Author: "Tursi, A." / Database: OAIster - Searchworks@Jio Institute Digital Library Search Results

Your search keyword '"Tursi, A."' showing total 241 results

Start Over Author "Tursi, A." Database OAIster

241 results on '"Tursi, A."'

1. Ustekinumab safety and effectiveness in patients with ulcerative colitis: results from a large real-life study

Author: Tursi, Antonio, Mocci, Giammarco, Scaldaferri, Franco, Napolitano, Daniele, Maresca, Rossella, Pugliese, Daniela, Semprucci, Gianluca, Savarino, Edoardo, Cuomo, Antonio, Donnarumma, Laura, Bodini, Giorgia, Pasta, Andrea, Maconi, Giovanni, Cataletti, Giovanni, Pranzo, Giuseppe, Rodinò, Stefano, Sebkova, Ladislava, Costa, Francesco, Ferronato, Antonio, Gaiani, Federica, Marzo, Manuela, Luppino, Ileana, Fabiano, Giulia, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Grossi, Laurino, Serio, Mariaelena, Scarcelli, Antonella, Lorenzetti, Roberto, Allegretta, Leonardo, Chiri, Stefania, Grasso, Giuseppina, Antonelli, Elisabetta, Bassotti, Gabrio, Spagnuolo, Rocco, Luzza, Francesco, Fanigliulo, Libera, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Rocchi, Chiara, Bolognini, Laura, Bendia, Emanuele, Bianco, Maria Antonia, Capone, Pietro, Meucci, Costantino, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Della Valle, Nicola, Felice, Carla, Pica, Roberta, Cocco, Andrea, Forti, Giacomo, Onidi, Francesca Maria, Usai Satta, Paolo, Checchin, Davide, Gravina, Antonietta Gerarda, Pellegrino, Raffaele, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Scaldaferri, Franco, Napolitano, Daniele, Maresca, Rossella, Pugliese, Daniela, Semprucci, Gianluca, Savarino, Edoardo, Cuomo, Antonio, Donnarumma, Laura, Bodini, Giorgia, Pasta, Andrea, Maconi, Giovanni, Cataletti, Giovanni, Pranzo, Giuseppe, Rodinò, Stefano, Sebkova, Ladislava, Costa, Francesco, Ferronato, Antonio, Gaiani, Federica, Marzo, Manuela, Luppino, Ileana, Fabiano, Giulia, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Grossi, Laurino, Serio, Mariaelena, Scarcelli, Antonella, Lorenzetti, Roberto, Allegretta, Leonardo, Chiri, Stefania, Grasso, Giuseppina, Antonelli, Elisabetta, Bassotti, Gabrio, Spagnuolo, Rocco, Luzza, Francesco, Fanigliulo, Libera, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Rocchi, Chiara, Bolognini, Laura, Bendia, Emanuele, Bianco, Maria Antonia, Capone, Pietro, Meucci, Costantino, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Della Valle, Nicola, Felice, Carla, Pica, Roberta, Cocco, Andrea, Forti, Giacomo, Onidi, Francesca Maria, Usai Satta, Paolo, Checchin, Davide, Gravina, Antonietta Gerarda, Pellegrino, Raffaele, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: BackgroundUstekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting.Research design and methodsThis is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, <= 1) and the safety of UST. Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and fecal calprotectin (FC) reduction at week 24.ResultsWe included 256 consecutive patients with UC (M/F 139/117, median age 52). The clinical remission and clinical response rates at eight weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 (p = 0.0004) and 24 (p = 0.038). At eight weeks, patients naive or with one previous biologic treatment showed higher remission (p = 0.002) and clinical response rates (p = 0.018) than patients previously treated with >= 2. Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy.ConclusionThis real-world study shows that UST effectively and safely treats patients with UC.
Published: 2024

2. Neural entrainment as a tool to explore human cognition across development.

Author: Bettoni, R, Bulf, H, Silvestri, V, Aquilino, B, Tursi, B, Peykarjou, S, &amp, Macchi Cassia, V, Bettoni R., Bulf H., Silvestri V., Aquilino B., Tursi B., Peykarjou S., &, Macchi Cassia, V., Bettoni, R, Bulf, H, Silvestri, V, Aquilino, B, Tursi, B, Peykarjou, S, &amp, Macchi Cassia, V, Bettoni R., Bulf H., Silvestri V., Aquilino B., Tursi B., Peykarjou S., &, and Macchi Cassia, V.
Published: 2022

3. Microbiota Composition in Diverticular Disease: Implications for Therapy

Author: Tursi, Antonio, Papa, Valerio, Lopetuso, Loris Riccardo, Settanni, Carlo Romano, Gasbarrini, Antonio, Papa, Alfredo, Tursi A., Papa V. (ORCID:0000-0002-3709-8924), Lopetuso L. R., Settanni C. R., Gasbarrini A. (ORCID:0000-0002-7278-4823), Papa A. (ORCID:0000-0002-4186-7298), Tursi, Antonio, Papa, Valerio, Lopetuso, Loris Riccardo, Settanni, Carlo Romano, Gasbarrini, Antonio, Papa, Alfredo, Tursi A., Papa V. (ORCID:0000-0002-3709-8924), Lopetuso L. R., Settanni C. R., Gasbarrini A. (ORCID:0000-0002-7278-4823), and Papa A. (ORCID:0000-0002-4186-7298)
Abstract: Gut microbiota (GM) composition and its imbalance are crucial in the pathogenesis of several diseases, mainly those affecting the gastrointestinal tract. Colon diverticulosis and its clinical manifestations (diverticular disease, DD) are among the most common digestive disorders in developed countries. In recent literature, the role of GM imbalance in the onset of the different manifestations within the clinical spectrum of DD has been highlighted. This narrative review aims to summarize and critically analyze the current knowledge on GM dysbiosis in diverticulosis and DD by comparing the available data with those found in inflammatory bowel disease (IBD). The rationale for using probiotics to rebalance dysbiosis in DD is also discussed.
Published: 2022

4. Intestinal Microbiome Modulation During Coronavirus Disease 2019: Another Chance to Manage the Disease?

Author: Tursi, Antonio, Papa, Alfredo, Tursi A., Papa A. (ORCID:0000-0002-4186-7298), Tursi, Antonio, Papa, Alfredo, Tursi A., and Papa A. (ORCID:0000-0002-4186-7298)
Published: 2022

5. Safety of extended interval dosing immune checkpoint inhibitors:a multicenter cohort study

Author: Cantini, Luca, Paoloni, Francesco, Pecci, Federica, Spagnolo, Francesco, Genova, Carlo, Tanda, Enrica Teresa, Aerts, Sophie, Rebuzzi, Sara Elena, Fornarini, Giuseppe, Zoratto, Federica, Fancelli, Sara, Lupi, Alessio, Della Corte, Carminia Maria, Parisi, Alessandro, Bennati, Chiara, Ortega, Cinzia, Atzori, Francesco, Piovano, Pier Luigi, Orciuolo, Corrado, De Tursi, Michele, Ghidini, Michele, Botticelli, Andrea, Scagnoli, Simone, Belluomini, Lorenzo, Leporati, Rita, Veccia, Antonello, Di Giacomo, Anna Maria, Festino, Lucia, Cortinovis, Diego, Acquati, Mirko, Filetti, Marco, Giusti, Raffaele, Tucci, Marco, Sergi, Maria Chiara, Garutti, Mattia, Puglisi, Fabio, Manglaviti, Sara, Citarella, Fabrizio, Santoni, Matteo, Rijavec, Erika, Lo Russo, Giuseppe, Santini, Daniele, Addeo, Alfredo, Antonuzzo, Lorenzo, Indini, Alice, Rocchi, Marco Bruno Luigi, Cortellini, Alessio, Grossi, Francesco, Ascierto, Paolo Antonio, Aerts, Joachim G.J.V., Berardi, Rossana, Cantini, Luca, Paoloni, Francesco, Pecci, Federica, Spagnolo, Francesco, Genova, Carlo, Tanda, Enrica Teresa, Aerts, Sophie, Rebuzzi, Sara Elena, Fornarini, Giuseppe, Zoratto, Federica, Fancelli, Sara, Lupi, Alessio, Della Corte, Carminia Maria, Parisi, Alessandro, Bennati, Chiara, Ortega, Cinzia, Atzori, Francesco, Piovano, Pier Luigi, Orciuolo, Corrado, De Tursi, Michele, Ghidini, Michele, Botticelli, Andrea, Scagnoli, Simone, Belluomini, Lorenzo, Leporati, Rita, Veccia, Antonello, Di Giacomo, Anna Maria, Festino, Lucia, Cortinovis, Diego, Acquati, Mirko, Filetti, Marco, Giusti, Raffaele, Tucci, Marco, Sergi, Maria Chiara, Garutti, Mattia, Puglisi, Fabio, Manglaviti, Sara, Citarella, Fabrizio, Santoni, Matteo, Rijavec, Erika, Lo Russo, Giuseppe, Santini, Daniele, Addeo, Alfredo, Antonuzzo, Lorenzo, Indini, Alice, Rocchi, Marco Bruno Luigi, Cortellini, Alessio, Grossi, Francesco, Ascierto, Paolo Antonio, Aerts, Joachim G.J.V., and Berardi, Rossana
Abstract: BACKGROUND: Real-life spectrum and survival implications of immune-related adverse events (irAEs) in patients treated with extended interval dosing (ED) immune checkpoint inhibitors (ICIs) are unknown. METHODS: Characteristics of 812 consecutive solid cancer patients who received at least 1 cycle of ED monotherapy (pembrolizumab 400 mg Q6W or nivolumab 480 mg Q4W) after switching from canonical interval dosing (CD; pembrolizumab 200 mg Q3W or nivolumab 240 mg Q2W) or treated upfront with ED were retrieved. The primary objective was to compare irAEs patterns within the same population (before and after switch to ED). irAEs spectrum in patients treated upfront with ED and association between irAEs and overall survival were also described. RESULTS: A total of 550 (68%) patients started ICIs with CD and switched to ED. During CD, 225 (41%) patients developed any grade and 17 (3%) G3 or G4 irAEs; after switching to ED, any grade and G3 or G4 irAEs were experienced by 155 (36%) and 20 (5%) patients. Switching to ED was associated with a lower probability of any grade irAEs (adjusted odds ratio [aOR] = 0.83, 95% confidence interval [CI] = 0.64 to 0.99; P = .047), whereas no difference for G3 or G4 events was noted (aOR = 1.55, 95% CI = 0.81 to 2.94; P = .18). Among patients who started upfront with ED (n = 232, 32%), 107 (41%) developed any grade and 14 (5%) G3 or G4 irAEs during ED. Patients with irAEs during ED had improved overall survival (adjusted hazard ratio [aHR] = 0.53, 95% CI = 0.34 to 0.82; P = .004 after switching; aHR = 0.57, 95% CI = 0.35 to 0.93; P = .025 upfront). CONCLUSIONS: Switching ICI treatment from CD and ED did not increase the incidence of irAEs and represents a safe option also outside clinical trials.
Published: 2023

6. Codon-specific KRAS mutations predict survival benefit of trifluridine/tipiracil in metastatic colorectal cancer

Author: van de Haar, Jori, Ma, Xuhui, Ooft, Salo N, van der Helm, Pim W, Hoes, Louisa R, Mainardi, Sara, Pinato, David J, Sun, Kristi, Salvatore, Lisa, Tortora, Giampaolo, Zurlo, Ina Valeria, Leo, Silvana, Giampieri, Riccardo, Berardi, Rossana, Gelsomino, Fabio, Merz, Valeria, Mazzuca, Federica, Antonuzzo, Lorenzo, Rosati, Gerardo, Stavraka, Chara, Ross, Paul, Rodriquenz, Maria Grazia, Pavarana, Michele, Messina, Carlo, Iveson, Timothy, Zoratto, Federica, Thomas, Anne, Fenocchio, Elisabetta, Ratti, Margherita, Depetris, Ilaria, Cergnul, Massimiliano, Morelli, Cristina, Libertini, Michela, Parisi, Alessandro, De Tursi, Michele, Zanaletti, Nicoletta, Garrone, Ornella, Graham, Janet, Longarini, Raffaella, Gobba, Stefania Maria, Petrillo, Angelica, Tamburini, Emiliano, La Verde, Nicla, Petrelli, Fausto, Ricci, Vincenzo, Wessels, Lodewyk F A, Ghidini, Michele, Cortellini, Alessio, Voest, Emile E, Valeri, Nicola, Tortora, Giampaolo (ORCID:0000-0002-1378-4962), van de Haar, Jori, Ma, Xuhui, Ooft, Salo N, van der Helm, Pim W, Hoes, Louisa R, Mainardi, Sara, Pinato, David J, Sun, Kristi, Salvatore, Lisa, Tortora, Giampaolo, Zurlo, Ina Valeria, Leo, Silvana, Giampieri, Riccardo, Berardi, Rossana, Gelsomino, Fabio, Merz, Valeria, Mazzuca, Federica, Antonuzzo, Lorenzo, Rosati, Gerardo, Stavraka, Chara, Ross, Paul, Rodriquenz, Maria Grazia, Pavarana, Michele, Messina, Carlo, Iveson, Timothy, Zoratto, Federica, Thomas, Anne, Fenocchio, Elisabetta, Ratti, Margherita, Depetris, Ilaria, Cergnul, Massimiliano, Morelli, Cristina, Libertini, Michela, Parisi, Alessandro, De Tursi, Michele, Zanaletti, Nicoletta, Garrone, Ornella, Graham, Janet, Longarini, Raffaella, Gobba, Stefania Maria, Petrillo, Angelica, Tamburini, Emiliano, La Verde, Nicla, Petrelli, Fausto, Ricci, Vincenzo, Wessels, Lodewyk F A, Ghidini, Michele, Cortellini, Alessio, Voest, Emile E, Valeri, Nicola, and Tortora, Giampaolo (ORCID:0000-0002-1378-4962)
Abstract: Genomics has greatly improved how patients with cancer are being treated; however, clinical-grade genomic biomarkers for chemotherapies are currently lacking. Using whole-genome analysis of 37 patients with metastatic colorectal cancer (mCRC) treated with the chemotherapy trifluridine/tipiracil (FTD/TPI), we identified KRAS codon G12 (KRAS(G12)) mutations as a potential biomarker of resistance. Next, we collected real-world data of 960 patients with mCRC receiving FTD/TPI and validated that KRAS(G12) mutations were significantly associated with poor survival, also in analyses restricted to the RAS/RAF mutant subgroup. We next analyzed the data of the global, double-blind, placebo-controlled, phase 3 RECOURSE trial (n = 800 patients) and found that KRAS(G12) mutations (n = 279) were predictive biomarkers for reduced overall survival (OS) benefit of FTD/TPI versus placebo (unadjusted interaction P = 0.0031, adjusted interaction P = 0.015). For patients with KRAS(G12) mutations in the RECOURSE trial, OS was not prolonged with FTD/TPI versus placebo (n = 279; hazard ratio (HR) = 0.97; 95% confidence interval (CI) = 0.73-1.20; P = 0.85). In contrast, patients with KRAS(G13) mutant tumors showed significantly improved OS with FTD/TPI versus placebo (n = 60; HR = 0.29; 95% CI = 0.15-0.55; P < 0.001). In isogenic cell lines and patient-derived organoids, KRAS(G12) mutations were associated with increased resistance to FTD-based genotoxicity. In conclusion, these data show that KRAS(G12) mutations are biomarkers for reduced OS benefit of FTD/TPI treatment, with potential implications for approximately 28% of patients with mCRC under consideration for treatment with FTD/TPI. Furthermore, our data suggest that genomics-based precision medicine may be possible for a subset of chemotherapies.A combination of real-world evidence and a reanalysis of phase 3 clinical trial data unveils KRAS codon G12 mutations as a biomarker of resistance to trifluridine/tipiracil in metastatic
Published: 2023

