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1. Trends in liver transplantation for primary sclerosing cholangitis

Author

Viganò, Raffaella, Fornasiere, Ezio, Catanzaro, Elisa, Marrone, Giuseppe, Milana, Martina, Calleri, Alberto, Scorzoni, Chiara, Frassanito, Gabriella, Lionetti, Raffaella, Dibenedetto, Clara, Morelli, Maria Cristina, Gambato, Martina, Martini, Silvia, Carrai, Paola, Toniutto, Pierluigi, Giannelli, Valerio, Donato, Francesca, Lenci, Ilaria, Pasulo, Luisa, Mazzarelli, Chiara, Ferrarese, Alberto, Rendina, Maria, Grieco, Antonio, Lanza, Alfonso Galeota, Baroni, Gianluca Svegliati, De Maria, Nicola, Marenco, Simona, Mameli, Laura, Ponziani, Francesca Romana, Vitale, Giovanni, and Burra, Patrizia

Published
2024
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2. Safe pregnancy after liver transplantation: Evidence from a multicenter Italian collaborative study

Author

Sciarrone, Salvatore Stefano, Ferrarese, Alberto, Bizzaro, Debora, Volpato, Sofia, Donato, Francesca Maria, Invernizzi, Federica, Trespidi, Laura, Ramezzana, Ilaria Giuditta, Avolio, Alfonso Wolfango, Nure, Erida, Pascale, Marco Maria, Fagiuoli, Stefano, Pasulo, Luisa, Merli, Manuela, Lapenna, Lucia, Toniutto, Pierluigi, Lenci, Ilaria, Di Donato, Roberto, De Maria, Nicola, Villa, Erica, Galeota Lanza, Alfonso, Marenco, Simona, Bhoori, Sherrie, Mameli, Laura, Cillo, Umberto, Boccagni, Patrizia, Russo, Francesco Paolo, Bo, Patrizio, Cosmi, Erich, and Burra, Patrizia

Published
2022
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4. Trends in liver transplantation for primary sclerosing cholangitis.

Author

Morelli, Maria Cristina, Gambato, Martina, Martini, Silvia, Carrai, Paola, Toniutto, Pierluigi, Giannelli, Valerio, Donato, Francesca, Lenci, Ilaria, Pasulo, Luisa, Mazzarelli, Chiara, Ferrarese, Alberto, Rendina, Maria, Grieco, Antonio, Lanza, Alfonso Galeota, Baroni, Gianluca Svegliati, De Maria, Nicola, Marenco, Simona, Mameli, Laura, Ponziani, Francesca Romana, and Vitale, Giovanni

Abstract

Primary sclerosing cholangitis is a cholestatic disease with a low prevalence in Italy. Indications for liver transplantation and the time of listing are not stated. We performed a national survey to investigate the listing criteria, comorbidities, and outcomes. In April 2022, we surveyed liver transplantation in primary sclerosing cholangitis nationwide for the last 15 years. From 2007 to 2021, 445 patients were included on waiting lists, and 411 had undergone liver transplants. The median age at transplantation was 46 years (males 63.9%); 262 patients (59%) presented an inflammatory bowel disease. Transplants increased over the years, from 1.8 % in 2007 to 3.0 % in 2021. Cholangitis (51%) and hepatic decompensation (45%) were the main indications for listing. The disease recurred in 81 patients (20%). Patient survival after the first transplant was 94 %, 86% and 84% at one, five, and ten years. Twenty-four died in the first year (50% surgical complications, 25% infections); 33 between one to five years (36% recurrence, 21% cholangiocarcinoma recurrence) and nine after five years (56% de novo cancer, 44% recurrence). Primary sclerosing cholangitis has been an increasing indication for transplantation in Italy. Cholangitis and decompensation were the main indications for listing. Recurrence and cancer were the leading causes of death. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Safety and Efficacy of Atezolizumab/Bevacizumab in Patients with Hepatocellular Carcinoma and Impaired Liver Function: A Systematic Review and Meta-Analysis.

Author

Pasta, Andrea, Calabrese, Francesco, Jaffe, Ariel, Labanca, Sara, Marenco, Simona, Pieri, Giulia, Plaz Torres, Maria Corina, Strazzabosco, Mario, and Giannini, Edoardo G.

Subjects
HEPATOCELLULAR carcinoma, ATEZOLIZUMAB, BEVACIZUMAB, ADVERSE health care events, LIVER
Abstract

Background: Safety and outcome of atezolizumab/bevacizumab in Child-Pugh B patients with hepatocellular carcinoma (HCC) have not been completely characterized. Objectives: In this study, we aimed at addressing safety and efficacy of atezolizumab/bevacizumab in Child-Pugh B patients by reviewing the available data and analyzing them by meta-analysis. Methods: We compared the safety and efficacy of atezolizumab/becavizumab treatment in patients with unresectable HCC and various degrees of liver dysfunction. A total of 8 retrospective, non-randomized, cohort studies were included in this meta-analysis, for a total of 1,071 Child-Pugh A and 225 Child-Pugh B patients. The albumin-bilirubin (ALBI) grade was also used to assess liver function, when available. Results: Grade ≥3 adverse events were observed in 11.8% of Child-Pugh class A and 26.8% class B patients (p = 0.0001), with an odds ratio (OR) of 0.43 (confidence interval [CI] 0.21–0.90; p = 0.02). Progression-free survival (PFS) at both 6 months (4.90 ± 2.08 vs. 4.75 ± 2.08 months; p = 0.0004) and 12 months (8.83 ± 2.32 vs. 7.26 ± 2.33 months; p = 0.002) was lower in Child-Pugh class B patients. A trend toward a higher objective response rate (ORR) was observed in Child-Pugh class A patients (219/856, 25.6%) as compared to Child-Pugh class B patients (25/138, 18.1%; p = 0.070), while the probability of obtaining an ORR was significantly greater in Child-Pugh A patients (OR 1.79, CI 1.12–2.86; p = 0.02). Median overall survival (OS) was 16.8 ± 2.0 and 6.8 ± 3.2 months in Child-Pugh A and B patients, respectively (mean difference 9.06 months, CI 7.01–11.1, p < 0.0001). Lastly, OS was longer in patients with ALBI grades 1–2 than in those with grade 3 (8.3 ± 11.4 vs. 3.3 ± 5.0 months, p = 0.0008). Conclusions: Oncological efficacy of atezolizumab/bevacizumab is moderate in Child-Pugh class B patients, and the shorter PFS and OS associated with the greater likelihood of experiencing treatment-related adverse events observed in these patients suggest great caution and individualization of treatment, possibly with the support of the ALBI grade. [ABSTRACT FROM AUTHOR]

Published
2024
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9. The Italian data on SARS-CoV-2 infection in transplanted patients support an organ specific immune response in liver recipients

