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115 results on '"De Simone, I"'

1. Survival analysis of the non-metastatic cohort of the Italian Association for Medical Oncology (AIOM) Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy (GARIBALDI)

Author

Reni, M., Milella, M., Bergamo, F., Di Marco, M., Giommoni, E., Cardellino, G.G., Cavanna, L., Bonomi, M., Zustovich, F., Bozzarelli, S., Salmaso, F., Spada, M., Orsi, G., Macchini, M., Insolda, J., Procaccio, L., Santoni, A., De Simone, I., Caldirola, L., Galli, F., and Pinto, C.

Published
2025
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2. Survival analysis of the metastatic cohort of Italian Association of Medical Oncology (AIOM) GARIBALDI survey

Author

Reni, M., Giommoni, E., Bergamo, F., Cavanna, L., Simionato, F., Spada, M., Di Marco, M., Bernardini, I., Cordio, S.S., Latiano, T., Spallanzani, A., Silvestris, N., Cardellino, G.G., Bonomi, M., Milella, M., Luchena, G., Tamburini, E., Macchini, M., Orsi, G., Modesti, M., Procaccio, L., Santoni, A., De Simone, I., Caldirola, L., Galli, F., and Pinto, C.

Published
2024
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3. Efficacy and safety of ramucirumab plus carboplatin and paclitaxel in untreated metastatic thymic carcinoma: RELEVENT phase II trial (NCT03921671)

Author

Proto, C., Ganzinelli, M., Manglaviti, S., Imbimbo, M., Galli, G., Marabese, M., Zollo, F., Alvisi, M.F., Perrino, M., Cordua, N., Borea, F., de Vincenzo, F., Chella, A., Cappelli, S., Pardini, E., Ballatore, Z., Lucarelli, A., Ambrosini, E., Giuliano, M., Pietroluongo, E., Mulargiu, C., Fabbri, A., Prelaj, A., Occhipinti, M., Brambilla, M., Mazzeo, L., Beninato, T., Vigorito, R., Ruggirello, M., Greco, F.G., Calareso, G., Miliziano, D., Rulli, E., De Simone, I., Torri, V., de Braud, F.G.M., Pasello, G., De Placido, P., Berardi, R., Petrini, I., Zucali, P., Garassino, M.C., and Lo Russo, G.

Published
2024
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4. Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey

Author

Reni, Michele, Macchini, Marina, Orsi, Giulia, Peretti, Umberto, Valente, Mariamaddalena, Giommoni, Elisa, Antonuzzo, Lorenzo, Di Costanzo, Francesco, Bergamo, Francesca, Zagonel, Vittorina, Lonardi, Sara, Buggin, Federica, Milella, Michele, Palmerio, Silvia, Cavanna, Luigi, Di Nunzio, Camilla, Di Marco, Maria Cristina, Grassi, Elisa, Spada, Massimiliano, Messina, Marco, Cordio, Stefano, Avola, Francesco, Aprile, Giuseppe, Pagano, Salvatore, Simionato, Francesca, Cardellino, Giovanni Gerardo, Majer, Federica, Maiello, Evaristo, Latiano, Tiziana Pia, Chiarazzo, Cinzia, Artioli, Fabrizio, Razzini, Giorgia, Pasqualini, Antonella, Ghidini, Michele, Binda, Elisa, Lazzarelli, Silvia, Bozzarelli, Silvia, Sala, Simona, Luppi, Gabriele, Pettorelli, Elisa, Spallanzani, Andrea, Vicario, Giovanni, Salmaso, Flavia, Basso, Marco, Silvestris, Nicola, Del Curatolo, Sabina, Zustovich, Fable, Bongiovanni, Francesca, Longobardi, Ciro, Sandi, Ilenia, Fontanella, Caterina, Montelatici, Silvia, Giordano, Monica, Luchena, Giovanna, Gilardoni, Micol, Tamburini, Emiliano, Rudnas, Britt, Venturini, Barbara, Merelli, Barbara, Negrini, Giorgia, Vici, Elio Maria, Marabese, Alessandra, Garetto, Cristina, Curcio, Paola, Cinieri, Saverio, Cinefra, Margherita, Ferrara, Pasqualinda, Cantore, Maurizio, Morselli, Patrizia, Fumi, Guglielmo, Isidori, Agnese, Ciccarese, Giovanni, Paolo Frassineti, Giovanni Luca, Pagan, Flavia, Vaccaro, Vanja, Spoto, Chiara, Ferrara, Marianna, Garufi, Carlo, Caporale, Marta, Vasile, Enrico, Salani, Francesca, Barone, Elisa, Berardi, Rossana, Onofri, Azzurra, Ballatore, Zelmira, Lucarelli, Alessandra, Barucca, Alessandra, Pancotti, Amedeo, Scipioni, Teresa, Bencardino, Katia, Marrapese, Giovanna, Idotta, Laura, Petrelli, Fausto, Lonati, Veronica, Ceribelli, Anna, Giuli, Angelo, Zannori, Cristina, Bassanelli, Maria, Mambrini, Andrea, Ginocchi, Laura, Orlandi, Massimo, Celio, Luigi, Niger, Monica, Biamonte, Lavinia, Tamberi, Stefano, Piancastelli, Alessandra, Papiani, Giorgio, Valli, Irene, Allione, Paolo, Boe, Maria Giovanna, Scartozzi, Mario, Lai, Eleonora, Pireddu, Annagrazia, Ziranu, Pina, Demurtas, Laura, Puzzoni, Marco, Mariani, Stefano, Pretta, Andrea, Liscia, Nicole, Savastano, Clementina, Malaspina, Valentina, Tonini, Giuseppe, Grassani, Teresa, Barco, Barbara, Pierosandro, Tagliaferri, Ciliberto, Domenico, Ierardi, Antonella, Calandruccio, Natale Daniele, Minotti, Vincenzo, Matocci, Roberta, Torri, Valter, Porcu, Luca, Rulli, Erica, De Simone, Irene, Carlucci, Luciano, Rulli, Eliana, Poli, Davide, Tonto, Paola, Scellato, Francesca, Pinto, Carmine, Reni, M., Giommoni, E., Bergamo, F., Milella, M., Cavanna, L., Di Marco, M.C., Spada, M., Cordio, S., Aprile, G., Cardellino, G.G., Maiello, E., Bernardini, I., Ghidini, M., Bozzarelli, S., Macchini, M., Orsi, G., De Simone, I., Rulli, Er., Porcu, L., Torri, V., and Pinto, C.