7. Assessment of small intestinal bacterial overgrowth and methane production in patients on chronic proton-pump inhibitor treatment: prevalence and role of rifaximin in its management in primary care

Author: DE Bastiani, Rudi, Lopetuso, Loris Riccardo, DE Bastiani, Marco, Bacchin, Paolo, Benedetto, Edoardo, Boscariolo, Laura, Caneve, Rosanna, Chesani, Fabio, Chiumeo, Francesco, Civic, Zinaida, Dainese, Antonio, DE Polo, Manuela, Disclafani, Giuseppe, Grattagliano, Ignazio, Mana, Ornella, Mancuso, Maurizio Stefano, Mastronuzzi, Tecla, Pati, Antonino, Pirrotta, Enzo, Salandini, Maurizio, Sanna, Guido, Scoglio, Riccardo, Severino, Pietro, Tosetti, Cesare, Turnava, Leyla, Zamparella, Maria, Elisei, Walter, Gasbarrini, Antonio, Tursi, Antonio, Lopetuso, Loris R, Mancuso, Maurizio, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), DE Bastiani, Rudi, Lopetuso, Loris Riccardo, DE Bastiani, Marco, Bacchin, Paolo, Benedetto, Edoardo, Boscariolo, Laura, Caneve, Rosanna, Chesani, Fabio, Chiumeo, Francesco, Civic, Zinaida, Dainese, Antonio, DE Polo, Manuela, Disclafani, Giuseppe, Grattagliano, Ignazio, Mana, Ornella, Mancuso, Maurizio Stefano, Mastronuzzi, Tecla, Pati, Antonino, Pirrotta, Enzo, Salandini, Maurizio, Sanna, Guido, Scoglio, Riccardo, Severino, Pietro, Tosetti, Cesare, Turnava, Leyla, Zamparella, Maria, Elisei, Walter, Gasbarrini, Antonio, Tursi, Antonio, Lopetuso, Loris R, Mancuso, Maurizio, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)
Abstract: Background: Although proton pump inhibitor (PPI) drugs have considered able to induce small intestinal bacterial overgrowth (SIBO), no data are so far available from primary care (PC). We assessed the prevalence of SIBO and methane (CH4) production consequent to chronic PPI therapy using Lactulose Breath Test (LBT). Secondary aim was to explore the possible role of rifaximin in treating PPI-induced SIBO patients. Methods: One hundred twenty-five gastroesophageal reflux disease patients, constantly treated with PPI for at least 6 months and undergoing to LBT, were retrospectively assessed. An age-matched control population (control) of 100 patients, which had not used PPI in the last 6 months, was also enrolled. In the PPI group, SIBO positive patients and CH4 producers were treated with rifaximin 1200 mg/daily for 14 days and re-checked with LBT one month after the end of treatment. The area under the curve (AUC) before and after treatment was also calculated for both SIBO positive patients and CH4 producers. Results: In the PPI group, SIBO prevalence was significantly higher vs. controls (38/125 [30.4%] vs. 27/100 [27%], P<0.05). 77/125 (61.6%) PPI patients were found to be CH4 producers vs. 21/100 (21%) controls (P<0.05). Among SIBO patients in the PPI group, 34 (89.4%) were also CH4 producers vs. 17/27 (63%) controls (P<0.05). After treatment, LBT resulted negative in 15/22 SIBO patients (68.1%) (P<0.05) and in 18/34 CH4 producers (52.9%) (P<0.05). At the AUC analysis, an overall reduction of 54.2% for H2 in SIBO patients and of 47.7% for CH4 was assessed after rifaximin treatment (P<0.05). Conclusions: Our data showed that chronic use of PPI could be able to increase the prevalence of SIBO and to shift the intestinal microbial composition towards a CH4-producing flora. rifaximin could represent a useful therapeutical option for PPI-induced SIBO and for modulating CH4-producing flora.
Published: 2023

8. Real-world efficacy and safety of vedolizumab in managing ulcerative colitis versus Crohn's disease: results from an Italian multicenter study

Author: Mocci, Giammarco, Tursi, Antonio, Maconi, Giovanni, Cataletti, Giovanni, Mantia, Beatrice, Serio, Mariaelena, Scarcelli, Antonella, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Pranzo, Giuseppe, Luppino, Ileana, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Ferronato, Antonio, Perini, Barbara, Savarino, Edoardo, Onidi, Francesca Maria, Binaghi, Laura, Usai Satta, Paolo, Schiavoni, Elisa, Napolitano, Daniele, Scaldaferri, Franco, Pugliese, Daniela, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Rodino, Stefano, Sebkova, Ladislava, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Gaiani, Federica, De Angelis, Gianluigi, Kayali, Stefano, Fanigliulo, Libera, Lorenzetti, Roberto, Allegretta, Leonardo, Scorza, Stefano, Cuomo, Antonio, Donnarumma, Laura, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Antonelli, Elisabetta, Bassotti, Gabrio, Iannelli, Chiara, Luzza, Francesco, Aragona, Giovanni, Perazzo, Patrizia, Lauria, Angelo, Piergallini, Simona, Colucci, Raffaele, Bianco, Maria Antonia, Meucci, Costantino, Giorgetti, Gianmarco, Clemente, Valeria, Fiorella, Serafina, Penna, Antonio, De Medici, Antonio, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Mocci, Giammarco, Tursi, Antonio, Maconi, Giovanni, Cataletti, Giovanni, Mantia, Beatrice, Serio, Mariaelena, Scarcelli, Antonella, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Pranzo, Giuseppe, Luppino, Ileana, Paese, Pietro, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Ferronato, Antonio, Perini, Barbara, Savarino, Edoardo, Onidi, Francesca Maria, Binaghi, Laura, Usai Satta, Paolo, Schiavoni, Elisa, Napolitano, Daniele, Scaldaferri, Franco, Pugliese, Daniela, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Rodino, Stefano, Sebkova, Ladislava, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Gaiani, Federica, De Angelis, Gianluigi, Kayali, Stefano, Fanigliulo, Libera, Lorenzetti, Roberto, Allegretta, Leonardo, Scorza, Stefano, Cuomo, Antonio, Donnarumma, Laura, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Antonelli, Elisabetta, Bassotti, Gabrio, Iannelli, Chiara, Luzza, Francesco, Aragona, Giovanni, Perazzo, Patrizia, Lauria, Angelo, Piergallini, Simona, Colucci, Raffaele, Bianco, Maria Antonia, Meucci, Costantino, Giorgetti, Gianmarco, Clemente, Valeria, Fiorella, Serafina, Penna, Antonio, De Medici, Antonio, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: BackgroundVedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn's disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ.Research design and methods Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints.Results729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6(th) month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6(th) month of treatment (p=0.001) and being naive to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016).ConclusionWe found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug's longterm efficacy.
Published: 2023

9. Comparison of Performances of Adalimumab Biosimilars SB5, ABP501, GP2017, and MSB11022 in Treating Patients with Inflammatory Bowel Diseases: A Real-Life, Multicenter, Observational Study

Author: Tursi, Antonio, Mocci, Giammarco, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Cuomo, Antonio, Della Valle, Nicola, Ferronato, Antonio, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Pica, Roberta, Pranzo, Giuseppe, Rodino', Stefano, Scarcelli, Antonella, Zampaletta, Costantino, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De' Angelis, Gianluigi, Donnarumma, Laura, Faggiani, Roberto, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Picchio, Marcello, Sacco, Rodolfo, Sebkova, Ladislava, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Scaldaferri, Franco, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Elisei, Walter, Maconi, Giovanni, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Cuomo, Antonio, Della Valle, Nicola, Ferronato, Antonio, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Pica, Roberta, Pranzo, Giuseppe, Rodino', Stefano, Scarcelli, Antonella, Zampaletta, Costantino, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De' Angelis, Gianluigi, Donnarumma, Laura, Faggiani, Roberto, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Picchio, Marcello, Sacco, Rodolfo, Sebkova, Ladislava, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Scaldaferri, Franco, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Elisei, Walter, Maconi, Giovanni, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Armuzzi, Alessandro (ORCID:0000-0003-1572-0118), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: Background Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce. We compare the efficacy and safety of ADA biosimilars SB5, APB501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting. Methods A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars. Results A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint. Conclusions Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars.Lay Summary We treated 533 IBD patients with adalimumab (ADA) biosimilars SB5, APB501, GP2017, and MSB11022. No differences between these 4 ADA biosimilars were found for reaching remission in naive p
Published: 2023

10. Use of tofacitinib as first or second-line therapy is associated with better outcomes in patients with ulcerative colitis: data from a real-world study

Author: Tursi, Antonio, Mocci, Giammarco, Cingolani, Linda, Savarino, Edoardo, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Napolitano, Daniele, Schiavoni, Elisa, Pugliese, Daniela, Scaldaferri, Franco, Costa, Francesco, Marzo, Manuela, Serio, Mariaelena, Scarcelli, Antonella, Bolognini, Laura, Bendia, Emanuele, Maconi, Giovanni, Cannatelli, Rosanna, Piergallini, Simona, Bodini, Giorgia, Calabrese, Francesco, Ferronato, Antonio, Pranzo, Giuseppe, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Rodinò, Stefano, Sebkova, Ladislava, Grossi, Laurino, Gaiani, Federica, dè Angelis, Gianluigi, Lorenzetti, Roberto, Allegretta, Leonardo, Cazzato, Alessia Immacolata, Scorza, Stefano, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Onidi, Francesca Maria, Usai Satta, Paolo, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Cingolani, Linda, Savarino, Edoardo, Pica, Roberta, Cocco, Andrea, Zippi, Maddalena, Napolitano, Daniele, Schiavoni, Elisa, Pugliese, Daniela, Scaldaferri, Franco, Costa, Francesco, Marzo, Manuela, Serio, Mariaelena, Scarcelli, Antonella, Bolognini, Laura, Bendia, Emanuele, Maconi, Giovanni, Cannatelli, Rosanna, Piergallini, Simona, Bodini, Giorgia, Calabrese, Francesco, Ferronato, Antonio, Pranzo, Giuseppe, Elisei, Walter, Monterubbianesi, Rita, Faggiani, Roberto, Rodinò, Stefano, Sebkova, Ladislava, Grossi, Laurino, Gaiani, Federica, dè Angelis, Gianluigi, Lorenzetti, Roberto, Allegretta, Leonardo, Cazzato, Alessia Immacolata, Scorza, Stefano, Della Valle, Nicola, Sacco, Rodolfo, Forti, Giacomo, Colucci, Raffaele, Tonti, Paolo, Neve, Viviana, Rocco, Giulia, Sacchi, Carlotta, Zampaletta, Costantino, Pagnini, Cristiano, Graziani, Maria Giovanna, Di Paolo, Maria Carla, Onidi, Francesca Maria, Usai Satta, Paolo, Picchio, Marcello, Papa, Alfredo, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: BackgroundData regarding the real-world (RW) use of tofacitinib (TOF) in patients with ulcerative colitis (UC) are limited. We aimed to investigate TOF's RW efficacy and safety in Italian UC patients.Research design and methodsA retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of TOF.ResultsWe enrolled 166 patients with a median follow-up of 24 (IQR 8-36) weeks. Clinical remission was achieved in 61/166 (36.7%) and 75/166 (45.2%) patients at 8-week and 24-week follow-ups, respectively. The optimization was requested in 27 (16.3%) patients. Clinical remission was achieved more frequently when TOF was used as a first/second line rather than a third/fourth line treatment (p = 0.007). Mucosal healing was reported in 46% of patients at the median follow-up time. Colectomy occurred in 8 (4.8%) patients. Adverse events occurred in 12 (5.4%) patients and severe in 3 (1.8%). One case of simple Herpes Zoster and one of renal vein thrombosis were recorded.ConclusionsOur RW data confirm that TOF is effective and safe in UC patients. It performs remarkably better when used as the first/second line of treatment.
Published: 2023

11. Diverticular Inflammation and Complication Assessment classification, CODA score and fecal calprotectin in clinical assessment of patients with diverticular disease: A decision curve analysis

