we introduce the concept of converse therapeutic hierarchy, in which therapies are ordered according to their conversion abilities or adjuvant abilities (ie, from systemic therapy to surgery).

Published
2023

3. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, Aghemo, A, Brancaccio G., Coco B., Nardi A., Quaranta M. G., Tosti M. E., Ferrigno L., Cacciola I., Messina V., Chessa L., Morisco F., Milella M., Barbaro F., Ciancio A., Russo F. P., Coppola N., Blanc P., Claar E., Verucchi G., Puoti M., Zignego A. L., Chemello L., Madonia S., Fagiuoli S., Marzano A., Ferrari C., Lampertico P., Di Marco V., Craxì A., Santantonio T. A., Raimondo G., Brunetto M. R., Gaeta G. B., Kondili L. A., Pasulo L., Coppola C., Pisano F., Romano M., Porcu C., Bottalico I. F., Cossiga V., Tata X., Sagnelli C., Pierotti P., Degasperi E., Rosato V., Badia L., Ieluzzi D., Monti M., Bavetta M. G., Cavalletto L., Toniutto P., Fornasiere E., Colecchia A., Ferrarese A., Nardone G., Rocco A., Viganò M., Foschi F. G., Conti F., Morsica G., Salpietro S., Torti C., Costa C., Federico A., Dallio M., Giorgini A., Anselmo M., De Leo P., Zaltron S., Cambianica A., Piscaglia F., Serio I., Schivazappa S., Mastroianni A., Chidichimo L., Massari M., Mazzaro C., Marrone A., D'Amore F. M., D'Offizi G., Licata A., Niro G. A., Pollicino T., Aghemo A., Brancaccio, G, Coco, B, Nardi, A, Quaranta, M, Tosti, M, Ferrigno, L, Cacciola, I, Messina, V, Chessa, L, Morisco, F, Milella, M, Barbaro, F, Ciancio, A, Russo, F, Coppola, N, Blanc, P, Claar, E, Verucchi, G, Puoti, M, Zignego, A, Chemello, L, Madonia, S, Fagiuoli, S, Marzano, A, Ferrari, C, Lampertico, P, Di Marco, V, Craxì, A, Santantonio, T, Raimondo, G, Brunetto, M, Gaeta, G, Kondili, L, Pasulo, L, Coppola, C, Pisano, F, Romano, M, Porcu, C, Bottalico, I, Cossiga, V, Tata, X, Sagnelli, C, Pierotti, P, Degasperi, E, Rosato, V, Badia, L, Ieluzzi, D, Monti, M, Bavetta, M, Cavalletto, L, Toniutto, P, Fornasiere, E, Colecchia, A, Ferrarese, A, Nardone, G, Rocco, A, Viganò, M, Foschi, F, Conti, F, Morsica, G, Salpietro, S, Torti, C, Costa, C, Federico, A, Dallio, M, Giorgini, A, Anselmo, M, De Leo, P, Zaltron, S, Cambianica, A, Piscaglia, F, Serio, I, Schivazappa, S, Mastroianni, A, Chidichimo, L, Massari, M, Mazzaro, C, Marrone, A, D'Amore, F, D'Offizi, G, Licata, A, Niro, G, Pollicino, T, Aghemo, A, Brancaccio G., Coco B., Nardi A., Quaranta M. G., Tosti M. E., Ferrigno L., Cacciola I., Messina V., Chessa L., Morisco F., Milella M., Barbaro F., Ciancio A., Russo F. P., Coppola N., Blanc P., Claar E., Verucchi G., Puoti M., Zignego A. L., Chemello L., Madonia S., Fagiuoli S., Marzano A., Ferrari C., Lampertico P., Di Marco V., Craxì A., Santantonio T. A., Raimondo G., Brunetto M. R., Gaeta G. B., Kondili L. A., Pasulo L., Coppola C., Pisano F., Romano M., Porcu C., Bottalico I. F., Cossiga V., Tata X., Sagnelli C., Pierotti P., Degasperi E., Rosato V., Badia L., Ieluzzi D., Monti M., Bavetta M. G., Cavalletto L., Toniutto P., Fornasiere E., Colecchia A., Ferrarese A., Nardone G., Rocco A., Viganò M., Foschi F. G., Conti F., Morsica G., Salpietro S., Torti C., Costa C., Federico A., Dallio M., Giorgini A., Anselmo M., De Leo P., Zaltron S., Cambianica A., Piscaglia F., Serio I., Schivazappa S., Mastroianni A., Chidichimo L., Massari M., Mazzaro C., Marrone A., D'Amore F. M., D'Offizi G., Licata A., Niro G. A., Pollicino T., and Aghemo A.

Abstract

Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy. Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used. Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P <0.0001) and that of anti-hepatitis D virus (HDV) remained stable (9.3% vs 8.3%). In both cohorts, about 25% of the patients had cirrhosis, and those in the PITER cohort were older. HBeAg-positive was 5.0% vs 12.6% (P <0.0001) and anti-HDV positive 24.8% vs 17.5% (P <0.0017). In the logistic model, the variables associated with cirrhosis were anti-HDV-positive (odds ratio = 10.08; confidence interval 7.63-13.43), age, sex, and body mass index; the likelihood of cirrhosis was reduced by 40% in the PITER cohort. Among non-Italians, 12.3% were HBeAg-positive (vs 23.4% in the MASTER cohort; P <0.0001), and 12.3% were anti-HDV-positive (vs 11.1%). Overall, the adherence to the European Association for the Study of the Liver recommendations for antiviral treatment increased over time. Conclusion: Chronic hepatitis B virus infection appears to be in the process of becoming under control in Italy; however, HDV infection is still a health concern in patients with cirrhosis and in migrants.

Published
2023

4. Analysis of Patients’ Characteristics and Treatment Profile of People Who Use Drugs (PWUDs) with and without a Co-Diagnosis of Viral Hepatitis C: A Real-World Retrospective Italian Analysis

Author

Nava, F, Mangia, A, Riglietta, M, Somaini, L, Foschi, F, Claar, E, Maida, I, Ucciferri, C, Frigerio, F, Hernandez, C, Dovizio, M, Perrone, V, Degli Esposti, L, Puoti, M, Nava F. A., Mangia A., Riglietta M., Somaini L., Foschi F. G., Claar E., Maida I., Ucciferri C., Frigerio F., Hernandez C., Dovizio M., Perrone V., Degli Esposti L., Puoti M., Nava, F, Mangia, A, Riglietta, M, Somaini, L, Foschi, F, Claar, E, Maida, I, Ucciferri, C, Frigerio, F, Hernandez, C, Dovizio, M, Perrone, V, Degli Esposti, L, Puoti, M, Nava F. A., Mangia A., Riglietta M., Somaini L., Foschi F. G., Claar E., Maida I., Ucciferri C., Frigerio F., Hernandez C., Dovizio M., Perrone V., Degli Esposti L., and Puoti M.

Abstract

Purpose: Hepatitis C virus (HCV) spreads from contact with blood of an infected person. HCV infections are common among people who use drugs (PWUDs), when sharing needles, syringes, or other equipment for injected drugs. The advent of pangenotypic direct-antiviral agents (DAA) in 2017 transformed the treatment landscape for HCV, but PWUDs remain a complex and hard-to-treat population with high risk of HCV reinfection. The aim of this real-world analysis was to characterize the demographic and clinical features of PWUDs in Italy, also focusing on comorbidity profile, treatment with DAAs, resource consumptions for the National Health System (NHS). Patients and Methods: During 01/2011–06/2020, administrative databases of Italian healthcare entities, covering 3,900,000 individuals, were browsed to identify PWUDs with or without HCV infection. Among HCV+ patients, a further stratification was made into treated and untreated with DAAs. The date of PWUD or HCV first diagnosis or DAA first prescription was considered as index-date. Patients were then followed-up for one year. Alcohol-dependency was also investigated. Results: Total 3690 PWUDs were included, of whom 1141 (30.9%) PWUD-HCV+ and 2549 (69.1%) PWUD-HCV-. HCV-positive were significantly older (43.6 vs 38.5 years, p < 0.001), had a worse comorbidity profile (Charlson-index: 0.8 vs 0.4, p < 0.001), and high rates of psychiatric, respiratory, dermatological, musculoskeletal diseases and genitourinary (sexually transmitted) infections. Moreover, they received more drug prescriptions (other than DAAs, like anti-acids, antiepileptics, psycholeptics) and had undergone more frequent hospitalization, predominantly for hepatobiliary, respiratory system and mental disorders. DDA-untreated had significantly higher Charlson-index than DAA-treated (0.9 vs 0.6, p = 0.003). Alcoholism was found in 436 (11.8%) cases. Conclusion: This Italian real-world analysis suggests that PWUDs with HCV infection, especially those untreat

Published
2023

6. Incidence and risk factors of esophagogastric varices bleeding in cirrhotic patients with advanced hepatocellular carcinoma treated with lenvatinib

Author

Iavarone, M., primary, Alimenti, E., additional, Tada, T., additional, Shimose, S., additional, Suda, G., additional, Yoo, C., additional, Soldà, C., additional, Piscaglia, F., additional, Casadei-Gardini, A., additional, Marra, F., additional, Vivaldi, C., additional, Conti, F., additional, Schirripa, M., additional, Iwamoto, H., additional, Sho, T., additional, Lee, So Heun, additional, Rizzato, M.D., additional, Tonnini, M., additional, Rimini, M., additional, Campani, C., additional, Masi, G., additional, Foschi, F., additional, Bruccoleri, M., additional, Kawaguchi, T., additional, Kumada, T., additional, Hiraoka, A., additional, Atsukawa, M., additional, Fukunishi, S., additional, Ishikawa, T., additional, Tajiri, K., additional, Ochi, H., additional, Yasuda, S., additional, Toyoda, H., additional, Hatanaka, T., additional, Kakizaki, S., additional, Kawata, K., additional, Tada, F., additional, Ohama, H., additional, Itokawa, N., additional, Okubo, T., additional, Arai, T., additional, Imai, M., additional, Naganuma, A., additional, Tosetti, G., additional, and Lampertico, P., additional

Published
2023
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7. Structure-activity exploration of a small-molecule allosteric inhibitor of T790M/L858R double mutant EGFR

Author

Foschi, F, Tinivella, A, Crippa, V, Pinzi, L, Mologni, L, Passarella, D, Rastelli, G, Foschi, Francesca, Tinivella, Annachiara, Crippa, Valentina, Pinzi, Luca, Mologni, Luca, Passarella, Daniele, Rastelli, Giulio, Foschi, F, Tinivella, A, Crippa, V, Pinzi, L, Mologni, L, Passarella, D, Rastelli, G, Foschi, Francesca, Tinivella, Annachiara, Crippa, Valentina, Pinzi, Luca, Mologni, Luca, Passarella, Daniele, and Rastelli, Giulio

Abstract

EGFR is a protein kinase whose aberrant activity is frequently involved in the development of non-small lung cancer (NSCLC) drug resistant forms. The allosteric inhibition of this enzyme is currently one among the most attractive approaches to design and develop anticancer drugs. In a previous study, we reported the identification of a hit compound acting as type III allosteric inhibitor of the L858R/T790M double mutant EGFR. Herein, we report the design, synthesis and in vitro testing of a series of analogues of the previously identified hit with the aim of exploring the structure-activity relationships (SAR) around this scaffold. The performed analyses allowed us to identify two compounds 15 and 18 showing improved inhibition of double mutant EGFR with respect to the original hit, as well as interesting antiproliferative activity against H1975 NSCLC cancer cells expressing double mutant EGFR. The newly discovered compounds represent promising starting points for further hit-to-lead optimisation.