Author

Rendina, Maria, primary, Barone, Michele, additional, Lillo, Chiara, additional, Trapani, Silvia, additional, Masiero, Lucia, additional, Trerotoli, Paolo, additional, Puoti, Francesca, additional, Lupo, Luigi Giovanni, additional, Tandoi, Francesco, additional, Agnes, Salvatore, additional, Grieco, Antonio, additional, Andorno, Enzo, additional, Marenco, Simona, additional, Giannini, Edoardo Giovanni, additional, Baccarani, Umberto, additional, Toniutto, Pierluigi, additional, Carraro, Amedeo, additional, Colecchia, Antonio, additional, Cescon, Matteo, additional, Morelli, Maria Cristina, additional, Cillo, Umberto, additional, Burra, Patrizia, additional, Angeli, Paolo, additional, Colledan, Michele, additional, Fagiuoli, Stefano, additional, De Carlis, Luciano, additional, Belli, Luca, additional, De Simone, Paolo, additional, Carrai, Paola, additional, Di Benedetto, Fabrizio, additional, De Maria, Nicola, additional, Ettorre, Giuseppe Maria, additional, Giannelli, Valerio, additional, Gruttadauria, Salvatore, additional, Volpes, Riccardo, additional, Corsale, Sveva, additional, Mazzaferro, Vincenzo, additional, Bhoori, Sherrie, additional, Romagnoli, Renato, additional, Martini, Silvia, additional, Rossi, Giorgio, additional, Caccamo, Lucio, additional, Donato, Maria Francesca, additional, Rossi, Massimo, additional, Ginanni Corradini, Stefano, additional, Spada, Marco, additional, Maggiore, Giuseppe, additional, Tisone, Giuseppe, additional, Lenci, Ilaria, additional, Vennarecci, Giovanni, additional, Tortora, Raffaella, additional, Vivarelli, Marco, additional, Svegliati Baroni, Gianluca, additional, Zamboni, Fausto, additional, Mameli, Laura, additional, Tafuri, Silvio, additional, Simone, Simona, additional, Gesualdo, Loreto, additional, Cardillo, Massimo, additional, and Di Leo, Alfredo, additional

Published
2023
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11. Prophylaxis of HBV-recurrence after liver transplantation in patients with HCC: risk of HCC recurrence from a large, multicentre retrospective study from Italy

Author

Burra, Patrizia, primary, Battistella, Sara, additional, Russo, Francesco Paolo, additional, Turco, Laura, additional, Manuli, Chiara, additional, Calleri, Alberto, additional, Pasulo, Luisa, additional, Giannelli, Valerio, additional, DiBenedetto, Clara, additional, Mameli, Laura, additional, Ferrarese, Alberto, additional, Marenco, Simona, additional, Ferri, Flaminia, additional, Lenci, Ilaria, additional, Forastiere, Domenico, additional, Schiavone, Silvia, additional, Vero, Vittoria, additional, Vizioli, Luca, additional, Carroli, Agnese, additional, Frassanito, Gabriella, additional, Scandali, Giulia, additional, Biolato, Marco, additional, Fornasiere, Ezio, additional, Ponziani, Francesca, additional, Svegliati-Baroni, Gianluca, additional, Giannini, Edoardo Giovanni, additional, Toniutto, Pierluigi, additional, Lanza, Alfonso Galeota, additional, Rendina, Maria Grazia, additional, Donato, Maria Francesca, additional, Fagiuoli, Stefano, additional, De Maria, Nicola, additional, Morelli, Maria Cristina, additional, Martini, Silvia, additional, Trapani, Silvia, additional, Grossi, Paolo Antonio, additional, Aghemo, Alessio, additional, and Zanetto, Alberto, additional

Published
2023
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12. Primary sclerosing cholangitis recurrence after liver transplantation: a nationwide survey in Italy

Author

Morelli, Maria Cristina, primary, Gambato, Martina, additional, Martini, Silvia, additional, Carrai, Paola, additional, Toniutto, Pierluigi, additional, Giannelli, Valerio, additional, Donato, Maria Francesca, additional, Lenci, Ilaria, additional, Pasulo, Luisa, additional, Mazzarelli, Chiara, additional, Ferrarese, Alberto, additional, Rendina, Maria Grazia, additional, Grieco, Antonio, additional, Lanza, Alfonso Galeota, additional, Svegliati-Baroni, Gianluca, additional, De Maria, Nicola, additional, Mameli, Laura, additional, Marenco, Simona, additional, and Burra, Patrizia, additional

Published
2023
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17. Impact of SARS-CoV-2 Pandemic on the Management of Patients with Hepatocellular Carcinoma

Author

Maria, Guarino, Valentina, Cossiga, Mario, Capasso, Chiara, Mazzarelli, Filippo, Pelizzaro, Rodolfo, Sacco, Francesco Paolo, Russo, Alessandro, Vitale, Franco, Trevisani, Giuseppe, Cabibbo, Baccarani, Umberto, Bhoori, Sherrie, Borzio, Mauro, Brancaccio, Giuseppina, Burra, Patrizia, Casadei Gardini, Andrea, Carrai, Paola, Centonze, Leonardo, Cescon, Matteo, Cillo, Umberto, Cozzolongo, Raffaele, Cucchetti, Alessandro, De Matthaeis, Nicoletta, Di Costanzo, Giovan Giuseppe, Di Sandro, Stefano, Famularo, Simone, Farinati, Fabio, Finotti, Michele, Giuseppe Foschi, Francesco, Galati, Giovanni, Gambato, Martina, Giovanni Giannini, Edoardo, Giuliante, Felice, Ghinolfi, Davide, Gruttaduria, Salvatore, Iavarone, Massimo, Kostandini, Alba, Lai, Quirino, Lenci, Ilaria, Giovanni Lupo, Luigi, Manzia, Tommaso, Marasco, Giovanni, Marenco, Simona, Masarone, Mario, Mazzocato, Susanna, Melandro, Fabio, Mescoli, Claudia, Miele, Luca, Morisco, Filomena, Nicolini, Daniele, Pagano, Duilio, Persico, Marcello, Platz Torres, Maria Corina, Ponziani, Francesca Romana, Pravisani, Riccardo, Rendina, Maria, Renzulli, Matteo, Ricci, Lilia, Romano, Fabrizio, Battista Levi Sandri, Giovanni, Sangiovanni, Angelo, Sposito, Carlo, Tortora, Raffaella, Viganò, Luca, Viganò, Mauro, Vincenzi, Valter, Violi, Pola, Nicoletta, De Matthaeis, Felice, Giuliante (ORCID:0000-0001-9517-8220), Luca, Miele (ORCID:0000-0003-3464-0068), Francesca Romana, Ponziani (ORCID:0000-0002-5924-6238), Maria, Guarino, Valentina, Cossiga, Mario, Capasso, Chiara, Mazzarelli, Filippo, Pelizzaro, Rodolfo, Sacco, Francesco Paolo, Russo, Alessandro, Vitale, Franco, Trevisani, Giuseppe, Cabibbo, Baccarani, Umberto, Bhoori, Sherrie, Borzio, Mauro, Brancaccio, Giuseppina, Burra, Patrizia, Casadei Gardini, Andrea, Carrai, Paola, Centonze, Leonardo, Cescon, Matteo, Cillo, Umberto, Cozzolongo, Raffaele, Cucchetti, Alessandro, De Matthaeis, Nicoletta, Di Costanzo, Giovan Giuseppe, Di Sandro, Stefano, Famularo, Simone, Farinati, Fabio, Finotti, Michele, Giuseppe Foschi, Francesco, Galati, Giovanni, Gambato, Martina, Giovanni Giannini, Edoardo, Giuliante, Felice, Ghinolfi, Davide, Gruttaduria, Salvatore, Iavarone, Massimo, Kostandini, Alba, Lai, Quirino, Lenci, Ilaria, Giovanni Lupo, Luigi, Manzia, Tommaso, Marasco, Giovanni, Marenco, Simona, Masarone, Mario, Mazzocato, Susanna, Melandro, Fabio, Mescoli, Claudia, Miele, Luca, Morisco, Filomena, Nicolini, Daniele, Pagano, Duilio, Persico, Marcello, Platz Torres, Maria Corina, Ponziani, Francesca Romana, Pravisani, Riccardo, Rendina, Maria, Renzulli, Matteo, Ricci, Lilia, Romano, Fabrizio, Battista Levi Sandri, Giovanni, Sangiovanni, Angelo, Sposito, Carlo, Tortora, Raffaella, Viganò, Luca, Viganò, Mauro, Vincenzi, Valter, Violi, Pola, Nicoletta, De Matthaeis, Felice, Giuliante (ORCID:0000-0001-9517-8220), Luca, Miele (ORCID:0000-0003-3464-0068), and Francesca Romana, Ponziani (ORCID:0000-0002-5924-6238)

Abstract

Worldwide, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) significantly increases mortality and morbidity. The Coronavirus Disease 2019 (COVID-19) outbreak has had a considerable impact on healthcare systems all around the world, having a significant effect on planned patient activity and established care pathways, in order to meet the difficult task of the global pandemic. Patients with hepatocellular carcinoma (HCC) are considered a particularly susceptible population and conceivably at increased risk for severe COVID-19 because of two combined risk factors: chronic advanced liver disease and HCC itself. In these challenging times, it is mandatory to reshape clinical practice in a prompt way to preserve the highest standards of patient care and safety. However, due to the stay-at-home measures instituted to stop the spread of COVID-19, HCC surveillance has incurred a dramatic drop, and care for HCC patients has been rearranged by refining the algorithm for HCC treatment to the COVID-19 pandemic, permitting these patients to be safely managed by identifying those most at risk of neoplastic disease progression.