Author: Tursi, Antonio, Piovani, Daniele, Brandimarte, Giovanni, Di Mario, Francesco, Elisei, Walter, Picchio, Marcello, Allegretta, Leonardo, Annunziata, Maria Laura, Bafutto, Mauro, Bassotti, Gabrio, Bianco, Maria Antonia, Colucci, Raffaele, Conigliaro, Rita, Dumitrascu, Dan L., Escalante, Ricardo, Ferrini, Luciano, Forti, Giacomo, Franceschi, Marilisa, Graziani, Maria Giovanna, Lammert, Frank, Latella, Giovanni, Maconi, Giovanni, Compare, Debora, Nardone, Gerardo, Camara De Castro Oliveira, Lucia, Oliveira, Enio Chave, Papa, Alfredo, Papagrigoriadis, Savva, Pietrzak, Anna, Pontone, Stefano, Poskus, Toma, Pranzo, Giuseppe, Reichert, Matthias Christian, Rodinò, Stefano, Regula, Jaroslaw, Scaccianoce, Giuseppe, Scaldaferri, Franco, Vassallo, Roberto, Zampaletta, Costantino, Zullo, Angelo, Spaziani, Erasmo, Bonovas, Stefano, Danese, Silvio, Null, Null, Papa, Alfredo (ORCID:0000-0002-4186-7298), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Tursi, Antonio, Piovani, Daniele, Brandimarte, Giovanni, Di Mario, Francesco, Elisei, Walter, Picchio, Marcello, Allegretta, Leonardo, Annunziata, Maria Laura, Bafutto, Mauro, Bassotti, Gabrio, Bianco, Maria Antonia, Colucci, Raffaele, Conigliaro, Rita, Dumitrascu, Dan L., Escalante, Ricardo, Ferrini, Luciano, Forti, Giacomo, Franceschi, Marilisa, Graziani, Maria Giovanna, Lammert, Frank, Latella, Giovanni, Maconi, Giovanni, Compare, Debora, Nardone, Gerardo, Camara De Castro Oliveira, Lucia, Oliveira, Enio Chave, Papa, Alfredo, Papagrigoriadis, Savva, Pietrzak, Anna, Pontone, Stefano, Poskus, Toma, Pranzo, Giuseppe, Reichert, Matthias Christian, Rodinò, Stefano, Regula, Jaroslaw, Scaccianoce, Giuseppe, Scaldaferri, Franco, Vassallo, Roberto, Zampaletta, Costantino, Zullo, Angelo, Spaziani, Erasmo, Bonovas, Stefano, Danese, Silvio, Null, Null, Papa, Alfredo (ORCID:0000-0002-4186-7298), and Scaldaferri, Franco (ORCID:0000-0001-8334-7541)
Abstract: Background and AimsThe Diverticular Inflammation and Complication Assessment (DICA) classification and the Combined Overview on Diverticular Assessment (CODA) were found to be effective in predicting the outcomes of Diverticular Disease (DD). We ascertain whether fecal calprotectin (FC) can further aid in improving risk stratification. MethodsA three-year international, multicentre, prospective cohort study was conducted involving 43 Gastroenterology and Endoscopy centres. Survival methods for censored observations were used to estimate the risk of acute diverticulitis (AD) in newly diagnosed DD patients according to basal FC, DICA, and CODA. The net benefit of management strategies based on DICA, CODA and FC in addition to CODA was assessed with decision curve analysis, which incorporates the harms and benefits of using a prognostic model for clinical decisions. ResultsAt the first diagnosis of diverticulosis/DD, 871 participants underwent FC measurement. FC was associated with the risk of AD at 3 years (HR per each base 10 logarithm increase: 3.29; 95% confidence interval, 2.13-5.10) and showed moderate discrimination (c-statistic: 0.685; 0.614-0.756). DICA and CODA were more accurate predictors of AD than FC. However, FC showed high discrimination capacity to predict AD at 3 months, which was not maintained at longer follow-up times. The decision curve analysis comparing the combination of FC and CODA with CODA alone did not clearly indicate a larger net benefit of one strategy over the other. ConclusionsFC measurement could be used as a complementary tool to assess the immediate risk of AD. In all other cases, treatment strategies based on the CODA score alone should be recommended.
Published: 2023

12. Prevalence and Natural History of Segmental Colitis Associated With Diverticulosis

Author: Tursi, Antonio, Piovani, Daniele, Brandimarte, Giovanni, Di Mario, Francesco, Elisei, Walter, Picchio, Marcello, Allegretta, Leonardo, Annunziata, Maria Laura, Bafutto, Mauro, Bassotti, Gabrio, Bianco, Maria Antonia, Colucci, Raffaele, Conigliaro, Rita, Dumitrascu, Dan L., Escalante, Ricardo, Ferrini, Luciano, Forti, Giacomo, Franceschi, Marilisa, Graziani, Maria Giovanna, Lammert, Frank, Latella, Giovanni, Maconi, Giovanni, Compare, Debora, Nardone, Gerardo, Camara De Castro Oliveira, Lucia, Chaves Oliveira, Enio, Papagrigoriadis, Savva, Pietrzak, Anna, Pontone, Stefano, Stundiene, Ieva, Pranzo, Giuseppe, Reichert, Matthias Christian, Rodinò, Stefano, Regula, Jaroslaw, Scaccianoce, Giuseppe, Scaldaferri, Franco, Vassallo, Roberto, Zampaletta, Costantino, Zullo, Angelo, Spaziani, Erasmo, Bonovas, Stefano, Papa, Alfredo, Danese, Silvio, Null, Null, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Piovani, Daniele, Brandimarte, Giovanni, Di Mario, Francesco, Elisei, Walter, Picchio, Marcello, Allegretta, Leonardo, Annunziata, Maria Laura, Bafutto, Mauro, Bassotti, Gabrio, Bianco, Maria Antonia, Colucci, Raffaele, Conigliaro, Rita, Dumitrascu, Dan L., Escalante, Ricardo, Ferrini, Luciano, Forti, Giacomo, Franceschi, Marilisa, Graziani, Maria Giovanna, Lammert, Frank, Latella, Giovanni, Maconi, Giovanni, Compare, Debora, Nardone, Gerardo, Camara De Castro Oliveira, Lucia, Chaves Oliveira, Enio, Papagrigoriadis, Savva, Pietrzak, Anna, Pontone, Stefano, Stundiene, Ieva, Pranzo, Giuseppe, Reichert, Matthias Christian, Rodinò, Stefano, Regula, Jaroslaw, Scaccianoce, Giuseppe, Scaldaferri, Franco, Vassallo, Roberto, Zampaletta, Costantino, Zullo, Angelo, Spaziani, Erasmo, Bonovas, Stefano, Papa, Alfredo, Danese, Silvio, Null, Null, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: INTRODUCTION: We assessed the prevalence and clinical outcomes of segmental colitis associated with diverticulosis (SCAD) in patients with newly diagnosed diverticulosis.METHODS: A 3-year international, multicenter, prospective cohort study was conducted involving 2,215 patients.RESULTS: SCAD diagnosis was posed in 44 patients (30 male patients; median age: 64.5 years; prevalence of 1.99%, 95% confidence interval, 1.45%-2.66%). Patients with SCAD types D and B showed worse symptoms, higher fecal calprotectin values, needed more steroids, and reached less likely complete remission.DISCUSSION: Although SCAD generally had a benign outcome, types B and D were associated with more severe symptoms and worse clinical course.[GRAPHICS].
Published: 2023

13. Predictive ability of a drug-based score in patients with advanced non-small-cell lung cancer receiving first-line immunotherapy

Author: Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, Cortellini A, Buti, S, Bersanelli, M, Perrone, F, Bracarda, S, Di Maio, M, Giusti, R, Nigro, O, Cortinovis, D, Aerts, J, Guaitoli, G, Barbieri, F, Ferrara, M, Bria, E, Grossi, F, Bareggi, C, Berardi, R, Torniai, M, Cantini, L, Sforza, V, Genova, C, Chiari, R, Rocco, D, Della Gravara, L, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Citarella, F, Russano, M, Mazzoni, F, Garassino, M, De Toma, A, Signorelli, D, Gelibter, A, Siringo, M, Follador, A, Bisonni, R, Tuzi, A, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Tabbò, F, Olmetto, E, Metro, G, Adamo, V, Russo, A, Spinelli, G, Banna, G, Addeo, A, Friedlaender, A, Cannita, K, Porzio, G, Ficorella, C, Carmisciano, L, Pinato, D, Mazzaschi, G, Tiseo, M, Cortellini, A, Buti S, Bersanelli M, Perrone F, Bracarda S, Di Maio M, Giusti R, Nigro O, Cortinovis D, Aerts JGJV, Guaitoli G, Barbieri F, Ferrara MG, Bria E, Grossi F, Bareggi C, Berardi R, Torniai M, Cantini L, Sforza V, Genova C, Chiari R, Rocco D, Della Gravara L, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Citarella F, Russano M, Mazzoni F, Garassino MC, De Toma A, Signorelli D, Gelibter A, Siringo M, Follador A, Bisonni R, Tuzi A, Minuti G, Landi L, Ricciardi S, Migliorino MR, Tabbò F, Olmetto E, Metro G, Adamo V, Russo A, Spinelli GP, Banna GL, Addeo A, Friedlaender A, Cannita K, Porzio G, Ficorella C, Carmisciano L, Pinato DJ, Mazzaschi G, Tiseo M, and Cortellini A
Abstract: Background: We previously demonstrated the cumulative poor prognostic role of concomitant medications on the clinical outcome of patients with advanced cancer treated with immune checkpoint inhibitors, creating and validating a drug-based prognostic score to be calculated before immunotherapy initiation in patients with advanced solid tumours. This ‘drug score’ was calculated assigning score 1 for each between proton-pump inhibitor and antibiotic administration until a month before cancer therapy initiation and score 2 in case of corticosteroid intake. The good risk group included patients with score 0, intermediate risk with score 1–2 and poor risk with score 3–4. Methods: Aiming at validating the prognostic and putative predictive ability depending on the anticancer therapy, we performed the present comparative analysis in two cohorts of advanced non–small-cell lung cancer (NSCLC), respectively, receiving first-line pembrolizumab or chemotherapy through a random case-control matching and through a pooled multivariable analysis including the interaction between the computed score and the therapeutic modality (pembrolizumab vs chemotherapy). Results: Nine hundred fifty and 595 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. After the case-control random matching, 589 patients from the pembrolizumab cohort and 589 from the chemotherapy cohort were paired, with no statistically significant differences between the characteristics of the matched subjects. Among the pembrolizumab-treated group, good, intermediate and poor risk evaluable patients achieved an objective response rate (ORR) of 50.0%, 37.7% and 23.4%, respectively, (p < 0.0001), whereas among the chemotherapy-treated group, patients achieved an ORR of 37.0%, 40.0% and 32.4%, respectively (p = 0.4346). The median progression-free survival (PFS) of good, intermediate and poor risk groups was 13.9 months, 6.3 months and 2.8 months, respectively, within the pembrolizumab coh
Published: 2021

14. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author: Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, Porzio G, Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, D, Cornelissen, R, Baldessari, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Follador, A, Rastelli, F, Chiari, R, Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, M, Russano, M, Cantini, L, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, M, Napoli, V, Leone, G, Metro, G, Banna, G, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini A, De Giglio A, Cannita K, Cortinovis D, Cornelissen R, Baldessari C, Giusti R, D'Argento E, Grossi F, Santoni M, Catino A, Berardi R, Sforza V, Rossi G, Antonuzzo L, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Follador A, Rastelli F, Chiari R, Gravara LD, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Pensieri MV, Russano M, Cantini L, Nigro O, Leonetti A, Bordi P, Minuti G, Landi L, De Toma A, Donisi C, Ricciardi S, Migliorino MR, Napoli VM, Leone G, Metro G, Banna GL, Friedlaender A, Addeo A, Ficorella C, and Porzio G
Abstract: Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat
Published: 2021

15. The lung immuno-oncology prognostic score (LIPS-3): a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author: Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, Addeo A., Banna, G, Cortellini, A, Cortinovis, D, Tiseo, M, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Grossi, F, Pizzutilo, P, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Marco, R, Cantini, L, Nigro, O, D'Argento, E, Buti, S, Minuti, G, Landi, L, Guaitoli, G, Lo Russo, G, De Toma, A, Donisi, C, Friedlaender, A, De Giglio, A, Metro, G, Porzio, G, Ficorella, C, Addeo, A, Banna GL, Cortellini A, Cortinovis D, Tiseo M, Aerts JGJV, Barbieri F, Giusti R, Bria E, Grossi F, Pizzutilo P, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Filetti M, Montrone M, Citarella F, Marco R, Cantini L, Nigro O, D'Argento E, Buti S, Minuti G, Landi L, Guaitoli G, Lo Russo G, De Toma A, Donisi C, Friedlaender A, De Giglio A, Metro G, Porzio G, Ficorella C, and Addeo A.
Abstract: Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.
Published: 2021

16. Post-progression outcomes of NSCLC patients with PD-L1 expression ≥ 50% receiving first-line single-agent pembrolizumab in a large multicentre real-world study

Author: Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, Porzio G, Cortellini, A, Cannita, K, Tiseo, M, Cortinovis, D, Aerts, J, Baldessari, C, Giusti, R, Ferrara, M, D'Argento, E, Grossi, F, Guida, A, Berardi, R, Morabito, A, Genova, C, Antonuzzo, L, Mazzoni, F, De Toma, A, Signorelli, D, Gelibter, A, Targato, G, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Filetti, M, Bracarda, S, Citarella, F, Russano, M, Cantini, L, Nigro, O, Buti, S, Minuti, G, Landi, L, Ricciardi, S, Migliorino, M, Natalizio, S, Simona, C, De Filippis, M, Metro, G, Adamo, V, Russo, A, Spinelli, G, Di Maio, M, Banna, G, Friedlaender, A, Addeo, A, Pinato, D, Ficorella, C, Porzio, G, Cortellini A, Cannita K, Tiseo M, Cortinovis D, Aerts JGJV, Baldessari C, Giusti R, Ferrara MG, D'Argento E, Grossi F, Guida A, Berardi R, Morabito A, Genova C, Antonuzzo L, Mazzoni F, De Toma A, Signorelli D, Gelibter A, Targato G, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Filetti M, Bracarda S, Citarella F, Russano M, Cantini L, Nigro O, Buti S, Minuti G, Landi L, Ricciardi S, Migliorino MR, Natalizio S, Simona C, De Filippis M, Metro G, Adamo V, Russo A, Spinelli GP, Di Maio M, Banna GL, Friedlaender A, Addeo A, Pinato DJ, Ficorella C, and Porzio G
Abstract: Background: Treatment sequencing with first-line immunotherapy, followed by second-line chemotherapy, is still a viable option for NSCLC patients with PD-L1 expression ≥50%. Methods: We evaluated post-progression treatment pathways in a large real-world cohort of metastatic NSCLC patients with PD-L1 expression ≥ 50% treated with first-line pembrolizumab monotherapy. Results: Overall, 974 patients were included. With a median follow-up of 22.7 months (95%CI: 21.6–38.2), the median overall survival (OS) of the entire population was 15.8 months (95%CI: 13.5–17.5; 548 events). At the data cutoff, among the 678 patients who experienced disease progression, 379 (55.9%) had not received any further treatment, and 359 patients (52.9%) had died. Patients who did not receive post-progression therapies were older (p = 0.0011), with a worse ECOG-PS (p < 0.0001) and were on corticosteroids prior to pembrolizumab (p = 0.0024). At disease progression, 198 patients (29.2%) received a switched approach and 101 (14.9%) received pembrolizumab ByPD either alone (64 [9.4%]) or in combination with local ablative treatments (37 [5.5%]) (LATs). After a random-case control matching according to ECOG-PS, CNS metastases, bone metastases, and (previous) best response to pembrolizumab, patients receiving pembrolizumab ByPD plus LATs were confirmed to have a significantly longer post-progression OS compared to patients receiving pembrolizumab ByPD alone 13.9 months versus 7.8 months (p = 0.0179) 241 patients (35.5%) among the 678 who had experienced PD, received a second-line systemic treatment (regardless of previous treatment beyond PD). As compared to first-line treatment commencement, patients’ features at the moment of second-line initiation showed a significantly higher proportion of patients aged under 70 years (p = 0.0244), with a poorer ECOG-PS (p < 0.0001) and having CNS (p = 0.0001), bone (p = 0.0266) and liver metastases (p = 0.0148). Conclusions: In the real-world scenario NSC
Published: 2021