Published
2023

8. Missed treatment in an Italian HBV infected patients cohort: HBV RER

Author

Ferrari, C., Giuberti, T., Villa, E., Andreone, P., Pietrangelo, A., Abbati, G., Magnani, G., Massari, M., Verucchi, G., Cancellieri, C., Ricca Rosellini, S., Levantesi, F., Mazzella, G., Sacchini, D., Fornaciari, G., Mussini, C., Borghi, V., Foschi, F., Libanore, M., Carradori, S.D., Contini, C., Ballardini, G., Macchia, S., Boccia, S., Vandelli, C., Bassi, P., Zanotti, M., Loria, P., Sbolli, G., Fornari, F., di Maira, P.V., Bellentani, S., Arlotti, M., Grosso, C., Bolondi, G., Pazzi, P., Mazzocchi, A., Govoni, A., Fusaroli, P., Giacomoni, P.L., Lenzi, M., Pedretti, G., Cuomo, Gianluca, Borghi, Vanni, Andreone, Pietro, Massari, Marco, Villa, Erica, Pietrangelo, Antonello, Verucchi, Gabriella, and Ferrari, Carlo

Published
2016
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9. Dual Modulators

Author

Tinivella, A., primary, Nwachukwu, J.C., additional, Angeli, A., additional, Foschi, F., additional, Benatti, A.L., additional, Pinzi, L., additional, Izard, T., additional, Ferraroni, M., additional, Rangarajan, E.S., additional, Christodoulou, M., additional, Passarella, D., additional, Supuran, C., additional, Nettles, K.W., additional, and Rastelli, G., additional

Published
2022
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10. The role of antiplatelet therapies on incidence and mortality of hepatocellular carcinoma

Author

Lai, Q., De Matthaeis, N., Finotti, M., Galati, G., Marrone, G., Melandro, F., Morisco, F., Nicolini, D., Pravisani, R., Giannini, E. G., Aglitti, A., Aliberti, C., Baccarani, U., Bhoori, S., Borzio, M., Brancaccio, G., Burra, P., Cabibbo, G., Casadei Gardini, A., Carrai, P., Cillo, U., Conti, F., Cucchetti, A., D'Ambrosio, R., Dell'Unto, C., Di Costanzo, G. G., Di Sandro, S., Foschi, F. G., Fucilli, F., Gambato, M., Gasbarrini, A., Giuliante, F., Ghinolfi, D., Grieco, A., Gruttaduria, S., Guarino, M., Kostandini, A., Iavarone, M., Lenci, I., Levi Sandri, G. B., Losito, F., Lupo, L. G., Manzia, T. M., Mazzocato, S., Mescoli, C., Miele, L., Muley, M., Persico, M., Plaz Torres, M. C., Pompili, M., Ponziani, F. R., Rapaccini, G. L., Rendina, M., Renzulli, M., Rossi, M., Rreka, E., Russo, F. P., Sacco, R., Sangiovanni, A., Sessa, A., Simonetti, N., Sposito, C., Tortora, R., Trevisani, F., Vigano, L., Vigano, M., Villa, E., Vincenzi, V., Violi, P., and Vitale, A.

Subjects
clopidogrel, aspirin, Clinical Biochemistry, incidence, occurrence, survival, General Medicine, Biochemistry, Settore MED/18
Abstract

To evaluate the impact of antiplatelet therapy (APT)on the incidence of hepatocellular carcinoma (HCC) and mortality following its treatment.A systematic literature search was performed using PubMed and Cochrane Central Register of Controlled Trials Databases. Two HCC clinical settings were explored: (i) incidence, and (ii) death after any HCC treatment. Odds ratios (OR) and 95% confidence intervals (95%CI) were calculated to compare the pooled data between patients who received or did not receive APT.A total of 20 studies were identified, of whom 15 focused on HCC incidence, including 2,685,009 patients, and five on post-treatment death, including 3281 patients. APT was associated with an overall reduced risk of HCC incidence (OR: 0.63; 95%CI = 0.51-0.79; p 0.001) as well as of post-treatment mortality (OR: 0.54; 95%CI = 0.35-0.83; p = 0.006).Current data suggest that APT correlated with higher HCC incidence and poor overall survival following tumour treatment.

Published
2023

11. Overview of prognostic systems for hepatocellular carcinoma and ITA.LI.CA external validation of MESH and CNLC classifications

Author

Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, E, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, G, Di Sandro, S, Famularo, S, Foschi, F, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, G, Losito, F, Lupo, L, Marasco, G, Manzia, T, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, F, Pravisani, R, Rapaccini, G, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, F, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, M, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E. G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G. G., Di Sandro S., Famularo S., Foschi F. G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G. V., Losito F., Lupo L. G., Marasco G., Manzia T. M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F. R., Pravisani R., Rapaccini G. L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F. P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M. R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., Zoli M., Vitale, A, Farinati, F, Finotti, M, Di Renzo, C, Brancaccio, G, Piscaglia, F, Cabibbo, G, Caturelli, E, Missale, G, Marra, F, Sacco, R, Giannini, E, Trevisani, F, Cillo, U, Bhoori, S, Borzio, M, Burra, P, Casadei Gardini, A, Carrai, P, Conti, F, Cozzolongo, R, Cucchetti, A, D'Ambrosio, R, Dell'Unto, C, De Matthaeis, N, Di Costanzo, G, Di Sandro, S, Famularo, S, Foschi, F, Fucilli, F, Galati, G, Gambato, M, Gasbarrini, A, Giuliante, F, Ghinolfi, D, Grieco, A, Gruttadauria, S, Guarino, M, Iavarone, M, Kostandini, A, Lai, Q, Lenci, I, Levi Sandri, G, Losito, F, Lupo, L, Marasco, G, Manzia, T, Mazzocato, S, Masarone, M, Melandro, F, Mescoli, C, Miele, L, Morisco, F, Muley, M, Nicolini, D, Pagano, D, Persico, M, Pompili, M, Ponziani, F, Pravisani, R, Rapaccini, G, Rendina, M, Renzulli, M, Romano, F, Rossi, M, Rreka, E, Russo, F, Sangiovanni, A, Sessa, A, Simonetti, N, Sposito, C, Tortora, R, Vigano, L, Vigano, M, Villa, E, Vincenzi, V, Violi, P, Azzaroli, F, Brunetto, M, Di Marco, A, Masotto, A, Mega, A, Nardone, G, Oliveri, F, Raimondo, G, Svegliati Baroni, G, Vidili, G, Zoli, M, Vitale A., Farinati F., Finotti M., Di Renzo C., Brancaccio G., Piscaglia F., Cabibbo G., Caturelli E., Missale G., Marra F., Sacco R., Giannini E. G., Trevisani F., Cillo U., Bhoori S., Borzio M., Burra P., Casadei Gardini A., Carrai P., Conti F., Cozzolongo R., Cucchetti A., D'ambrosio R., Dell'unto C., De Matthaeis N., Di Costanzo G. G., Di Sandro S., Famularo S., Foschi F. G., Fucilli F., Galati G., Gambato M., Gasbarrini A., Giuliante F., Ghinolfi D., Grieco A., Gruttadauria S., Guarino M., Iavarone M., Kostandini A., Lai Q., Lenci I., Levi Sandri G. V., Losito F., Lupo L. G., Marasco G., Manzia T. M., Mazzocato S., Masarone M., Melandro F., Mescoli C., Miele L., Morisco F., Muley M., Nicolini D., Pagano D., Persico M., Pompili M., Ponziani F. R., Pravisani R., Rapaccini G. L., Rendina M., Renzulli M., Romano F., Rossi M., Rreka E., Russo F. P., Sangiovanni A., Sessa A., Simonetti N., Sposito C., Tortora R., Vigano L., Vigano M., Villa E., Vincenzi V., Violi P., Azzaroli F., Brunetto M. R., Di Marco A., Masotto A., Mega A., Nardone G., Oliveri F., Raimondo G., Svegliati Baroni G., Vidili G., and Zoli M.

Abstract

Prognostic assessment in patients with HCC remains an extremely difficult clinical task due to the complexity of this cancer where tumour characteristics interact with degree of liver dysfunction, patient general health status, and a large span of available treatment options. Several prognostic systems have been proposed in the last three decades, both from the Asian and European/North American countries. Prognostic scores, such as the CLIP score and the recent MESH score, have been generated on a solid statistical basis from real life population data, while staging systems, such as the BCLC scheme and the recent CNLC classification, have been created by experts according to recent HCC prognostic evidences from the literature. A third category includes combined prognostic systems that can be used both as prognostic scores and staging systems. A recent example is the ITA.LI.CA prognostic system including either a prognostic score and a simplified staging system. This review focuses first on an overview of the main prognostic systems for HCC classified according to the above three categories, and, second, on a comprehensive description of the methodology required for a correct comparison between different systems in terms of prognostic performance. In this second section the main studies in the literature comparing different prognostic systems are described in detail. Lastly, a formal comparison between the last prognostic systems proposed for each of the above three categories is performed using a large Italian database including 6882 HCC patients in order to concretely apply the comparison rules previously described.

Published
2021

12. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., and Andrealli A.

Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay

Published
2021

16. Hepatectomy Versus Sorafenib in Advanced Non-Metastatic Hepatocellular Carcinoma: A Real-Life Multicentric Weighted Comparison

Author

Famularo, S, Donadon, M, Cipriani, F, Giuliante, F, Ferri, S, Celsa, C, Ferrero, A, Foschi, F, Baiocchi, G, Biasini, E, Campani, C, Valle, R, Pellizzaro, F, Baroni, G, Raimondo, G, Mega, A, Chiarelli, M, Maestri, M, Gasbarrini, A, Jovine, E, Grazi, G, Rapaccini, G, Ruzzenente, A, Morisco, F, Sacco, R, Memeo, R, Crespi, M, Antonucci, A, Bernasconi, D, Romano, F, Griseri, G, Aldrighetti, L, Torzilli, G, Trevisani, F, Famularo, Simone, Donadon, Matteo, Cipriani, Federica, Giuliante, Felice, Ferri, Silvia, Celsa, Ciro, Ferrero, Alessandro, Foschi, Francesco Giuseppe, Baiocchi, Gian Luca, Biasini, Elisabetta, Campani, Claudia, Valle, Raffaele Dalla, Pellizzaro, Filippo, Baroni, Gianluca Svegliati, Raimondo, Giovanni, Mega, Andrea, Chiarelli, Marco, Maestri, Marcello, Gasbarrini, Antonio, Jovine, Elio, Grazi, Gian Luca, Rapaccini, Gian Ludovico, Ruzzenente, Andrea, Morisco, Filomena, Sacco, Rodolfo, Memeo, Riccardo, Crespi, Michele, Antonucci, Adelmo, Bernasconi, Davide P, Romano, Fabrizio, Griseri, Guido, Aldrighetti, Luca, Torzilli, Guido, Trevisani, Franco, Famularo, S, Donadon, M, Cipriani, F, Giuliante, F, Ferri, S, Celsa, C, Ferrero, A, Foschi, F, Baiocchi, G, Biasini, E, Campani, C, Valle, R, Pellizzaro, F, Baroni, G, Raimondo, G, Mega, A, Chiarelli, M, Maestri, M, Gasbarrini, A, Jovine, E, Grazi, G, Rapaccini, G, Ruzzenente, A, Morisco, F, Sacco, R, Memeo, R, Crespi, M, Antonucci, A, Bernasconi, D, Romano, F, Griseri, G, Aldrighetti, L, Torzilli, G, Trevisani, F, Famularo, Simone, Donadon, Matteo, Cipriani, Federica, Giuliante, Felice, Ferri, Silvia, Celsa, Ciro, Ferrero, Alessandro, Foschi, Francesco Giuseppe, Baiocchi, Gian Luca, Biasini, Elisabetta, Campani, Claudia, Valle, Raffaele Dalla, Pellizzaro, Filippo, Baroni, Gianluca Svegliati, Raimondo, Giovanni, Mega, Andrea, Chiarelli, Marco, Maestri, Marcello, Gasbarrini, Antonio, Jovine, Elio, Grazi, Gian Luca, Rapaccini, Gian Ludovico, Ruzzenente, Andrea, Morisco, Filomena, Sacco, Rodolfo, Memeo, Riccardo, Crespi, Michele, Antonucci, Adelmo, Bernasconi, Davide P, Romano, Fabrizio, Griseri, Guido, Aldrighetti, Luca, Torzilli, Guido, and Trevisani, Franco

Abstract

OBJECTIVE: The aim of the study was to compare SURG vs SOR regarding the OS and progression-free survival (PFS) in a real-world clinical scenario. BACKGROUND DATA: The treatment for advanced nonmetastatic HCC belonging to the Barcelona Clinic Liver Cancer stage C (BCLC C) is still controversial. METHODS: BCLC C patients without extrahepatic spread and tumoral invasion of the main portal trunk were considered. Surgical patients were obtained from the HE.RC.O.LE.S. Register, whereas sorafenib patients were obtained from the ITA.LI.CA register The inverse probability weighting (IPW) method was adopted to balance the confounders between the 2 groups. RESULTS: Between 2008 and 2019, 478 patients were enrolled: 303 in SURG and 175 in SOR group. Eastern Cooperative Oncological Group Performance Status (ECOG-PS), presence of cirrhosis, steatosis, Child-Pugh grade, hepatitis B virus and hepatitis C virus, alcohol intake, collateral veins, bilobar disease, localization of the tumor thrombus, number of nodules, alpha-fetoprotein, age, and Charlson Comorbidity index were weighted by IPW to create two balanced pseudo-populations: SURG = 374 and SOR = 263. After IPW, 1-3-5 years OS was 83.6%, 68.1%, 55.9% for SURG, and 42.3%, 17.8%, 12.8% for SOR (P [removed]0, and by the intrahepatic location of portal vein invasion. At Cox regression, sorafenib treatment (hazard ratio 4.436; 95% confidence interval 3.19-6.15; P < 0.001) and Charlson Index (hazard ratio 1.162; 95% confidence interval 1.06-1.27; P = 0.010) were the only independent predictors of mortality. PFS at 1-3-5 years were 65.9%, 40.3%, 24.3% for SURG and 21.6%, 3.5%, 2.9% for SOR (P = 0.007). CONCLUSIONS: In BCLC C patients without extrahepatic spread but with intrahepatic portal invasion, liver resection, if feasible, was followed by better OS and PFS compared with sorafenib.