Published
2022

18. Curative therapies are superior to standard of care (transarterial chemoembolization) for intermediate stage hepatocellular carcinoma

Author

Pecorelli, Anna, Lenzi, Barbara, Gramenzi, Annagiulia, Garuti, Francesca, Farinati, Fabio, Giannini, Edoardo G., Ciccarese, Francesca, Piscaglia, Fabio, Rapaccini, Gian Lodovico, Di Marco, Maria, Caturelli, Eugenio, Zoli, Marco, Borzio, Franco, Sacco, Rodolfo, Cabibbo, Giuseppe, Felder, Martina, Morisco, Filomena, Gasbarrini, Antonio, Baroni, Gianluca Svegliati, Foschi, Francesco G., Biasini, Elisabetta, Masotto, Alberto, Virdone, Roberto, Bernardi, Mauro, Trevisani, Franco, Bolondi, Luigi, Biselli, Maurizio, Bucci, Laura, Caraceni, Paolo, Cucchetti, Alessandro, Domenicali, Marco, Magalotti, Donatella, Serra, Carla, Venerandi, Laura, Giacomin, Anna, Maddalo, Gemma, Pozzan, Caterina, Vani, 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, Ialungo, Anna Maria, Bruzzone, Linda, Picciotto, Antonino, Marenco, Simona, Risso, Domenico, Sammito, Giorgio, Savarino, Vincenzo, Cammà, Calogero, Maida, Marcello, Costantino, Andrea, Barcellona, Maria Rosa, Affronti, Andrea, Mega, Andrea, Rinninella, Emanuele, Mismas, Valeria, Cappa, Federica Mirici, DallʼAglio, Anna Chiara, Feletti, Valentina, Lanzi, Arianna, Neri, Elga, Stefanini, Giuseppe Francesco, Tamberi, Stefano, Missale, Gabriele, Porro, Emanuela, Guarino, Maria, Gemini, Stefano, and Schiadà, Laura

Published
2017
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19. Measurement of sorafenib plasma concentration by high-performance liquid chromatography in patients with advanced hepatocellular carcinoma: is it useful the application in clinical practice? A pilot study

Author

Fucile, Carmen, Marenco, Simona, Bazzica, Marco, Zuccoli, Maria Laura, Lantieri, Francesca, Robbiano, Luigi, Marini, Valeria, Di Gion, Paola, Pieri, Giulia, Stura, Paola, Martelli, Antonietta, Savarino, Vincenzo, Mattioli, Francesca, and Picciotto, Antonino

Published
2015
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20. Immune checkpoint inhibitors in malignancies after liver transplantation: A systematic review and pooled analysis.

Author

Kayali, Stefano, Pasta, Andrea, Plaz Torres, Maria Corina, Jaffe, Ariel, Strazzabosco, Mario, Marenco, Simona, and Giannini, Edoardo G.

Subjects
IMMUNE checkpoint inhibitors, LIVER transplantation, IPILIMUMAB, GRAFT rejection, OFF-label use (Drugs), HEPATOCELLULAR carcinoma, OVERALL survival
Abstract

Background and aims: Treatment of de novo malignancies and recurrent hepatocellular carcinoma with immune checkpoint inhibitors (ICI) in liver transplant recipients (LT) is an attractive strategy that is infrequently pursued because of the lack of strong evidence regarding their safety and efficacy. In this systematic review with pooled analysis, we aimed to assess safety and efficacy of ICI therapy following LT. Methods: We performed a systematic search of case reports and series published until January 2022. We included 31 publications reporting a total of 52 patients treated with ICIs after LT and assessed in a pooled analysis the risk of graft rejection and the outcome of ICI therapy. Results: Acute graft rejection occurred in 15 patients (28.8%) and 7 patients (13.4% of the total cohort) died because of graft loss. Rejection was associated with shorter overall survival (OS) (17.2 months, confidence interval [CI] 12.1–22.2 vs. 3.5 months, CI 1.6–5.4, p < 0.001). Disease control rate was 44.2% (n = 23), and in these patients, OS was longer than in non‐responders (26.4 months, CI 20.8–32.0 vs. 3.4 months, CI 2.1–4.7, p < 0.001). Conclusions: Observational, off‐label experience suggests that treatment with ICI for advanced malignancies in LT recipients might not be discarded a priori. This notwithstanding, ICI treatment in these patients is associated with a substantial risk of graft rejection and mortality. Prospective studies are needed to provide adequate safety and efficacy figures of ICI treatment in this fragile population. [ABSTRACT FROM AUTHOR]

Published
2023
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23. Safe pregnancy after liver transplantation: Evidence from a multicenter Italian collaborative study

Author

Sciarrone, Salvatore Stefano, primary, Ferrarese, Alberto, additional, Bizzaro, Debora, additional, Volpato, Sofia, additional, Donato, Francesca Maria, additional, Invernizzi, Federica, additional, Trespidi, Laura, additional, Ramezzana, Ilaria Giuditta, additional, Avolio, Alfonso Wolfango, additional, Nure, Erida, additional, Pascale, Marco Maria, additional, Fagiuoli, Stefano, additional, Pasulo, Luisa, additional, Merli, Manuela, additional, Lapenna, Lucia, additional, Toniutto, Pierluigi, additional, Lenci, Ilaria, additional, Di Donato, Roberto, additional, De Maria, Nicola, additional, Villa, Erica, additional, Galeota Lanza, Alfonso, additional, Marenco, Simona, additional, Bhoori, Sherrie, additional, Mameli, Laura, additional, Cillo, Umberto, additional, Boccagni, Patrizia, additional, Russo, Francesco Paolo, additional, Bo, Patrizio, additional, Cosmi, Erich, additional, and Burra, Patrizia, additional

Published
2021
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24. Resistance and phylogenetic analysis in HCV-2c infected patients within the Italian network VIRONET-C

Author

Di Maio, Velia Chiara, Barbaliscia, Silvia, Fabeni, Lavinia, Teti, Elisabetta, Paolucci, Stefania, Minichini, Carmine, Aragri, Marianna, La Rosa, Katia Yu, Pasquazzi, Caterina, Milana, Martina, Foroghi, Luca, Pollicino, Teresa, Licata, Anna, Pieri, Alessandro, Palitti, Valeria Pace, Bruzzone, Bianca, Valeria Micheli, Bertoli, Ada, Baiocchi, Leonardo, Callegaro, Maria Paola, Carioti, Luca, Pellicelli, Adriano, Morisco, Filomena, Gulminetti, Roberto, Novati, Stefano, Lichtner, Miriam, Mastroianni, Claudio M., Di Lorenzo, Francesco, Andreone, Pietro, Rossetti, Barbara, Marenco, Simona, Taliani, Gloria, Boeri, Enzo, Hasson, Hamid, Monno, Laura, Nicolini, Laura Ambra, Landonio, Simona, Paternoster, Claudio, Puoti, Massimo, Babudieri, Sergio, Quartini, Mariano, Iapadre, Nerio, Cozzolongo, Raffaele, Sangiovanni, Vincenzo, Parruti, Giustino, Sarmati, Loredana, Coppola, Nicola, Zazzi, Maurizio, Raimondo, Giovanni, Mario, Angelico, Perno, Carlo-Federico, Andreoni, Massimo, Craxi, Antonio, and Silberstein, Francesca Ceccherini

Subjects
Hepatology
Published
2020

26. Safety and Efficacy of Atezolizumab/Bevacizumab in Patients with Hepatocellular Carcinoma and Impaired Liver Function: A Systematic Review and Meta-Analysis

Author

Pasta, Andrea, Calabrese, Francesco, Jaffe, Ariel, Labanca, Sara, Marenco, Simona, Pieri, Giulia, Plaz Torres, Maria Corina, Strazzabosco, Mario, and Giannini, Edoardo G.

