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583 results on '"Gion, M"'

1. Trastuzumab deruxtecan in patients with previously treated HER2-low advanced breast cancer and active brain metastases: the DEBBRAH trial

Author

Vaz Batista, M., Pérez-García, J.M., Cortez, P., Garrigós, L., Fernández-Abad, M., Gion, M., Martínez-Bueno, A., Saavedra, C., Teruel, I., Fernandez-Ortega, A., Servitja, S., Ruiz-Borrego, M., de la Haba-Rodríguez, J., Martrat, G., Pérez-Escuredo, J., Alcalá-López, D., Sampayo-Cordero, M., Braga, S., Cortés, J., and Llombart-Cussac, A.

Published
2024
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2. Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015–04 (PANGEA-Breast) study

Author

de la Cruz-Merino, L., Gion, M., Cruz, J., Alonso-Romero, JL., Quiroga, V., Moreno, F., Andrés, R., Santisteban, M., Ramos, M., Holgado, E., Cortés, J., López-Miranda, E., Cortés, A., Henao, F., Palazón-Carrión, N., Rodriguez, L. M., Ceballos, I., Soto, A., Puertes, A., Casas, M., Benito, S., Chiesa, M., Bezares, S., Caballero, R., Jiménez-Cortegana, C., Sánchez-Margalet, V., and Rojo, F.

Published
2022
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3. Use of Routine Health Datasets to Assess the Appropriateness of Diagnostic Tests in the Follow-Up of Breast Cancer Patients: A Population-Based Study on 3930 Patients

Author

Gion M, Cardinali G, Guzzinati S, Morandi P, Trevisiol C, Fabricio ASC, Rugge M, and Zorzi M

Subjects
tumour markers, imaging exams, adherence to guidelines, routinely-collected health data, Public aspects of medicine, RA1-1270
Abstract

Massimo Gion,1 Giulia Cardinali,2 Stefano Guzzinati,3 Paolo Morandi,4 Chiara Trevisiol,5 Aline SC Fabricio,5 Massimo Rugge,3,6 Manuel Zorzi3 1Regional Center for Biomarkers, Department of Clinical Pathology, Azienda ULSS 3 Serenissima, Venice, Italy; 2Management Control Unit, Azienda ULSS 3 Serenissima, Venice, Italy; 3Veneto Tumour Registry, Azienda Zero, Padua, Italy; 4Medical Oncology Unit, Azienda ULSS 3 Serenissima, Venice, Italy; 5Veneto Institute of Oncology IOV - IRCCS, Padua, Italy; 6University of Padova, Department of Medicine DIMED, Padua, ItalyCorrespondence: Massimo Gion, Regional Center for Biomarkers, Department of Clinical Pathology, Azienda ULSS 3 Serenissima, Ospedale SS. Giovanni e Paolo – Castello, Venezia, 6777 – 30122, Italy, Tel +39 041 5294260, Fax +39 041 5295603, Email massimo.gion@aulss3.veneto.itPurpose: Clinical practice guidelines (CPGs) recommend against intensive follow-up in asymptomatic women with breast cancer (BC). The present study assessed the adherence to CPGs of diagnostic tests ordering during BC follow-up by exploring routinely collected health data through an algorithm developed to distinguish patients according to their status at follow-up.Patients and Methods: A retrospective population-based cohort study was performed monitoring the diagnostic tests ordered during 5 years of follow-up in all BC cases incident in 2013 in the Veneto Region, Italy. Data were extracted from the Veneto Tumour Registry, the Hospital Discharge Records and the Outpatients’ Records of Diagnostic and Therapeutic Procedures. The algorithm was developed using information on infusion of anticancer agents, imaging exams ordered, and death.Results: The algorithm classified patients by status at follow-up in four groups: (i) probably no-evidence-of-disease (NED), (ii) suspicious signs of relapse not confirmed, (iii) increased risk of relapse and (iv) advanced disease at presentation or progressive disease. A total of 3930 consecutive incident cases were followed-up for 5 years, corresponding to 17,184 person-years, 15,345 of which pertaining to NED cases. In NED cases, 32,900 tumour markers and 15,858 imaging exams were ordered. Liver ultrasonography and chest radiography were most frequently ordered.Conclusion: In contrast with recommendations of CPGs, a substantial overordering of tumour markers and imaging exams occurred in NED BC patients. The developed algorithm can be repeatedly applied to routine health datasets for regular monitoring of the adherence to CPGs and of the impact of interventions to improve appropriateness.Keywords: tumour markers, imaging exams, adherence to guidelines, routinely collected health data