Published
2022

17. Long‐term outcomes of direct acting antivirals in post‐transplant advanced hepatitis C virus recurrence and fibrosing cholestatic hepatitis

Author

Vukotic, R., Conti, F., Fagiuoli, S., Morelli, M. C., Pasulo, L., Colpani, M., Foschi, F. G., Berardi, S., Pianta, P., Mangano, M., Donato, M. F., Malinverno, F., Monico, S., Tamè, M., Mazzella, G., Belli, L. S., Viganò, R., Carrai, P., Burra, P., Russo, F. P., Lenci, I., Toniutto, P., Merli, M., Loiacono, L., Iemmolo, R., Degli Antoni, A. M., Romano, A., Picciotto, A., Rendina, M., and Andreone, P.

Published
2017
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18. Hepatocellular carcinoma recurrence in patients with curative resection or ablation: impact of HCV eradication does not depend on the use of interferon

Author

Petta, S., Cabibbo, G., Barbara, M., Attardo, S., Bucci, L., Farinati, F., Giannini, E. G., Tovoli, F., Ciccarese, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Virdone, R., Marra, F., Felder, M., Morisco, F., Benvegnù, L., Gasbarrini, A., Svegliati‐Baroni, G., Foschi, F. G., Olivani, A., Masotto, A., Nardone, G., Colecchia, A., Persico, M., Boccaccio, V., Craxì, A., Bruno, S., Trevisani, F., Cammà, C., Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Domenicali, Marco, Piscaglia, Fabio, Gramenzi, Annagiulia, Granito, Alessandro, Magalotti, Donatella, Serra, Carla, Negrini, Giulia, Napoli, L., Napoli, Lucia, Salvatore, Veronica, Benevento, Francesca, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Poggio, Paolo Del, Olmi, Stefano, de Matthaeis, Nicoletta, Balsamo, Claudia, Vavassori, Elena, Roselli, Paola, DellʼIsola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Rini, Francesca, Costantino, Andrea, Affronti, Andrea, Affronti, Marco, Mascari, Marta, Mega, Andrea, Pompili, Maurizio, Rinninella, Emanuele, Mismas, Valeria, DallʼAglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Biasini, Elisabetta, Missale, Gabriele, Guarino, Maria, Ortolani, Alessio, Chiaramonte, Maria, Marchetti, Fabiana, Valerio, Matteo, Aburas, Sami, Inghilesi, Andrea L., Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Coccoli, Piero, and Zamparelli, Marco Sanduzzi

Published
2017
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19. A regional audit system for stillbirth: a way to better understand the phenomenon

Author

Po G., Monari F., Zanni F., Grandi G., Lupi C., Facchinetti F., Mancini L., Lugli L., Lanzoni C., Sgarbi L., Chiossi C., Ricchieri F., Roberta C., Contiero R., Garani G., Pedriali M., Rossi S., Fini S., Di Bartolo M., Radi D., Vancini A., Donati A., Guadalupi E., Righetti F., Salerno A., Cocchi G., Morandi R., Gabrielli L., Graziano C., Seri M., Caprara G., Mario S. N. C., Fantuz F., Ferlini F., Righi E., Silvestrini D., Foschi F., Fieni S., Frusca T., Ferretti A., Galli L., Magnani C., Silini E., Balduzzi L., Bellini M., Rodolfi A. M., Sgarabotto M. P., Fragni G., Comitini G., Bonasoni M. P., Fioroni L., Rozzi C., Tuzio A., Vito I., Mammoliti P., De Ambrosi E., Ricci M., Bandini A., Belosi C., Muratori C., Zago S., Turci A., Vitarelli M., Po G., Monari F., Zanni F., Grandi G., Lupi C., Facchinetti F., Mancini L., Lugli L., Lanzoni C., Sgarbi L., Chiossi C., Ricchieri F., Roberta C., Contiero R., Garani G., Pedriali M., Rossi S., Fini S., Di Bartolo M., Radi D., Vancini A., Donati A., Guadalupi E., Righetti F., Salerno A., Cocchi G., Morandi R., Gabrielli L., Graziano C., Seri M., Caprara G., Mario S.N.C., Fantuz F., Ferlini F., Righi E., Silvestrini D., Foschi F., Fieni S., Frusca T., Ferretti A., Galli L., Magnani C., Silini E., Balduzzi L., Bellini M., Rodolfi A.M., Sgarabotto M.P., Fragni G., Comitini G., Bonasoni M.P., Fioroni L., Rozzi C., Tuzio A., Vito I., Mammoliti P., De Ambrosi E., Ricci M., Bandini A., Belosi C., Muratori C., Zago S., Turci A., and Vitarelli M.

Subjects
Clinical audit, Multivariate analysis, Placenta Diseases, Perinatal Death, Eastern, Umbilical Cord, Africa, Northern, Pregnancy, Risk Factors, Cause of Death, Northern, Europe, Eastern, Pregnancy Complications, Infectious, Multivariate Analysi, Causes of death, Cause of death, Fetal Growth Retardation, Obstetrics, Placenta Disease, Infectious, Obstetrics and Gynecology, Stillbirth, Perinatal audit, Quality of care, Adult, Africa South of the Sahara, Clinical Audit, Female, Fetal Death, Fetal Diseases, Humans, India, Italy, Multivariate Analysis, Pregnancy Complications, Quality of Health Care, Pregnancy Complication, Europe, Gestation, Human, Research Article, medicine.medical_specialty, Reproductive medicine, Fetal Disease, Audit, lcsh:Gynecology and obstetrics, medicine, lcsh:RG1-991, Late Stillbirth, business.industry, Risk Factor, medicine.disease, Africa, Pregnancy Complications, Infectiou, business
Abstract

Background Implementation of high-quality national audits for perinatal mortality are needed to improve the registration of all perinatal deaths and the identification of the causes of death. This study aims to evaluate the implementation of a Regional Audit System for Stillbirth in Emilia-Romagna Region, Italy. Methods For each stillbirth (≥ 22 weeks of gestation, ≥ 500 g) occurred between January 1, 2014 to December 1, 2016 (n = 332), the same diagnostic workup was performed and a clinical record with data about mother and stillborn was completed. Every case was discussed in a multidisciplinary local audit to assess both the cause of death (ReCoDe classification) and the quality of care. Data were reviewed by the Regional Audit Group. Stillbirth rates, causes of death and the quality of care were established for each case. Results Total stillbirth rate was 3.09 per 1000 births (332/107,528). Late stillbirth rate was 2.3 per 1000 (251/107,087). Sixteen stillbirths were not registered by the Regional Birth Register. The most prevalent cause of death was placental disorder (33.3%), followed by fetal (17.6%), cord (14.2%) and maternal disorders (7.6%). Unexplained cases were 14%. Compared to local audits, the regional group attributed different causes of death in 17% of cases. At multivariate analysis, infections were associated with early stillbirths (OR 3.38, CI95% 1.62–7.03) and intrapartum cases (OR 6.64, CI95% 2.61–17.02). Placental disorders were related to growth restriction (OR 1.89, CI95% 1.06–3.36) and were more frequent before term (OR 1.86, CI95% 1.11–3.15). Stillbirths judged possibly/probably preventable with a different management (10.9%) occurred more frequently in non-Italian women and were mainly related to maternal disorders (OR 6.64, CI95% 2.61–17.02). Conclusions Regional Audit System for Stillbirth improves the registration of stillbirth and allows to define the causes of death. Moreover, sub-optimal care was recognized, allowing to identify populations which could benefit from preventive measures.

Published
2019

20. Is there an association between commonly employed biomarkers of liver fibrosis and liver stiffness in the general population?

Author

Foschi F. G., Domenicali M., Giacomoni P., Dall'Aglio A. C., Conti F., Borghi A., Bevilacqua V., Napoli L., Mirici F., Cucchetti A., Ercolani G., Gardini A. C., Bellentani S., Gastaldelli A., Giuffre M., Tiribelli C., Bedogni G., BEDOGNI, GIORGIO, Foschi F.G., Domenicali M., Giacomoni P., Dall'Aglio A.C., Conti F., Borghi A., Bevilacqua V., Napoli L., Mirici F., Cucchetti A., Ercolani G., Gardini A.C., Bellentani S., Gastaldelli A., Giuffre M., Tiribelli C., and Bedogni G.

Subjects
Liver Cirrhosis, Male, Percentile, Cross-sectional study, Epidemiology, Specialties of internal medicine, Chronic liver disease, Gastroenterology, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Medicine, Metabolic Syndrome, education.field_of_study, Elasticity imaging technique, Alanine Transaminase, gamma-Glutamyltransferase, General Medicine, Middle Aged, RC581-951, 030220 oncology & carcinogenesis, Elasticity Imaging Techniques, Biomarker (medicine), Female, 030211 gastroenterology & hepatology, Fatty Liver, Alcoholic, Adult, medicine.medical_specialty, Population, Liver fibrosis, 03 medical and health sciences, Internal medicine, BAAT, Humans, Clinical significance, Aspartate Aminotransferases, Obesity, education, Hepatology, Platelet Count, business.industry, Cholesterol, HDL, Cholesterol, LDL, Biomarker, Overweight, medicine.disease, business, Transient elastography, Biomarkers
Abstract

Introduction and objectives Surrogate biomarkers of liver fibrosis developed in tertiary care are increasingly used in general populations. We evaluated the association between liver stiffness (LS) and five continuous (AST/ALT, APRI, Forns Index, FIB-4, GGT) and two discrete biomarkers (BARD, BAAT) in a general population. Patients and methods 636 (29%) of the 2159 citizens of the Bagnacavallo Study had LS measured by transient elastography. Using linear regression with univariate multiple imputation, we evaluated the association of LS with the above biomarkers in the total sample of 2159 citizens. Results The mean change of LS between the 5th and 95th internal percentile of any continuous biomarker was ≤1 kPa. The mean change of LS between scores 0 and 3 of BARD and scores 0 and ≥3 of BAAT was >1 kPa but of doubtful clinical relevance. Conclusion We found a modest association between LS and seven biomarkers of liver fibrosis in a general population.

Published
2020

21. Quality of life in liver transplant recipients during the Corona virus disease 19 pandemic: A multicentre study

Author

Gitto, S., Golfieri, L., Mannelli, N., Tame, M. R., Lopez, I., Ceccato, R., Montanari, S., Falcini, M., Vitale, G., De Maria, N., Presti, D. L., Marzi, L., Mega, A., Valente, G., Borghi, A., Foschi, F. G., Grandi, S., Forte, P., Cescon, M., Di Benedetto, F., Andreone, P., Arcangeli, G., De Simone, P., Bonacchi, A., Sofi, F., Morelli, M. C., Petranelli, M., Lau, C., Marra, F., Chiesi, F., Vizzutti, F., Vero, V., Di Donato, R., Berardi, S., Pianta, P., D'Anzi, S., Schepis, F., Gualandi, N., Miceli, F., Villa, E., Piai, G., Valente, M., Campani, C., Lynch, E., Magistri, P., Cursaro, C., Chiarelli, A., Carrai, P., Petruccelli, S., Dinu, M., and Pagliai, G.