Published
2023
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5. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

Cortinovis, D., Canova, S., Colonese, F., Abbate, M.I., Sala, L., Sala, E., Perez Gila, M., Bono, F., Pagni, F., Ceresoli, G.L., D’Aveni, A., Bonomi, M., Grosso, F., De Angelis, A., Ugo, F., Belletti, M., Zucali, P.A., Perrino, M., De Vincenzo, F., Santoro, A., Gelsomino, F., Ardizzoni, A., Pasello, G., Frega, S., Mencoboni, M., Carlucci, L., De Simone, I., D’Incalci, M., Galli, F., Poli, D., Rulli, E., Torri, V., and Cortinovis, D.L.

Published
2022
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6. Assessing the mid-term impact of enhanced prostate cancer screening in Caucasian men with germline DNA repair pathogenic variants

Author

Fasulo, V., primary, Buffi, N.M., additional, Casale, P., additional, Saita, A., additional, Hurle, R., additional, Finocchiaro, A., additional, Aljoulani, M., additional, Paciotti, M., additional, Asselta, R., additional, Soldà, G., additional, De Simone, I., additional, Colombo, P., additional, Cieri, M., additional, Maura, F., additional, Cavalli, P., additional, Lughezzani, G., additional, and Lazzeri, M., additional

Published
2024
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8. PB0214 Evaluation of Innovative Laboratory Tests to Predict a Thrombotic Phenotype in a Family with Dysfibrinogenemia and a Novel FGG Mutation

Author

Monard, A., primary, Heubel-Moenen, F., additional, Castoldi, E., additional, de simone, I., additional, van der Meijden, P., additional, Wichapong, K., additional, van Doorn, W., additional, Spada, S., additional, Hellenbrand, D., additional, Stork, A., additional, ten Cate, H., additional, Beckers, E., additional, and Henskens, Y., additional

Published
2023
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9. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

Canova, S, Ceresoli, G, Grosso, F, Zucali, P, Gelsomino, F, Pasello, G, Mencoboni, M, Rulli, E, Galli, F, De Simone, I, Carlucci, L, De Angelis, A, Belletti, M, Bonomi, M, D'Aveni, A, Perrino, M, Bono, F, Cortinovis, D, Colonese, F, Abbate, M, Sala, L, Sala, E, Perez Gila, M, Pagni, F, Ugo, F, De Vincenzo, F, Santoro, A, Ardizzoni, A, Frega, S, D'Incalci, M, Poli, D, Torri, V, Canova S., Ceresoli G. L., Grosso F., Zucali P. A., Gelsomino F., Pasello G., Mencoboni M., Rulli E., Galli F., De Simone I., Carlucci L., De Angelis A., Belletti M., Bonomi M., D'Aveni A., Perrino M., Bono F., Cortinovis D. L., Cortinovis D., Colonese F., Abbate M. I., Sala L., Sala E., Perez Gila M., Pagni F., Ugo F., De Vincenzo F., Santoro A., Ardizzoni A., Frega S., D'Incalci M., Poli D., Torri V., Canova, S, Ceresoli, G, Grosso, F, Zucali, P, Gelsomino, F, Pasello, G, Mencoboni, M, Rulli, E, Galli, F, De Simone, I, Carlucci, L, De Angelis, A, Belletti, M, Bonomi, M, D'Aveni, A, Perrino, M, Bono, F, Cortinovis, D, Colonese, F, Abbate, M, Sala, L, Sala, E, Perez Gila, M, Pagni, F, Ugo, F, De Vincenzo, F, Santoro, A, Ardizzoni, A, Frega, S, D'Incalci, M, Poli, D, Torri, V, Canova S., Ceresoli G. L., Grosso F., Zucali P. A., Gelsomino F., Pasello G., Mencoboni M., Rulli E., Galli F., De Simone I., Carlucci L., De Angelis A., Belletti M., Bonomi M., D'Aveni A., Perrino M., Bono F., Cortinovis D. L., Cortinovis D., Colonese F., Abbate M. I., Sala L., Sala E., Perez Gila M., Pagni F., Ugo F., De Vincenzo F., Santoro A., Ardizzoni A., Frega S., D'Incalci M., Poli D., and Torri V.

Abstract

Background: Malignant pleural mesothelioma (MPM) is a cancer with a high mortality rate and few therapeutic options. After platinum–pemetrexed combination, no further promising drug seems to be effective. Immune checkpoint inhibitors may have some activity in pretreated patients and no data are available in this population about durvalumab. Materials and methods: DIADEM was a multicenter, open-label, single-arm, phase II trial aimed at evaluating the efficacy and safety of durvalumab. Patients with locally advanced/metastatic MPM who progressed after platinum–pemetrexed chemotherapy were enrolled to receive durvalumab (1500 mg, intravenously Q4W) for 12 months or until evidence of disease progression or unacceptable toxicity. The primary endpoint was the proportion of patients alive and free from progression at 16 weeks (PFS16wks) calculated from treatment initiation. Secondary endpoints were progression-free survival, overall survival, overall response rate, and safety. Results: Sixty-nine patients with a median age of 69 years (range 44-82 years) were enrolled; 62 patients (89.9%) had epithelioid histotype. As first-line treatment, all patients received platinum derivatives–pemetrexed combination (60.9% with carboplatin and 39.1% with cisplatin). As of March 2021, the median follow-up was 9.2 months (interquartile range 5.2-11.1 months). Six patients (8.7%) completed the 12-month treatment; 60 patients discontinued, of whom 42 for progressive disease, and 4 died. Seventeen patients (28.3%; 95% confidence interval 17.5% to 41.4%) were alive or free from progression at 16 weeks. Eleven patients (18.6%) had a grade 3 or 4 treatment-related adverse event (AE), and one (1.4%) had a grade ≥3 immune-related, treatment-related AE. There was one drug-related death. Conclusion: Durvalumab alone in pretreated non-selected MPM did not reach a meaningful clinical activity, showing any new major safety issue signals.