Published
2022

4. Implementation of preventive and predictive BRCA testing in patients with breast, ovarian, pancreatic, and prostate cancer: a position paper of Italian Scientific Societies

Author

Russo, A, Incorvaia, L, Capoluongo, E, Tagliaferri, P, Gori, S, Cortesi, L, Genuardi, M, Turchetti, D, De Giorgi, U, Di Maio, M, Barberis, M, Dessena, M, Del Re, M, Lapini, A, Luchini, C, Jereczek-Fossa, B, Sapino, A, Cinieri, S, Beretta, G, Bella, M, Bracarda, S, Colombo, N, Conteduca, V, Del Mastro, L, Galvano, A, Gristina, V, Guarneri, V, La Verde, N, Lorusso, D, Marchetti, P, Normanno, N, Ottini, L, Pensabene, M, Pignata, S, Procopio, G, Ricevuto, E, Silvestris, N, Tassone, P, Tucci, M, Donato, V, Carrara, S, Paiella, S, Gentilini, O, Gunelli, R, Nicolis, F, Buttitta, F, Colecchia, M, Fassan, M, Malapelle, U, Marchetti, A, Marchio, C, Scarpa, A, Truini, M, Zamboni, G, Gion, M, Trevisiol, C, Gronchi, A, Danesi, R, Di Marco, V, Carrera, P, Ghiorzo, P, Pasini, B, Varesco, L, Artibani, W, Ludovico, G, Campanella, O, Vatrano, S, Tagliafico, E, Russo A., Incorvaia L., Capoluongo E., Tagliaferri P., Gori S., Cortesi L., Genuardi M., Turchetti D., De Giorgi U., Di Maio M., Barberis M., Dessena M., Del Re M., Lapini A., Luchini C., Jereczek-Fossa B. A., Sapino A., Cinieri S., Beretta G., Bella M. A., Bracarda S., Colombo N., Conteduca V., Del Mastro L., Galvano A., Gristina V., Guarneri V., La Verde N., Lorusso D., Marchetti P., Normanno N., Ottini L., Pensabene M., Pignata S., Procopio G., Ricevuto E., Silvestris N., Tassone P., Tucci M., Donato V., Carrara S., Paiella S., Gentilini O., Gunelli R., Nicolis F., Buttitta F., Colecchia M., Fassan M., Malapelle U., Marchetti A., Marchio C., Scarpa A., Truini M., Zamboni G., Gion M., Trevisiol C., Gronchi A., Danesi R., Di Marco V., Carrera P., Ghiorzo P., Pasini B., Varesco L., Artibani W., Ludovico G., Campanella O., Vatrano S., Tagliafico E., Russo, A, Incorvaia, L, Capoluongo, E, Tagliaferri, P, Gori, S, Cortesi, L, Genuardi, M, Turchetti, D, De Giorgi, U, Di Maio, M, Barberis, M, Dessena, M, Del Re, M, Lapini, A, Luchini, C, Jereczek-Fossa, B, Sapino, A, Cinieri, S, Beretta, G, Bella, M, Bracarda, S, Colombo, N, Conteduca, V, Del Mastro, L, Galvano, A, Gristina, V, Guarneri, V, La Verde, N, Lorusso, D, Marchetti, P, Normanno, N, Ottini, L, Pensabene, M, Pignata, S, Procopio, G, Ricevuto, E, Silvestris, N, Tassone, P, Tucci, M, Donato, V, Carrara, S, Paiella, S, Gentilini, O, Gunelli, R, Nicolis, F, Buttitta, F, Colecchia, M, Fassan, M, Malapelle, U, Marchetti, A, Marchio, C, Scarpa, A, Truini, M, Zamboni, G, Gion, M, Trevisiol, C, Gronchi, A, Danesi, R, Di Marco, V, Carrera, P, Ghiorzo, P, Pasini, B, Varesco, L, Artibani, W, Ludovico, G, Campanella, O, Vatrano, S, Tagliafico, E, Russo A., Incorvaia L., Capoluongo E., Tagliaferri P., Gori S., Cortesi L., Genuardi M., Turchetti D., De Giorgi U., Di Maio M., Barberis M., Dessena M., Del Re M., Lapini A., Luchini C., Jereczek-Fossa B. A., Sapino A., Cinieri S., Beretta G., Bella M. A., Bracarda S., Colombo N., Conteduca V., Del Mastro L., Galvano A., Gristina V., Guarneri V., La Verde N., Lorusso D., Marchetti P., Normanno N., Ottini L., Pensabene M., Pignata S., Procopio G., Ricevuto E., Silvestris N., Tassone P., Tucci M., Donato V., Carrara S., Paiella S., Gentilini O., Gunelli R., Nicolis F., Buttitta F., Colecchia M., Fassan M., Malapelle U., Marchetti A., Marchio C., Scarpa A., Truini M., Zamboni G., Gion M., Trevisiol C., Gronchi A., Danesi R., Di Marco V., Carrera P., Ghiorzo P., Pasini B., Varesco L., Artibani W., Ludovico G., Campanella O., Vatrano S., and Tagliafico E.