Subjects
liver transplant, Hepatology, quality of life, COVID-19
Published
2022

22. Pattern of macrovascular invasion in hepatocellular carcinoma

Author

Guarino, M., Cucchetti, A., Pontillo, G., Farinati, F., Benevento, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Rodolfo, S., Cabibbo, G., Marra, F., Mega, A., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Giannini, E. G., Morisco, F., Biselli, M., Caraceni, P., Garuti, F., Gramenzi, A., Neri, A., Rampoldi, D., Santi, V., Forgione, A., Granito, A., Muratori, L., Piscaglia, F., Sansone, V., Tovoli, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Cela, E. M., Facciorusso, A., Pelizzaro, F., Imondi, A., Sartori, A., Penzo, B., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., Pieri, G., de Matthaeis, N., Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Olivari, A., Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Borghi, A., Gardini, A. C., Conti, F., Berardinelli, D., Ercolani, G., Napoli, L., Campani, C., Di Bonaventura, C., Gitto, S., Coccoli, P., Malerba, A., Capasso, M., Fiorentino, A., Pignata, L., Cossiga, V., Romagnoli, V., Guarino M., Cucchetti A., Pontillo G., Farinati F., Benevento F., Rapaccini G.L., Di Marco M., Caturelli E., Zoli M., Rodolfo S., Cabibbo G., Marra F., Mega A., Gasbarrini A., Svegliati-Baroni G., Foschi F.G., Missale G., Masotto A., Nardone G., Raimondo G., Azzaroli F., Vidili G., Oliveri F., Trevisani F., Giannini E.G., Morisco F., Biselli M., Caraceni P., Garuti F., Gramenzi A., Neri A., Rampoldi D., Santi V., Forgione A., Granito A., Muratori L., Piscaglia F., Sansone V., Tovoli F., Dajti E., Marasco G., Ravaioli F., Cappelli A., Golfieri R., Mosconi C., Renzulli M., Cela E.M., Facciorusso A., Pelizzaro F., Imondi A., Sartori A., Penzo B., Cacciato V., Casagrande E., Moscatelli A., Pellegatta G., Pieri G., de Matthaeis N., Allegrini G., Lauria V., Ghittoni G., Pelecca G., Chegai F., Coratella F., Ortenzi M., Olivari A., Inno A., Marchetti F., Busacca A., Camma C., Di Martino V., Rizzo G.E.M., Franze M.S., Saitta C., Sauchella A., Bevilacqua V., Borghi A., Gardini A.C., Conti F., Berardinelli D., Ercolani G., Napoli L., Campani C., Di Bonaventura C., Gitto S., Coccoli P., Malerba A., Capasso M., Fiorentino A., Pignata L., Cossiga V., Romagnoli V., Guarino, M., Cucchetti, A., Pontillo, G., Farinati, F., Benevento, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Rodolfo, S., Cabibbo, G., Marra, F., Mega, A., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Giannini, E. G., Morisco, F., Biselli, M., Caraceni, P., Garuti, F., Gramenzi, A., Neri, A., Rampoldi, D., Santi, V., Forgione, A., Granito, A., Muratori, L., Piscaglia, F., Sansone, V., Tovoli, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Cela, E. M., Facciorusso, A., Pelizzaro, F., Imondi, A., Sartori, A., Penzo, B., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., Pieri, G., de Matthaeis, N., Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Olivari, A., Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Borghi, A., Gardini, A. C., Conti, F., Berardinelli, D., Ercolani, G., Napoli, L., Campani, C., Di Bonaventura, C., Gitto, S., Coccoli, P., Malerba, A., Capasso, M., Fiorentino, A., Pignata, L., Cossiga, V., and Romagnoli, V.

Subjects
Ablation Techniques, Male, Registrie, Cirrhosis, Clinical Biochemistry, Mesenteric Vein, loco-regional treatment, 030204 cardiovascular system & hematology, Biochemistry, Gastroenterology, surgery, Antineoplastic Agent, Liver disease, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, cirrhosis, hepatocellular carcinoma, portal vein thrombosis, transplantation, Ascites, Ablation Technique, Registries, 030212 general & internal medicine, Chronic, Settore MED/12 - Gastroenterologia, Portal Vein, Liver Diseases, Liver Neoplasms, General Medicine, Middle Aged, Sorafenib, Prognosis, Hepatitis B, Alcoholic, Hepatitis C, Tumor Burden, Survival Rate, Italy, Liver Neoplasm, Hepatocellular carcinoma, Ascite, Female, medicine.symptom, Liver cancer, Human, medicine.medical_specialty, Carcinoma, Hepatocellular, Prognosi, Antineoplastic Agents, End Stage Liver Disease, 03 medical and health sciences, Mesenteric Veins, Hepatitis B, Chronic, Internal medicine, medicine, Humans, Hepatectomy, Neoplasm Invasiveness, portal vein thrombosi, Liver Diseases, Alcoholic, Aged, Neoplasm Invasivene, Performance status, business.industry, Carcinoma, Settore MED/09 - MEDICINA INTERNA, Patient Acuity, Hepatocellular, Hepatitis C, Chronic, medicine.disease, Liver Transplantation, Transplantation, Liver function, business, cirrhosi
Abstract

Background and aims: In patients with hepatocellular carcinoma (HCC), macrovascular invasion (MaVI) limits treatment options and decreases survival. Detailed data on the relationship between MaVI extension and patients' characteristics, and its impact on patients' outcome are limited. We evaluated the prevalence and extension of MaVI in a large cohort of consecutive HCC patients, analysing its association with liver disease and tumour characteristics, as well as with treatments performed and patients' survival. Methods: We analysed data of 4774 patients diagnosed with HCC recorded in the Italian Liver Cancer (ITA.LI.CA) database (2008-2018). Recursive partition analysis (RPA) was performed to evaluate interactions between MaVI, clinical variables and treatment, exploring the inter-relationship determining overall survival. Results: MaVI prevalence was 11.1%, and median survival of these patients was 6.0months (95% CI, 5.1-7.1). MaVI was associated with younger age at diagnosis, presence of symptoms, worse Performance Status (PS) and liver function, high alphafetoprotein levels and large HCCs. MaVI extension was associated with worse PS, ascites and greater impairment in liver function. RPA identified patients' categories with different treatment indications and survival, ranging from 2.4months in those with PS>1 and ascites, regardless of MaVI extension (receiving best supportive care in 90.3% of cases), to 14.1months in patients with PS 0-1, no ascites and Vp1-Vp2 MaVI (treated with surgery in 19.1% of cases). Conclusions: MaVI presence and extension, together with PS and ascites, significantly affect patients' survival and treatment selection. The decision tree based on these parameters may help assess patients' prognosis and inform therapeutic decisions.

Published
2021

23. Years of life that could be saved from prevention of hepatocellular carcinoma

Author

Cucchetti, A., Trevisani, F., Bucci, L., Ravaioli, M., Farinati, F., Giannini, E. G., Ciccarese, F., Piscaglia, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Maida, M., Felder, M., Morisco, F., Gasbarrini, A., Gemini, S., Foschi, F. G., Missale, G., Masotto, A., Affronti, A., Bernardi, M., Pinna, A. D., Bolondi, Luigi, Biselli, Maurizio, Caraceni, Paolo, Domenicali, Marco, Gramenzi, Annagiulia, Magalotti, Donatella, Pecorelli, Anna, Serra, Carla, Venerandi, Laura, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Poggio, Paolo Del, Olmi, Stefano, Balsamo, Claudia, Vavassori, Elena, Benvegnù, Luisa, Cappelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Bosco, Giulia, Roselli, Paola, DellʼIsola, Serena, Lalungo, Anna Maria, Rastrelli, Elena, Moscatelli, Alessandro, Pellegatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Barcellona, Maria Rosa, Virdone, Roberto, Mega, Andrea, Rinninella, Emanuele, Mismas, Valeria, DallʼAglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Guarino, Maria, Baroni, Gianluca Svegliati, Schiadà, Laura, Chiaramonte, Maria, Marchetti, Fabiana, and Valerio, Matteo

Published
2016
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24. Comparison between alcohol- and hepatitis C virus-related hepatocellular carcinoma: clinical presentation, treatment and outcome

Author

Bucci, L., Garuti, F., Camelli, V., Lenzi, B., Farinati, F., Giannini, E. G., Ciccarese, F., Piscaglia, F., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Borzio, F., Sacco, R., Maida, M., Felder, M., Morisco, F., Gasbarrini, A., Gemini, S., Foschi, F. G., Missale, G., Masotto, A., Affronti, A., Bernardi, M., Trevisani, F., Bolondi, Luigi, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Domenicali, Marco, Gramenzi, Annagiulia, Magalotti, Donatella, Pecorelli, Anna, Serra, Carla, Venerandi, Laura, Gazzola, Alessia, Murer, Francesca, Pozzan, Caterina, Vanin, Veronica, Poggio, Paolo Del, Olmi, Stefano, Balsamo, Claudia, Vavassori, Elena, Benvegnù, Luisa, Capelli, Alberta, Golfieri, Rita, Mosconi, Cristina, Renzulli, Matteo, Roselli, Paola, Isola, Serena, Ialungo, Anna Maria, Rastrelli, Elena, Moscatelli, Alessandro, Pelagatta, Gaia, Picciotto, Antonino, Savarino, Vincenzo, Barcellona, Maria Rosa, Cammà, Calogero, Cabibbo, Giuseppe, Costantino, Andrea, Virdone, Roberto, Mega, Andrea, Rinninella, Emanuele, Mismas, Valeria, DallʼAglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Cappa, Federica Mirici, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Biasini, Elisabetta, Porro, Emanuela, Guarino, Maria, Baroni, Gianluca Svegliati, Schiadà, Laura, Chiaramonte, Maria, Marchetti, Fabiana, and Valerio, Matteo

Published
2016
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26. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author

Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., Ieluzzi D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Marcellusi A., Viti R., Kondili L. A., Rosato S., Vella S., Mennini F. S., Quaranta M. G., Tosti M. E., Weimer L. E., Ferrigno L., D'Angelo F., Falzano L., Benedetti A., Schiada L., Cucco M., Giacometti A., Brescini L., Castelletti S., Drenaggi D., Mazzaro C., Angarano G., Milella M., DiLeo A., Rendina M., Contaldo A., Iannone A., La Fortezza F., Rizzi M., Cologni G., Bolondi L., Benevento F., Serio I., Andreone P., Caraceni P., Guarneri V., Margotti M., Simonetti G., Mazzella G., Verucchi G., Donati V., Mian P., Rimenti G., Rossini A., Contessi G. B., Castelli F., Zaltron S., Spinetti A., Odolini S., Leandro G., Cozzolongo R., Zappimbulso M., Russello M., Benigno R., Coco C., Torti C., Costa C., Greco G., Mazzitelli M., Pisani V., Cosco L., Quintieri F., DeSiena M., Giancotti F., Vecchiet J., Falasca K., Mastroianni A., Apuzzo G., Chidichimo L., Foschi F. G., Dall'Aglio A. C., Libanore M., Segala D., Sighinolfi L., Bartolozzi D., Salomoni E., Blanc P., Baragli F., DelPin B., Mariabelli E., Mazzotta F., Poggi A., Zignego A. L., Monti M., Madia F., Xheka A., Cela E. M., Santantonio T. A., Bruno S. R., Viscoli C., Alessandrini A. I., Curti C., DiBiagio A., Nicolini L. A., Balletto E., Mastroianni C., Blerta K., Prati D., Raffaele L., Andreoletti M., Perboni G., Costa P., Manzini L., Raimondo G., Filomia R., Lazzarin A., Morsica G., Salpietro S., Puoti M., Baiguera C., Vassalli S., Rumi M. G., Labanca S., Zuin M., Giorgini A., Orellana D., D'ArminioMonforte A., Debona A., Solaro S., Fargion S., Valenti L., Periti G., Pelusi S., Galli M., Calvi E., Milazzo L., Peri A., Lampertico P., Borghi M., D'Ambrosio R., Degasperi E., Vinci M., Villa E., Bernabucci V., Bristot L., Pereira F., Chessa L., Pasetto M. C., Loi M., Gori A., Beretta I., Pastore V., Soria A., Strazzabosco M., Ciaccio A., Gemma M., Borgia G., Foggia A., Zappulo E., Gentile I., Buonomo A. R., Abrescia N., Maddaloni A., Caporaso N., Morisco F., Camera S., Donnarumma L., Coppola C., Amoruso D. C., Staiano L., Saturnino M. R., Coppola N., Martini S., Monari C., Federico A., Dallio M., Loguercio C., Gaeta G. B., Brancaccio G., Nardone G., Sgamato C., D'Adamo G., Alberti A., Gonzo M., Piovesan S., Chemello L., Buggio A., Cavalletto L., Barbaro F., Castelli E., Floreani A., Cazzagon N., Franceschet I., Russo F. P., Zanetto A., Franceschet E., Madonia S., Cannizzaro M., Montalto G., Licata A., Capitano A. R., Craxi A., Petta S., Calvaruso V., Rini F., Ferrari C., Negri E., Orlandini A., Pesci M., Bruno R., Lombardi A., Zuccaro V., Gulminetti R., Asti A., Villaraggia M., Mondelli M., Ludovisi S., Baldelli F., Di Candilo F., Parruti G., Di Stefano P., Sozio F., Gizzi M. C., Brunetto M. R., Colombatto P., Coco B., Surace L., Foti G., Pellicano S., Fornaciari G., Schianchi S., Vignoli P., Massari M., Corsini R., Garlassi E., Ballardini G., Andreoni M., Cerva C., Angelico M., Gasbarrini A., Siciliano M., De Siena M., Nosotti L., Taliani G., Biliotti E., Santori M., Spaziante M., Tamburini F., Vullo V., D'Ettorre G., Cavallari E. N., Gebremeskel T. S., Pavone P., Cauda R., Cingolani A., Lamonica S., D'Offizi G., Lionetti R., Visco Comandini U., Grieco A., D'Aversa F., Picardi A., De Vincentis A., Galati G., Gallo P., Dell'Unto C., Aghemo A., Gatti Comini A., Persico M., Masarone M., Anselmo M., De Leo P., Marturano M., Brunelli E., Ridolfi F., Schimizzi A. M., Ayoubi Khajekini M., Framarin L., Di Perri G., Cariti G., Boglione L., Cardellino C., Marinaro L., Saracco G. M., Ciancio A., Toniutto P., Alterini G., Capra F., and Ieluzzi D.