Abstract

Background:Safety and outcome of atezolizumab/bevacizumab in Child-Pugh B patients with hepatocellular carcinoma (HCC) have not been completely characterized. Objectives:In this study, we aimed at addressing safety and efficacy of atezolizumab/bevacizumab in Child-Pugh B patients by reviewing the available data and analyzing them by meta-analysis. Methods:We compared the safety and efficacy of atezolizumab/becavizumab treatment in patients with unresectable HCC and various degrees of liver dysfunction. A total of 8 retrospective, non-randomized, cohort studies were included in this meta-analysis, for a total of 1,071 Child-Pugh A and 225 Child-Pugh B patients. The albumin-bilirubin (ALBI) grade was also used to assess liver function, when available. Results:Grade ≥3 adverse events were observed in 11.8% of Child-Pugh class A and 26.8% class B patients (p= 0.0001), with an odds ratio (OR) of 0.43 (confidence interval [CI] 0.21–0.90; p= 0.02). Progression-free survival (PFS) at both 6 months (4.90 ± 2.08 vs. 4.75 ± 2.08 months; p= 0.0004) and 12 months (8.83 ± 2.32 vs. 7.26 ± 2.33 months; p= 0.002) was lower in Child-Pugh class B patients. A trend toward a higher objective response rate (ORR) was observed in Child-Pugh class A patients (219/856, 25.6%) as compared to Child-Pugh class B patients (25/138, 18.1%; p= 0.070), while the probability of obtaining an ORR was significantly greater in Child-Pugh A patients (OR 1.79, CI 1.12–2.86; p= 0.02). Median overall survival (OS) was 16.8 ± 2.0 and 6.8 ± 3.2 months in Child-Pugh A and B patients, respectively (mean difference 9.06 months, CI 7.01–11.1, p< 0.0001). Lastly, OS was longer in patients with ALBI grades 1–2 than in those with grade 3 (8.3 ± 11.4 vs. 3.3 ± 5.0 months, p= 0.0008). Conclusions:Oncological efficacy of atezolizumab/bevacizumab is moderate in Child-Pugh class B patients, and the shorter PFS and OS associated with the greater likelihood of experiencing treatment-related adverse events observed in these patients suggest great caution and individualization of treatment, possibly with the support of the ALBI grade.

Published
2023
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27. THU-527 - Primary sclerosing cholangitis recurrence after liver transplantation: a nationwide survey in Italy

Author

Morelli, Maria Cristina, Gambato, Martina, Martini, Silvia, Carrai, Paola, Toniutto, Pierluigi, Giannelli, Valerio, Donato, Maria Francesca, Lenci, Ilaria, Pasulo, Luisa, Mazzarelli, Chiara, Ferrarese, Alberto, Rendina, Maria Grazia, Grieco, Antonio, Lanza, Alfonso Galeota, Svegliati-Baroni, Gianluca, De Maria, Nicola, Mameli, Laura, Marenco, Simona, and Burra, Patrizia

Published
2023
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28. OS-069 - Prophylaxis of HBV-recurrence after liver transplantation in patients with HCC: risk of HCC recurrence from a large, multicentre retrospective study from Italy

Author

Burra, Patrizia, Battistella, Sara, Russo, Francesco Paolo, Turco, Laura, Manuli, Chiara, Calleri, Alberto, Pasulo, Luisa, Giannelli, Valerio, DiBenedetto, Clara, Mameli, Laura, Ferrarese, Alberto, Marenco, Simona, Ferri, Flaminia, Lenci, Ilaria, Forastiere, Domenico, Schiavone, Silvia, Vero, Vittoria, Vizioli, Luca, Carroli, Agnese, Frassanito, Gabriella, Scandali, Giulia, Biolato, Marco, Fornasiere, Ezio, Ponziani, Francesca, Svegliati-Baroni, Gianluca, Giannini, Edoardo Giovanni, Toniutto, Pierluigi, Lanza, Alfonso Galeota, Rendina, Maria Grazia, Donato, Maria Francesca, Fagiuoli, Stefano, De Maria, Nicola, Morelli, Maria Cristina, Martini, Silvia, Trapani, Silvia, Grossi, Paolo Antonio, Aghemo, Alessio, and Zanetto, Alberto

Published
2023
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32. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