Abstract

Constitutional BRCA1/BRCA2 pathogenic or likely pathogenic variants (PVs) are associated with an increased risk for developing breast and ovarian cancers. Current evidence indicates that BRCA1/2 PVs are also associated with pancreatic cancer, and that BRCA2 PVs are associated with prostate cancer risk. The identification of carriers of constitutional PVs in the BRCA1/2 genes allows the implementation of individual and family prevention pathways, through validated screening programs and risk-reducing strategies. According to the relevant and increasing therapeutic predictive implications, the inclusion of BRCA testing in the routine management of patients with breast, ovarian, pancreatic and prostate cancers represent a key requirement to optimize medical or surgical therapeutic and prevention decision-making, and access to specific anticancer therapies. Therefore, accurate patient selection, the use of standardized and harmonized procedures, and adherence to homogeneous testing criteria, are essential elements to implement BRCA testing in clinical practice. This consensus position paper has been developed and approved by a multidisciplinary Expert Panel of 64 professionals on behalf of the AIOM–AIRO–AISP–ANISC–AURO–Fondazione AIOM–SIAPEC/IAP–SIBioC–SICO–SIF–SIGE–SIGU–SIU–SIURO–UROP Italian Scientific Societies, and a patient association (aBRCAdaBRA Onlus). The working group included medical, surgical and radiation oncologists, medical and molecular geneticists, clinical molecular biologists, surgical and molecular pathologists, organ specialists such as gynecologists, gastroenterologists and urologists, and pharmacologists. The manuscript is based on the expert consensus and reports the best available evidence, according to the current eligibility criteria for BRCA testing and counseling, it also harmonizes with current Italian National Guidelines and Clinical Recommendations.