Abstract

Objective: We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy. Methods: A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered. Results: The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively. Conclusions: This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

Published
2019

27. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author

Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D’Angelo, F., Falzano, L., Benedetti, A., Schiadà, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, Peter, Rimenti, G., Rossini, A., Contessi, G. B., Castelli, Fulvio, Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, Lucia, Quintieri, F., De Siena, Martina, Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall’Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., DelundefinedPin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, Francesca, Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., DiundefinedBiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, Chiara, Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D’ArminioundefinedMonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, Margherita, D’Ambrosio, R., Degasperi, E., Vinci, Maria Rosaria, Villa, E., Bernabucci, V., Bristot, Luca, Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, Alex, Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D’Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, Enrico, Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, Maria Chiara, Montalto, G., Licata, A., Capitano, A. R., Craxì, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, Paolo, Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, Antonio, Siciliano, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, Roberto, Cingolani, Antonella, Lamonica, S., D’Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, Antonio, D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, Patrizia, Dell’Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, Monia, Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Kondili LA, Vella S, Quaranta MG, Rosato S, Tosti ME, Weimer LE, Ferrigno L, D'Angelo F, Falzano L, Benedetti A, Schiadà L, Cucco M, Giacometti A, Brescini L, Castelletti S, Drenaggi D, Mazzaro C, Angarano G, Milella M, Di Leo A, Rendina M, Contaldo A, Iannone A, La Fortezza F, Rizzi M, Cologni G, Bolondi L, Benevento F, Serio I, Andreone P, Caraceni P, Guarneri V, Margotti M, Simonetti G, Mazzella G, Verucchi G, Donati V, Mian P, Rimenti G, Rossini A, Contessi GB, Castelli F, Zaltron S, Spinetti A, Odolini S, Leandro G, Cozzolongo R, Zappimbulso M, Russello M, Benigno R, Coco C, Torti C, Costa C, Greco G, Mazzitelli M, Pisani V, Cosco L, Quintieri F, De Siena M, Giancotti F, Vecchiet J, Falasca K, Mastroianni A, Apuzzo G, Chidichimo L, Foschi FG, Dall'Aglio AC, Libanore M, Segala D, Sighinolfi L, Bartolozzi D, Salomoni E, Blanc P, Baragli F, Del Pin B, Mariabelli E, Mazzotta F, Poggi A, Zignego AL, Monti M, Madia F, Xheka A, Cela EM, Santantonio TA, Bruno SR, Viscoli C, Alessandrini AI, Curti C, Di Biagio A, Nicolini LA, Balletto E, Mastroianni C, Blerta K, Prati D, Raffaele L, Andreoletti M, Perboni G, Costa P, Manzini L, Raimondo G, Filomia R, Lazzarin A, Morsica G, Salpietro S, Puoti M, Baiguera C, Vassalli S, Rumi MG, Labanca S, Zuin M, Giorgini A, Orellana D, D'Arminio Monforte A, Debona A, Solaro S, Fargion S, Valenti L, Periti G, Pelusi S, Galli M, Calvi E, Milazzo L, Peri A, Lampertico P, Borghi M, D'Ambrosio R, Degasperi E, Vinci M, Villa E, Bernabucci V, Bristot L, Pereira F, Chessa L, Pasetto MC, Loi M, Gori A, Beretta I, Pastore V, Soria A, Strazzabosco M, Ciaccio A, Gemma M, Borgia G, Foggia A, Zappulo E, Gentile I, Buonomo AR, Abrescia N, Maddaloni A, Caporaso N, Morisco F, Camera S, Donnarumma L, Coppola C, Amoruso DC, Staiano L, Saturnino MR, Coppola N, Martini S, Monari C, Federico A, Dallio M, Loguercio C, Gaeta GB, Brancaccio G, Nardone G, Sgamato C, D'Adamo G, Alberti A, Gonzo M, Piovesan S, Chemello L, Buggio A, Cavalletto L, Barbaro F, Castelli E, Floreani A, Cazzagon N, Franceschet I, Russo FP, Zanetto A, Franceschet E, Madonia S, Cannizzaro M, Montalto G, Licata A, Capitano AR, Craxì A, Petta S, Calvaruso V, Rini F, Ferrari C, Negri E, Orlandini A, Pesci M, Bruno R, Lombardi A, Zuccaro V, Gulminetti R, Asti A, Villaraggia M, Mondelli M, Ludovisi S, Baldelli F, Di Candilo F, Parruti G, Di Stefano P, Sozio F, Gizzi MC, Brunetto MR, Colombatto P, Coco B, Surace L, Foti G, Pellicano S, Fornaciari G, Schianchi S, Vignoli P, Massari M, Corsini R, Garlassi E, Ballardini G, Andreoni M, Cerva C, Angelico M, Gasbarrini A, Siciliano M, De Siena M, Nosotti L, Taliani G, Biliotti E, Santori M, Spaziante M, Tamburini F, Vullo V, D'Ettorre G, Cavallari EN, Gebremeskel TS, Pavone P, Cauda R, Cingolani A, Lamonica S, D'Offizi G, Lionetti R, Visco Comandini U, Grieco A, D'Aversa F, Picardi A, De Vincentis A, Galati G, Gallo P, Dell'Unto C, Aghemo A, Gatti Comini A, Persico M, Masarone M, Anselmo M, De Leo P, Marturano M, Brunelli E, Ridolfi F, Schimizzi AM, Ayoubi Khajekini M, Framarin L, Di Perri G, Cariti G, Boglione L, Cardellino C, Marinaro L, Saracco GM, Ciancio A, Toniutto P, Alterini G, Capra F, Ieluzzi D., Marcellusi, A., Viti, R., Kondili, L. A., Rosato, S., Vella, S., Mennini, F. S., Quaranta, M. G., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Dileo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, P., Rimenti, G., Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., Desiena, M., Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall'Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Delpin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, F., Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., Dibiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, C., Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminiomonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Vinci, M., Villa, E., Bernabucci, V., Bristot, L., Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D'Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, E., Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capitano, A. R., Craxi, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, P., Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., De Siena, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D'Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lamonica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D'Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell'Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, M., Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L.A., Quaranta, M.G., Tosti, M.E., Weimer, L.E., D’Angelo, F., Schiadà, L., Di&nbsp, Leo, A., Contessi, G.B., De&nbsp, Siena, M., Foschi, F.G., Dall’Aglio, A.C., Del&nbsp, Pin, B., Zignego, A.L., Cela, E.M., Santantonio, T.A., Bruno, S.R., Alessandrini, A.I., Biagio, A., Nicolini, L.A., Rumi, M.G., D’Arminio&nbsp, Monforte, A., D’Ambrosio, R., Pasetto, M.C., Buonomo, A.R., Amoruso, D.C., Saturnino, M.R., Gaeta, G.B., D’Adamo, G., Russo, F.P., Capitano, A.R., Craxì, A., Gizzi, M.C., Brunetto, M.R., D’Ettorre, G., Cavallari, E.N., Gebremeskel, T.S., D’Offizi, G., D’Aversa, F., Dell’Unto, C., Schimizzi, A.M., Saracco, G.M., Cosco, Alfredo, Dall’Aglio, A. C., Salomoni, Valentina, Nicolini, Elvira, Calvi, Marta, Soria, Giovanni, D'Adamo, Danilo, ALONSO ALBERTI, MARIA PALOMA CARMEN, Orlandini, Giovanni, DE ASTIS, Fabio, Sozio, Concetta, Terzini, Angelico, DE SIENA, ANDREA URIEL, Taliani, Sabrina, Spaziante, Agata, Lamonica, Emilia, and Capra, Carlo

Subjects
Liver Cirrhosis, Pediatrics, Time Factors, Settore MED/09 - Medicina Interna, National Health Programs, ERADICATION, OUTBREAK, antiviral treatment, anti HCV, economic consequences, Hepacivirus, LIVER FIBROSIS, Severity of Illness Index, Health Services Accessibility, COST-EFFECTIVENESS, Indirect costs, 0302 clinical medicine, Epidemiology, virus infection, 030212 general & internal medicine, health care economics and organizations, cost effectiveness, 030503 health policy & services, Health Policy, Health services research, health, Hepatitis C, Markov Chains, chronic hepatitis C, virus infection, fibrosis progression, cost effectiveness, liver fibrosis, Italy, Pharmacology, Public Health, Environmental and Occupational Health, Cohort, Settore SECS-P/03 - Scienza delle Finanze, Disease Progression, Public Health, 0305 other medical science, Viral hepatitis, Anti-HCV antiviral treatment, CHRONIC HEPATITIS-C, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, VIRUS-INFECTION, Antiviral Agents, NO, 03 medical and health sciences, Cost Savings, Humans, medicine, MANAGEMENT, chronic hepatitis C, INDUCED DISEASES, METAANALYSIS, Health economics, business.industry, Public health, Environmental and Occupational Health, medicine.disease, FIBROSIS PROGRESSION, business
Abstract

OBJECTIVE:\ud We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.\ud \ud METHODS:\ud A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.\ud \ud RESULTS:\ud The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.\ud \ud CONCLUSIONS:\ud This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.

Published
2019

29. Regenerative Endodontic Procedures for the Treatment of Necrotic Mature Teeth with Apical Periodontitis: A Systematic Review and Meta-analysis of Randomized Controlled Trials

Author

Glynis, A. Foschi, F. Kefalou, I. Koletsi, D. Tzanetakis, G.N.