Published
2022

10. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

Canova, S., primary, Ceresoli, G.L., additional, Grosso, F., additional, Zucali, P.A., additional, Gelsomino, F., additional, Pasello, G., additional, Mencoboni, M., additional, Rulli, E., additional, Galli, F., additional, De Simone, I., additional, Carlucci, L., additional, De Angelis, A., additional, Belletti, M., additional, Bonomi, M., additional, D’Aveni, A., additional, Perrino, M., additional, Bono, F., additional, Cortinovis, D.L., additional, Cortinovis, D., additional, Canova, S., additional, Colonese, F., additional, Abbate, M.I., additional, Sala, L., additional, Sala, E., additional, Perez Gila, M., additional, Pagni, F., additional, Ugo, F., additional, De Vincenzo, F., additional, Santoro, A., additional, Ardizzoni, A., additional, Frega, S., additional, D’Incalci, M., additional, Poli, D., additional, and Torri, V., additional

Published
2022
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11. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Mangano, S., Tonato, M., Zucca, E., Valsecchi, M.G., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., Dell'Oro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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12. EP07.01-004 Long Survivor Epithelioid Pleural Mesotheliomas Are Characterized by Tertiary Lymphoid Structures: An Update to the MATCH Study

Author

Grosso, F., primary, Mannarino, L., additional, Paracchini, L., additional, Pezzuto, F., additional, Moracci, L., additional, Olteanu, G.-E., additional, Delfanti, S., additional, Callari, M., additional, Penpa, S., additional, Maconi, A., additional, De Simone, I., additional, Bosetti, C., additional, Allavena, P., additional, Marchini, S., additional, Calabrese, F., additional, and D'Incalci, M., additional

Published
2022
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13. High-dose ivermectin for early treatment of COVID-19 (COVER study): a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial

Author

Buonfrate D, Chesini F, Martini D, Roncaglioni MC, Ojeda Fernandez ML, Alvisi MF, De Simone I, Rulli E, Nobili A, Casalini G, Antinori S, Gobbi M, Campoli C, Deiana M, Pomari E, Lunardi G, Tessari R, and Bisoffi Z

Subjects
COVID-19, Ivermectin, Randomised controlled trial, SARS-CoV-2
Abstract

High concentrations of ivermectin demonstrated antiviral activity against SARS-CoV-2 in vitro. The aim of this study was to assess the safety and efficacy of high-dose ivermectin in reducing viral load in individuals with early SARS-CoV-2 infection. This was a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial. Participants were adults recently diagnosed with asymptomatic/oligosymptomatic SARS-CoV-2 infection. Exclusion criteria were: pregnant or lactating women; CNS disease; dialysis; severe medical condition with prognosis 10viral load reduction was 2.9 (1.6) in arm C, 2.5 (2.2) in arm B and 2.0 (2.1) in arm A, with no significant differences (P = 0.099 and 0.122 for C vs. A and B vs. A, respectively). High-dose ivermectin was safe but did not show efficacy to reduce viral load. For anonymization purpose, the dates of recruitment have been shifted of an unspecifiednumber of days. However, timeframe between follow up visits remains fixed.

Published
2022

16. Post-biopsy cell-free DNA from blood in primary prostate cancer: How to get genetics data for decision making

Author

Lazzeri, M., primary, Chiarelli, G., additional, Corbetta, M., additional, Asselta, R., additional, De Simone, I., additional, Soldà, G., additional, Duga, S., additional, Zuradelli, M., additional, Casale, P., additional, Saita, A., additional, Lughezzani, G., additional, Guazzoni, G., additional, Hurle, R., additional, Benetti, A., additional, Saitta, C., additional, Fasulo, V., additional, and Buffi, N., additional

Published
2022
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17. Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma

Author

Silvani A., De Simone I., Fregoni V., Biagioli E., Marchioni E., Caroli M., Salmaggi A., Pace A., Torri V., Gaviani P., Quaquarini E., Simonetti G., Rulli E., D'Incalci M., Poli D., Mariotti E., Caramia G., Gritti A. P., Pacchetti I., Zucchetti M., Lanza A., Basso G., Bini P., Berzero G., Diamanti L., Di Cristofori A., Manzoni A., Lanfranchi G., Ardizzoia A., Villani V., Silvani, A., De Simone, I., Fregoni, V., Biagioli, E., Marchioni, E., Caroli, M., Salmaggi, A., Pace, A., Torri, V., Gaviani, P., Quaquarini, E., Simonetti, G., Rulli, E., D'Incalci, M., Poli, D., Mariotti, E., Caramia, G., Gritti, A. P., Pacchetti, I., Zucchetti, M., Lanza, A., Basso, G., Bini, P., Berzero, G., Diamanti, L., Di Cristofori, A., Manzoni, A., Lanfranchi, G., Ardizzoia, A., Villani, V., Silvani, A, De Simone, I, Fregoni, V, Biagioli, E, Marchioni, E, Caroli, M, Salmaggi, A, Pace, A, Torri, V, Gaviani, P, Quaquarini, E, Simonetti, G, Rulli, E, D'Incalci, M, Poli, D, Mariotti, E, Caramia, G, Gritti, A, Pacchetti, I, Zucchetti, M, Lanza, A, Basso, G, Bini, P, Berzero, G, Diamanti, L, Di Cristofori, A, Manzoni, A, Lanfranchi, G, Ardizzoia, A, and Villani, V

Subjects
Oncology, Male, Cancer Research, medicine.medical_treatment, Phases of clinical research, Antineoplastic Agent, 0302 clinical medicine, Recurrence, Stage (cooking), Leukopenia, Brain Neoplasms, Middle Aged, Prognosis, Survival Rate, Bridged-Ring Compound, Neurology, 030220 oncology & carcinogenesis, Ortataxel, Female, Taxoids, medicine.symptom, Human, medicine.drug, Adult, Bridged-Ring Compounds, medicine.medical_specialty, Prognosi, Antineoplastic Agents, Taxane, Neutropenia, Follow-Up Studie, Brain Neoplasm, 03 medical and health sciences, Internal medicine, medicine, Humans, Progression-free survival, Survival rate, Aged, Chemotherapy, Temozolomide, business.industry, medicine.disease, Neurology (clinical), Neoplasm Recurrence, Local, business, Glioblastoma, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

Background and purpose: Glioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment. Methods: In this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered eligible. Patients included were treated with ortataxel 75mg/m2 i.v. every 3weeks until disease progression. The primary objective of the study was to evaluate the activity of ortataxel in terms of progression free survival (PFS) at 6months after the enrollment. PFS, overall survival at 9months after the enrollment, objective response rate, compliance and safety were evaluated as secondary endpoints. Results: Between Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients. Conclusion: Overall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time. Trial registration: This study is registered with ClinicalTrials.gov, number NCT01989884.