Published
2022

5. Language production impairments in patients with a first episode of psychosis

Author

Gargano, G, Caletti, E, Perlini, C, Turtulici, N, Bellani, M, Bonivento, C, Garzitto, M, Siri, F, Longo, C, Bonetto, C, Cristofalo, D, Scocco, P, Semrov, E, Preti, A, Lazzarotto, L, Gardellin, F, Lasalvia, A, Ruggeri, M, Marini, A, Brambilla, P, Bertani, M, Bissoli, S, De Santi, K, Lunardi, S, Negretto, V, Poli, S, Tosato, S, Zamboni, M, Ballarin, M, De Girolamo, G, Fioritti, A, Neri, G, Pileggi, F, Rucci, P, Chiavetto, L, Scasselatti, C, Zanardini, R, Bertoldo, A, Marinelli, V, Rambaldelli, G, Bardella, S, Lamonaca, D, Lunardon, M, Magnabosco, R, Martucci, M, Nicolau, S, Nifosi, F, Pavanati, M, Rossi, M, Piazza, C, Piccione, G, Sala, A, Sale, A, Stefani, B, Zotos, S, Balbo, M, Boggian, I, Ceccato, E, Dall'Agnola, R, Girotto, B, Goss, C, Leoni, R, Mai, A, Pasqualini, A, Roccato, S, Rossi, A, Strizzolo, S, Urbani, A, Aldi, F, Bianchi, B, Cappellari, P, Conti, R, De Battisti, L, Lazzarin, E, Merlin, S, Migliorini, G, Pozzan, T, Sarto, L, Visona, S, Brazzoli, A, Campi, A, Carmagnani, R, Giambelli, S, Gianella, A, Lunardi, L, Madaghiele, D, Maestrelli, P, Paiola, L, Posteri, E, Viola, L, Zamberlan, V, Zenari, M, Zanoni, M, Bonadonna, G, Bonomo, M, Santonastaso, P, Cremonese, C, Veronese, A, Anderle, P, Angelozzi, A, Baron, I, Candeago, E, Castelli, F, Chieco, M, Di Costanzo, E, Derossi, M, Doriguzzi, M, Galvano, O, Lattanzi, M, Lezzi, R, Marcato, M, Marcolin, A, Marini, F, Matranga, M, Scalabrin, D, Zucchetto, M, Zadro, F, Austoni, G, Bianco, M, Bordino, F, Dario, F, De Risio, A, Gatto, A, Grana, S, Favero, E, Franceschini, A, Friederici, S, Marangon, V, Pascolo, M, Ramon, L, Zambolin, S, Riolo, R, Buffon, A, Di Bortolo, E, Fortin, S, Matarrese, F, Mogni, S, Codemo, N, Russi, A, Silvestro, A, Turella, E, Viel, P, Dominoni, A, Andreose, L, Boemio, M, Bressan, L, Cabbia, A, Canesso, E, Cian, R, Dal Piccol, C, Pasqua, M, Di Prisco, A, Mantellato, L, Luison, M, Morgante, S, Santi, M, Sacillotto, M, Scabbio, M, Sponga, P, Sguotto, M, Stach, F, Vettorato, M, Martinello, G, Dassie, F, Marino, S, Cibiniel, L, Masetto, I, Cabianca, O, Valente, A, Caberlotto, L, Passoni, A, Flumian, P, Daniel, L, Gion, M, Stanziale, S, Alborino, F, Bortolozzo, V, Bacelle, L, Bicciato, L, Basso, D, Navaglia, F, Manoni, F, Ercolin, M, Giubilini, F, Imbesi, M, Leuci, E, Mazzi, F, Anelli, S, Amore, M, Bigi, L, Britta, W, Anna, G, Bonatti, U, Borziani, M, Crosato, S, Fabris, I, Galluccio, R, Galeotti, M, Gozzi, M, Greco, V, Guagnini, E, Pagani, S, Maccherozzi, S, Malvasi, R, Marchi, F, Melato, E, Mazzucchi, E, Marzullo, F, Pellegrini, P, Petrolini, N, Volta, P, Bonara, F, Brusamonti, E, Croci, R, Flamia, I, Fontana, F, Losi, R, Marchioro, R, Raffaini, L, Ruju, L, Saginario, A, Tondelli, M, Marrama, D, Bernardelli, L, Bonacini, F, Florindo, A, Merli, M, Nappo, P, Sola, L, Tondelli, O, Tonna, M, Torre, M, Tosatti, M, Venturelli, G, Zampolla, D, Bernardi, A, Cavalli, C, Cigala, L, Ciraudo, C, Di