Abstract

Introduction: Regenerative endodontic procedures (REPs) are intended to repair and regenerate part of the pulp-dentin complex. The aim of this study was to systematically appraise the existing evidence on the effectiveness of REPs on mature teeth with pulp necrosis and apical periodontitis. Methods: Electronic database and hand searches were performed on 8 databases of published and unpublished literature from inception to January 3, 2021, for the identification of randomized controlled trials (RCTs) or prospective clinical trials. The related key words included “regenerative,” “pulp revascularization,” “revitalization procedure,” and “necrotic mature teeth.” A random effects meta-analysis was conducted assessing success as the main outcome treatment. Risk of bias was assessed through the Cochrane Risk of Bias 2.0 tool, and the quality of the evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Of the 337 initial hits, 4 RCTs were eligible for inclusion, whereas 3 were included in the quantitative synthesis. Overall, there was no difference in the relative risk for a successful/unsuccessful treatment outcome between REPs or conventional treatment (3 studies, relative risk = 1.03; 95% confidence interval, 0.92–1.15; P =.61; heterogeneity I2 = 0.0%, P =.53; prediction interval = 0.51–2.09). Risk of bias ranged from low to raising some concerns, whereas the quality of the evidence was graded as moderate. Conclusions: Based on moderate-quality evidence, REPs appear as a viable treatment alternative for mature necrotic teeth with periapical lesions at present. Furthermore, well-designed RCTs might also provide confirmatory evidence in this respect while also framing a backbone for standardization of the therapeutic protocol of REPs. © 2021 American Association of Endodontists

Published
2021

30. Pattern of macrovascular invasion in hepatocellular carcinoma

Author

Guarino, Mariateresa, Cucchetti, A., Pontillo, G., Farinati, F., Benevento, F., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Rodolfo, S., Cabibbo, G., Marra, F., Mega, A., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Giannini, E. G., Morisco, F., Biselli, M., Caraceni, P., Garuti, F., Gramenzi, A., Neri, A., Rampoldi, D., Santi, V., Forgione, Alessandra, Granito, A., Muratori, L., Piscaglia, F., Sansone, V., Tovoli, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Cela, E. M., Facciorusso, A., Pelizzaro, F., Imondi, A., Sartori, A., Penzo, B., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., Pieri, G., De Matthaeis, Nicoletta, Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Olivari, Elena Armida, Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Borghi, A., Gardini, A. C., Conti, Francesco, Berardinelli, D., Ercolani, G., Napoli, L., Campani, C., Di Bonaventura, C., Gitto, S., Coccoli, P., Malerba, A., Capasso, Monica, Fiorentino, Alice, Pignata, L., Cossiga, V., Romagnoli, V., Guarino M., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Forgione A., de Matthaeis N., Olivari A., Conti F., Capasso M., Fiorentino A., Guarino, Mariateresa, Cucchetti, A., Pontillo, G., Farinati, F., Benevento, F., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Rodolfo, S., Cabibbo, G., Marra, F., Mega, A., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Giannini, E. G., Morisco, F., Biselli, M., Caraceni, P., Garuti, F., Gramenzi, A., Neri, A., Rampoldi, D., Santi, V., Forgione, Alessandra, Granito, A., Muratori, L., Piscaglia, F., Sansone, V., Tovoli, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Cela, E. M., Facciorusso, A., Pelizzaro, F., Imondi, A., Sartori, A., Penzo, B., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., Pieri, G., De Matthaeis, Nicoletta, Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Olivari, Elena Armida, Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Borghi, A., Gardini, A. C., Conti, Francesco, Berardinelli, D., Ercolani, G., Napoli, L., Campani, C., Di Bonaventura, C., Gitto, S., Coccoli, P., Malerba, A., Capasso, Monica, Fiorentino, Alice, Pignata, L., Cossiga, V., Romagnoli, V., Guarino M., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Forgione A., de Matthaeis N., Olivari A., Conti F., Capasso M., and Fiorentino A.

Abstract

Background and aims: In patients with hepatocellular carcinoma (HCC), macrovascular invasion (MaVI) limits treatment options and decreases survival. Detailed data on the relationship between MaVI extension and patients' characteristics, and its impact on patients' outcome are limited. We evaluated the prevalence and extension of MaVI in a large cohort of consecutive HCC patients, analysing its association with liver disease and tumour characteristics, as well as with treatments performed and patients' survival. Methods: We analysed data of 4774 patients diagnosed with HCC recorded in the Italian Liver Cancer (ITA.LI.CA) database (2008-2018). Recursive partition analysis (RPA) was performed to evaluate interactions between MaVI, clinical variables and treatment, exploring the inter-relationship determining overall survival. Results: MaVI prevalence was 11.1%, and median survival of these patients was 6.0 months (95% CI, 5.1-7.1). MaVI was associated with younger age at diagnosis, presence of symptoms, worse Performance Status (PS) and liver function, high alphafetoprotein levels and large HCCs. MaVI extension was associated with worse PS, ascites and greater impairment in liver function. RPA identified patients' categories with different treatment indications and survival, ranging from 2.4 months in those with PS > 1 and ascites, regardless of MaVI extension (receiving best supportive care in 90.3% of cases), to 14.1 months in patients with PS 0-1, no ascites and Vp1-Vp2 MaVI (treated with surgery in 19.1% of cases). Conclusions: MaVI presence and extension, together with PS and ascites, significantly affect patients' survival and treatment selection. The decision tree based on these parameters may help assess patients' prognosis and inform therapeutic decisions.

Published
2021

31. The changing scenario of hepatocellular carcinoma in Italy: an update

Author

Garuti, F., Neri, A., Avanzato, F., Gramenzi, A., Rampoldi, D., Rucci, P., Farinati, F., Giannini, E. G., Piscaglia, F., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Brunetto, M. R., Trevisani, F., Biselli, M., Caraceni, P., Santi, V., Granito, A., Muratori, L., Sansone, V., Tovoli, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Cela, E. M., Facciorusso, A., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., De Matthaeis, Nicoletta, Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Biasini, E., Olivani, A., Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Berardinelli, D., Borghi, A., Gardini, A. C., Conti, Francesco, Cucchetti, A., Dall'Aglio, A. C., Ercolani, G., Campani, C., Di Bonaventura, C., Gitto, S., Malerba, P. C. A., Capasso, Monica, Guarino, Mariateresa, Oliveri, F., Romagnoli, V., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), de Matthaeis N., Conti F., Capasso M., Guarino M., Garuti, F., Neri, A., Avanzato, F., Gramenzi, A., Rampoldi, D., Rucci, P., Farinati, F., Giannini, E. G., Piscaglia, F., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Brunetto, M. R., Trevisani, F., Biselli, M., Caraceni, P., Santi, V., Granito, A., Muratori, L., Sansone, V., Tovoli, F., Dajti, E., Marasco, G., Ravaioli, F., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Cela, E. M., Facciorusso, A., Cacciato, V., Casagrande, E., Moscatelli, A., Pellegatta, G., De Matthaeis, Nicoletta, Allegrini, G., Lauria, V., Ghittoni, G., Pelecca, G., Chegai, F., Coratella, F., Ortenzi, M., Biasini, E., Olivani, A., Inno, A., Marchetti, F., Busacca, A., Camma, C., Di Martino, V., Rizzo, G. E. M., Franze, M. S., Saitta, C., Sauchella, A., Bevilacqua, V., Berardinelli, D., Borghi, A., Gardini, A. C., Conti, Francesco, Cucchetti, A., Dall'Aglio, A. C., Ercolani, G., Campani, C., Di Bonaventura, C., Gitto, S., Malerba, P. C. A., Capasso, Monica, Guarino, Mariateresa, Oliveri, F., Romagnoli, V., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), de Matthaeis N., Conti F., Capasso M., and Guarino M.

Abstract

Background and aims: Epidemiology of hepatocellular carcinoma (HCC) is changing in most areas of the world. This study aimed at updating the changing scenario of aetiology, clinical presentation, management and prognosis of HCC in Italy during the last 15 years. Methods: Retrospective analysis of the Italian Liver Cancer (ITA.LI.CA) database included 6034 HCC patients managed in 23 centres from 2004 to 2018. Patients were divided into three groups according to the date of cancer diagnosis (2004-2008, 2009-2013 and 2014-2018). Results: The main results were: (i) a progressive patient ageing; (ii) a progressive increase of non-viral cases and, particularly, of ‘metabolic’ and ‘metabolic + alcohol’ HCCs; (iii) a slightly decline of cases diagnosed under surveillance, but with an incremental use of the semiannual schedule; (iv) a favourable cancer stage migration; (v) an increased use of radiofrequency ablation to the detriment of percutaneous ethanol injection; (vi) improved outcomes of ablative and transarterial treatments; (vii) an improved overall survival (adjusted for the lead time in surveyed patients) in the last calendar period, particularly in viral patients; (viii) a large gap between the number of potential candidates (according to oncologic criteria and age) to liver transplant and that of transplanted patients. Conclusions: During the last 15 years several aspects of HCC scenario have changed, as well as its management. The improvement in patient survival observed in the last period was likely because of a larger use of thermal ablation with respect to the less effective alcohol injection and to an improved management of intermediate stage patients.

Published
2021

32. Changes in hepatocellular carcinoma aggressiveness characteristics with an increase in tumor diameter

Author

Carr, B. I., Guerra, V., Donghia, R., Farinati, F., Giannini, E. G., Piscaglia, F., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Carr, B. I., Guerra, V., Donghia, R., Farinati, F., Giannini, E. G., Piscaglia, F., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Missale, G., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., and Gasbarrini A. (ORCID:0000-0002-7278-4823)

Abstract

Background: Hepatocellular carcinoma prognosis depends on both liver and tumor determinants, especially on maximum tumor diameter, multifocality, and presence of portal vein thrombosis, despite apparently complete tumor removal by resection or liver transplantation. Aims: To examine parameters of hepatocellular carcinoma aggressiveness as tumor size increases. Methods: A large hepatocellular carcinoma database was examined for trends in serum alpha-fetoprotein and the percentage of patients with macroscopic portal vein thrombosis or tumor multifocality. Results: A total of 13,016 hepatocellular carcinoma patients were identified having full tumor and survival data. Of these, 76.56% were male and 23.44% were female, with a median age of 64.4 years. We found that as the maximum tumor diameter increased, there was a significant trend for increased alpha-fetoprotein levels (P<0.001) and an increased percentage of patients with either portal vein thrombosis or tumor multifocality, each P<0.0001. Furthermore, the increases of both alpha-fetoprotein and portal vein thrombosis were proportionately greater than the related maximum tumor diameter increases. These trends of increased alpha-fetoprotein, portal vein thrombosis, and multifocality with increasing maximum tumor diameter had non-linear patterns. Within alpha-fetoprotein and multifocality trends, there were identifiable sub-trends associated with specific maximum tumor diameter ranges. Conclusions: The greater fold-increases in alpha-fetoprotein and portal vein thrombosis compared with increases in maximum tumor diameter imply that hepatocellular carcinoma characteristics may change with increasing size to a more aggressive phenotype, suggesting that follow-up tumor sampling might be useful, in addition to baseline tumor sampling, for optimal therapeutic choices to be made.

Published
2021

33. Identification of clinical phenotypes and related survival in patients with large hccs

Author

Carr, B. I., Guerra, V., Donghia, R., Farinati, F., Giannini, E. G., Muratori, L., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Sacco, R., Celsa, C., Campani, C., Mega, A., Guarino, M., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F. G., Biasini, E., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Brunetto, M. R., Trevisani, F., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Guarino M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Carr, B. I., Guerra, V., Donghia, R., Farinati, F., Giannini, E. G., Muratori, L., Rapaccini, G. L., Di Marco, M., Caturelli, E., Zoli, M., Sacco, R., Celsa, C., Campani, C., Mega, A., Guarino, M., Gasbarrini, A., Svegliati-Baroni, G., Foschi, F. G., Biasini, E., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Brunetto, M. R., Trevisani, F., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Guarino M., and Gasbarrini A. (ORCID:0000-0002-7278-4823)

Abstract

Background. Hepatocellular carcinoma (HCC) factors, especially maximum tumor diameter (MTD), tumor multifocality, portal vein thrombosis (PVT), and serum alpha-fetoprotein (AFP), influence survival. Aim. To examine patterns of tumor factors in large HCC patients. Methods. A database of large HCC patients was examined. Results. A multiple Cox proportional hazard model on death identified low serum albumin levels and the presence of PVT and multifocality, with each having a hazard ratio ≥2.0. All combinations of these three parameters were examined in relation to survival. Using univariate Cox analysis, the combination of albumin >3.5 g/dL and the absence of both PVT and multifocality had the best survival rate, while all combinations that included the presence of PVT had poor survival and hazard ratios. We identified four clinical phenotypes, each with a distinct median survival: patients with or without PVT or multifocality plus serum albumin ≥3.5 (g/dL), with each subgroup displaying high (≥100 IU/mL) or low (<100 IU/mL) blood AFP levels. Across a range of MTDs, we identified only two significant trends, blood AFP and platelets. Conclusions. Patients with large HCCs have distinct phenotypes and survival, as identified by the combination of PVT, multifocality, and blood albumin levels.