Bertoli, Ada, Sorbo, Maria Chiara, Aragri, Marianna, Lenci, Ilaria, Teti, Elisabetta, Polilli, Ennio, Di Maio, Velia Chiara, Gianserra, Laura, Biliotti, Elisa, Masetti, Chiara, Magni, Carlo F., Babudieri, Sergio, Nicolini, Laura A., Milana, Martina, Cacciatore, Pierluigi, Sarmati, Loredana, Pellicelli, Adriano, Paolucci, Stefania, Craxì, Antonio, Morisco, Filomena, Palitti, Valeria Pace, Siciliano, Massimo, Coppola, Nicola, Iapadre, Nerio, Puoti, Massimo, Rizzardini, Giuliano, Taliani, Gloria, Pasquazzi, Caterina, Andreoni, Massimo, Parruti, Giustino, Angelico, Mario, Perno, Carlo Federico, Cento, Valeria, Ceccherini-Silberstein, Francesca, Andreone, Pietro, Baldanti, Fausto, Barbarini, Giorgio, Boccaccio, Vincenzo, Boglione, Lucio, Bolis, Matteo, Bonora, Stefano, Borghi, Vanni, Brancaccio, Giuseppina, Bruno, Savino, Bruzzone, Bianca, Calvaruso, Vincenza, Caporaso, Nicola, Ciaccio, Antonio, Ciancio, Alessia, Colombatto, Piero, Cozzolongo, Raffaele, D'Ambrosio, Cecilia, D'Ettorre, Gabriella, De Leonardis, Francesco, De Luca, Andrea, Di Biagio, Antonio, Di Perri, Giovanni, Francioso, Simona, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Ghisetti, Valeria, Giorgini, Alessia, Grieco, Antonio, Gubertini, Guido, Gulminetti, Roberto, Lambiase, Lara, Landonio, Simona, Lichtner, Miriam, Maida, Ivana, Marenco, Simona, Marinaro, Letizia, Maserati, Renato, Melis, Michela, Menzaghi, Barbara, Meregalli, Elisa, Micheli, Valeria, Niero, Fosca, Paoloni, Maurizio, Pieri, Alessandro, Rendina, Maria, Romagnoli, Dante, Rossetti, Barbara, Ruggiero, Tina, Sangiovanni, Vincenzo, Starace, Mario, Sticchi, Laura, Tarquini, Pierluigi, Toniutto, Pierluigi, Vullo, Vincenzo, Zazzi, Maurizio, HCV Virology Italian Resistance Network, Bertoli A1, Sorbo MC1, Aragri M1, Lenci I2, Teti E3, Polilli E4, Di Maio VC1, Gianserra L5, Biliotti E6, Masetti C2, Magni CF7, Babudieri S8, Nicolini LA9, Milana M2, Cacciatore P4, Sarmati L3, Pellicelli A10, Paolucci S11, Craxì A, Morisco F13, Palitti VP14, Siciliano M15, Coppola N16, Iapadre N17, Puoti M18, Rizzardini G7, Taliani G6, Pasquazzi C5, Andreoni M3, Parruti G4, Angelico M2, Perno CF19, Cento V20, Ceccherini-Silberstein F1, HCV Virology Italian Resistance Network (VIRONET-C)., Bertoli, Ada, Sorbo, Maria Chiara, Aragri, Marianna, Lenci, Ilaria, Teti, Elisabetta, Polilli, Ennio, Di Maio, Velia Chiara, Gianserra, Laura, Biliotti, Elisa, Masetti, Chiara, Magni, Carlo F., Babudieri, Sergio, Nicolini, Laura A., Milana, Martina, Cacciatore, Pierluigi, Sarmati, Loredana, Pellicelli, Adriano, Paolucci, Stefania, Craxì, Antonio, Morisco, Filomena, Palitti, Valeria Pace, Siciliano, Massimo, Coppola, Nicola, Iapadre, Nerio, Puoti, Massimo, Rizzardini, Giuliano, Taliani, Gloria, Pasquazzi, Caterina, Andreoni, Massimo, Parruti, Giustino, Angelico, Mario, Perno, Carlo Federico, Cento, Valeria, Ceccherini-Silberstein, Francesca, Andreone, Pietro, Baldanti, Fausto, Barbarini, Giorgio, Boccaccio, Vincenzo, Boglione, Lucio, Bolis, Matteo, Bonora, Stefano, Borghi, Vanni, Brancaccio, Giuseppina, Bruno, Savino, Bruzzone, Bianca, Calvaruso, Vincenza, Caporaso, Nicola, Ciaccio, Antonio, Ciancio, Alessia, Colombatto, Piero, Cozzolongo, Raffaele, D'Ambrosio, Cecilia, D'Ettorre, Gabriella, De Leonardis, Francesco, De Luca, Andrea, Di Biagio, Antonio, Di Perri, Giovanni, Francioso, Simona, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Ghisetti, Valeria, Giorgini, Alessia, Grieco, Antonio, Gubertini, Guido, Gulminetti, Roberto, Lambiase, Lara, Landonio, Simona, Lichtner, Miriam, Maida, Ivana, Marenco, Simona, Marinaro, Letizia, Maserati, Renato, Melis, Michela, Menzaghi, Barbara, Meregalli, Elisa, Micheli, Valeria, Niero, Fosca, Paoloni, Maurizio, Pieri, Alessandro, Rendina, Maria, Romagnoli, Dante, Rossetti, Barbara, Ruggiero, Tina, Sangiovanni, Vincenzo, Starace, Mario, Sticchi, Laura, Tarquini, Pierluigi, Toniutto, Pierluigi, Vullo, Vincenzo, Zazzi, Maurizio, Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Sorbo, Mc, Di Maio, Vc, Magni, Cf, Nicolini, La, Craxì, A, Palitti, Vp, Perno, Cf, Gaeta, Gb, and Zazzi, M.

Subjects
Male, 0301 basic medicine, Sofosbuvir, Hepacivirus, Drug Resistance, lcsh:Medicine, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Hepatitis C Virus, HCV resistance-test, chemistry.chemical_compound, 0302 clinical medicine, Genotype, Prevalence, Viral, lcsh:Science, Multidisciplinary, biology, Hepatitis C, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Italy, Cohort, HCV, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, medicine.medical_specialty, HCV RAS, Hepatitis C virus, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, medicine, Humans, Aged, NS5A, NS5B, business.industry, lcsh:R, Hepatitis C Virus, HCV resistance-test, biology.organism_classification, medicine.disease, 030104 developmental biology, chemistry, lcsh:Q, business
Abstract

Natural resistance-associated substitutions (RASs) are reported with highly variable prevalence across different HCV genotypes (GTs). Frequency of natural RASs in a large Italian real-life cohort of patients infected with the 4 main HCV-GTs was investigated. NS3, NS5A and NS5B sequences were analysed in 1445 HCV-infected DAA-naïve patients. Sanger-sequencing was performed by home-made protocols on 464 GT1a, 585 GT1b, 92 GT2c, 199 GT3a, 16 GT4a and 99 GT4d samples. Overall, 20.7% (301/1455) of patients showed natural RASs, and the prevalence of multiclass-resistance was 7.3% (29/372 patients analysed). NS3-RASs were particularly common in GT1a and GT1b (45.2-10.8%, respectively), mainly due to 80K presence in GT1a (17%). Almost all GTs showed high prevalence of NS5A-RASs (range: 10.2–45.4%), and especially of 93H (5.1%). NS5A-RASs with fold-change >100x were detected in 6.8% GT1a (30H/R-31M-93C/H), 10.3% GT1b (31V-93H), 28.4% GT2c (28C-31M-93H), 8.5% GT3a (30K-93H), 45.5% GT4a (28M-30R-93H) and 3.8% GT4d (28V-30S-93H). Sofosbuvir RAS 282T was never detected, while the 159F and 316N RASs were found in GT1b (13.4–19.1%, respectively). Natural RASs are common in Italian patients infected with HCV-GTs 1–4. High prevalence of clinically-relevant RASs (such as Y93H) supports the appropriateness of HCV resistance-test to properly guide DAA-based therapy.

Published
2018

34. THU-133-Resistance-guided retreatment of HCV infected patients with a previous failure to an NS5A inhibitor-containing regimen: Italian real life experience

Author

Maio, Velia Chiara Di, primary, Aragri, Marianna, additional, Masetti, Chiara, additional, Paolucci, Stefania, additional, Bruzzone, Bianca, additional, Degasperi, Elisabetta, additional, Barbaliscia, Silvia, additional, Pollicino, Teresa, additional, Minichini, Carmine, additional, Calvaruso, Vincenza, additional, Rendina, Maria Grazia, additional, Cento, Valeria, additional, Teti, Elisabetta, additional, Micheli, Valeria, additional, Ghisetti, Valeria, additional, Polilli, Ennio, additional, Palitti, Valeria Pace, additional, Landonio, Simona, additional, Lenci, Ilaria, additional, Donnarumma, Laura, additional, Nicolini, Laura Ambra, additional, Bertoli, Ada, additional, Pasquazzi, Caterina, additional, Callegaro, Maria Paola, additional, Morisco, Filomena, additional, Cenderrello, Giovanni, additional, Marenco, Simona, additional, Gulminetti, Roberto, additional, Novati, Stefano, additional, Andreone, Pietro, additional, Ciancio, Alessia, additional, Sangiovanni, Vincenzo, additional, Cuomo, Nunzia, additional, Morsica, Giulia, additional, Borghi, Vanni, additional, Maida, Ivana Rita, additional, Brunetto, Maurizia, additional, Cozzolongo, Raffaele, additional, Santis, Adriano De, additional, Lichtner, Miriam, additional, Babudieri, Sergio, additional, Taliani, Gloria, additional, Santantonio, Teresa, additional, Paternoster, Claudio, additional, Ganga, Roberto, additional, Puoti, Massimo, additional, Rizzardini, Giuliano, additional, Pellicelli, Adriano, additional, Lampertico, Pietro, additional, Parruti, Giustino, additional, Nicola, Coppola, additional, Zazzi, Maurizio, additional, Raimondo, Giovanni, additional, Andreoni, Massimo, additional, Craxi, Antonio, additional, Mario, Angelico, additional, Perno, Carlo Federico, additional, and Ceccherini, Silberstein Francesca, additional