Published
2018

18. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., Nitti, D., Daniele, B., Mini, E., Poli, D., Santoro, A., Mosconi, S., Casaretti, R., Boni, C., Pinotti, G., Bidoli, P., Landi, L., Rosati, G., Ravaioli, A., Cantore, M., Di Fabio, F., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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19. Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma

Author

Silvani, A, De Simone, I, Fregoni, V, Biagioli, E, Marchioni, E, Caroli, M, Salmaggi, A, Pace, A, Torri, V, Gaviani, P, Quaquarini, E, Simonetti, G, Rulli, E, D'Incalci, M, Poli, D, Mariotti, E, Caramia, G, Gritti, A, Pacchetti, I, Zucchetti, M, Lanza, A, Basso, G, Bini, P, Berzero, G, Diamanti, L, Di Cristofori, A, Manzoni, A, Lanfranchi, G, Ardizzoia, A, Villani, V, Silvani A., De Simone I., Fregoni V., Biagioli E., Marchioni E., Caroli M., Salmaggi A., Pace A., Torri V., Gaviani P., Quaquarini E., Simonetti G., Rulli E., D'Incalci M., Poli D., Mariotti E., Caramia G., Gritti A. P., Pacchetti I., Zucchetti M., Lanza A., Basso G., Bini P., Berzero G., Diamanti L., Di Cristofori A., Manzoni A., Lanfranchi G., Ardizzoia A., Villani V., Silvani, A, De Simone, I, Fregoni, V, Biagioli, E, Marchioni, E, Caroli, M, Salmaggi, A, Pace, A, Torri, V, Gaviani, P, Quaquarini, E, Simonetti, G, Rulli, E, D'Incalci, M, Poli, D, Mariotti, E, Caramia, G, Gritti, A, Pacchetti, I, Zucchetti, M, Lanza, A, Basso, G, Bini, P, Berzero, G, Diamanti, L, Di Cristofori, A, Manzoni, A, Lanfranchi, G, Ardizzoia, A, Villani, V, Silvani A., De Simone I., Fregoni V., Biagioli E., Marchioni E., Caroli M., Salmaggi A., Pace A., Torri V., Gaviani P., Quaquarini E., Simonetti G., Rulli E., D'Incalci M., Poli D., Mariotti E., Caramia G., Gritti A. P., Pacchetti I., Zucchetti M., Lanza A., Basso G., Bini P., Berzero G., Diamanti L., Di Cristofori A., Manzoni A., Lanfranchi G., Ardizzoia A., and Villani V.

Abstract

Background and purpose: Glioblastoma (GBM) is the most aggressive and frequent subtype of all malignant gliomas. At the time of recurrence, therapeutic options are lacking. Ortataxel, a second-generation taxane was reported to be effective in pre-clinical and phase I clinical studies. The aim of this study was to evaluate a potential therapeutic activity of ortataxel in patients with GBM recurring after surgery and first line treatment. Methods: In this phase II study, according to a two stage design, adult patients with histologically confirmed GBM in recurrence after surgery or biopsy, standard radiotherapy and chemotherapy with temozolomide were considered eligible. Patients included were treated with ortataxel 75 mg/m2 i.v. every 3 weeks until disease progression. The primary objective of the study was to evaluate the activity of ortataxel in terms of progression free survival (PFS) at 6 months after the enrollment. PFS, overall survival at 9 months after the enrollment, objective response rate, compliance and safety were evaluated as secondary endpoints. Results: Between Nov 26, 2013 and Dec 12, 2015, 40 patients were recruited across six centres. The number of patients alive and free from progression at 6 months after the enrollment, observed in the first stage was four (11.4%), out of 35 patients included in the analysis, below the minimum number of events (7 out of 33) required to continue the study with the second stage The most important toxicities were neutropenia and hepatotoxicity that occurred in 13.2% of patients and leukopenia that occurred in 15.8% of patients. Conclusion: Overall ortataxel treatment fail to demonstrate a significant activity in recurrent GBM patients. However in a limited number of patients the drug produced a benefit that lasted for a long time. Trial registration: This study is registered with ClinicalTrials.gov, number NCT01989884

Published
2019

21. 1666P Non-metastatic cohort of the Italian Association for Medical Oncology (AIOM) guideline application in real-world: Multi-Institutional based survey of adjuvant and first-line pancreatic ductal adenocarcinoma treatment in Italy (GARIBALDI)

Author

Pinto, C., Milella, M., Bergamo, F., Di Marco, M.C., Cardellino, G.G., Cavanna, L., Giommoni, E., Zustovich, F., Bonomi, M., Bozzarelli, S., Vicario, G., Parlagreco, E., Frassineti, G.L., Macchini, M., Orsi, G., Santoni, A., Caldirola, L., De Simone, I., and Reni, M.

Published
2023
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22. Non-Operative Management Versus Total Mesorectal Excision for Locally Advanced Rectal Cancer with Clinical Complete Response After Neoadjuvant Chemoradiotherapy: a GRADE Approach by the Rectal Cancer Guidelines Writing Group of the Italian Association of Medical Oncology (AIOM)

Author

Capelli, Giovanni, De Simone, Idor, Spolverato, G., Cinquini, M., Moschetti, I., Lonardi, S., Masi, G., Carlomagno, C., Corsi, Domenico Cristiano, Luppi, Sergio Guido, Gambacorta, Maria Antonietta, Valvo, F., Cannizzaro, R., Grillo, F., Barbaro, Brunella, Restivo, Attilio, Messina, M., Pastorino, A., Aschele, C., Pucciarelli, S., Capelli G., De Simone I., Corsi D., Luppi G., Gambacorta M. A. (ORCID:0000-0001-5455-8737), Barbaro B. (ORCID:0000-0002-9638-543X), Restivo A., Capelli, Giovanni, De Simone, Idor, Spolverato, G., Cinquini, M., Moschetti, I., Lonardi, S., Masi, G., Carlomagno, C., Corsi, Domenico Cristiano, Luppi, Sergio Guido, Gambacorta, Maria Antonietta, Valvo, F., Cannizzaro, R., Grillo, F., Barbaro, Brunella, Restivo, Attilio, Messina, M., Pastorino, A., Aschele, C., Pucciarelli, S., Capelli G., De Simone I., Corsi D., Luppi G., Gambacorta M. A. (ORCID:0000-0001-5455-8737), Barbaro B. (ORCID:0000-0002-9638-543X), and Restivo A.

Abstract

Background: The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM). Methods: The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes. Results: Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low. Conclusions: NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.