Published
2021

34. Comparison of prognostic models in advanced hepatocellular carcinoma patients undergoing Sorafenib: A multicenter study

Author

Marasco, G., Colecchia, A., Bacchi Reggiani, M. L., Celsa, C., Farinati, F., Giannini, E. G., Benevento, F., Rapaccini, Gian Ludovico, Caturelli, E., Di Marco, Maria Teresa, Biasini, E., Marra, F., Morisco, F., Foschi, F. G., Zoli, M., Gasbarrini, Antonio, Baroni, G. S., Masotto, A., Sacco, R., Raimondo, G., Azzaroli, F., Mega, A., Vidili, G., Brunetto, M. R., Nardone, G., Dajti, E., Ravaioli, F., Avanzato, F., Festi, D., Trevisani, F., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Marasco, G., Colecchia, A., Bacchi Reggiani, M. L., Celsa, C., Farinati, F., Giannini, E. G., Benevento, F., Rapaccini, Gian Ludovico, Caturelli, E., Di Marco, Maria Teresa, Biasini, E., Marra, F., Morisco, F., Foschi, F. G., Zoli, M., Gasbarrini, Antonio, Baroni, G. S., Masotto, A., Sacco, R., Raimondo, G., Azzaroli, F., Mega, A., Vidili, G., Brunetto, M. R., Nardone, G., Dajti, E., Ravaioli, F., Avanzato, F., Festi, D., Trevisani, F., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., and Gasbarrini A. (ORCID:0000-0002-7278-4823)

Abstract

Background: Sorafenib is the gold standard therapy for the advanced hepatocellular carcinoma (HCC). No scoring/staging is universally accepted to predict the survival of these patients. Aims: To evaluate the accuracy of the available prognostic models for HCC to predict the survival of advanced HCC patients treated with Sorafenib included in the Italian Liver Cancer (ITA.LI.CA.) multicenter cohort. Methods: The performance of several prognostic scores was assessed through a Cox regression-model evaluating the C-index and the Akaike Information Criterion (AIC). Results: Data of 1129 patients were analyzed. The mean age of patients was 61.6 years, and 80.8% were male. During a median follow-up period of 13 months, 789 patients died. The median period of Sorafenib administration was 4 months. All the prognostic scores were able to predict the overall survival (p<0.001) at univariate analysis, except the Albumin-Bilirubin score. The Italian Liver Cancer score (CLIP) yielded the highest accuracy (C-index 0.604, AIC 9898), followed by the ITA.LI.CA. prognostic score (C-index 0.599, AIC 9915). Conclusions: The CLIP score had the highest accuracy in predicting the overall survival of HCC patients treated with Sorafenib, although its performance remained poor. Further studies are needed to refine the current ability to predict the outcome of HCC patients undergoing Sorafenib.

Published
2021

35. Monofocal hepatocellular carcinoma: How much does size matter?

Author

Pelizzaro, F., Penzo, B., Peserico, G., Imondi, A., Sartori, A., Vitale, A., Cillo, U., Giannini, E. G., Forgione, A., Ludovico Rapaccini, G., Di Marco, M., Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, A., Svegliati-Baroni, G., Giuseppe Foschi, F., Olivani, A., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Farinati, F., Vitale A., Forgione A., Di Marco M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Pelizzaro, F., Penzo, B., Peserico, G., Imondi, A., Sartori, A., Vitale, A., Cillo, U., Giannini, E. G., Forgione, A., Ludovico Rapaccini, G., Di Marco, M., Caturelli, E., Zoli, M., Sacco, R., Cabibbo, G., Marra, F., Mega, A., Morisco, F., Gasbarrini, A., Svegliati-Baroni, G., Giuseppe Foschi, F., Olivani, A., Masotto, A., Nardone, G., Raimondo, G., Azzaroli, F., Vidili, G., Oliveri, F., Trevisani, F., Farinati, F., Vitale A., Forgione A., Di Marco M., and Gasbarrini A. (ORCID:0000-0002-7278-4823)

Abstract

BACKGROUND & AIMS: According to the Barcelona Clinic Liver Cancer (BCLC) staging system, monofocal hepatocellular carcinoma (HCC) is classified as early (BCLC A) irrespective of its size, even though controversies still exist regarding staging and treatment of large tumours. We aimed at evaluating the appropriate staging and treatment for large (>5 cm) monofocal (HCC). METHODS: From the Italian Liver Cancer database, we selected 924 patients with small early monofocal HCC (2-5 cm; SEM-HCC), 163 patients with larger tumours (>5 cm; LEM-HCC) and 1048 intermediate stage patients (BCLC B). RESULTS: LEM-HCC patients had a worse overall survival (OS) than SEM-HCC (31.0 vs 49.0 months; P < .0001), and this was confirmed at multivariate analysis (HR 1.63, 95% CI 1.29-2.05; P < .0001). The small difference in OS between LEM-HCC and BCLC B patients (31.0 vs 27.0 months; P = .03) disappeared in the multivariate model (HR 0.98, 95% CI 0.77-1.25; P = .89). In all monofocal tumours, treatment was the strongest independent predictor of survival, with a progressively decreasing survival benefit moving from "curative" to "palliative" therapies. The survival of resected patients with LEM-HCC was significantly shorter than that of SEM-HCC (44.0 vs 78.0 months; P = .002), but liver resection provided the highest survival benefit in both groups compared to other treatments. CONCLUSIONS: Monofocal HCC larger than 5 cm should not be staged as BCLC A and either a different staging system or a different subgrouping of patients (e.g. BCLC AB) should be used. Liver resection, if feasible, remains the recommended treatment for all these patients.

Published
2021

36. Surveillance as determinant of long-term survival in non-transplanted hepatocellular carcinoma patients

Author

Pelizzaro, F., Vitale, Antonio, Sartori, A., Vieno, A., Penzo, B., Russo, F. P., Frigo, A. C., Giannini, E. G., Piccinnu, M., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Sacco, R., Celsa, C., Marra, F., Mega, A., Guarino, Mariateresa, Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Olivani, A., Masotto, A., Coccoli, P., Raimondo, G., Azzaroli, F., Vidili, G., Brunetto, M. R., Trevisani, F., Farinati, F., Vitale A., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Guarino M., Gasbarrini A. (ORCID:0000-0002-7278-4823), Pelizzaro, F., Vitale, Antonio, Sartori, A., Vieno, A., Penzo, B., Russo, F. P., Frigo, A. C., Giannini, E. G., Piccinnu, M., Rapaccini, Gian Ludovico, Di Marco, Maria Teresa, Caturelli, E., Zoli, M., Sacco, R., Celsa, C., Marra, F., Mega, A., Guarino, Mariateresa, Gasbarrini, Antonio, Svegliati-Baroni, G., Foschi, F. G., Olivani, A., Masotto, A., Coccoli, P., Raimondo, G., Azzaroli, F., Vidili, G., Brunetto, M. R., Trevisani, F., Farinati, F., Vitale A., Rapaccini G. L. (ORCID:0000-0002-6467-857X), Di Marco M., Guarino M., and Gasbarrini A. (ORCID:0000-0002-7278-4823)

Abstract

Purpose: We aimed at assessing the impact of surveillance on long-term survival in HCC patients. Methods: From the ITA.LI.CA database, we selected 1028 cases with long (≥5 years, LS group) and 2721 controls with short-term survival (<5 years, SS group). The association between surveillance and LS was adjusted for confounders by multivariable logistic regression analysis. Survival of surveilled patients was presented both as observed and corrected for the lead-time bias, and the comparison of survival between surveillance and no surveillance groups was also performed after balancing the baseline characteristics with inverse probability weights (IPW). Results: LS patients were more frequently diagnosed under surveillance (p < 0.0001), and had more favorable baseline characteristics. Surveillance was an independent predictor of LS (OR = 1.413, 95% CI 1.195– 1.671; p < 0.0001). The observed and the lead-time corrected survival of surveilled patients were significantly longer compared to the survival of not surveilled patients (p < 0.0001 and p = 0.0008, respectively). In IPW adjusted populations, no survival differences were demonstrated between the two groups (p = 0.30). Conclusions: Surveillance, increasing early-stage diagnosis and applicability of curative treatments, is a fundamental determinant of long-term survival in HCC patients. A wide implementation of surveillance programs should be pursued in order to improve HCC patients’ prognosis.

Published
2021

39. Reply

Author

Patel, S., primary, Foschi, F., additional, Mannocci, F., additional, and Patel, K., additional

Published
2021
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40. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Author

Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., and Salerno F.

Abstract

Background: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. Methods: We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794. Findings: From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events. Interpretation: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding: Italian Medicine Agency.

Published
2018

41. Correction to: Prognostic Role of Blood Eosinophil Count in Patients with Sorafenib-Treated Hepatocellular Carcinoma (Targeted Oncology, (2020), 15, 6, (773-785), 10.1007/s11523-020-00757-3)

Author

Orsi G., Tovoli F., Dadduzio V., Vivaldi C., Brunetti O., Ielasi L., Conti F., Rovesti G., Gramantieri L., Rizzato M. D., Pecora I., Argentiero A., Teglia F., Lonardi S., Salani F., Granito A., Zagonel V., Marisi G., Cabibbo G., Foschi F. G., Benevento F., Cucchetti A., Piscaglia F., Cascinu S., Scartozzi M., Casadei-Gardini A., Orsi G., Tovoli F., Dadduzio V., Vivaldi C., Brunetti O., Ielasi L., Conti F., Rovesti G., Gramantieri L., Rizzato M.D., Pecora I., Argentiero A., Teglia F., Lonardi S., Salani F., Granito A., Zagonel V., Marisi G., Cabibbo G., Foschi F.G., Benevento F., Cucchetti A., Piscaglia F., Cascinu S., Scartozzi M., and Casadei-Gardini A.

Subjects
not applicable
Abstract

An Online First version of this article was made available online at https://link.springer.com/article/10.1007/s11523-020-00757-3 on 12 October 2020. Errors were subsequently identified in the article, and the following corrections should be noted.

Published
2020

42. Could inflammatory indices and metabolic syndrome predict the risk of cancer development? Analysis from the bagnacavallo population study

Author

Rimini, M., Casadei-Gardini, A., Ravaioli, A., Rovesti, G., Conti, F., Borghi, A., Dall'Aglio, A. C., Bedogni, G., Domenicali, M., Giacomoni, P., Tiribelli, C., Bucchi, L., Falcini, F., Foschi, F. G., Gastaldelli, A., Ercolani, G., Cucchetti, A., Dazzani, F., Bevilacqua, V., Napoli, L., Mirici, F., Bellentani, S., Lanzi, A., Saini, G., Bernardi, M., Andreone, P., and Stefanini, G. F.