Published
2019
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35. Scelte terapeutiche e trattamento con sorafenib nell'epatocarcinoma: Analisi finale dello studio GIDEON in Italia

Author

D'Angelo, Salvatore, Germano, Domenico, Zolfino, Teresa, Sansonno, Domenico, Giannitrapani, Lydia, Benedetti, Antonio, Montesarchio, Vincenzo, Attili, Adolfo, Buonadonna, Angela, Barni, Sandro, Gasbarrini, Antonio, Burlone, Michela E., Cillo, Umberto, Marenco, Simona, Villa, Erica, Giovanis, Petros, Proserpio, Ilaria, Saitta, Carlo, Magini, Giulia, Cengarle, Rita, Fava, Giammarco, Cuttone, Filiana, Calvani, Nicola, Angelico, Mario, Di Costanzo, Francesco, Noto, Alfonso, Poggi, Guido, Marignani, Massimo, Cascinu, Stefano, Amoroso, Domenico, Palmieri, Vincenzo, Massa, Elena, Croce', Saveria, Picardi, Antonio, Tumulo, Salvatore, Erminero, Claudia, Lencioni, Riccardo, Lorusso, Vito, D’Angelo, S, Germano, D, Zolfino, T, Sansonno, D, Giannitrapani, L, Benedetti, A, Montesarchio, V, Attili, A, Buonadonna, A, Barni, S, Gasbarrini, A, Burlone, ME, Cillo, U, Marenco, S, Villa, E, Giovanis, P, Proserpio, I, Saitta, C, Magini, G, Cengarle, R, Fava, G, Cuttone, F, Calvani, N, Angelico, M, Di Costanzo, F, Noto, A, Poggi, G, Marignani, M, Cascinu, S, Amoroso, D, Palmieri, V, Massa, E, Crocè, LS, Picardi, A, Tumulo, S, Erminero, C, Lencioni, R, Lorusso, V, D'Angelo, Salvatore, Germano, Domenico, Zolfino, Teresa, Sansonno, Domenico, Giannitrapani, Lydia, Benedetti, Antonio, Montesarchio, Vincenzo, Attili, Adolfo, Buonadonna, Angela, Barni, Sandro, Gasbarrini, Antonio, Burlone, Michela E., Cillo, Umberto, Marenco, Simona, Villa, Erica, Giovanis, Petro, Proserpio, Ilaria, Saitta, Carlo, Magini, Giulia, Cengarle, Rita, Fava, Giammarco, Cuttone, Filiana, Calvani, Nicola, Angelico, Mario, Di Costanzo, Francesco, Noto, Alfonso, Poggi, Guido, Marignani, Massimo, Cascinu, Stefano, Amoroso, Domenico, Palmieri, Vincenzo, Massa, Elena, Croce', Saveria, Picardi, Antonio, Tumulo, Salvatore, Erminero, Claudia, Lencioni, Riccardo, and Lorusso, Vito

Subjects
Phenylurea Compound, Adult, Male, Niacinamide, Carcinoma, Hepatocellular, Hepatocellular carcinoma, Antineoplastic Agents, Antineoplastic Agent, 80 and over, Humans, Prospective Studies, Aged, Aged, 80 and over, GIDEON study, Sorafenib, Female, Italy, Liver Neoplasms, Middle Aged, Phenylurea Compounds, Medicine (all), Carcinoma, Hepatocellular, Prospective Studie, Hepatocellular carcinoma, sorafenib, GIDEON study, Liver Neoplasm, Human
Abstract

Summary. Introduction. Sorafenib, an oral multikinase inhibitor, is the only targeted agent approved for the treatment of patients with hepatocellular carcinoma (HCC) after demonstration to increase overall survival compared to placebo in two randomized phase III study. GIDEON (Global Investigation of therapeutic DEcisions in HCC and Of its treatment with sorafeNib) is the largest, global, non-interventional, prospective study of patients with uHCC (n>3200) treated with sorafenib in real-life clinical practice conditions. Here we report the final analysis of safety and efficacy in the Italian cohort of patients. Methods. Patients with unresectable HCC who are candidates for systemic therapy, and for whom a decision has been made to treat with sorafenib, are eligible for inclusion. Patients demographics disease characteristics and treatment history were recorded at baseline visit. Sorafenib dose, concomitant medications, performance status, liver function, adverse events and efficacy (survival and response rate) were collected throughout the study. Results. In the Italian cohort of the GIDEON study 278 patients were included in 36 centers. The global rate of adverse events was 81%. Drug-related events accounted for 67%, mostly of grade 1 and 2, and only 8% were classified as serious. The most common were diarrhea (24%), fatigue (23%), dermatological (14%), rash/exfoliation (10%), hypertension (9%), hemorrage/bleeding of gastrointestinal tract (6%). Overall survival was 14.4 months and time to progression 6.2 months. Objective responses were observed in 14 patients (5%) with 3 complete responses (1%). Stable diseases of at least 6 weeks were observed in 113 patients (41%) with a 30% of disease control rate. Discussion. The safety profile of sorafenib in terms of rate and type of adverse events is similar to that emerged in the global international GIDEON study as well as in the pivotal registration studies.

Published
2015

36. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author

Di Maio, Velia Chiara, primary, Cento, Valeria, additional, Aragri, Marianna, additional, Paolucci, Stefania, additional, Pollicino, Teresa, additional, Coppola, Nicola, additional, Bruzzone, Bianca, additional, Ghisetti, Valeria, additional, Zazzi, Maurizio, additional, Brunetto, Maurizia, additional, Bertoli, Ada, additional, Barbaliscia, Silvia, additional, Galli, Silvia, additional, Gennari, William, additional, Baldanti, Fausto, additional, Raimondo, Giovanni, additional, Perno, Carlo Federico, additional, Ceccherini-Silberstein, Francesca, additional, Andreone, Pietro, additional, Andreoni, Massimo, additional, Angelico, Mario, additional, Babudieri, Sergio, additional, Barbarini, Giorgio, additional, Boccaccio, Vincenzo, additional, Boglione, Lucio, additional, Bolis, Matteo, additional, Bonora, Stefano, additional, Borghi, Vanni, additional, Brancaccio, Giuseppina, additional, Bruno, Savino, additional, Cacciatore, Pierluigi, additional, Calvaruso, Vincenza, additional, Caporaso, Nicola, additional, Ciaccio, Antonio, additional, Ciancio, Alessia, additional, Colombatto, Piero, additional, Cozzolongo, Raffaele, additional, Craxì, Antonio, additional, D'Ambrosio, Cecilia, additional, D'Ettorre, Gabriella, additional, De Luca, Andrea, additional, Di Biagio, Antonio, additional, Di Perri, Giovanni, additional, Francioso, Simona, additional, Gaeta, Giovanni Battista, additional, Giorgini, Alessia, additional, Grieco, Antonio, additional, Gubertini, Guido, additional, Gulminetti, Roberto, additional, Lambiase, Lara, additional, Lenci, Ilaria, additional, Lichtner, Miriam, additional, Maida, Ivana, additional, Marenco, Simona, additional, Marinaro, Letizia, additional, Maserati, Renato, additional, Masetti, Chiara, additional, Melis, Michela, additional, Meregalli, Elisa, additional, Micheli, Valeria, additional, Morisco, Filomena, additional, Niero, Fosca, additional, Nicolini, Laura Ambra, additional, Palitti, Valeria Pace, additional, Paoloni, Maurizio, additional, Parruti, Giustino, additional, Pasquazzi, Caterina, additional, Pellicelli, Adriano, additional, Polilli, Ennio, additional, Ponti, Maria Laura, additional, Puoti, Massimo, additional, Rendina, Maria, additional, Rizzardini, Giuliano, additional, Rossetti, Barbara, additional, Ruggiero, Tina, additional, Sangiovanni, Vincenzo, additional, Starace, Mario, additional, Sticchi, Laura, additional, Tarquini, Pierluigi, additional, Toniutto, Pierluigi, additional, and Vullo, Vincenzo, additional