Bari, A, Ferri, L, Gombi, F, Leurini, S, Mandatelli, E, Maccaferri, S, Oroboncoide, M, Pisa, B, Ricci, C, Poggi, E, Zurlini, C, Malpeli, M, Colla, R, Teodori, E, Vecchia, L, D'Andrea, R, Trenti, T, Paolini, P, Carpeggiani, P, Ghigi, D, Gagliostro, M, Pratelli, M, Antonelli, A, Battistini, L, Bellini, F, Bonini, E, Capelli, C, Didomizio, C, Drei, C, Fucci, G, Gualandi, A, Grazia, M, Losi, A, Mazzoni, F, Marangoni, D, Monna, G, Morselli, M, Oggioni, A, Oprandi, S, Paganelli, W, Passerini, M, Piscitelli, M, Reggiani, G, Rossi, G, Salvatori, F, Trasforini, S, Uslenghi, C, Veggetti, S, Bartolucci, G, Baruffa, R, Bertelli, R, Borghi, L, Ciavarella, P, Paltrinieri, E, Rizzardi, F, Serra, P, Suzzi, D, Arienti, P, Aureli, F, Avanzi, R, Callegari, V, Corsino, A, Host, P, Michetti, R, Rizzo, F, Simoncelli, P, Soldati, E, Succi, E, Bertozzi, M, Canetti, E, Cavicchioli, L, Ceccarelli, E, Cenni, S, Marzola, G, Gallina, V, Leoni, C, Olivieri, A, Piccolo, E, Ravagli, S, Russo, R, Tedeschini, D, Verenini, M, Abram, W, Granata, V, Curcio, A, Guerra, G, Granini, S, Natali, L, Montanari, E, Pasi, F, Ventura, U, Valenti, S, Francesca, M, Farneti, R, Ravagli, P, Floris, R, Maroncelli, O, Volpones, G, Casali, D, Miceli, M, Bencini, A, Cellini, M, De Biase, L, Barbara, L, Charles, L, Pratesi, C, Tanini, A, Loparrino, R, Ulivelli, C, Cussoto, C, Dei, N, Fumanti, E, Pantani, M, Zeloni, G, Bellini, R, Cellesi, R, Dorigo, N, Gulli, P, Ialeggio, L, Pisanu, M, Rinaldi, G, Konze, A, Cocchi, A, Meneghelli, A, Frova, M, Monzani, E, Zanobio, A, Malagoli, M, Pagani, R, Barbera, S, Morganti, C, Amade, E, Brambilla, V, Montanari, A, Caterina, G, Lopez, C, Marocchi, A, Moletta, A, Sberna, M, Cascio, M, Scarone, S, Gargano G., Caletti E., Perlini C., Turtulici N., Bellani M., Bonivento C., Garzitto M., Siri F. M., Longo C., Bonetto C., Cristofalo D., Scocco P., Semrov E., Preti A., Lazzarotto L., Gardellin F., Lasalvia A., Ruggeri M., Marini A., Brambilla P., Bertani M. E., Bissoli S., De Santi K., Lunardi S., Negretto V., Poli S., Tosato S., Zamboni M. G., Ballarin M., De Girolamo G., Fioritti A., Neri G., Pileggi F., Rucci P., Chiavetto L. B., Scasselatti C., Zanardini R., Bertoldo A., Marinelli V., Rambaldelli G., Bardella S., Lamonaca D., Lunardon M., Magnabosco R., Martucci M., Nicolau S., Nifosi F., Pavanati M., Rossi M., Piazza C., Piccione G., Sala A., Sale A., Stefani B., Zotos S., Balbo M., Boggian I., Ceccato E., Dall'Agnola R., Girotto B., Goss C., Leoni R., Mai A., Pasqualini A., Roccato S., Rossi A., Strizzolo S., Urbani A., Aldi F., Bianchi B., Cappellari P., Conti R., De Battisti L., Lazzarin E., Merlin S., Migliorini G., Pozzan T., Sarto L., Visona S., Brazzoli A., Campi A., Carmagnani R., Giambelli S., Gianella A., Lunardi L., Madaghiele D., Maestrelli P., Paiola L., Posteri E., Viola L., Zamberlan V., Zenari M., Zanoni M., Bonadonna G., Bonomo M., Santonastaso P., Cremonese C., Veronese A., Anderle P., Angelozzi A., Baron I. A. G., Candeago E. B. F., Castelli F., Chieco M., Di Costanzo E., Derossi M., Doriguzzi M., Galvano O., Lattanzi M., Lezzi R., Marcato M., Marcolin A., Marini F., Matranga M., Scalabrin D., Zucchetto M., Zadro F., Austoni G., Bianco M., Bordino F., Dario F., De Risio A., Gatto A., Grana S., Favero E., Franceschini A., Friederici S., Marangon V., Pascolo M., Ramon L., Zambolin S., Riolo R., Buffon A., Di Bortolo E., Fortin S., Matarrese F., Mogni