17. Osimertinib beyond disease progression in T790M EGFR-positive NSCLC patients: a multicenter study of clinicians' attitudes

Author: Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, Tiseo M., Cortellini, A, Leonetti, A, Catino, A, Pizzutillo, P, Ricciuti, B, De Giglio, A, Chiari, R, Bordi, P, Santini, D, Giusti, R, De Tursi, M, Brocco, D, Zoratto, F, Rastelli, F, Citarella, F, Russano, M, Filetti, M, Marchetti, P, Berardi, R, Torniai, M, Cortinovis, D, Sala, E, Maggioni, C, Follador, A, Macerelli, M, Nigro, O, Tuzi, A, Iacono, D, Migliorino, M, Banna, G, Porzio, G, Cannita, K, Ferrara, M, Bria, E, Galetta, D, Ficorella, C, Tiseo, M, Cortellini A, Leonetti A, Catino A, Pizzutillo P, Ricciuti B, De Giglio A, Chiari R, Bordi P, Santini D, Giusti R, De Tursi M, Brocco D, Zoratto F, Rastelli F, Citarella F, Russano M, Filetti M, Marchetti P, Berardi R, Torniai M, Cortinovis D, Sala E, Maggioni C, Follador A, Macerelli M, Nigro O, Tuzi A, Iacono D, Migliorino MR, Banna G, Porzio G, Cannita K, Ferrara MG, Bria E, Galetta D, Ficorella C, and Tiseo M.
Abstract: Background: In most cases, T790M EGFR-positive NSCLC patients receiving osimertinib developed “non-drugable” progression, as the patients with common EGFR-sensitizing mutations were treated with first-line osimertinib. In both settings, chemotherapy represents the standard treatment and local ablative treatments (LATs) are potential useful options in the case of oligo-progression. Methods: We conducted a study on “post-progression” (pp) outcomes of T790M EGFR-positive NSCLC patients treated with osimertinib, according to the therapeutic strategy applied: osimertinib beyond progression (± LATs), “switched therapies” or best supportive care only (BSC). Results: 144 consecutive patients were evaluated: 53 (36.8%) did not received post-progression treatments (BSC), while 91 (63.2%) patients received at least 1 subsequent treatment; 50 patients (54.9%) received osimertinib beyond disease progression [19 (20.9%) of them with adjunctive LATs] and 41 (45.1%) a switched therapy. Median ppPFS (progression-free survival) and median ppOS (overall survival) of patients who received osimertinib beyond progression vs. switched therapies were 6.4 months vs. 4.7 months, respectively [HR 0.57 (95% CI 0.35–0.92), p = 0.0239] and 11.3 months vs 7.8 months, respectively [HR 0.57 (95% CI 0.33–0.98), p = 0.0446]. Among patients who received osimertinib beyond progression with and without LATs median ppPFS was 6.4 months and 5.7 months, respectively [HR 0.90 (95% CI 0.68–1.18), p = 0.4560], while median ppOS was 20.2 months and 9.9 months, respectively [HR 0.73 (95% CI 0.52–1.03), p = 0.0748]. At the univariate analysis, the only factor significantly related to the ppPFS was the therapeutic strategy in favor of osimertinib beyond progression (± LATs). Moreover, the only variable which was significantly related to ppOS at the multivariate analysis was osimertinib beyond progression (± LATs). Conclusion: Our study confirmed that in clinical practice, in case of “non-druggable” disease progre
Published: 2020

18. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression ≥ 50%: a multicenter study with external validation

Author: Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, Ficorella C., Cortellini, A, Ricciuti, B, Tiseo, M, Bria, E, Banna, G, Aerts, J, Barbieri, F, Giusti, R, Cortinovis, D, Migliorino, M, Catino, A, Passiglia, F, Torniai, M, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, M, Rastelli, F, Chiari, R, Rocco, D, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Grossi, F, Filetti, M, Pizzutilo, P, Russano, M, Citarella, F, Cantini, L, Targato, G, Nigro, O, Ferrara, M, Buti, S, Scodes, S, Landi, L, Guaitoli, G, Della Gravara, L, Tabbò, F, Ricciardi, S, De Toma, A, Friedlaender, A, Petrelli, F, Addeo, A, Porzio, G, Ficorella, C, Cortellini A, Ricciuti B, Tiseo M, Bria E, Banna GL, Aerts JG, Barbieri F, Giusti R, Cortinovis D, Migliorino MR, Catino A, Passiglia F, Torniai M, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Gelibter A, Occhipinti MA, Rastelli F, Chiari R, Rocco D, Inno A, De Tursi M, Di Marino P, Mansueto G, Zoratto F, Grossi F, Filetti M, Pizzutilo P, Russano M, Citarella F, Cantini L, Targato G, Nigro O, Ferrara MG, Buti S, Scodes S, Landi L, Guaitoli G, Della Gravara L, Tabbò F, Ricciardi S, De Toma A, Friedlaender A, Petrelli F, Addeo A, Porzio G, and Ficorella C.
Abstract: Background The association between obesity and outcomes in patients receiving programmed death-1/programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04-2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37-0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45-0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01-1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49-0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.
Published: 2020

19. Clinicopathologic correlates of first-line pembrolizumab effectiveness in patients with advanced NSCLC and a PD-L1 expression of ≥ 50

Author: Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, Porzio G., Cortellini, A, Tiseo, M, Banna, G, Cappuzzo, F, Aerts, J, Barbieri, F, Giusti, R, Bria, E, Cortinovis, D, Grossi, F, Migliorino, M, Galetta, D, Passiglia, F, Santini, D, Berardi, R, Morabito, A, Genova, C, Mazzoni, F, Di Noia, V, Signorelli, D, Tuzi, A, Gelibter, A, Marchetti, P, Macerelli, M, Rastelli, F, Chiari, R, Rocco, D, Gori, S, De Tursi, M, Mansueto, G, Zoratto, F, Santoni, M, Tudini, M, Rijavec, E, Filetti, M, Catino, A, Pizzutilo, P, Sala, L, Citarella, F, Marco, R, Torniai, M, Cantini, L, Targato, G, Sforza, V, Nigro, O, Ferrara, M, D'Argento, E, Buti, S, Bordi, P, Antonuzzo, L, Scodes, S, Landi, L, Guaitoli, G, Baldessari, C, Della Gravara, L, Dal Bello, M, Belderbos, R, Bironzo, P, Carnio, S, Ricciardi, S, Grieco, A, De Toma, A, Proto, C, Friedlaender, A, Cantale, O, Ricciuti, B, Addeo, A, Metro, G, Ficorella, C, Porzio, G, Cortellini A, Tiseo M, Banna GL, Cappuzzo F, Aerts JGJV, Barbieri F, Giusti R, Bria E, Cortinovis D, Grossi F, Migliorino MR, Galetta D, Passiglia F, Santini D, Berardi R, Morabito A, Genova C, Mazzoni F, Di Noia V, Signorelli D, Tuzi A, Gelibter A, Marchetti P, Macerelli M, Rastelli F, Chiari R, Rocco D, Gori S, De Tursi M, Mansueto G, Zoratto F, Santoni M, Tudini M, Rijavec E, Filetti M, Catino A, Pizzutilo P, Sala L, Citarella F, Marco R, Torniai M, Cantini L, Targato G, Sforza V, Nigro O, Ferrara MG, D'Argento E, Buti S, Bordi P, Antonuzzo L, Scodes S, Landi L, Guaitoli G, Baldessari C, Della Gravara L, Dal Bello MG, Belderbos RA, Bironzo P, Carnio S, Ricciardi S, Grieco A, De Toma A, Proto C, Friedlaender A, Cantale O, Ricciuti B, Addeo A, Metro G, Ficorella C, and Porzio G.
Abstract: Background: Single-agent pembrolizumab represents the standard first-line option for metastatic non-small-cell lung cancer (NSCLC) patients with a PD-L1 (programmed death-ligand 1) expression of ≥ 50%. Methods: We conducted a multicenter retrospective study aimed at evaluating the clinicopathologic correlates of pembrolizumab effectiveness in patients with treatment-naïve NSCLC and a PD-L1 expression of ≥ 50%. Results: One thousand and twenty-six consecutive patients were included. The objective response rate (ORR) was 44.5% (95% CI 40.2–49.1), while the median progression free survival (PFS) and overall survival (OS) were 7.9 months (95% CI 6.9–9.5; 599 events) and 17.2 months (95% CI 15.3–22.3; 598 censored patients), respectively. ECOG-PS ≥ 2 (p < 0.0001) and bone metastases (p = 0.0003) were confirmed to be independent predictors of a worse ORR. Former smokers (p = 0.0002), but not current smokers (p = 0.0532) were confirmed to have a significantly prolonged PFS compared to never smokers at multivariate analysis. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a worse PFS. Previous palliative RT was significantly related to a shortened OS (p = 0.0104), while previous non-palliative RT was significantly related to a prolonged OS (p = 0.0033). Former smokers (p = 0.0131), but not current smokers (p = 0.3433) were confirmed to have a significantly prolonged OS compared to never smokers. ECOG-PS (p < 0.0001), bone metastases (p < 0.0001) and liver metastases (p < 0.0001) were also confirmed to be independent predictors of a shortened OS. A PD-L1 expression of ≥ 90%, as assessed by recursive partitioning, was associated with significantly higher ORR (p = 0.0204), and longer and OS (p = 0.0346) at multivariable analysis. Conclusion: Pembrolizumab was effective in a large cohort of NSCLC patients treated outside of clinical trials. Questions regarding the effe
Published: 2020

20. Chemotherapy in non-small cell lung cancer patients after prior immunotherapy: The multicenter retrospective CLARITY study

Author: Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., Tiseo M., Bersanelli, M, Buti, S, Giannarelli, D, Leonetti, A, Cortellini, A, Russo, G, Signorelli, D, Toschi, L, Milella, M, Pilotto, S, Bria, E, Proto, C, Marinello, A, Randon, G, Rossi, S, Vita, E, Sartori, G, D'Argento, E, Qako, E, Giaiacopi, E, Ghilardi, L, Bettini, A, Rapacchi, E, Mazzoni, F, Lavacchi, D, Scotti, V, Ciccone, L, De Tursi, M, Di Marino, P, Santini, D, Russano, M, Bordi, P, Di Maio, M, Audisio, M, Filetti, M, Giusti, R, Berardi, R, Fiordoliva, I, Cerea, G, Pizzutilo, E, Bearz, A, De Carlo, E, Cecere, F, Renna, D, Camisa, R, Caruso, G, Ficorella, C, Banna, G, Cortinovis, D, Brighenti, M, Garassino, M, Tiseo, M, Bersanelli M., Buti S., Giannarelli D., Leonetti A., Cortellini A., Russo G. L., Signorelli D., Toschi L., Milella M., Pilotto S., Bria E., Proto C., Marinello A., Randon G., Rossi S., Vita E., Sartori G., D'Argento E., Qako E., Giaiacopi E., Ghilardi L., Bettini A. C., Rapacchi E., Mazzoni F., Lavacchi D., Scotti V., Ciccone L. P., De Tursi M., Di Marino P., Santini D., Russano M., Bordi P., Di Maio M., Audisio M., Filetti M., Giusti R., Berardi R., Fiordoliva I., Cerea G., Pizzutilo E. G., Bearz A., De Carlo E., Cecere F., Renna D., Camisa R., Caruso G., Ficorella C., Banna G. L., Cortinovis D., Brighenti M., Garassino M. C., and Tiseo M.
Abstract: Objectives: In the most of cases, for non-small cell lung cancer (NSCLC) patients who progressed to previous immune checkpoint inhibitors (CKI) administered as first- or as second-line therapy, chemotherapy (CT) remains the only viable options in the absence of “druggable” mutations. We aimed to explore the efficacy of salvage chemotherapy after immunotherapy (SCAI) in advanced NSCLC patients. Materials and Methods: We designed a retrospective, multicenter study, involving 20 Italian centers, with the primary objective of describing the clinical outcome of advanced NSCLC patients treated with SCAI at the participating institutions from November 2013 to July 2019. The primary endpoint of the study was represented by overall survival (OS), defined as the time from CT initiation to death. Secondary outcome endpoints of the SCAI (progression free survival, PFS, objective response rate, ORR and toxicity) and explorative biomarkers (lactate dehydrogenase, LDH, and neutrophil-to-lymphocyte ratio, NLR during immunotherapy) were also analyzed. Results: In our study population of 342 NSCLC patients, SCAI obtained a median OS of 6.8 months (95 % confidence interval, CI 5.5–8.1), median PFS of 4.1 months (95 % CI 3.4−4.8) and ORR of 22.8 %. A “Post-CKI score” was constructed by combining significant predictors of OS at the multivariate analyses (sex, ECOG PS, disease control with prior immunotherapy), Harrell'C was 0.65, (95 % CI:0.59−0.71). Conclusions: Despite the late-line settings, our findings support the hypothesis that previous immunotherapy might increase the sensitivity of the tumor to the subsequent chemotherapy. The “Post-CKI score” was clinically effective in successfully discriminating three distinct prognostic subgroups of patients after the failure of CKI, representing a possibly useful tool for the tailored decision-making process of advanced treatment-line settings in NSCLC.
Published: 2020

21. Covid-19 and the management of patients with inflammatory bowel disease: a practical decalogue for the post-pandemic phase

Author: Papa, Alfredo, Papa, Valerio, Lopetuso, Loris Riccardo, Gasbarrini, Antonio, Tursi, Antonio, Papa A. (ORCID:0000-0002-4186-7298), Papa V. (ORCID:0000-0002-3709-8924), Lopetuso L. R., Gasbarrini A. (ORCID:0000-0002-7278-4823), Tursi A., Papa, Alfredo, Papa, Valerio, Lopetuso, Loris Riccardo, Gasbarrini, Antonio, Tursi, Antonio, Papa A. (ORCID:0000-0002-4186-7298), Papa V. (ORCID:0000-0002-3709-8924), Lopetuso L. R., Gasbarrini A. (ORCID:0000-0002-7278-4823), and Tursi A.
Abstract: The coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has raised several concerns for patients with chronic immune-mediated diseases, including inflammatory bowel disease (IBD). As the outbreak appears to be in the descending phase, at least in some part of the world, as in most European countries, guidance is urgently needed to provide optimal care for our IBD patients in order to gradually and safely reduce the gap in care that has been accumulated in the months of lockdown and to face all the backlogs. Therefore, we have provided a decalogue of practical recommendations for gastroenterologists to manage patients with IBD in the post-peak phase of the COVID-19 pandemic. They include all the aspects of IBD care, not only pharmacological ones but also endoscopy, surgery, psychological treatment, telemedicine, diagnostics and educational tasks provided by doctors and patient associations.
Published: 2020