Published
2018
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37. Cost per care of the first year of direct antiviral agents in the Liguria Region: a multicenter analysis

Author

Cenderello,Giovanni, Fanizza,Caterina, Marenco,Simona, Nicolini,Laura Ambra, Artioli,Stefania, Baldissarro,Isabella, Dentone,Chiara, De Leo,Pasqualina, Di Biagio,Antonio, Cenderello,Giovanni, Fanizza,Caterina, Marenco,Simona, Nicolini,Laura Ambra, Artioli,Stefania, Baldissarro,Isabella, Dentone,Chiara, De Leo,Pasqualina, and Di Biagio,Antonio

Abstract

Giovanni Cenderello,1 Caterina Fanizza,2 Simona Marenco,3 Laura Ambra Nicolini,4 Stefania Artioli,5 Isabella Baldissarro,3 Chiara Dentone,6 Pasqualina De Leo,7 Antonio Di Biagio4 1SC Malattie Infettive, EO Ospedali Galliera, 2Rete ligure HIV, 3SSD Epatologia, AOU S. Martino, 4Clinica Malattie Infettive, AOU S. Martino, Genoa, 5SC Malattie Infettive ASL5 La Spezia, 6SC Malattie Infettive, ASL‑1, Sanremo, 7SC Malattie Infettive ASL2, San Paolo, Savona, Italy Aims: Despite the remarkable efficacy shown in clinical practice, concerns have been raised about the costs associated with direct antiviral agent (DAA) therapy. This article presents the real-life costs for DAA treatment sustained by the Italian National Health Service in the Liguria Region (Northern Italy).Methods: A retrospective analysis of the cost per care sustained for DAA treatment, relating to the period from January 1 to December 31, 2015 in five centers in Liguria was performed. All patients undergoing DAA-based treatments for hepatitis C virus (HCV) infection were enrolled. On-treatment costs included: HCV treatment, laboratory test, outpatient services, attended visits, drugs used for the management of adverse events (erythropoietin, albumin or red blood cell packs) and inpatient service admissions.Results: In total, 327 patients were enrolled. No difference in terms of sustained virologic response (SVR) rate among different treatments was reported. The majority (85.0%) of patients did not report any side effects and only 15 (4.6%) required hospital admission. Forty-two patients (12.8%) required high-cost drugs for the management of adverse events. The overall cost sustained was €14,744,433. DAA±ribavirin (RBV) accounted for the wide majority of this cost (98.9%; €14,585,123). Genotype (GT) 1, the most commonly treated GT, was associated with an average cost of €43,445 per patient. Detailed analysis of the costs for GT 1 showed the treatment ba

Published
2017

39. Correlation between LDH levels and response to sorafenib in HCC patients: an analysis of the ITA.LI.CA database

Author

Sacco, Rodolfo, Mismas, Valeria, Granito, Alessandro, Musettini, Gianna, Masi, Gianluca, Caparello, Chiara, Vivaldi, Caterina, Felder, Martina, Bresci, Giampaolo, Fornaro, Lorenzo, Trevisani, Franco, Bernardi, Mauro, Bolondi, Luigi, Piscaglia, Fabio, Zoli, Marco, Biselli, Maurizio, Caraceni, Paolo, Cucchetti, Alessandro, Domenicali, Marco, Frigerio, Marta, Erroi, Virginia, Garuti, Francesca, Gramenzi, Annagiulia, Lenzi, Barbara, Magalotti, Donatella, Pecorelli, Anna, Venerandi, Laura, Farinati, Fabio, Giacomin, Anna, Vanin, Veronica, Pozzan, Caterina, Maddalo, Gemma, Ciccarese, Francesca, Del Poggio, Paolo, Olmi, Stefano, Di Marco, Mariella, Balsamo, Claudia, Di Nolfo, Maria Anna, Vavassori, Elena, Alberti, Alfredo, Benvegnã¹, Luisa, Gatta, Angelo, Gios, Maurizio, Golfieri, Rita, Giampalma, Emanuela, Mosconi, Cristina, Renzulli, Matteo, Rapaccini, Gian Lodovico, Bosco, Giulia, Caturelli, Eugenio, Roselli, Paola, Dell’isola, Serena, Ialungo, Anna Maria, Giannini, Edoardo G., Risso, Domenico, Marenco, Simona, Bruzzone, Linda, Savarino, Vincenzo, Picciotto, Antonino, Chiaramonte, Maria, Cabibbo, Giuseppe, Cammã , Calogero, Maida, Marcello, Di Martino, Arezia, Barcellona, Maria Rosa, Mega, Andrea, Gasbarrini, Antonio, Rinninella, Emanuele, Rotella, Virginia, Ginanni, Barbara, Foschi, Francesco Giuseppe, Lanzi, Arianna, Stefanini, Giuseppe Francesco, Dall’aglio, Anna Chiara, Cappa, Federica Mirici, Neri, Elga, Bassi, Paolo, Zanotti, Miriam, Missale, Gabriele, Biasini, Elisabetta, Porro, Emanuela, Morisco, Filomena, Guarino, Maria, Baroni, Gianluca Svegliati, Schiadã , Laura, Gemini, Stefano, Borzio, Francesco, Virdone, Roberto, Rodolfo Sacco, Valeria Misma, Alessandro Granito, Gianna Musettini, Gianluca Masi, Chiara Caparello, Caterina Vivaldi, Martina Felder, Giampaolo Bresci, Lorenzo Fornaro, for the Italian Liver Cancer (ITA.LI.CA) group: [.., Franco Trevisani, Mauro Bernardi, Luigi Bolondi, Fabio Piscaglia, Marco Zoli, Maurizio Biselli, Paolo Caraceni, Alessandro Cucchetti, Marco Domenicali, Marta Frigerio, Virginia Erroi, Francesca Garuti, Annagiulia Gramenzi, Barbara Lenzi, Donatella Magalotti, Anna Pecorelli, Laura Venerandi, Rita Golfieri, Emanuela Giampalma, Cristina Mosconi, Matteo Renzulli, and ]

Subjects
Oncology, Male, Pathology, Cancer Research, Clinical Biochemistry, Drug Resistance, L-Lactate dehydrogenase, Biomarkers, HCC, LDH, Sorafenib, Aged, Antineoplastic Agents, Biomarkers, Tumor, Carcinoma, Hepatocellular, Drug Resistance, Neoplasm, Female, Humans, Kaplan-Meier Estimate, L-Lactate Dehydrogenase, Liver Neoplasms, Middle Aged, Niacinamide, Phenylurea Compounds, ROC Curve, Retrospective Studies, Treatment Outcome, 2734, Antineoplastic Agent, Retrospective Studie, Neoplasm, Tumor, Liver Neoplasm, Hepatocellular carcinoma, Human, medicine.drug, Phenylurea Compound, medicine.medical_specialty, Sorafenib treatment, Pathology and Forensic Medicine, Text mining, Internal medicine, medicine, Carcinoma, neoplasms, business.industry, Retrospective cohort study, Hepatocellular, Biomarker, medicine.disease, digestive system diseases, business
Abstract