S., Codemo N., Russi A., Silvestro A., Turella E., Viel P., Dominoni A., Andreose L., Boemio M., Bressan L., Cabbia A., Canesso E., Cian R., Dal Piccol C., Pasqua M. M. D., Di Prisco A., Mantellato L., Luison M., Morgante S., Santi M., Sacillotto M., Scabbio M., Sponga P., Sguotto M., Stach F., Vettorato M., Martinello G., Dassie F., Marino S., Cibiniel L., Masetto I., Cabianca O., Valente A., Caberlotto L., Passoni A., Flumian P., Daniel L., Gion M., Stanziale S., Alborino F., Bortolozzo V., Bacelle L., Bicciato L., Basso D., Navaglia F., Manoni F., Ercolin M., Giubilini F., Imbesi M., Leuci E., Mazzi F., Anelli S., Amore M., Bigi L., Britta W., Anna G. B., Bonatti U., Borziani M., Crosato S., Fabris I., Galluccio R., Galeotti M., Gozzi M., Greco V., Guagnini E., Pagani S., Maccherozzi S., Malvasi R., Marchi F., Melato E., Mazzucchi E., Marzullo F., Pellegrini P., Petrolini N., Volta P., Bonara F., Brusamonti E., Croci R., Flamia I., Fontana F., Losi R., Marchioro R., Raffaini L., Ruju L., Saginario A., Tondelli M., Marrama D., Bernardelli L., Bonacini F., Florindo A., Merli M., Nappo P., Sola L., Tondelli O., Tonna M., Torre M., Tosatti M., Venturelli G., Zampolla D., Bernardi A., Cavalli C., Cigala L., Ciraudo C., Di Bari A., Ferri L., Gombi F., Leurini S., Mandatelli E., Maccaferri S., Oroboncoide M., Pisa B., Ricci C., Poggi E., Zurlini C., Malpeli M., Colla R., Teodori E., Vecchia L., D'Andrea R., Trenti T., Paolini P., Carpeggiani P., Ghigi D., Gagliostro M., Pratelli M., Antonelli A., Battistini L., Bellini F., Bonini E., Capelli C. B. R., DiDomizio C., Drei C., Fucci G., Gualandi A., Grazia M. R., Losi A. M., Mazzoni F. M. P., Marangoni D., Monna G., Morselli M., Oggioni A., Oprandi S., Paganelli W., Passerini M., Piscitelli M., Reggiani G., Rossi G., Salvatori F., Trasforini S., Uslenghi C., Veggetti S., Bartolucci G., Baruffa R., Bertelli R., Borghi L., Ciavarella P., Paltrinieri E., Rizzardi F., Serra P., Suzzi D., Arienti P., Aureli F., Avanzi R., Callegari V., Corsino A., Host P., Michetti R., Rizzo F., Simoncelli P., Soldati E., Succi E., Bertozzi M., Canetti E., Cavicchioli L., Ceccarelli E., Cenni S., Marzola G., Gallina V., Leoni C., Olivieri A., Piccolo E., Ravagli S., Russo R., Tedeschini D., Verenini M., Abram W., Granata V., Curcio A., Guerra G., Granini S., Natali L., Montanari E., Pasi F., Ventura U., Valenti S., Francesca M., Farneti R., Ravagli P., Floris R., Maroncelli O., Volpones G., Casali D., Miceli M., Bencini A., Cellini M., De Biase L., Barbara L., Charles L., Pratesi C., Tanini A., Loparrino R., Ulivelli C., Cussoto C., Dei N., Fumanti E., Pantani M., Zeloni G., Bellini R., Cellesi R., Dorigo N., Gulli P., Ialeggio L., Pisanu M., Rinaldi G., Konze A., Cocchi A., Meneghelli A., Frova M., Monzani E., Zanobio A., Malagoli M., Pagani R., Barbera S., Morganti C., Amade E. S., Brambilla V., Montanari A., Caterina G., Lopez C., Marocchi A., Moletta A., Sberna M., Cascio M. T., Scarone S., Gargano, G, Caletti, E, Perlini, C, Turtulici, N, Bellani, M, Bonivento, C, Garzitto, M, Siri, F, Longo, C, Bonetto, C, Cristofalo, D, Scocco, P, Semrov, E, Preti, A, Lazzarotto, L, Gardellin, F, Lasalvia, A, Ruggeri, M, Marini, A, Brambilla, P, Bertani, M, Bissoli, S, De