Published
2020

24. P01.067 Multicenter, single arm, phase II trial on the efficacy of ortataxel in recurrent glioblastoma: the experience of the Italian Association of Neuro-Oncology

Author

Simonetti, G, primary, Silvani, A, additional, Biagioli, E, additional, Botturi, A, additional, Caroli, M, additional, de Simone, I, additional, Fregoni, V, additional, Gaviani, P, additional, Lanza, A, additional, Marchioni, E, additional, Pace, A, additional, Quaquarini, E, additional, Salmaggi, A, additional, and D’Incalci, M, additional

Published
2018
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26. Emerging effects of early environmental factors over genetic background for type 1 diabetes susceptibility: Evidence from a nationwide Italian twin study

Author

Nisticò, L, Iafusco, D, Galderisi, A, Fagnani, C, Cotichini, R, Toccaceli, V, Stazi, Ma, Study Group on Diabetes of the Italian Society of Pediatric Endocrinology, Collaborators: Cherubini V, D. i. a. b. e. t. o. l. o. g. y., Iannilli, A, Paparusso, Am, Cavallo, L, Zecchino, C, de Filippo, G, Gargantini, L, Salardi, S, Zucchini, S, Maltoni, G, Pasquino, B, Kaufmann, P, Buzi, F, Prandi, E, Gallo, F, Cicchetti, M, Castaldo, E, Citriniti, F, Chiarelli, F, Tumini, S, Di Stefano, A, Sperlì, D, De Marco, R, Banin, P, Toni, S, Lenzi, L, Del Vecchio, M, Lorini, R, D'Annunzio, G, Ingletto, D, Scaramuzza, A, Zuccotti, Gv, Chiumello, G, Meschi, F, Bonfanti, R, Frontino, G, de Luca, F, Lombardo, F, Salzano, G, Iughetti, L, Franzese, A, Buono, P, De Simone, I, Prisco, F, Cocca, A, Cadario, F, Monciotti, Cm, Savio, V, Cardella, F, Vanelli, M, Chiari, G, Errico, K, Iovane, B, Calcaterra, V, Citro, F, Cantoni, S, Marsciani, A, Cappa, M, Patera, Pi, Schiaffini, R, Sulli, N, Spoletini, M, Cerutti, Franco, Rabbone, I, Sicignano, S, Cauvin, V, Bellizzi, M, Tonini, G, Faleschini, E, Salvatoni, A, Pinelli, L, Maffeis, C, Contreas, G., Nisticò, L, Iafusco, D, Galderisi, A, Fagnani, C, Cotichini, R, Toccaceli, V, Stazi, Ma, and the Study Group on Diabetes of the Italian Society of Pediatric Endocrinology and, Diabetology

Subjects
Adult, Male, Endocrinology, Diabetes and Metabolism, Biochemistry, Endocrinology, Clinical Biochemistry, Biochemistry (medical), medicine.medical_specialty, Adolescent, Child, Child, Preschool, Diabetes Mellitus, Type 1, Environment, Female, Humans, Infant, Kaplan-Meier Estimate, Twins, Dizygotic, Twins, Monozygotic, Genetic Predisposition to Disease, type 1 diabetes, Concordance, Population, Twins, Context (language use), Monozygotic, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Dizygotic, medicine, Preschool, education, Type 1 diabetes, education.field_of_study, business.industry, medicine.disease, Twin study, Zygosity, Diabetes and Metabolism, Cohort, Environmental Exposures, business, Type 1
Abstract

Context:The incidence of type 1 diabetes has been increasing over time.Objective:We estimated the genetic and environmental components of type 1 diabetes susceptibility in a twin cohort of recent-onset cases to explore the sources of changing disease epidemiology.Design:We linked the population-based Italian Twin Registry with 14803 type 1 diabetes records from 36 pediatric diabetes care centers throughout Italy, except Sardinia, and identified 173 diabetic twins. Patients were positive for at least one autoantibody to islet cell, glutamate decarboxylase, tyrosine phosphatase, insulin, or zinc transporter 8 and were insulin dependent since their diagnosis. Zygosity was determined by DNA genotyping or by questionnaire.Outcome Measures:We estimated proband-wise concordance, cotwin recurrence risk with Kaplan-Meier method, and genetic and environmental proportions of susceptibility variance by structural equation models.Results:We recruited 104 diabetic twins (53 males) from 88 pairs (34 monozygotic, 54 dizygotic) and one triplet. The mean age at diagnosis was 8.1 yr (range 1.1-20.5 yr), and the median year of diagnosis was 2002. Proband-wise concordances were 45.5 and 16.4% in monozygotic and dizygotic pairs (P = 0.01). Recurrence risks in monozygotic and dizygotic cotwins were 37 and 12% after 10 yr from the proband's diagnosis (P = 0.005). Genetic contribution to type 1 diabetes susceptibility was 40% (95% confidence interval 8-78), and the shared and individual-specific environmental components were 51% (14-77) and 9% (4-19), respectively.Conclusions:In addition to the moderate genetic effects on type 1 diabetes susceptibility, our results draw attention to the substantial shared environmental effects, suggesting that exposures in fetal or early postnatal life may contribute to the increasing incidence of the disease.

Published
2012

27. ISTOLOGIA

Author

Caputo, G, Casali, A, Colombo, R, DE SIMONE, I, Gargiulo, G, Guidotti, L, Maraldi, N, Millo, R, Rizzotti, M, Rosati, P, Tajana, Gianfranco, Tessitote, V, and Urzi', F.

Published
2008

37. Study on Polymer-Surfactant Interactions for the Improvement of Drug Delivery Systems Wettability.

Author

De Simone, I., Coceani, N., Farra, R., Fiorentino, S. M., Grassi, G., Lapasin, R., Hasa, D., Perissutti, B., Grassi, M., and Voinovich, D.

Subjects
*DRUG delivery systems, *POLYMERS, *SURFACE active agents, *WETTING, *MECHANICAL chemistry, *NANOCRYSTALS
Abstract

One of the possible causes of failure of the mechanochemical activation of poorly soluble drugs relies on the scarce drug wettability. Indeed, the mechanochemical process comports the disposition of drug nano-crystals and amorphous drug, generated by the destruction of original drug macro-crystals, on the surface of the carrier (acting as stabiliser), usually represented by crosslinked polymeric particles. Accordingly, the scarce drug wettability can reduce the beneficial action of mechanochemical activation (nano-crystals and amorphous drug are characterised by a higher solubility with respect to the original macro-crystals). In this light, this paper is focussed on the use of surfactants for the increase of delivery system (drug plus carrier) wettability. In particular, the surfactant-polymer systems are characterised for what concerns their bulk and surface properties. This allows to select the best surfactant and to experimentally verify its effect on the release kinetics of a poorly soluble and wettable drug. [ABSTRACT FROM AUTHOR]

Published
2012

41. Final results of DIADEM, a phase II study to investigate the efficacy and safety of durvalumab in advanced pretreated malignant pleural mesothelioma