22. Distinct HR expression patterns significantly affect the clinical behavior of metastatic HER2+ breast cancer and degree of benefit from novel anti-HER2 agents in the real world setting

Author: Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., Vici P., Pizzuti, L, Krasniqi, E, Barchiesi, G, Della Giulia, M, Izzo, F, Sanguineti, G, Marchetti, P, Mazzotta, M, Giusti, R, Botticelli, A, Gamucci, T, Natoli, C, Grassadonia, A, Tinari, N, Iezzi, L, Tomao, S, Tomao, F, Tonini, G, Santini, D, Astone, A, Michelotti, A, De Angelis, C, Mentuccia, L, Vaccaro, A, Magnolfi, E, Gelibter, A, Magri, V, Cortesi, E, D'Onofrio, L, Cassano, A, Rossi, E, Cazzaniga, M, Moscetti, L, Omarini, C, Piacentini, F, Fabbri, M, Scinto, A, Corsi, D, Carbognin, L, Bria, E, La Verde, N, Samaritani, R, Garufi, C, Barni, S, Mirabelli, R, Sarmiento, R, Veltri, E, D'Auria, G, Paris, I, Giotta, F, Lorusso, V, Cardillo, F, Landucci, E, Mauri, M, Ficorella, C, Roselli, M, Adamo, V, Ricciardi, G, Russo, A, Berardi, R, Pistelli, M, Fiorio, E, Cannita, K, Sini, V, D'Ostilio, N, Foglietta, J, Greco, F, Zamagni, C, Garrone, O, Di Cocco, B, Baldini, E, Livi, L, Desideri, I, Meattini, I, Sarobba, G, Del Medico, P, De Tursi, M, Generali, D, De Maria, R, Risi, E, Ciliberto, G, Sperduti, I, Villa, A, Barba, M, Di Leo, A, Vici, P, Pizzuti L., Krasniqi E., Barchiesi G., Della Giulia M., Izzo F., Sanguineti G., Marchetti P., Mazzotta M., Giusti R., Botticelli A., Gamucci T., Natoli C., Grassadonia A., Tinari N., Iezzi L., Tomao S., Tomao F., Tonini G., Santini D., Astone A., Michelotti A., De Angelis C., Mentuccia L., Vaccaro A., Magnolfi E., Gelibter A., Magri V., Cortesi E., D'Onofrio L., Cassano A., Rossi E., Cazzaniga M., Moscetti L., Omarini C., Piacentini F., Fabbri M. A., Scinto A. F., Corsi D., Carbognin L., Bria E., La Verde N., Samaritani R., Garufi C., Barni S., Mirabelli R., Sarmiento R., Veltri E. M., D'Auria G., Paris I., Giotta F., Lorusso V., Cardillo F., Landucci E., Mauri M., Ficorella C., Roselli M., Adamo V., Ricciardi G. R. R., Russo A., Berardi R., Pistelli M., Fiorio E., Cannita K., Sini V., D'Ostilio N., Foglietta J., Greco F., Zamagni C., Garrone O., Di Cocco B., Baldini E., Livi L., Desideri I., Meattini I., Sarobba G., Del Medico P., De Tursi M., Generali D., De Maria R., Risi E., Ciliberto G., Sperduti I., Villa A., Barba M., Di Leo A., and Vici P.
Abstract: We analyzed data from 738 HER2-positive metastatic breast cancer (mbc) patients treated with pertuzumab-based regimens and/or T-DM1 at 45 Italian centers. Outcomes were explored in relation to tumor subtype assessed by immunohistochemistry (IHC). The median progression-free survival at first-line (mPFS1) was 12 months. Pertuzumab as first-line conferred longer mPFS1 compared to other first-line treatments (16 vs. 9 months, p = 0.0001), regardless of IHC subtype. Median PFS in second-line (mPFS2) was 7 months, with no difference by IHC subtype, but it was more favorable with T-DM1 compared to other agents (7 vs. 6 months, p = 0.03). There was no PFS2 gain in patients with tumors expressing both hormonal receptors (HRs; p = 0.17), while a trend emerged for tumors with one HR (p = 0.05). Conversely, PFS2 gain was significant in HRs-negative tumors (p = 0.04). Median overall survival (mOS) was 74 months, with no significant differences by IHC subtypes. Survival rates at 2 and 3 years in patients treated with T-DM1 in second-line after pertuzumab were significantly lower compared to pertuzumab-naïve patients (p = 0.01). When analyzed by IHC subtype, the outcome was confirmed if both HRs or no HRs were expressed (p = 0.02 and p = 0.006, respectively). Our results confirm that HRs expression impacts the clinical behavior and novel treatment-related outcomes of HER2-positive tumors when treatment sequences are considered. Moreover, multivariate analysis showed that HRs expression had no effect on PFS and OS. Further studies are warranted to confirm our findings and clarify the interplay between HER2 and estrogen receptor pathways in HER2-positive (mbc) patients
Published: 2020

23. Food selection and habitat use patterns of immature green turtles (Chelonia mydas) on Caribbean seagrass beds dominated by the alien species Halophila stipulacea

Author: Siegwalt, Flora, Jeantet, Lorène, Lelong, Pierre, Martin, Jordan, Girondot, Marc, Bustamante, Paco, Benhalilou, Abdelwahab, Murgale, Céline, Andreani, Lucas, Jacaria, François, Campistron, Guilhem, Lathière, Anthony, Barotin, Charlène, Buret-rochas, Gaëlle, Barre, Philippe, Hielard, Gaëlle, Arqué, Alexandre, Régis, Sidney, Lecerf, Nicolas, Frouin, Cédric, Lefebvre, Fabien, Aubert, Nathalie, Arthus, Mosiah, Etienne, Denis, Allenou, Jean-pierre, Delnatte, César, Lafolle, Rachelle, Thobor, Florence, Chevallier, Pascale, Chevallier, Tao, Lepori, Muriel, Assio, Cindy, Grand, Clément, Bonola, Marc, Tursi, Yannick, Varkala, Pierre-walter, Meslier, Stéphane, Landreau, Anthony, Le Maho, Yvon, Habold, Caroline, Robin, Jean-patrice, Chevallier, Damien, Siegwalt, Flora, Jeantet, Lorène, Lelong, Pierre, Martin, Jordan, Girondot, Marc, Bustamante, Paco, Benhalilou, Abdelwahab, Murgale, Céline, Andreani, Lucas, Jacaria, François, Campistron, Guilhem, Lathière, Anthony, Barotin, Charlène, Buret-rochas, Gaëlle, Barre, Philippe, Hielard, Gaëlle, Arqué, Alexandre, Régis, Sidney, Lecerf, Nicolas, Frouin, Cédric, Lefebvre, Fabien, Aubert, Nathalie, Arthus, Mosiah, Etienne, Denis, Allenou, Jean-pierre, Delnatte, César, Lafolle, Rachelle, Thobor, Florence, Chevallier, Pascale, Chevallier, Tao, Lepori, Muriel, Assio, Cindy, Grand, Clément, Bonola, Marc, Tursi, Yannick, Varkala, Pierre-walter, Meslier, Stéphane, Landreau, Anthony, Le Maho, Yvon, Habold, Caroline, Robin, Jean-patrice, and Chevallier, Damien
Abstract: Marine herbivores face rapid changes in the coastal ecosystems where they forage. In the Caribbean, the recent and fast expansion of the invasive phanerogam species Halophila stipulacea is threatening native seagrass ecosystems. So far, H. stipulacea is escaping most Caribbean herbivores, certainly because of its recent introduction or lower nutritional value. We investigated the impact of H. stipulacea invasion on fine-scale foraging habitat selection and food resource selection of immature green turtles at critical foraging sites in Les Anses d’Arlet, Martinique. The analysis of seagrass distribution and nutritional content, together with turtle behaviour and resource selection, showed that H. stipulacea may be of contrasting interest to green turtles. Compositional analysis confirmed the lower nutritional value of H. stipulacea compared to the native species, but the invasive species showed higher digestibility than native ones, which calls into question the energetic advantage of consuming the native plants over the exotic plant. Thus, although green turtles mostly selected the native seagrass Thalassia testudinum in multispecies seagrass beds, some individuals fed on H. stipulacea. Accordingly, in bays entirely invaded by H. stipulacea, one possibility for resident green turtles is to increase foraging on this species, but, if so, the consequences on their growth and survival still remain to be determined. As the expansion of H. stipulacea may have been facilitated by factors such as shipping, anchor scarring and fishing activities, protection of native seagrass beds and immature green turtles from human disturbances is urgently required to ensure the long-term adaptation of green turtles to this new foraging environment.
Published: 2022
Full Text: View/download PDF

24. The spatial representation of serial order in infancy

Author: Bettoni, R, Rinaldi, L, Arioli, M, Tursi, B, Bulf, H, Macchi Cassia, V, Bettoni, R, Rinaldi, L, Arioli, M, Tursi, B, Bulf, H, and Macchi Cassia, V
Published: 2022

25. Mass cytometry analysis of blood from peanut-sensitized tolerant and clinically allergic infants

Author: Tursi, AR, Saba, NK, Dunham, D, Manohar, M, Peters, RL, Saffery, R, Koplin, JJ, Nadeau, KC, Neeland, MR, Andorf, S, Tursi, AR, Saba, NK, Dunham, D, Manohar, M, Peters, RL, Saffery, R, Koplin, JJ, Nadeau, KC, Neeland, MR, and Andorf, S
Abstract: IgE-mediated food allergies in infants are a significant health concern, with peanut allergy being of particular interest due to its prevalence and severity. Among individuals who produce peanut-specific IgE some experience no adverse reaction on peanut consumption. This asymptomatic phenotype is known as sensitized tolerance. To elucidate the immune environment of peanut sensitized tolerant and clinically allergic one-year-olds, high-dimensional mass cytometry was conducted as part of the HealthNuts study. The resulting data includes peripheral blood mononuclear cells from 36 participants encompassing non-allergic, peanut sensitized with tolerance, and clinically peanut allergic infants. The raw mass cytometry data is described here and freely available for reuse through the Immunology Database and Analysis Portal (ImmPort). Additional allergy information and serum vitamin D levels of the participants were measured and are also included in the data upload. These high-dimensional mass cytometry data, when combined with clinical information, offer a broad immune profile of peanut allergic and sensitized tolerant infants.
Published: 2022

26. PANDEMICS IN PARALLEL: VIOLIN MUSIC DURING THE SPANISH INFLUENZA (WORLD WAR I) AND COVID 19

Author: Tursi, Erica and Tursi, Erica
Abstract: My dissertation incorporates in-depth research of composers (and their relevant compositions) living through parallel pandemics and political crises. These periods of time include: COVID-19 and international conflict, as well as The Spanish Flu and World War I. The pieces for violin alone were all created in 2020 as part of the Alone Together Project, launched by Jennifer Koh in response to COVID-19 and the financial hardship it placed on so many in the arts community. There are sixteen current composers which will be noted in the following pages. Composers and their works from the past include, Claude Debussy (Violin Sonata in G minor), Leos Janáček (Violin Sonata), Vaughan Williams (The Lark Ascending), and Igor Stravinsky (L’Histoire du Soldat score for clarinet, violin, and piano). My dissertation delves into each composer’s experiences, gaining awareness of how they cope with these difficult times, what inspires their compositions, and their productivity during these uncertain times. Three video recitals are included in my dissertation representing Program 1, Program 2 and Program 3 as described in detail in the written supporting materials.
Published: 2022

27. Food selection and habitat use patterns of immature green turtles (Chelonia mydas) on Caribbean seagrass beds dominated by the alien species Halophila stipulacea

Author: Siegwalt, Flora, Jeantet, Lorène, Lelong, Pierre, Martin, Jordan, Girondot, Marc, Bustamante, Paco, Benhalilou, Abdelwahab, Murgale, Céline, Andreani, Lucas, Jacaria, François, Campistron, Guilhem, Lathière, Anthony, Barotin, Charlène, Buret-rochas, Gaëlle, Barre, Philippe, Hielard, Gaëlle, Arqué, Alexandre, Régis, Sidney, Lecerf, Nicolas, Frouin, Cédric, Lefebvre, Fabien, Aubert, Nathalie, Arthus, Mosiah, Etienne, Denis, Allenou, Jean-pierre, Delnatte, César, Lafolle, Rachelle, Thobor, Florence, Chevallier, Pascale, Chevallier, Tao, Lepori, Muriel, Assio, Cindy, Grand, Clément, Bonola, Marc, Tursi, Yannick, Varkala, Pierre-walter, Meslier, Stéphane, Landreau, Anthony, Le Maho, Yvon, Habold, Caroline, Robin, Jean-patrice, Chevallier, Damien, Siegwalt, Flora, Jeantet, Lorène, Lelong, Pierre, Martin, Jordan, Girondot, Marc, Bustamante, Paco, Benhalilou, Abdelwahab, Murgale, Céline, Andreani, Lucas, Jacaria, François, Campistron, Guilhem, Lathière, Anthony, Barotin, Charlène, Buret-rochas, Gaëlle, Barre, Philippe, Hielard, Gaëlle, Arqué, Alexandre, Régis, Sidney, Lecerf, Nicolas, Frouin, Cédric, Lefebvre, Fabien, Aubert, Nathalie, Arthus, Mosiah, Etienne, Denis, Allenou, Jean-pierre, Delnatte, César, Lafolle, Rachelle, Thobor, Florence, Chevallier, Pascale, Chevallier, Tao, Lepori, Muriel, Assio, Cindy, Grand, Clément, Bonola, Marc, Tursi, Yannick, Varkala, Pierre-walter, Meslier, Stéphane, Landreau, Anthony, Le Maho, Yvon, Habold, Caroline, Robin, Jean-patrice, and Chevallier, Damien
Abstract: Marine herbivores face rapid changes in the coastal ecosystems where they forage. In the Caribbean, the recent and fast expansion of the invasive phanerogam species Halophila stipulacea is threatening native seagrass ecosystems. So far, H. stipulacea is escaping most Caribbean herbivores, certainly because of its recent introduction or lower nutritional value. We investigated the impact of H. stipulacea invasion on fine-scale foraging habitat selection and food resource selection of immature green turtles at critical foraging sites in Les Anses d’Arlet, Martinique. The analysis of seagrass distribution and nutritional content, together with turtle behaviour and resource selection, showed that H. stipulacea may be of contrasting interest to green turtles. Compositional analysis confirmed the lower nutritional value of H. stipulacea compared to the native species, but the invasive species showed higher digestibility than native ones, which calls into question the energetic advantage of consuming the native plants over the exotic plant. Thus, although green turtles mostly selected the native seagrass Thalassia testudinum in multispecies seagrass beds, some individuals fed on H. stipulacea. Accordingly, in bays entirely invaded by H. stipulacea, one possibility for resident green turtles is to increase foraging on this species, but, if so, the consequences on their growth and survival still remain to be determined. As the expansion of H. stipulacea may have been facilitated by factors such as shipping, anchor scarring and fishing activities, protection of native seagrass beds and immature green turtles from human disturbances is urgently required to ensure the long-term adaptation of green turtles to this new foraging environment.
Published: 2022
Full Text: View/download PDF