Background Lactate dehydrogenase (LDH) is a predictor of clinical outcome in hepatocellular carcinoma (HCC) patients. However, its predictive role in the clinical outcomes of sorafenib treatment has been poorly documented. The correlation between LDH levels and clinical outcomes in HCC patients treated with sorafenib and included in the nationwide Italian database ITA.LI.CA was investigated here. Patients and Methods The ITA.LI.CA database contains data for 5,136 HCC patients. All patients treated with sorafenib treatment and with available LDH values were considered. Overall survival (OS) and time to progression (TTP) were compared in patients with LDH levels above and below a defined threshold, determined through an ROC analysis. An explorative analysis investigated the relationship between the variation of LDH levels during treatment and response to sorafenib. Results Baseline LDH levels were available for 97 patients. The most accurate cutoff value for LDH concentration was 297 U/L. Patients with LDH values above (n=45) and below (n=52) this threshold showed equal OS (12.0 months) and TTP (4.0 months) values. Data on LDH levels during sorafenib treatment were reported for 10 patients. LDH values decreased in 3 patients (mean difference = -219 U/L) who also reported a prolonged OS and TTP versus those with unmodified/increased LDH (OS: NE (not evaluated) vs. 8.0 months, p=0.0083; TTP: 19.0 vs. 3.0 months, p=0.008). Conclusions The clinical benefits of sorafenib do not seem to be influenced by baseline LDH. According to the results of an explorative analysis, however, a decreased LDH concentration during sorafenib might be associated with improved clinical outcomes.

Published
2015

41. Behavior of soluble HLA-A, -B, -C and HLA-G molecules in patients with chronic hepatitis C virus infection undergoing pegylated interferon-α and ribavirin treatment: potential role as markers of response to antiviral therapy

Author

Murdaca, Giuseppe, primary, Contini, Paola, additional, Cagnati, Paola, additional, Marenco, Simona, additional, Pieri, Giulia, additional, Lantieri, Francesca, additional, Picciotto, Antonino, additional, and Puppo, Francesco, additional

Published
2015
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42. Clinical Trial: The Association Between Rifaximin And Partially Hydrolyzed Guar Gum Is More Effective Than Rifaximin Alone In Eradicating SIBO

Author

Furnari , Manuele, Parodi , Andrea, Gemignani , Lorenzo, Giannini , Edoardo G, Marenco , Simona, Savarino , Edoardo, Assandri , Lorenzo, Fazio , Valentina, Bonfanti , Daria, Inferrera , Simona, Savarino , Vincenzo, Gastroenterology Unit, Universita degli Studi di Padova, Gastroenterology, and Sanremo Hospital

Subjects
Medicine
Abstract

International audience; Background: Abnormal intestinal clearance is involved in the pathogenesis of small intestinal bacterial overgrowth (SIBO). It is known that partially hydrolyzed Guar gum (PHGG) affects intestinal motility. Eradication therapy of SIBO is based on antibiotic treatment: no data are available about the role of fibers supplementation in eradicating SIBO. Aims: To assess whether the association between PHGG plus rifaximin is more effective than rifaximin alone in the treatment of SIBO. Methods: 50g-glucose breath test (GBT) was given to 500 consecutive patients. Patients with positive GBT and predisposing conditions to SIBO entered into the study, and were randomized to receive rifaximin 1200mg/die or rifaximin 1200mg/die plus PHGG 5g/die for 10 days. Patients completed a symptom questionnaire and GBT both in basal condition and 1 month after withdrawal of therapy. Results: Seventy-seven patients had SIBO. SIBO eradication rate was 62.1% in the rifaximin group (both on per-protocol and intention-to-treat analyses), and 87.1% (per-protocol, p=0.017) and 85.0% (intention-to-treat, p=0.036) in the rifaximin-plus-PHGG group. Clinical improvement was observed in 86.9% and 91.1% of eradicated cases in rifaximin and rifaximin-plus-PHGG groups, respectively (p=0.677). Conclusion: The association between rifaximin and PHGG seems to be more useful in eradicating SIBO compared to rifaximin alone.

Published
2010

43. Therapeutic Management of Chronic Hepatitis B in Clinical Practice

Author

Giannini, Edoardo G., primary, Marenco, Simona, additional, Boni, Silvia, additional, Beltrame, Andrea, additional, Nicolini, Laura A., additional, Taramasso, Lucia, additional, Feasi, Marcello, additional, Grasso, Alessandro, additional, De Leo, Pasqualina, additional, Percario, Gianfranco, additional, Bartolacci, Valentina, additional, Artioli, Stefania, additional, Viscoli, Claudio, additional, Cassola, Giovanni, additional, Testa, Roberto, additional, Anselmo, Marco, additional, Riccio, Giovanni, additional, Savarino, Vincenzo, additional, and Picciotto, Antonino, additional

Published
2015
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45. HOMA, BMI, and Serum Leptin Levels Variations during Antiviral Treatment Suggest Virus-Related Insulin Resistance in Noncirrhotic, Nonobese, and Nondiabetic Chronic Hepatitis C Genotype 1 Patients

Author

Grasso, Alessandro, primary, Malfatti, Federica, additional, Andraghetti, Gabriella, additional, Marenco, Simona, additional, Mazzucchelli, Chiara, additional, Labanca, Sara, additional, Cordera, Renzo, additional, Testa, Roberto, additional, and Picciotto, Antonino, additional

Published
2015
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46. Inherent transcriptional signatures of NK cells are associated with response to IFNα + rivabirin therapy in patients with Hepatitis C Virus

Author

Ascierto, Maria, primary, Bozzano, Federica, additional, Bedognetti, Davide, additional, Marras, Francesco, additional, Schechterly, Cathy, additional, Matsuura, Kentaro, additional, Picciotto, Antonino, additional, Marenco, Simona, additional, Zhao, Yingdong, additional, DeGiorgi, Valeria, additional, Sommariva, Michele, additional, Moretta, Lorenzo, additional, Wang, Ena, additional, Alter, Harvey J, additional, Marincola, Francesco M, additional, and De Maria, Andrea, additional

Published
2015
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47. Measurement of sorafenib plasma concentration by high-performance liquid chromatography in patients with advanced hepatocellular carcinoma: is it useful the application in clinical practice? A pilot study

Author

Fucile, Carmen, primary, Marenco, Simona, additional, Bazzica, Marco, additional, Zuccoli, Maria Laura, additional, Lantieri, Francesca, additional, Robbiano, Luigi, additional, Marini, Valeria, additional, Di Gion, Paola, additional, Pieri, Giulia, additional, Stura, Paola, additional, Martelli, Antonietta, additional, Savarino, Vincenzo, additional, Mattioli, Francesca, additional, and Picciotto, Antonino, additional

Published
2014
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48. Durability of the response to peginterferon-α2b and ribavirin in patients with chronic hepatitis C

Author

Giordanino, Chiara, primary, Sacco, Marco, additional, Ceretto, Simone, additional, Smedile, Antonina, additional, Ciancio, Alessia, additional, Cariti, Giuseppe, additional, De Blasi, Tiziano, additional, Picciotto, Antonio, additional, Marenco, Simona, additional, Grasso, Alessandro, additional, Pirisi, Mario, additional, Smirne, Carlo, additional, Colletta, Cosimo, additional, Traverso, Antonio, additional, Mazzucco, Dario, additional, Ciccone, Giovannino, additional, Simondi, Daniele, additional, Rizzetto, Mario, additional, and Saracco, Giorgio, additional

Published
2014
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49. Genomic scale analysis of NK cells impact on response to IFN-α

Author

Ascierto, Maria L, primary, Alter, Harvey, additional, Bozzano, Federica, additional, Picciotto, Antonio, additional, Marenco, Simona, additional, Marras, Francesco, additional, Schechterly, Cathy, additional, Bedognetti, Davide, additional, De Giorgi, Valeria, additional, Sommariva, Michele, additional, Ascierto, Paolo A, additional, Moretta, Lorenzo, additional, Wang, Ena, additional, Marincola, Francesco M, additional, and De Maria, Andrea, additional

Published
2013
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