Author

S. Canova, G.L. Ceresoli, F. Grosso, P.A. Zucali, F. Gelsomino, G. Pasello, M. Mencoboni, E. Rulli, F. Galli, I. De Simone, L. Carlucci, A. De Angelis, M. Belletti, M. Bonomi, A. D’Aveni, M. Perrino, F. Bono, D.L. Cortinovis, D. Cortinovis, F. Colonese, M.I. Abbate, L. Sala, E. Sala, M. Perez Gila, F. Pagni, F. Ugo, F. De Vincenzo, A. Santoro, A. Ardizzoni, S. Frega, M. D’Incalci, D. Poli, V. Torri, Canova, S, Ceresoli, G, Grosso, F, Zucali, P, Gelsomino, F, Pasello, G, Mencoboni, M, Rulli, E, Galli, F, De Simone, I, Carlucci, L, De Angelis, A, Belletti, M, Bonomi, M, D'Aveni, A, Perrino, M, Bono, F, Cortinovis, D, Colonese, F, Abbate, M, Sala, L, Sala, E, Perez Gila, M, Pagni, F, Ugo, F, De Vincenzo, F, Santoro, A, Ardizzoni, A, Frega, S, D'Incalci, M, Poli, D, and Torri, V

Subjects
immune checkpoint inhibitors, Cancer Research, durvalumab, malignant pleural mesothelioma, second line, Oncology, immune checkpoint inhibitor
Abstract

Background: Malignant pleural mesothelioma (MPM) is a cancer with a high mortality rate and few therapeutic options. After platinum–pemetrexed combination, no further promising drug seems to be effective. Immune checkpoint inhibitors may have some activity in pretreated patients and no data are available in this population about durvalumab. Materials and methods: DIADEM was a multicenter, open-label, single-arm, phase II trial aimed at evaluating the efficacy and safety of durvalumab. Patients with locally advanced/metastatic MPM who progressed after platinum–pemetrexed chemotherapy were enrolled to receive durvalumab (1500 mg, intravenously Q4W) for 12 months or until evidence of disease progression or unacceptable toxicity. The primary endpoint was the proportion of patients alive and free from progression at 16 weeks (PFS16wks) calculated from treatment initiation. Secondary endpoints were progression-free survival, overall survival, overall response rate, and safety. Results: Sixty-nine patients with a median age of 69 years (range 44-82 years) were enrolled; 62 patients (89.9%) had epithelioid histotype. As first-line treatment, all patients received platinum derivatives–pemetrexed combination (60.9% with carboplatin and 39.1% with cisplatin). As of March 2021, the median follow-up was 9.2 months (interquartile range 5.2-11.1 months). Six patients (8.7%) completed the 12-month treatment; 60 patients discontinued, of whom 42 for progressive disease, and 4 died. Seventeen patients (28.3%; 95% confidence interval 17.5% to 41.4%) were alive or free from progression at 16 weeks. Eleven patients (18.6%) had a grade 3 or 4 treatment-related adverse event (AE), and one (1.4%) had a grade ≥3 immune-related, treatment-related AE. There was one drug-related death. Conclusion: Durvalumab alone in pretreated non-selected MPM did not reach a meaningful clinical activity, showing any new major safety issue signals.

Published
2022

42. Non-Operative Management Versus Total Mesorectal Excision for Locally Advanced Rectal Cancer with Clinical Complete Response After Neoadjuvant Chemoradiotherapy: a GRADE Approach by the Rectal Cancer Guidelines Writing Group of the Italian Association of Medical Oncology (AIOM)

Author

Domenico Corsi, Michela Cinquini, Federica Grillo, Marco Messina, Chiara Carlomagno, Renato Cannizzaro, Carlo Aschele, Angelo Restivo, Irene De Simone, Brunella Barbaro, Gianluca Masi, Alessandro Pastorino, Gabriele Luppi, Ivan Moschetti, Giulia Capelli, Maria Antonietta Gambacorta, Francesca Valvo, Salvatore Pucciarelli, Gaya Spolverato, Sara Lonardi, Capelli, G., De Simone, I., Spolverato, G., Cinquini, M., Moschetti, I., Lonardi, S., Masi, G., Carlomagno, C., Corsi, D., Luppi, G., Gambacorta, M. A., Valvo, F., Cannizzaro, R., Grillo, F., Barbaro, B., Restivo, A., Messina, M., Pastorino, A., Aschele, C., and Pucciarelli, S.

Subjects
Oncology, medicine.medical_specialty, Metanalysis, Colorectal cancer, Writing, medicine.medical_treatment, Locally advanced, Disease, Medical Oncology, Neoadjuvant chemotherapy, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Metanalysi, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, GRADE Approach, Rectal cancer, Grading (education), Neoplasm Staging, Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA, GRADE, Surgery, Rectal Neoplasms, business.industry, Gastroenterology, Colostomy, Chemoradiotherapy, medicine.disease, Total mesorectal excision, Neoadjuvant Therapy, Clinical trial, Treatment Outcome, Neoplasm Recurrence, Italy, Local, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Neoplasm Recurrence, Local, business, Neoadjuvant chemoradiotherapy
Abstract

Background: The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM). Methods: The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes. Results: Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low. Conclusions: NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.

Published
2020

43. ADPKD and metformin: from bench to bedside

Author

Antonio Pisani, Ivana Capuano, Simona Caccavallo, Eleonora Riccio, Imma De Simone, Capuano, I., Riccio, E., Caccavallo, S., De Simone, I., and Pisani, A.

Subjects
Nephrology, medicine.medical_specialty, endocrine system diseases, Physiology, business.industry, digestive, oral, and skin physiology, Disease progression, MEDLINE, nutritional and metabolic diseases, adpkd, urologic and male genital diseases, Polycystic kidney, Bench to bedside, Metformin, Physiology (medical), Internal medicine, medicine, business, Intensive care medicine, medicine.drug
Abstract

This is the frst record in the literature of the benefcial efect of metformin on ADPKD progression in the same family: during 10 years of follow-up, eGFR decreased in three sisters, but in one of them, it decreased slower after the introduction of metformin and without adverse event . Our results confrm the benefcial efect of metformin in delaying the progression of renal dysfunction in ADPKD patients with moderately impaired eGFR

Published
2019
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44. One-year glargine treatment can improve the course of lung disease in children and adolescents with cystic fibrosis and early glucose derangements

Author

Pasqualina Ferri, Valeria Raia, Gianfranco Mazzarella, Enza Mozzillo, Giuliana Valerio, Angela Sepe, Ilaria De Simone, Adriana Franzese, Mozzillo, E, Franzese, Adriana, Valerio, G, Sepe, A, De Simone, I, Mazzarella, G, Ferri, P, Raia, Valeria, Mozzillo E, 1., Franzese, A, and Ferri, G