28. The time-course of visual rule learning in preverbal infants: evidence from neural entrainment.

Author: Bettoni, R, Bulf, H, Silvestri, V, Tursi, B, Peykarjou, S, Macchi Cassia, V, Bettoni, R, Bulf, H, Silvestri, V, Tursi, B, Peykarjou, S, and Macchi Cassia, V
Published: 2022

29. Attention is a matter of time: effects of rhythmic stimulation on newborns’ attentional disengagement

Author: Arioli, M, Savoldi, M, Tursi, B, Colombo, L, Porro, M, Macchi Cassia, V, Arioli, M, Savoldi, M, Tursi, B, Colombo, L, Porro, M, and Macchi Cassia, V
Abstract: The Dynamic Attending Theory postulates that ongoing temporal structure of events entrains attention and affects perception (Jones et al., 2002). According to this theory, rhythm, defined as a sequence of short repeated intervals with regularities that allow us to build expectancies, is one of the main temporal cue which guides attention and facilitates performances in both visual and auditory domains. Evidence from the adult literature supports this hypothesis, showing that rhythm boosts perception (e.g., Elbaz & Yeshurun, 2020). However, no study has explored whether the rhythmic structure of external stimuli improves the efficiency with which infants attend to and process them. Given the ubiquitous nature of rhythms in the perceptual environment of the infant across the perinatal period, this question appears compelling. Indeed, it has been shown that foetuses in the last trimester of gestation are responsive to rhythmic stimulation that reaches them through the auditory, vestibular and tactile sensory channels (Lecanuet & Schaal, 2002), and it is claimed that this early exposure to rhythm plays a key role in the development of early communicative and cognitive abilities (Provasi et al., 2014). On this ground, we hypothesised that exposing the foetus to an enriched rhythmic environment might affect early infants’ attentional capabilities, which could be boosted by prenatal experience. The current study is part of a larger project aimed at testing this hypothesis, and was planned as a pilot investigation of the impact of rhythm on the orienting of visual spatial attention at birth. Two-day-old newborns were tested in an overlap task where a central stimulus, S1, was followed by a peripheral target, S2, (see Fig.1) and saccadic reaction times towards S2 were recorded as measure of attentional disengagement. S1 remained on the screen until the infant’s gaze landed on S2. On each trial, the same image was presented as S1 and S2. We manipulated the attributes
Published: 2022

30. Microbiota Composition in Diverticular Disease: Implications for Therapy

Author: Tursi, Antonio, Papa, Valerio, Lopetuso, Loris Riccardo, Settanni, Carlo Romano, Gasbarrini, Antonio, Papa, Alfredo, Papa, Valerio (ORCID:0000-0002-3709-8924), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Papa, Valerio, Lopetuso, Loris Riccardo, Settanni, Carlo Romano, Gasbarrini, Antonio, Papa, Alfredo, Papa, Valerio (ORCID:0000-0002-3709-8924), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: Gut microbiota (GM) composition and its imbalance are crucial in the pathogenesis of several diseases, mainly those affecting the gastrointestinal tract. Colon diverticulosis and its clinical manifestations (diverticular disease, DD) are among the most common digestive disorders in developed countries. In recent literature, the role of GM imbalance in the onset of the different manifestations within the clinical spectrum of DD has been highlighted. This narrative review aims to summarize and critically analyze the current knowledge on GM dysbiosis in diverticulosis and DD by comparing the available data with those found in inflammatory bowel disease (IBD). The rationale for using probiotics to rebalance dysbiosis in DD is also discussed.
Published: 2022

31. SARS-CoV-2 infection as a potential trigger factor for de novo occurrence of inflammatory bowel disease

Author: Tursi, Antonio, Lopetuso, Loris Riccardo, Vetrone, Lorenzo Maria, Gasbarrini, Antonio, Papa, Alfredo, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Lopetuso, Loris Riccardo, Vetrone, Lorenzo Maria, Gasbarrini, Antonio, Papa, Alfredo, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: n/a
Published: 2022

32. When to Perform a Colonoscopy in Diverticular Disease and Why: A Personalized Approach

Author: Tursi, Antonio, Papa, Valerio, Lopetuso, Loris Riccardo, Vetrone, Lorenzo Maria, Gasbarrini, Antonio, Papa, Alfredo, Papa, Valerio (ORCID:0000-0002-3709-8924), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Papa, Valerio, Lopetuso, Loris Riccardo, Vetrone, Lorenzo Maria, Gasbarrini, Antonio, Papa, Alfredo, Papa, Valerio (ORCID:0000-0002-3709-8924), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: Colonoscopy is a crucial diagnostic tool in managing diverticular disease (DD). Diverticulosis can often be an unexpected diagnosis when colonoscopy is performed in asymptomatic subjects, generally for colorectal cancer screening, or it could reveal an endoscopic picture compatible with DD, including acute diverticulitis, in patients suffering from abdominal pain or rectal bleeding. However, alongside its role in the differential diagnosis of colonic diseases, particularly with colon cancer after an episode of acute diverticulitis or segmental colitis associated with diverticulosis, the most promising use of colonoscopy in patients with DD is represented by its prognostic role when the DICA (Diverticular Inflammation and Complication Assessment) classification is applied. Finally, colonoscopy plays a crucial role in managing diverticular bleeding, and it could sometimes be used to resolve other complications, particularly as a bridge to surgery. This article aims to summarize "when" to safely perform a colonoscopy in the different DD settings and "why".
Published: 2022

33. Pancytopenia During Osimertinib Treatment in a Patient with EGFR-Mutated Non-Small Cell Lung Cancer

Author: Di Marino,Pietro, Chiapperino,Cosima, Primavera,Francesca Chiara, Martino,Maria Teresa, Brocco,Davide, Carella,Consiglia, Grassadonia,Antonino, Tinari,Nicola, De Tursi,Michele, Di Marino,Pietro, Chiapperino,Cosima, Primavera,Francesca Chiara, Martino,Maria Teresa, Brocco,Davide, Carella,Consiglia, Grassadonia,Antonino, Tinari,Nicola, and De Tursi,Michele
Abstract: Pietro Di Marino,1 Cosima Chiapperino,1 Francesca Chiara Primavera,1 Maria Teresa Martino,1 Davide Brocco,2 Consiglia Carella,1 Antonino Grassadonia,3 Nicola Tinari,4 Michele De Tursi3 1Clinical Oncology Unit, SS Annunziata Hospital, Chieti, Italy; 2Department of Pharmacy, University G. DâAnnunzio, Chieti- Pescara, Italy; 3Department of Innovative Technologies in Medicine and Dentistry, University G. DâAnnunzio, Chieti- Pescara, Italy; 4Department of Medical, Oral and Biotechnological Sciences, University G. DâAnnunzio, Chieti-Pescara, ItalyCorrespondence: Pietro Di Marino, Clinical Oncology Unit, SS Annunziata Hospital, Via Dei Vestini 5, Chieti, 66100, Italy, Tel +39 0871 35 8005, Fax +39 0871 35 8476, Email pietrodimarino@gmail.comBackground: Osimertinib is an irreversible tyrosine kinase inhibitor approved for the treatment of metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). In clinical trials, osimertinib has exhibited excellent activity and less toxicity compared to gefitinib, erlotinib and standard chemotherapy.Case Presentation: Herein, we describe the case of a 69-year-old man who received first-line osimertinib for metastatic EGFR-mutated NSCLC. Suspected osimertinib-induced pancytopenia together with a partial treatment response was assessed after 10 days of therapy. Osimertinib was resumed at 40 mg daily a month later while the patient exhibited durable stable disease. No other adverse events occurred.Conclusion: In the current case, first-line treatment with osimertinib at 80 mg daily in a patient with EGFR-mutated NSCLC resulted in severe pancytopenia and a rapid treatment response. Dose reduction to 40 mg daily resulted in excellent activity without any further adverse events. Osimertinib could be safely resumed at a reduced dose even after pancytopenia.Keywords: adverse events, anemia, EGFR, neutropenia, non-small cell lung cancer, osimertinib, pancytopenia, thrombocytopenia
Published: 2022

34. High familial burden of cancer correlates with improved outcome from immunotherapy in patients with NSCLC independent of somatic DNA damage response gene status

Author: Cortellini, Alessio, Giusti, Raffaele, Filetti, Marco, Citarella, Fabrizio, Adamo, Vincenzo, Santini, Daniele, Buti, Sebastiano, Nigro, Olga, Cantini, Luca, Di Maio, Massimo, Aerts, Joachim G.J.V., Bria, Emilio, Bertolini, Federica, Ferrara, Miriam Grazia, Ghidini, Michele, Grossi, Francesco, Guida, Annalisa, Berardi, Rossana, Morabito, Alessandro, Genova, Carlo, Mazzoni, Francesca, Antonuzzo, Lorenzo, Gelibter, Alain, Marchetti, Paolo, Chiari, Rita, Macerelli, Marianna, Rastelli, Francesca, Della Gravara, Luigi, Gori, Stefania, Tuzi, Alessandro, De Tursi, Michele, Di Marino, Pietro, Mansueto, Giovanni, Pecci, Federica, Zoratto, Federica, Ricciardi, Serena, Migliorino, Maria Rita, Passiglia, Francesco, Metro, Giulio, Spinelli, Gian Paolo, Banna, Giuseppe L., Friedlaender, Alex, Addeo, Alfredo, Ficorella, Corrado, Porzio, Giampiero, Tiseo, Marcello, Russano, Marco, Russo, Alessandro, Pinato, David James, Cortellini, Alessio, Giusti, Raffaele, Filetti, Marco, Citarella, Fabrizio, Adamo, Vincenzo, Santini, Daniele, Buti, Sebastiano, Nigro, Olga, Cantini, Luca, Di Maio, Massimo, Aerts, Joachim G.J.V., Bria, Emilio, Bertolini, Federica, Ferrara, Miriam Grazia, Ghidini, Michele, Grossi, Francesco, Guida, Annalisa, Berardi, Rossana, Morabito, Alessandro, Genova, Carlo, Mazzoni, Francesca, Antonuzzo, Lorenzo, Gelibter, Alain, Marchetti, Paolo, Chiari, Rita, Macerelli, Marianna, Rastelli, Francesca, Della Gravara, Luigi, Gori, Stefania, Tuzi, Alessandro, De Tursi, Michele, Di Marino, Pietro, Mansueto, Giovanni, Pecci, Federica, Zoratto, Federica, Ricciardi, Serena, Migliorino, Maria Rita, Passiglia, Francesco, Metro, Giulio, Spinelli, Gian Paolo, Banna, Giuseppe L., Friedlaender, Alex, Addeo, Alfredo, Ficorella, Corrado, Porzio, Giampiero, Tiseo, Marcello, Russano, Marco, Russo, Alessandro, and Pinato, David James
Abstract: Family history of cancer (FHC) is a hallmark of cancer risk and an independent predictor of outcome, albeit with uncertain biologic foundations. We previously showed that FHC-high patients experienced prolonged overall (OS) and progression-free survival (PFS) following PD-1/PD-L1 checkpoint inhibitors. To validate our findings in patients with NSCLC, we evaluated two multicenter cohorts of patients with metastatic NSCLC receiving either first-line pembrolizumab or chemotherapy. From each cohort, 607 patients were randomly case–control matched accounting for FHC, age, performance status, and disease burden. Compared to FHC-low/negative, FHC-high patients experienced longer OS (HR 0.67 [95% CI 0.46–0.95], p = 0.0281), PFS (HR 0.65 [95% CI 0.48–0.89]; p = 0.0074) and higher disease control rates (DCR, 86.4% vs 67.5%, p = 0.0096), within the pembrolizumab cohort. No significant associations were found between FHC and OS/PFS/DCR within the chemotherapy cohort. We explored the association between FHC and somatic DNA damage response (DDR) gene alterations as underlying mechanism to our findings in a parallel cohort of 118 NSCLC, 16.9% of whom were FHC-high. The prevalence of ≥ 1 somatic DDR gene mutation was 20% and 24.5% (p = 0.6684) in FHC-high vs. FHC-low/negative, with no differences in tumor mutational burden (6.0 vs. 7.6 Mut/Mb, p = 0.6018) and tumor cell PD-L1 expression. FHC-high status identifies NSCLC patients with improved outcomes from pembrolizumab but not chemotherapy, independent of somatic DDR gene status. Prospective studies evaluating FHC alongside germline genetic testing are warranted.
Published: 2022

35. The spatial representation of serial order in infancy

Author: Bettoni, R, Rinaldi, L, Arioli, M, Tursi, B, Bulf, H, Macchi Cassia, V, Bettoni, R, Rinaldi, L, Arioli, M, Tursi, B, Bulf, H, and Macchi Cassia, V
Published: 2022

36. Prognostic performance of the ‘DICA’ endoscopic classification and the ‘CODA’ score in predicting clinical outcomes of diverticular disease: an international, multicentre, prospective cohort study