Subjects
Breast cancer, Cancer incidence, Colon cancer, Inflammatory indices, Lung cancer, Metabolic Syndrome, NLR, PLR, SII
Published
2020

43. High admission prevalence of fluoroquinolone resistance in third-generation cephalosporin-resistant Enterobacteriaceae in German university hospitals

Author

Rohde, Anna M, Wiese-Posselt, Miriam, Zweigner, Janine, Schwab, Frank, Mischnik, Alexander, Seifert, Harald, Gastmeier, Petra, Kern, Winfried V, DZIF-ATHOS Study Group Armean, S, Behnke, M, Busch, D, Feihl, S, Först, G, Foschi, F, Gillis, M, Hamprecht, A, Hansen, D, Häcker, G, Heim, M, Hug, M, Kaier, K, Knobloch, J, Kola, A, Küpper, Mf, Langebartels, G, Liekweg, A, Lipp, Hp, Nordmann, M, Obermann, B, Peña-Diaz, La, Peter, S, Querbach, C, Rupp, J, Schneider, C, Schröder, C, Schröder, W, Spohn, K, Steib-Bauert, M, Tacconelli, E, Vehreschild, Jj, Vor dem Esche, U, and Willmann, M

Subjects
Male, 0301 basic medicine, Klebsiella, Cephalosporin, Rate ratio, Hospitals, University, 0302 clinical medicine, Drug Resistance, Multiple, Bacterial, Germany, Prevalence, Pharmacology (medical), Prospective Studies, 030212 general & internal medicine, Cross Infection, biology, Enterobacteriaceae Infections, Middle Aged, University hospital, Enterobacteriaceae, Anti-Bacterial Agents, Hospitalization, Ciprofloxacin, Infectious Diseases, Urinary Tract Infections, Female, Fluoroquinolones, medicine.drug, Adult, Microbiology (medical), medicine.medical_specialty, medicine.drug_class, 030106 microbiology, Microbial Sensitivity Tests, Pivmecillinam, 03 medical and health sciences, Fosfomycin, Internal medicine, Escherichia coli, medicine, Humans, Risk factor, Aged, Pharmacology, business.industry, biology.organism_classification, Fluoroquinolone resistance, Cephalosporins, business, Fosfomycin, Urinary Tract Infections, Pivmecillinam
Abstract

Objectives: Fluoroquinolone resistance (FQR) in third-generation cephalosporin-resistant Enterobacteriaceae 3GCRE) presents serious limitations to antibiotic therapy. The aim of this study was to investigate whether the FQR proportion among 3GCRE differs between community-acquired (CA) and hospital-acquired (HA) isolates. Methods: In a prospective observational study covering 2014 and 2015, we monitored the occurrence of 3GCRE in adult hospitalized patients in six German university hospitals. 3GCRE clinical isolates were subdivided into CA and HA. Multivariable analysis identified factors associated with in vitro non-susceptibility to ciprofloxacin. Results: The dataset included 5721 3GCRE isolates of which 52.9% were HA and 52.7% exhibited FQR. Interestingly, the FQR proportion was higher in CA 3GCRE than in HA 3GCRE (overall, 60.1% versus 46.2%, respectively, P

Published
2018

49. Laser ablation is superior to TACE in large-sized hepatocellular carcinoma: A pilot case-control study

Author

Morisco, Filomena, Camera, Silvia, Guarino, Maria, Tortora, Raffaella, Cossiga, Valentina, Vitiello, Anna, Cordone, Gabriella, Caporaso, Nicola, Di Costanzo, Giovan Giuseppe, Zoli, M., Garuti, F., Neri, A., Piscaglia, F., Lenzi, B., Valente, M., Trevisani, F., Bolondi, L., Biselli, M., Caraceni, P., Cucchetti, A., Domenicali, M., Gramenzi, A., Magalotti, D., Serra, C., Venerandi, L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Giannini, E. G., Brunacci, M., Moscatelli, A., Pellegatta, G., Savarino, V., Caturelli, E., Roselli, P., Lauria, V., Pelecca, G., Dell'Isola, S., Ialungo, A. M., Rastrelli, E., Cabibbo, G., Cammà, C., Attardo, S., Rossi, M., Cavani, G., Virdone, R., Affronti, A., Nardone, G., Felder, M., Mega, A., Ciccarese, F., Del Poggio, P., Olmi, S., Foschi, F. G., Bevilacqua, V., Dall'Aglio, A. C., Ercolani, G., Fiorini, E., Casadei Gardini, A., Lanzi, A., Mirici Cappa, F., Sacco, R., Mismas, V., Svegliati Barone, G., Schiadà, L., Farinati, F., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Rapaccini, G. L., de Matthaeis, N., Gasbarrini, A., Rinninella, E., Olivani, A., Missale, G., Biasini, E., Di Marco, M., Balsamo, C., Vavassori, E., Masotto, A., Marchetti, F., Valerio, M., Marra, F., Aburas, S., Campani, C., Dragoni, G., Borzio, F., Benvegnù, L., Festi, D., Marasco, Giovanni, Ravaioli, Federico, Morisco, Filomena, Camera, Silvia, Guarino, Maria, Tortora, Raffaella, Cossiga, Valentina, Vitiello, Anna, Cordone, Gabriella, Caporaso, Nicola, Di Costanzo, Giovan Giuseppe, Zoli, M., Garuti, F., Neri, A., Piscaglia, F., Lenzi, B., Valente, M., Trevisani, F., Bolondi, L., Biselli, M., Caraceni, P., Cucchetti, A., Domenicali, M., Gramenzi, A., Magalotti, D., Serra, C., Venerandi, L., Cappelli, A., Golfieri, R., Mosconi, C., Renzulli, M., Giannini, E.G., Brunacci, M., Moscatelli, A., Pellegatta, G., Savarino, V., Caturelli, E., Roselli, P., Lauria, V., Pelecca, G., Dell'Isola, S., Ialungo, A.M., Rastrelli, E., Cabibbo, G., Cammà, C., Attardo, S., Rossi, M., Cavani, G., Virdone, R., Affronti, A., Nardone, G., Felder, M., Mega, A., Ciccarese, F., Del Poggio, P., Olmi, S., Foschi, F.G., Bevilacqua, V., Dall'Aglio, A.C., Ercolani, G., Fiorini, E., Casadei Gardini, A., Lanzi, A., Mirici Cappa, F., Sacco, R., Mismas, V., Svegliati Barone, G., Schiadà, L., Farinati, F., Gazzola, A., Murer, F., Pozzan, C., Vanin, V., Rapaccini, G.L., de Matthaeis, N., Gasbarrini, A., Rinninella, E., Olivani, A., Missale, G., Biasini, E., Di Marco, M., Balsamo, C., Vavassori, E., Masotto, A., Marchetti, F., Valerio, M., Marra, F., Aburas, S., Campani, C., Dragoni, G., Borzio, F., Benvegnù, L., Festi, D., Marasco, Giovanni, Ravaioli, Federico, Giannini, E. G., Ialungo, A. M., Foschi, F. G., Dall'Aglio, A. C., Rapaccini, G. L., Garuti, Franca, Venerandi, Laura, Mega, Angela, Fiorini, Elisabetta, Lanzi, Andrea, and Balsamo, Carlo

Subjects
medicine.medical_specialty, Large HCC, Gastroenterology, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Survival rate, Laser ablation, TACE, Univariate analysis, business.industry, Standard treatment, Large HCC, Laser ablation, TACE, Oncology, Cancer, Hepatology, medicine.disease, BCLC Stage, Oncology, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Liver cancer, business, Research Paper
Abstract

// Filomena Morisco 1 , Silvia Camera 1 , Maria Guarino 1 , Raffaella Tortora 2 , Valentina Cossiga 1 , Anna Vitiello 1 , Gabriella Cordone 2 , Nicola Caporaso 1 , Giovan Giuseppe Di Costanzo 2 and Italian Liver Cancer (ITA.LI.CA) group 1 Gastroenterology Unit, Department of Clinical Medicine and Surgery, University of Naples “Federico II”, Naples, Italy 2 Hepatology Unit, “Cardarelli” Hospital, Naples, Italy Correspondence to: Filomena Morisco, email: filomena.morisco@unina.it Keywords: large HCC; laser ablation; TACE Received: December 13, 2017 Accepted: February 27, 2018 Published: April 03, 2018 ABSTRACT Background: Limited therapies are available for large (≥40 mm) unresectable hepatocellular carcinoma (HCC). Currently, the standard treatment with transarterial chemoembolisation (TACE) is unsatisfactory with high recurrence rate and limited effect on survival. Laser Ablation (LA) has emerged as a relatively new technique characterized by high efficacy and good safety. This study is aimed to evaluate the efficacy of LA in comparison to TACE in patients with large HCC. Methods: Eighty-two patients with a single HCC nodule ≥40 mm (BCLC stage A or B) were enrolled in this case-control study. Forty-one patients were treated with LA and 41 patients were treated with TACE. Response to therapy was evaluated according to the mRECIST criteria. Survival was calculated with Kaplan-Meier from the time of cancer diagnosis to death with values censored at the date of the last follow-up. Results: Twenty-six (63.4%) and 8 (19.5%) patients had a complete response after LA and TACE, respectively ( p 60 mm. LA resulted superior to TACE especially in nodules ranging between 51 and 60 mm in diameter, with a complete response rate post-LA and post-TACE of 75% and 14.3%, respectively ( p = 0.0133). The 36 months cumulative survival rate in patients treated with LA and TACE was 55.4% and 48.8%, respectively. The disease recurrence rates after LA and TACE were 19.5% and 75.0%, respectively. Conclusions: LA is a more effective therapeutic option than TACE in patients with solitary large HCC.

Published
2018

50. Patients with advanced hepatocellular carcinoma need a personalized management: A lesson from clinical practice

Author

Giannini E. G., Bucci L., Garuti F., Brunacci M., Lenzi B., Valente M., Caturelli E., Cabibbo G., Piscaglia F., Virdone R., Felder M., Ciccarese F., Foschi F. G., Sacco R., Svegliati Baroni G., Farinati F., Rapaccini G. L., Olivani A., Gasbarrini A., Di Marco M., Morisco F., Zoli M., Masotto A., Borzio F., Benvegnu L., Marra F., Colecchia A., Nardone G., Bernardi M., Trevisani F, Olmi S, on behalf of Italian Liver Cancer (ITA. LI. CA) group, Giannini, E. G., Bucci, L., Garuti, F., Brunacci, M., Lenzi, B., Valente, M., Caturelli, E., Cabibbo, G., Piscaglia, F., Virdone, R., Felder, M., Ciccarese, F., Foschi, F. G., Sacco, R., Svegliati Baroni, G., Farinati, F., Rapaccini, G. L., Olivani, A., Gasbarrini, A., Di Marco, M., Morisco, F., Zoli, M., Masotto, A., Borzio, F., Benvegnu, L., Marra, F., Colecchia, A., Nardone, G., Bernardi, M., Trevisani, F, Olmi, S, on behalf of Italian Liver Cancer (ITA. LI., CA) group, Giannini EG, Bucci L, Garuti F, Brunacci M, Lenzi B, Valente M, Caturelli E, Cabibbo G, Piscaglia F, Virdone R, Felder M, Ciccarese F, Foschi FG, Sacco R, Svegliati Baroni G, Farinati F, Rapaccini GL, Olivani A, Gasbarrini A, Di Marco M, Morisco F, Zoli M, Masotto A, Borzio F, Benvegnù L, Marra F, Colecchia A, Nardone G, Bernardi M, Trevisani F, Giannini, Edoardo G, Bucci, Laura, Garuti, Francesca, Brunacci, Matteo, Lenzi, Barbara, Valente, Matteo, Caturelli, Eugenio, Cabibbo, Giuseppe, Piscaglia, Fabio, Virdone, Roberto, Felder, Martina, Ciccarese, Francesca, Foschi, Francesco Giuseppe, Sacco, Rodolfo, Baroni, Gianluca Svegliati, Farinati, Fabio, Rapaccini, Gian Lodovico, Olivani, Andrea, Gasbarrini, Antonio, Di Marco, Maria, Morisco, Filomena, Zoli, Marco, Masotto, Alberto, Borzio, Franco, Benvegnù, Luisa, Marra, Fabio, Colecchia, Antonio, Nardone, Gerardo, Bernardi, Mauro, and Trevisani, Franco

Subjects
Sorafenib, Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Databases, Factual, Settore MED/12 - GASTROENTEROLOGIA, advanced stage, Gastroenterology, survival, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Internal medicine, medicine, Carcinoma, Humans, Stage (cooking), Precision Medicine, Cancer staging, Aged, Neoplasm Staging, Retrospective Studies, Aged, 80 and over, therapy, Hepatology, Performance status, business.industry, Liver Neoplasms, Middle Aged, medicine.disease, Prognosis, Survival Analysis, Liver cancer, sorafenib, Liver cancer, advanced stage, sorafenib, survival, therapy, Treatment Outcome, Liver, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Female, alpha-Fetoproteins, business, medicine.drug
Abstract

The Barcelona Clinic Liver Cancer advanced stage (BCLC C) of hepatocellular carcinoma (HCC) includes a heterogeneous population, where sorafenib alone is the recommended treatment. In this study our aim was to assess treatment and overall survival (OS) of BCLC C patients sub-classified according to clinical features (Performance Status [PS], macro-vascular invasion [MVI], extra-hepatic spread [EHS] or MVI+EHS) determining their allocation to this stage. From the Italian Liver Cancer database, we analysed 835 consecutive BCLC C patients diagnosed between 2008 and 2014. Patients were sub-classified as: PS1 alone (n=385, 46.1%), PS2 alone (n=146, 17.5%), MVI (n=224, 26.8%), EHS (n=51, 6.1%) and MVI+EHS (n=29, 3.5%). MVI, EHS and MVI+EHS patients had larger and multifocal/massive HCCs and higher alpha-fetoprotein levels than PS1 and PS2 patients. Median OS significantly declined from PS1 (38.6 months) to PS2 (22.3 months), EHS (11.2 months), MVI (8.2 months) and MVI+EHS (3.1 months) (P

Published
2018

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