Subjects
Lung Diseases, Spirometry, medicine.medical_specialty, Adolescent, Cystic Fibrosis, Endocrinology, Diabetes and Metabolism, Cystic fibrosis-related diabetes, Population, Insulin Glargine, Growth, Cystic fibrosis, Gastroenterology, Body Mass Index, glargine, Forced Expiratory Volume, Internal medicine, Diabetes mellitus, Glucose Intolerance, Diabetes Mellitus, Internal Medicine, Humans, Hypoglycemic Agents, Insulin, Medicine, Child, education, cystic fibrosi, Glycated Hemoglobin, Glucose tolerance test, education.field_of_study, medicine.diagnostic_test, diabetes, business.industry, Insulin glargine, Glucose Tolerance Test, medicine.disease, Insulin, Long-Acting, Treatment Outcome, Endocrinology, Hyperglycemia, Pediatrics, Perinatology and Child Health, business, Body mass index, medicine.drug
Abstract

Background: Diabetes increases morbidity and mortality in cystic fibrosis (CF) patients, but several studies indicate that also prediabetic status may have a potential impact on both nutrition and lung function. Objective: To evaluate the effect of glargine on the clinical course in CF patients with early glucose derangements. Methods: CF population was screened for glucose tolerance. CF patients with age >10 yr were screened with fasting hyperglycemia (FH). CF patients with age >10 yr without FH and those with age

Published
2009

45. Fibrin film on clots is increased by hematocrit but reduced by inflammation: implications for platelets and fibrinolysis.

Author

Alkarithi G, Duval C, McPherson HR, Stewart L, De Simone I, Macrae FL, and Ariëns RAS

Abstract

Background: Blood clot formation, triggered by vascular injury, is crucial for hemostasis and thrombosis. Blood clots are composed mainly of fibrin fibers, platelets, and red blood cells (RBCs). Recent studies show that clot surfaces also develop a fibrin film, which provides protection against wound infection and retains components such as RBCs within the clot. However, the role of fibrin films in thrombi remains poorly understood., Objectives: To explore the relationship between fibrin films and inflammation, RBC concentration, platelets, and fibrinolysis activity., Methods: We used laser scanning confocal and scanning electron microscopy, enzyme-linked immunosorbent assay, and turbidity and fibrinolysis assays to investigate the interactions between fibrin film and inflamed endothelium, RBCs, platelets, and fibrinolysis., Results: We found that plasma clots forming on top of inflamed endothelial cells show less fibrin film coverage and are characterized by higher fiber density and shorter lag time compared with control cells. Blood clots formed under conditions of high hematocrit showed significantly more fibrin film coverage than low hematocrit clots. We found that platelet adhesion was significantly reduced on clots with film compared with clots without film even when platelets were preactivated. Fibrinolysis was faster in clots without film than in clots with film, partly due to reductions in plasmin generation., Conclusion: Our findings indicate that reductions in fibrin film formation under thromboinflammatory conditions support continued clot growth through effects on increased platelet adhesion and activation. On the other hand, increased fibrin film impairs fibrinolysis. These data show a multifaceted role of the fibrin film in clot growth and stability., Competing Interests: Declaration of competing interests There are no competing interests to disclose., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2025
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46. Case Report: Laboratory detection of a thrombotic tendency in a family with hypodysfibrinogenemia and a novel FGG mutation.

Author

Monard A, Castoldi E, De Simone I, Wichapong K, van Duijl T, van den Biggelaar M, Spada S, van Doorn W, Hellenbrand D, van der Meijden P, Swieringa F, Stork A, Ten Cate H, Beckers E, Heubel-Moenen F, and Henskens Y

Abstract

Introduction: Hypodysfibrinogenemia is a rare congenital fibrinogen disorder (CFD) which may induce thrombotic and bleeding events. Therefore, patient management needs careful evaluation. Routine coagulation tests are inadequate to predict the clinical phenotype., Clinical Findings: A 60-year-old woman with both bleeding and thrombotic complications and her two daughters were referred to our center for genotypic and phenotypic analysis of a CFD., Diagnosis: Conventional laboratory results led to the diagnosis of hypodysfibrinogenemia in all three subjects. They all carried the same heterozygous c.1124A>G mutation in FGG resulting in p.Tyr375Cys amino acid substitution, which was confirmed by protein variant analysis from plasma. In silico structure analysis predicted possible conformational and functional changes of the fibrinogen molecule. Thrombin generation indicated a hypercoagulable state confirmed by microfluidics that showed enhanced fibrin formation in both daughters, regardless of the coagulation trigger., Conclusion: We report on a family with hypodysfibrinogenemia and a novel FGG heterozygous missense mutation, possibly leading to conformational changes or covalent dimerization. Thrombin generation and particularly microfluidic measurements disclosed a hypercoagulable state, which was not detected with routine coagulation tests, justifying a different patient management., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Monard, Castoldi, De Simone, Wichapong, van Duijl, van den Biggelaar, Spada, van Doorn, Hellenbrand, van der Meijden, Swieringa, Stork, ten Cate, Beckers, Heubel-Moenen and Henskens.)

Published
2024
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47. Platelet Activation Pathways Controlling Reversible Integrin αIIbβ3 Activation.

Author

Zou J, Sun S, De Simone I, Ten Cate H, de Groot PG, de Laat B, Roest M, Heemskerk JWM, and Swieringa F

Abstract

Background  Agonist-induced platelet activation, with the integrin αIIbβ3 conformational change, is required for fibrinogen binding. This is considered reversible under specific conditions, allowing a second phase of platelet aggregation. The signaling pathways that differentiate between a permanent or transient activation state of platelets are poorly elucidated. Objective  To explore platelet signaling mechanisms induced by the collagen receptor glycoprotein VI (GPVI) or by protease-activated receptors (PAR) for thrombin that regulate time-dependent αIIbβ3 activation. Methods  Platelets were activated with collagen-related peptide (CRP, stimulating GPVI), thrombin receptor-activating peptides, or thrombin (stimulating PAR1 and/or 4). Integrin αIIbβ3 activation and P-selectin expression was assessed by two-color flow cytometry. Signaling pathway inhibitors were applied before or after agonist addition. Reversibility of platelet spreading was studied by microscopy. Results  Platelet pretreatment with pharmacological inhibitors decreased GPVI- and PAR-induced integrin αIIbβ3 activation and P-selectin expression in the target order of protein kinase C (PKC) > glycogen synthase kinase 3 > β-arrestin > phosphatidylinositol-3-kinase. Posttreatment revealed secondary αIIbβ3 inactivation (not P-selectin expression), in the same order, but this reversibility was confined to CRP and PAR1 agonist. Combined inhibition of conventional and novel PKC isoforms was most effective for integrin closure. Pre- and posttreatment with ticagrelor, blocking the P2Y 12 adenosine diphosphate (ADP) receptor, enhanced αIIbβ3 inactivation. Spreading assays showed that PKC or P2Y 12 inhibition provoked a partial conversion from filopodia to a more discoid platelet shape. Conclusion  PKC and autocrine ADP signaling contribute to persistent integrin αIIbβ3 activation in the order of PAR1/GPVI > PAR4 stimulation and hence to stabilized platelet aggregation. These findings are relevant for optimization of effective antiplatelet treatment., Competing Interests: Conflict of Interest None declared., (The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. ( https://creativecommons.org/licenses/by/4.0/ ).)