Author: Tursi, Antonio, Brandimarte, Giovanni, Di Mario, Francesco, Elisei, Walter, Picchio, Marcello, Allegretta, Leonardo, Annunziata, Maria Laura, Bafutto, Mauro, Bassotti, Gabrio, Bianco, Maria Antonietta, Colucci, Raffaele, Conigliaro, Rita, Dumitrascu, Dan, Escalante, Ricardo, Ferrini, Luciano, Forti, Giacomo, Franceschi, Marilisa, Graziani, Maria Giovanna, Lammert, Frank, Latella, Giovanni, Maconi, Giovanni, Nardone, Gerardo, Camara de Castro Oliveira, Lucia, Chaves Oliveira, Enio, Papa, Alfredo, Papagrigoriadis, Savva, Pietrzak, Anna, Pontone, Stefano, Poskus, Toma, Pranzo, Giuseppe, Reichert, Matthias Christian, Rodinò, Stefano, Regula, Jaroslaw, Scaccianoce, Giuseppe, Scaldaferri, Franco, Vassallo, Roberto, Zampaletta, Costantino, Zullo, Angelo, Piovani, Daniele, Bonovas, Stefano, Danese, Silvio, Papa, Alfredo (ORCID:0000-0002-4186-7298), Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Tursi, Antonio, Brandimarte, Giovanni, Di Mario, Francesco, Elisei, Walter, Picchio, Marcello, Allegretta, Leonardo, Annunziata, Maria Laura, Bafutto, Mauro, Bassotti, Gabrio, Bianco, Maria Antonietta, Colucci, Raffaele, Conigliaro, Rita, Dumitrascu, Dan, Escalante, Ricardo, Ferrini, Luciano, Forti, Giacomo, Franceschi, Marilisa, Graziani, Maria Giovanna, Lammert, Frank, Latella, Giovanni, Maconi, Giovanni, Nardone, Gerardo, Camara de Castro Oliveira, Lucia, Chaves Oliveira, Enio, Papa, Alfredo, Papagrigoriadis, Savva, Pietrzak, Anna, Pontone, Stefano, Poskus, Toma, Pranzo, Giuseppe, Reichert, Matthias Christian, Rodinò, Stefano, Regula, Jaroslaw, Scaccianoce, Giuseppe, Scaldaferri, Franco, Vassallo, Roberto, Zampaletta, Costantino, Zullo, Angelo, Piovani, Daniele, Bonovas, Stefano, Danese, Silvio, Papa, Alfredo (ORCID:0000-0002-4186-7298), and Scaldaferri, Franco (ORCID:0000-0001-8334-7541)
Abstract: Objective To investigate the predictive value of the Diverticular Inflammation and Complication Assessment (DICA) classification and to develop and validate a combined endoscopic-clinical score predicting clinical outcomes of diverticulosis, named Combined Overview on Diverticular Assessment (CODA).Design A multicentre, prospective, international cohort study.Setting 43 gastroenterology and endoscopy centres located in Europe and South America.Participants 2215 patients (2198 completing the study) at the first diagnosis of diverticulosis/diverticular disease were enrolled. Patients were scored according to DICA classifications.Interventions A 3-year follow-up was performed.Main outcome measures To predict the acute diverticulitis and the surgery according to DICA classification. Survival methods for censored observation were used to develop and validate a novel combined endoscopic-clinical score for predicting diverticulitis and surgery (CODA score).Results The 3-year cumulative probability of diverticulitis and surgery was of 3.3% (95% CI 2.5% to 4.5%) in DICA 1, 11.6% (95% CI 9.2% to 14.5%) in DICA 2 and 22.0% (95% CI 17.2% to 28.0%) in DICA 3 (p<0.001), and 0.15% (95% CI 0.04% to 0.59%) in DICA 1, 3.0% (95% CI 1.9% to 4.7%) in DICA 2 and 11.0% (95% CI 7.5% to 16.0%) in DICA 3 (p<0.001), respectively. The 3-year cumulative probability of diverticulitis and surgery was <= 4%, and <= 0.7% in CODA A; 10% and >2.5% in CODA C, respectively. The CODA score showed optimal discrimination capacity in predicting the risk of surgery in the development (c-statistic: 0.829; 95% CI 0.811 to 0.846) and validation cohort (c-statistic: 0.943; 95% CI 0.905 to 0.981).Conclusions DICA classification has a significant role in predicting the risk of diverticulitis and surgery in patients with diverticulosis, which is significantly enhanced by the CODA score.
Published: 2022

37. Replacement of Adalimumab Originator to Adalimumab Biosimilar for a Non-Medical Reason in Patients with Inflammatory Bowel Disease: A Real-life Comparison of Adalimumab Biosimilars Currently Available in Italy

Author: Tursi, Antonio, Mocci, Giammarco, Cuomo, Antonio, Ferronato, Antonio, Elisei, Walter, Picchio, Marcello, Maconi, Giovanni, Scaldaferri, Franco, Papa, Alfredo, Italian group for switch of biologics,, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Della Valle, Nicola, Faggiani, Roberto, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De’ Angelis, Gianluigi, Donnarumma, Laura, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Pica, Roberta, Pranzo, Giuseppe, Rodino’, Stefano, Sacco, Rodolfo, Sebkova, Ladislava, Scarcelli, Antonella, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Zampaletta, Costantino, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), Papa, Alfredo (ORCID:0000-0002-4186-7298), Tursi, Antonio, Mocci, Giammarco, Cuomo, Antonio, Ferronato, Antonio, Elisei, Walter, Picchio, Marcello, Maconi, Giovanni, Scaldaferri, Franco, Papa, Alfredo, Italian group for switch of biologics,, Allegretta, Leonardo, Aragona, Giovanni, Bianco, Maria Antonia, Colucci, Raffaele, Della Valle, Nicola, Faggiani, Roberto, Forti, Giacomo, Gaiani, Federica, Giorgetti, Gianmarco, Graziani, Maria Giovanna, Lofano, Katia, Lorenzetti, Roberto, Larussa, Tiziana, Penna, Antonio, Bassotti, Gabrio, Cazzato, Alessia Immacolata, Chiri, Stefania, Clemente, Valeria, Cocco, Andrea, De’ Angelis, Gianluigi, Donnarumma, Laura, Graziosi, Camilla, Le Grazie, Marco, Luzza, Francesco, Meucci, Costantino, Monterubbianesi, Rita, Pagnini, Cristiano, Perazzo, Patrizia, Pica, Roberta, Pranzo, Giuseppe, Rodino’, Stefano, Sacco, Rodolfo, Sebkova, Ladislava, Scarcelli, Antonella, Serio, Mariaelena, Napolitano, Daniele, Pugliese, Daniela, Schiavoni, Elisa, Turchini, Laura, Armuzzi, Alessandro, Zampaletta, Costantino, Scaldaferri, Franco (ORCID:0000-0001-8334-7541), and Papa, Alfredo (ORCID:0000-0002-4186-7298)
Abstract: Background & Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason.Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars.Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild.Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.
Published: 2022

38. Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience

Author: Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti L., Giordano A., Michelotti A., Mazzotta M., Natoli C., Gamucci T., De Angelis C., Landucci E., Diodati L., Iezzi L., Mentuccia L., Fabbri A., Barba M., Sanguineti G., Marchetti P., Tomao S., Mariani L., Paris I., Lorusso V., Vallarelli S., Cassano A., Airoldi F., Orlandi A., Moscetti L., Sergi D., Sarobba M. G., Tonini G., Santini D., Sini V., Veltri E., Vaccaro A., Ferrari L., De Tursi M., Tinari N., Grassadonia A., Greco F., Botticelli A., La Verde N., Zamagni C., Rubino D., Cortesi E., Magri V., Pomati G., Scagnoli S., Capomolla E., Kayal R., Scinto A. F., Corsi D., Cazzaniga M., Laudadio L., Forciniti S., Mancini M., Carbognin L., Seminara P., Barni S., Samaritani R., Roselli M., Portarena I., Russo A., Ficorella C., Cannita K., Carpano S., Pistelli M., Berardi R., De Maria R., Sperduti I., Ciliberto G., Vici P., Pizzuti, L, Giordano, A, Michelotti, A, Mazzotta, M, Natoli, C, Gamucci, T, De Angelis, C, Landucci, E, Diodati, L, Iezzi, L, Mentuccia, L, Fabbri, A, Barba, M, Sanguineti, G, Marchetti, P, Tomao, S, Mariani, L, Paris, I, Lorusso, V, Vallarelli, S, Cassano, A, Airoldi, F, Orlandi, A, Moscetti, L, Sergi, D, Sarobba, M, Tonini, G, Santini, D, Sini, V, Veltri, E, Vaccaro, A, Ferrari, L, De Tursi, M, Tinari, N, Grassadonia, A, Greco, F, Botticelli, A, La Verde, N, Zamagni, C, Rubino, D, Cortesi, E, Magri, V, Pomati, G, Scagnoli, S, Capomolla, E, Kayal, R, Scinto, A, Corsi, D, Cazzaniga, M, Laudadio, L, Forciniti, S, Mancini, M, Carbognin, L, Seminara, P, Barni, S, Samaritani, R, Roselli, M, Portarena, I, Russo, A, Ficorella, C, Cannita, K, Carpano, S, Pistelli, M, Berardi, R, De Maria, R, Sperduti, I, Ciliberto, G, Vici, P, Pizzuti L., Giordano A., Michelotti A., Mazzotta M., Natoli C., Gamucci T., De Angelis C., Landucci E., Diodati L., Iezzi L., Mentuccia L., Fabbri A., Barba M., Sanguineti G., Marchetti P., Tomao S., Mariani L., Paris I., Lorusso V., Vallarelli S., Cassano A., Airoldi F., Orlandi A., Moscetti L., Sergi D., Sarobba M. G., Tonini G., Santini D., Sini V., Veltri E., Vaccaro A., Ferrari L., De Tursi M., Tinari N., Grassadonia A., Greco F., Botticelli A., La Verde N., Zamagni C., Rubino D., Cortesi E., Magri V., Pomati G., Scagnoli S., Capomolla E., Kayal R., Scinto A. F., Corsi D., Cazzaniga M., Laudadio L., Forciniti S., Mancini M., Carbognin L., Seminara P., Barni S., Samaritani R., Roselli M., Portarena I., Russo A., Ficorella C., Cannita K., Carpano S., Pistelli M., Berardi R., De Maria R., Sperduti I., Ciliberto G., and Vici P.
Abstract: Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.
Published: 2019

39. Factors Influencing Access to Transplant, Waitlist Mortality, and Post-Transplant Survival in the Italian National Heart Transplant Database

Author: Frigerio, M, Varrenti, M, Santolamazza, C, Bernasconi, D, Costa, A, Oliveti, A, Puoti, F, Bottio, T, Gerosa, G, Russo, C, Giannattasio, C, Tursi, V, Livi, U, Maiello, C, Amarelli, C, Potena, L, Martin Suarez, S, Boffini, M, Pace Napoleone, C, Clemenza, F, Musumeci, F, Maccherini, M, Faggian, G, Pellegrini, C, Terzi, A, Tramontin, C, De Angelis, D, Milano, A, Valsecchi, M, Frigerio, M., Varrenti, M., Santolamazza, C., Bernasconi, D. P., Costa, A. Nanni, Oliveti, A., Puoti, F., Bottio, T., Gerosa, G., Russo, C. F., Giannattasio, C., Tursi, V., Livi, U., Maiello, C., Amarelli, C., Potena, L., Martin Suarez, S., Boffini, M., Pace Napoleone, C., Clemenza, F., Musumeci, F., Maccherini, M., Faggian, G., Pellegrini, C., Terzi, A., Tramontin, C., De Angelis, D., Milano, A. D., Valsecchi, M., Frigerio, M, Varrenti, M, Santolamazza, C, Bernasconi, D, Costa, A, Oliveti, A, Puoti, F, Bottio, T, Gerosa, G, Russo, C, Giannattasio, C, Tursi, V, Livi, U, Maiello, C, Amarelli, C, Potena, L, Martin Suarez, S, Boffini, M, Pace Napoleone, C, Clemenza, F, Musumeci, F, Maccherini, M, Faggian, G, Pellegrini, C, Terzi, A, Tramontin, C, De Angelis, D, Milano, A, Valsecchi, M, Frigerio, M., Varrenti, M., Santolamazza, C., Bernasconi, D. P., Costa, A. Nanni, Oliveti, A., Puoti, F., Bottio, T., Gerosa, G., Russo, C. F., Giannattasio, C., Tursi, V., Livi, U., Maiello, C., Amarelli, C., Potena, L., Martin Suarez, S., Boffini, M., Pace Napoleone, C., Clemenza, F., Musumeci, F., Maccherini, M., Faggian, G., Pellegrini, C., Terzi, A., Tramontin, C., De Angelis, D., Milano, A. D., and Valsecchi, M.
Published: 2019

40. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3)

Author: G. L. Banna, A Cortellini, D. L. Cortinovis, M Tiseo, J.G.J.V. (Joachim) Aerts, F Barbieri, R Giusti, E Bria, F Grossi, P Pizzutilo, Rossana Berardi, A Morabito, C Genova, F Mazzoni, V Di Noia, D Signorelli, A Gelibter, M Macerelli, F Rastelli, R Chiari, D De Rocco, S Gori, M De Tursi, P Di Marino, G Mansueto, F Zoratto, M Filetti, M Montrone, F Citarella, R Marco, L. (Luca) Cantini, O Nigro, E D'Argento, S Buti, G Minuti, L Landi, G Guaitoli, G Russo, A Al-Toma, C Donisi, A Friedlaender, A De Giglio, G Metro, G Porzio, C Ficorella, A Addeo, G. L. Banna, A Cortellini, D. L. Cortinovis, M Tiseo, J.G.J.V. (Joachim) Aerts, F Barbieri, R Giusti, E Bria, F Grossi, P Pizzutilo, Rossana Berardi, A Morabito, C Genova, F Mazzoni, V Di Noia, D Signorelli, A Gelibter, M Macerelli, F Rastelli, R Chiari, D De Rocco, S Gori, M De Tursi, P Di Marino, G Mansueto, F Zoratto, M Filetti, M Montrone, F Citarella, R Marco, L. (Luca) Cantini, O Nigro, E D'Argento, S Buti, G Minuti, L Landi, G Guaitoli, G Russo, A Al-Toma, C Donisi, A Friedlaender, A De Giglio, G Metro, G Porzio, C Ficorella, and A Addeo
Published: 2021
Full Text: View/download PDF

41. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case–control matched analysis from a large multicenter study

Author: Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), Porzio, G. (Giampiero), Cortellini, A. (Alessio), De Giglio, A. (Andrea), Cannita, K. (Katia), Cortinovis, D.L. (Diego L.), Cornelissen, R. (Robin), Baldesarri, C. (Cinzia), Giusti, R. (Raffaele), D'Argento, E. (Ettore), Grossi, F. (Francesco), Santoni, M. (Matteo), Catino, A. (Annamaria), Berardi, R. (Rossana), Sforza, V. (Vincenzo), Rossi, G. (Giovanni), Antonuzzo, L. (Lorenzo), Di Noia, V. (Vincenzo), Signorelli, D. (Diego), Gelibter, A. (Alain), Occhipinti, M.A. (Mario Alberto), Follador, A. (Alessandro), Rastelli, F. (Francesca), Chiari, R. (Rita), Gravara, L.D. (Luigi Della), Inno, A. (Alessandro), De Tursi, M. (Michele), Di Marino, P. (Pietro), Mansueto, G. (Giovanni), Zoratto, F. (Federica), Filetti, M. (Marco), Montrone, M. (Michele), Citarella, F. (Fabrizio), Pensieri, M.V. (Maria Vittoria), Russano, M. (Marco), Cantini, L. (Luca), Nigro, O. (Olga), Leonetti, A. (Alessandro), Bordi, P. (Paola), Minuti, G. (Gabriele), Landi, L. (Lorenza), De Toma, A. (Alessandro), Donisi, C. (Clelia), Ricciardi, S. (Serena), Migliorino, M.R. (Maria Rita), Napoli, V.M. (Valerio Maria), Leone, G. (Gianmarco), Metro, G. (Giulio), Banna, G.L. (Giuseppe L.), Friedlaender, A. (Alex), Addeo, A. (Alfredo), Ficorella, C. (Corrado), and Porzio, G. (Giampiero)
Abstract: Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking stat
Published: 2021
Full Text: View/download PDF