Published
2024
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48. Nivolumab in pretreated pleural mesothelioma: Results from an observational real-world study of patients treated within the AIFA 5% Fund.

Author

Cerbone L, Delfanti S, Crivellari S, De Angelis AM, Mazzeo L, Proto C, Occhipinti M, Lo Russo G, Dellepiane C, Biello F, Alabiso I, Verderame F, Gauna R, De Simone I, Cuppone F, Petraglia S, Pasello G, Ceresoli GL, Garassino MC, Torri V, and Grosso F

Subjects
Humans, Male, Female, Aged, Middle Aged, Retrospective Studies, Aged, 80 and over, Antineoplastic Agents, Immunological therapeutic use, Mesothelioma, Malignant drug therapy, Adult, Prognosis, Immune Checkpoint Inhibitors therapeutic use, Treatment Outcome, Italy, Progression-Free Survival, Nivolumab therapeutic use, Pleural Neoplasms drug therapy, Pleural Neoplasms mortality, Mesothelioma drug therapy, Mesothelioma mortality, Mesothelioma pathology
Abstract

Background: Pleural mesothelioma is a rare cancer with a dismal prognosis and few therapeutic options, especially in the pretreated setting. Immunotherapy with checkpoint inhibitors as single agents yielded interesting results in refractory pleural mesothelioma, achieving a response rate between 10-20%, median progression-free survival of 2-5 months and median overall survival of 7-13 months., Patients and Methods: A retrospective, multi-institutional study of pleural mesothelioma patients treated with nivolumab in second and further line was performed. The endpoints of the study are response rate, disease control rate, progression free survival and overall survival., Results: Sixty-five patients with pleural mesothelioma treated with nivolumab in second and further line were enrolled at seven Italian institutions. The response rate was 8%, disease control rate was 37%, median progression free survival was 5.7 months (95% CI: 2.9-9.0) and median overall survival was 11.1 (95% CI 6.2-19.9) months. A higher neutrophils and neutrophils to lymphocytes ratio at baseline were associated with worse prognosis., Conclusion: Nivolumab as a single agent is fairly active in a cohort of unselected pretreated pleural mesothelioma patients. Further investigations on clinical and translational factors are needed to define which patient might benefit most from nivolumab treatment in pleural mesothelioma., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Published
2024
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49. Neoadjuvant Systemic Therapy in Early Breast Cancer: Results of a Prospective Observational Multicenter BRIDE Study.

Author

Gori S, Fabi A, Angiolini C, Turazza M, Salvini P, Ferretti G, Cretella E, Gianni L, Bighin C, Toss A, Zamagni C, Vici P, De Rossi C, Russo A, Bisagni G, Frassoldati A, Borgato L, Cariello A, Cappelletti C, Bordonaro R, Cinieri S, Modena A, Valerio M, Alvisi MF, De Simone I, Galli F, Rulli E, Santoni A, and Nicolis F

Abstract

To evaluate the rate of early breast cancer (EBC) patients treated with neoadjuvant systemic therapy (NAT) in Italy, criteria of patient selection and types of therapies delivered, an analysis of 1276 patients with stage I-II-III was conducted out of 1633 patients enrolled in the multicenter prospective observational BRIDE study. A total of 177 patients (13.9%) were treated with NAT and 1099 (85.9%) with surgery; in multivariate analysis, menopausal status, cT, cN, grade, HER2-positive and Triple negative (TN) subgroups were significantly associated with the decision to administer NAT. The type of NAT delivered was influenced by EBC subtype. NAT was administered to 53.2% of HER2+/HR-negative, 27.9% of HER2+/HR+, 7.1% of HER2-negative/HR+ and 30.3% of TN EBC patients. The pCR rates were similar to the ones reported in the literature: 74.2% in HER2+/HR-negative, 52.3% in HER2+/HR+, 17.2% in HER2-negative/HR+ and 37.9% in TN. In clinical practice, patient and tumor characteristics influenced oncologists in the decision to administer NAT in EBC and in the choice of the type of systemic therapy, according to ESMO and AIOM Guidelines. Currently, it is recommended always to evaluate the use of NAT in EBC, mainly in HER2+ and TN patients, considering that pCR is associated with significantly better survival of the patient and that effective therapies are now available for residual disease.

Published
2023
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50. Regulation of Glycoprotein VI-Dependent Platelet Activation and Thrombus Formation by Heparan Sulfate Proteoglycan Perlecan.

Author

Provenzale I, De Simone I, Gibbins JM, Heemskerk JWM, van der Meijden PEJ, and Jones CI

Subjects
Humans, Extracellular Matrix Proteins, Platelet Adhesiveness, Heparan Sulfate Proteoglycans, Thrombosis
Abstract

Proteoglycans form a heterogeneous family of proteins with covalently bound sulfated glycosaminoglycans. The extracellular matrix proteoglycan perlecan has been proposed to bind to the platelet- and megakaryocyte-specific receptor G6bB, co-regulating platelet glycoprotein VI (GPVI) signaling. The derived non-sulfate proteoglycan endorepellin was previously shown to enhance platelet adhesion via the collagen receptor, integrin α2β1. Here, we compared the roles of perlecan and other matrix proteoglycans in platelet responses and thrombus formation. We used multi-color flow cytometry to measure the degranulation and integrin αIIbβ3 activation of washed platelets in response to various proteoglycans and collagen-related peptide (CRP), the GPVI agonist. Perlecan, but not endorepellin, enhanced the CRP-induced activation of platelets in a time- and concentration-dependent manner. Similar to collagen, immobilized perlecan, but not other proteoglycans, supported static platelet adhesion and spreading. In-flowed whole-blood perlecan diminished shear-dependent platelet adhesion, while it enforced GPVI-dependent thrombus formation-to a larger extent than endorepellin-to induce more contracted aggregates of activated platelets. We concluded that the sulfated proteoglycan perlecan enhances GPVI-dependent platelet responses extending to thrombus formation, but it does so at the expense of reduced adhesion of platelets under flow.

Published
2023
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