42. Corrigendum to 'The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer': [ESMO Open Volume 6, Issue 2, April 2021, 100078

Author: Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.
Published: 2021

43. Vitamin D insufficiency is associated with reduced regulatory T cell frequency in food-allergic infants

Author: Neeland, MR, Tursi, AR, Perrett, KP, Saffery, R, Koplin, JJ, Nadeau, KC, Andorf, S, Neeland, MR, Tursi, AR, Perrett, KP, Saffery, R, Koplin, JJ, Nadeau, KC, and Andorf, S
Published: 2021

44. The lung immuno-oncology prognostic score (LIPS-3):a prognostic classification of patients receiving first-line pembrolizumab for PD-L1 ≥ 50% advanced non-small-cell lung cancer

Author: Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., Addeo, A., Banna, G. L., Cortellini, A., Cortinovis, D. L., Tiseo, M., Aerts, J. G.J.V., Barbieri, F., Giusti, R., Bria, E., Grossi, F., Pizzutilo, P., Berardi, R., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Macerelli, M., Rastelli, F., Chiari, R., Rocco, D., Gori, S., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Filetti, M., Montrone, M., Citarella, F., Marco, R., Cantini, L., Nigro, O., D'Argento, E., Buti, S., Minuti, G., Landi, L., Guaitoli, G., Lo Russo, G., De Toma, A., Donisi, C., Friedlaender, A., De Giglio, A., Metro, G., Porzio, G., Ficorella, C., and Addeo, A.
Abstract: Background: To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Methods: Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. Results: NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 [P < 0.001, hazard ratio (HR) 2.04], pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. Conclusions: We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC.
Published: 2021

45. A Digital Forensics Investigation of a Smart Scale IoT Ecosystem

Author: Grispos, George, Tursi, Frank, Choo, Raymond, Mahoney, William, Glisson, William Bradley, Grispos, George, Tursi, Frank, Choo, Raymond, Mahoney, William, and Glisson, William Bradley
Abstract: The introduction of Internet of Things (IoT) ecosystems into personal homes and businesses prompts the idea that such ecosystems contain residual data, which can be used as digital evidence in court proceedings. However, the forensic examination of IoT ecosystems introduces a number of investigative problems for the digital forensics community. One of these problems is the limited availability of practical processes and techniques to guide the preservation and analysis of residual data from these ecosystems. Focusing on a detailed case study of the iHealth Smart Scale ecosystem, we present an empirical demonstration of practical techniques to recover residual data from different evidence sources within a smart scale ecosystem. We also document the artifacts that can be recovered from a smart scale ecosystem, which could inform a digital (forensic) investigation. The findings in this research provides a foundation for future studies regarding the development of processes and techniques suitable for extracting and examining residual data from IoT ecosystems., Comment: Preprint version of paper accepted at the 20th IEEE International Conference on Trust, Security and Privacy in Computing and Communications (IEEE TrustCom 2021)
Published: 2021

46. Smoking status during first-line immunotherapy and chemotherapy in NSCLC patients: A case-control matched analysis from a large multicenter study

Author: Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, DL, Cornelissen, Robin, Baldesarri, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Follador, A, Rastelli, F, Chiari, R, Della Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, MV, Russano, M, Cantini, Luca, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, MR, Napoli, VM, Leone, G, Metro, G, Banna, GL, Friedlaender, A, Addeo, A, Ficorella, C, Porzio, G, Cortellini, A, De Giglio, A, Cannita, K, Cortinovis, DL, Cornelissen, Robin, Baldesarri, C, Giusti, R, D'Argento, E, Grossi, F, Santoni, M, Catino, A, Berardi, R, Sforza, V, Rossi, G, Antonuzzo, L, Di Noia, V, Signorelli, D, Gelibter, A, Occhipinti, MA, Follador, A, Rastelli, F, Chiari, R, Della Gravara, L, Inno, A, De Tursi, M, Di Marino, P, Mansueto, G, Zoratto, F, Filetti, M, Montrone, M, Citarella, F, Pensieri, MV, Russano, M, Cantini, Luca, Nigro, O, Leonetti, A, Bordi, P, Minuti, G, Landi, L, De Toma, A, Donisi, C, Ricciardi, S, Migliorino, MR, Napoli, VM, Leone, G, Metro, G, Banna, GL, Friedlaender, A, Addeo, A, Ficorella, C, and Porzio, G
Abstract: Background: Improved outcome in tobacco smoking patients with non-small cell lung cancer (NSCLC) following immunotherapy has previously been reported. However, little is known regarding this association during first-line immunotherapy in patients with high PD-L1 expression. In this study we compared clinical outcomes according to the smoking status of two large multicenter cohorts. Methods: We compared clinical outcomes according to the smoking status (never smokers vs. current/former smokers) of two retrospective multicenter cohorts of metastatic NSCLC patients, treated with first-line pembrolizumab and platinum-based chemotherapy. Results: A total of 962 NSCLC patients with PD-L1 expression ≥50% who received first-line pembrolizumab and 462 NSCLC patients who received first-line platinum-based chemotherapy were included in the study. Never smokers were confirmed to have a significantly higher risk of disease progression (hazard ratio [HR] = 1.49 [95% CI: 1.15–1.92], p = 0.0022) and death (HR = 1.38 [95% CI: 1.02–1.87], p = 0.0348) within the pembrolizumab cohort. On the contrary, a nonsignificant trend towards a reduced risk of disease progression (HR = 0.74 [95% CI: 0.52–1.05], p = 0.1003) and death (HR = 0.67 [95% CI: 0.45–1.01], p = 0.0593) were reported for never smokers within the chemotherapy cohort. After a random case–control matching, 424 patients from both cohorts were paired. Within the matched pembrolizumab cohort, never smokers had a significantly shorter progression-free survival (PFS) (HR = 1.68 [95% CI: 1.17–2.40], p = 0.0045) and a nonsignificant trend towards a shortened overall survival (OS) (HR = 1.32 [95% CI: 0.84–2.07], p = 0.2205). On the contrary, never smokers had a significantly longer PFS (HR = 0.68 [95% CI: 0.49–0.95], p = 0.0255) and OS (HR = 0.66 [95% CI: 0.45–0.97], p = 0,0356) compared to current/former smoker patients within the matched chemotherapy cohort. On pooled multivariable analysis, the interaction term between smoking s
Published: 2021

47. Inflammatory Bowel Disease Patients With Coronavirus Disease 2019: The Picture Is Taking Shape

Author: Papa, Alfredo, Lopetuso, Loris Riccardo, Tursi, A., Papa A. (ORCID:0000-0002-4186-7298), Lopetuso L. R., Papa, Alfredo, Lopetuso, Loris Riccardo, Tursi, A., Papa A. (ORCID:0000-0002-4186-7298), and Lopetuso L. R.
Abstract: We read with interest the systematic review on inflammatory bowel disease (IBD) patients with coronavirus disease 2019 (COVID-19) published by D’Amico et al.1 The authors provided a comprehensive and up-to-date picture on the epidemiologic and clinical characteristics of IBD patients affected by COVID-19. We would like to elaborate on some points covered in their review. In particular, D’Amico et al1 reported a cumulative prevalence of COVID-19 among IBD patients of 0.4%. This prevalence rate appears to be comparable with that found in the general population. Indeed, Taxonera et al2 recently reported that when these data were adjusted for age of the patients, a significantly lower standardized risk of COVID-19 was observed in patients with IBD compared with the general population (odds ratio, 0.74; 95% CI, 0.70–0.77; P < .001). We suggest that the reassuring prevalence rates of COVID-19 reported in patients with IBD largely are owing to IBD patients adhering to the preventive measures recommended by gastroenterologists. This belief also is confirmed by the absence of COVID-19 cases in 2 cohort studies of IBD patients from regions with a high prevalence of COVID-19 such as Wuhan (China) and Bergamo (Lombardy, Italy), where strict preventive measures were taken.3 , 4 The major preventive measures consisted of social distancing, hand washing, the use of personal protective equipment as recommended by the health authorities, and the creation of specific dedicated paths for patients who needed to access the hospital for the administration of biological infusion therapies.5 Obviously, similar preventive measures have been ensured for the health personnel involved in the management of these patients. Furthermore, all unnecessary visits were replaced with telemedicine. Hospitalizations and endoscopies were limited to emergencies.6 These positive results should encourage clinicians to continue diligent protection of patients with IBD, even in those countries where the pan
Published: 2021

48. Development and validation of predictive assessment of complicated diverticulitis score

Author: Covino, M., Papa, V., Tursi, A., Simeoni, B., Lopetuso, L. R., Vetrone, L. M., Franceschi, F., Rapaccini, G., Gasbarrini, A., Papa, A., Covino M. (ORCID:0000-0002-6709-2531), Papa V. (ORCID:0000-0002-3709-8924), Simeoni B., Lopetuso L. R., Vetrone L. M., Franceschi F. (ORCID:0000-0001-6266-445X), Rapaccini G. (ORCID:0000-0002-6467-857X), Gasbarrini A. (ORCID:0000-0002-7278-4823), Papa A. (ORCID:0000-0002-4186-7298), Covino, M., Papa, V., Tursi, A., Simeoni, B., Lopetuso, L. R., Vetrone, L. M., Franceschi, F., Rapaccini, G., Gasbarrini, A., Papa, A., Covino M. (ORCID:0000-0002-6709-2531), Papa V. (ORCID:0000-0002-3709-8924), Simeoni B., Lopetuso L. R., Vetrone L. M., Franceschi F. (ORCID:0000-0001-6266-445X), Rapaccini G. (ORCID:0000-0002-6467-857X), Gasbarrini A. (ORCID:0000-0002-7278-4823), and Papa A. (ORCID:0000-0002-4186-7298)
Abstract: The prevalence of acute diverticulitis (AD) has progressively increased in recent decades, with correspondingly greater morbidity and mortality. The aim of the study is to develop a predictive score to identify patients with the highest risk of complicated AD. The clinical records of 1089 patients referred to the emergency department (ED) over a five-year period were reviewed. In multivariate analysis, male sex (p < 0.001), constipation (p = 0.002), hemoglobin < 11.9 g/dL (p < 0.001), C reactive protein > 80 mg/L (p < 0.001), severe obesity (p = 0.049), and no proton pump inhibitor treatment (p = 0.003) were independently associated with complicated AD. The predictive assessment of complicated (PACO)-diverticulitis (D) score, including these six variables, was applied to the retrospective cohort and then validated prospectively in a cohort including 282 patients. It categorized patients into three risk classes for complicated AD. The PACO-D score showed fair discrimination for complicated AD with an area under the receiver operating characteristic curve of 0.674 and 0.648, in the retrospective and prospective cohorts, respectively. The PACO-D score could be a practical clinical tool to identify patients at highest risk for complicated AD referred to the ED so that appropriate diagnostic and therapeutic resources could be appropriately allocated. Further external validation is needed to confirm these results.
Published: 2021

49. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author: De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.
Abstract: Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist
Published: 2018

50. Baseline BMI and BMI variation during first line pembrolizumab in NSCLC patients with a PD-L1 expression >= 50%: a multicenter study with external validation

Author: Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., Ficorella, C., Cortellini, A., Ricciuti, B., Tiseo, M., Bria, E., Banna, G.L., Aerts, J.G.J.V. (Joachim), Barbieri, F. (Federica), Giusti, R., Cortinovis, D.L., Migliorino, M.R., Catino, A., Passiglia, F., Torniai, M., Morabito, A., Genova, C., Mazzoni, F., Di Noia, V., Signorelli, D., Gelibter, A., Occhipinti, M.A., Rastelli, F., Chiari, R., Rocco, D. (Daniela) de, Inno, A., De Tursi, M., Di Marino, P., Mansueto, G., Zoratto, F., Grossi, F., Filetti, M., Pizzutilo, P., Russano, M., Citarella, F., Cantini, L., Targato, G., Nigro, O., Ferrara, M.G., Buti, S., Scodes, S., Landi, L., Guaitoli, G., Della Gravara, L., Tabbo, F., Ricciardi, S., De Toma, A., Friedlaender, A., Petrelli, F., Addeo, A., Porzio, G., and Ficorella, C.
Abstract: Background The association between obesity and outcomes in patients receiving programmed death-1/ programmed death ligand-1 (PD-L1) checkpoint inhibitors has already been confirmed in pre-treated non-small cell lung cancer (NSCLC) patients, regardless of PD-L1 tumor expression. Methods We present the outcomes analysis according to baseline body mass index (BMI) and BMI variation in a large cohort of metastatic NSCLC patients with a PD-L1 expression ≥50%, receiving first line pembrolizumab. We also evaluated a control cohort of metastatic NSCLC patients treated with first line platinum-based chemotherapy. Normal weight was set as control group. Results 962 patients and 426 patients were included in the pembrolizumab and chemotherapy cohorts, respectively. Obese patients had a significantly higher objective response rate (ORR) (OR=1.61 (95% CI: 1.04– 2.50)) in the pembrolizumab cohort, while overweight patients had a significantly lower ORR (OR=0.59 (95% CI: 0.37–0.92)) within the chemotherapy cohort. Obese patients had a significantly longer progression-free survival (PFS) (HR=0.61 (95% CI: 0.45–0.82)) in the pembrolizumab cohort. Conversely, they had a significantly shorter PFS in the chemotherapy cohort (HR=1.27 (95% CI: 1.01–1.60)). Obese patients had a significantly longer overall survival (OS) within the pembrolizumab cohort (HR=0.70 (95% CI: 0.49–0.99)), while no significant differences according to baseline BMI were found in the chemotherapy cohort. BMI variation significantly affected ORR, PFS and OS in both the pembrolizumab and the chemotherapy cohorts. Conclusions Baseline obesity is associated to significantly improved ORR, PFS and OS in metastatic NSCLC patients with a PD-L1 expression of ≥50%, receiving first line pembrolizumab, but not among patients treated with chemotherapy. BMI variation is also significantly related to clinical outcomes.
Published: 2020
Full Text: View/download PDF

Catalog

Books, media, physical & digital resources

See catalog results

Searchworks

Select search scope, currently: Articles Catalog books, media & more in Jio Institute collections Articles journal articles & other e-resources

Search

Search Constraints

Refine your results

Search Limiters

Publication Year Range

Publication Type

Journal

Database

Publisher

241 results on '"Tursi, A."'

Search Results

Catalog

Select search scope, currently: Articles

Catalog

books, media & more in Jio Institute collections

Articles

journal articles & other e-resources