Santi, K, Lunardi, S, Negretto, V, Poli, S, Tosato, S, Zamboni, M, Ballarin, M, De Girolamo, G, Fioritti, A, Neri, G, Pileggi, F, Rucci, P, Chiavetto, L, Scasselatti, C, Zanardini, R, Bertoldo, A, Marinelli, V, Rambaldelli, G, Bardella, S, Lamonaca, D, Lunardon, M, Magnabosco, R, Martucci, M, Nicolau, S, Nifosi, F, Pavanati, M, Rossi, M, Piazza, C, Piccione, G, Sala, A, Sale, A, Stefani, B, Zotos, S, Balbo, M, Boggian, I, Ceccato, E, Dall'Agnola, R, Girotto, B, Goss, C, Leoni, R, Mai, A, Pasqualini, A, Roccato, S, Rossi, A, Strizzolo, S, Urbani, A, Aldi, F, Bianchi, B, Cappellari, P, Conti, R, De Battisti, L, Lazzarin, E, Merlin, S, Migliorini, G, Pozzan, T, Sarto, L, Visona, S, Brazzoli, A, Campi, A, Carmagnani, R, Giambelli, S, Gianella, A, Lunardi, L, Madaghiele, D, Maestrelli, P, Paiola, L, Posteri, E, Viola, L, Zamberlan, V, Zenari, M, Zanoni, M, Bonadonna, G, Bonomo, M, Santonastaso, P, Cremonese, C, Veronese, A, Anderle, P, Angelozzi, A, Baron, I, Candeago, E, Castelli, F, Chieco, M, Di Costanzo, E, Derossi, M, Doriguzzi, M, Galvano, O, Lattanzi, M, Lezzi, R, Marcato, M, Marcolin, A, Marini, F, Matranga, M, Scalabrin, D, Zucchetto, M, Zadro, F, Austoni, G, Bianco, M, Bordino, F, Dario, F, De Risio, A, Gatto, A, Grana, S, Favero, E, Franceschini, A, Friederici, S, Marangon, V, Pascolo, M, Ramon, L, Zambolin, S, Riolo, R, Buffon, A, Di Bortolo, E, Fortin, S, Matarrese, F, Mogni, S, Codemo, N, Russi, A, Silvestro, A, Turella, E, Viel, P, Dominoni, A, Andreose, L, Boemio, M, Bressan, L, Cabbia, A, Canesso, E, Cian, R, Dal Piccol, C, Pasqua, M, Di Prisco, A, Mantellato, L, Luison, M, Morgante, S, Santi, M, Sacillotto, M, Scabbio, M, Sponga, P, Sguotto, M, Stach, F, Vettorato, M, Martinello, G, Dassie, F, Marino, S, Cibiniel, L, Masetto, I, Cabianca, O, Valente, A, Caberlotto, L, Passoni, A, Flumian, P, Daniel, L, Gion, M, Stanziale, S, Alborino, F, Bortolozzo, V, Bacelle, L, Bicciato, L, Basso, D, Navaglia, F, Manoni, F, Ercolin, M, Giubilini, F, Imbesi, M, Leuci, E, Mazzi, F, Anelli, S, Amore, M, Bigi, L, Britta, W, Anna, G, Bonatti, U, Borziani, M, Crosato, S, Fabris, I, Galluccio, R, Galeotti, M, Gozzi, M, Greco, V, Guagnini, E, Pagani, S, Maccherozzi, S, Malvasi, R, Marchi, F, Melato, E, Mazzucchi, E, Marzullo, F, Pellegrini, P, Petrolini, N, Volta, P, Bonara, F, Brusamonti, E, Croci, R, Flamia, I, Fontana, F, Losi, R, Marchioro, R, Raffaini, L, Ruju, L, Saginario, A, Tondelli, M, Marrama, D, Bernardelli, L, Bonacini, F, Florindo, A, Merli, M, Nappo, P, Sola, L, Tondelli, O, Tonna, M, Torre, M, Tosatti, M, Venturelli, G, Zampolla, D, Bernardi, A, Cavalli, C, Cigala, L, Ciraudo, C, Di Bari, A, Ferri, L, Gombi, F, Leurini, S, Mandatelli, E, Maccaferri, S, Oroboncoide, M, Pisa, B, Ricci, C, Poggi, E, Zurlini, C, Malpeli, M, Colla, R, Teodori, E, Vecchia, L, D'Andrea, R, Trenti, T, Paolini, P, Carpeggiani, P, Ghigi, D, Gagliostro, M, Pratelli, M, Antonelli, A, Battistini, L, Bellini, F, Bonini, E, Capelli, C, Didomizio, C, Drei, C, Fucci, G, Gualandi, A, Grazia, M, Losi, A, Mazzoni, F, Marangoni, D, Monna, G, Morselli, M, Oggioni, A, Oprandi, S, Paganelli, W, Passerini, M, Piscitelli, M, Reggiani, G, Rossi, G, Salvatori, F, Trasforini, S, Uslenghi, C, Veggetti, S, Bartolucci, G, Baruffa, R, Bertelli, R, Borghi, L, Ciavarella, P, Paltrinieri, E, Rizzardi, F, Serra, P, Suzzi, D, Arienti, P, Aureli, F, Avanzi, R, Callegari, V, Corsino, A, Host, P, Michetti, R, Rizzo, F, Simoncelli, P, Soldati, E, Succi, E, Bertozzi, M, Canetti, E, Cavicchioli, L, Ceccarelli, E, Cenni, S, Marzola, G, Gallina, V, Leoni, C, Olivieri, A, Piccolo, E, Ravagli, S, Russo, R, Tedeschini, D, Verenini, M, Abram, W, Granata, V, Curcio, A, Guerra, G, Granini, S, Natali, L, Montanari, E, Pasi, F, Ventura, U, Valenti, S, Francesca, M, Farneti, R, Ravagli, P, Floris, R, Maroncelli, O, Volpones, G, Casali, D, Miceli, M, Bencini, A, Cellini, M, De Biase, L, Barbara, L, Charles, L, Pratesi, C, Tanini, A, Loparrino, R, Ulivelli, C, Cussoto, C, Dei, N, Fumanti, E, Pantani, M, Zeloni, G, Bellini, R, Cellesi, R, Dorigo, N, Gulli, P, Ialeggio, L, Pisanu, M, Rinaldi, G, Konze, A, Cocchi, A, Meneghelli, A, Frova, M, Monzani, E, Zanobio, A, Malagoli, M, Pagani, R, Barbera, S, Morganti, C, Amade, E, Brambilla, V, Montanari, A, Caterina, G, Lopez, C, Marocchi, A, Moletta, A, Sberna, M, Cascio, M, Scarone, S, Gargano G., Caletti E., Perlini C., Turtulici N., Bellani M., Bonivento C., Garzitto M., Siri F. M., Longo C., Bonetto C., Cristofalo D., Scocco P., Semrov E., Preti A., Lazzarotto L., Gardellin F., Lasalvia A., Ruggeri M., Marini A., Brambilla P., Bertani M. E., Bissoli S., De Santi K., Lunardi S., Negretto V., Poli S., Tosato S., Zamboni M. G., Ballarin M., De Girolamo G., Fioritti A., Neri G., Pileggi F., Rucci P., Chiavetto L. B., Scasselatti C., Zanardini R., Bertoldo A., Marinelli V., Rambaldelli G., Bardella S., Lamonaca D., Lunardon M., Magnabosco R., Martucci M., Nicolau S., Nifosi F., Pavanati M., Rossi M., Piazza C., Piccione G., Sala A., Sale A., Stefani B., Zotos S., Balbo M., Boggian I., Ceccato E., Dall'Agnola R., Girotto B., Goss C., Leoni R., Mai A., Pasqualini A., Roccato S., Rossi A., Strizzolo S., Urbani A., Aldi F., Bianchi B., Cappellari P., Conti R., De Battisti L., Lazzarin E., Merlin S., Migliorini G., Pozzan T., Sarto L., Visona S., Brazzoli A., Campi A., Carmagnani R., Giambelli S., Gianella A., Lunardi L., Madaghiele D., Maestrelli P., Paiola L., Posteri E., Viola L., Zamberlan V., Zenari M., Zanoni M., Bonadonna G., Bonomo M., Santonastaso P., Cremonese C., Veronese A., Anderle P., Angelozzi A., Baron I. A. G., Candeago E. B. F., Castelli F., Chieco M., Di Costanzo E., Derossi M., Doriguzzi M., Galvano O., Lattanzi M., Lezzi R., Marcato M., Marcolin A., Marini F., Matranga M., Scalabrin D., Zucchetto M., Zadro F., Austoni G., Bianco M., Bordino F., Dario F., De Risio A., Gatto A., Grana S., Favero E., Franceschini A., Friederici S., Marangon V., Pascolo M., Ramon L., Zambolin S., Riolo R., Buffon A., Di Bortolo E., Fortin S., Matarrese F., Mogni S., Codemo N., Russi A., Silvestro A., Turella E., Viel P., Dominoni A., Andreose L., Boemio M., Bressan L., Cabbia A., Canesso E., Cian R., Dal Piccol C., Pasqua M. M. D., Di Prisco A., Mantellato L., Luison M., Morgante S., Santi M., Sacillotto M., Scabbio M., Sponga P., Sguotto M., Stach F., Vettorato M., Martinello G., Dassie F., Marino S., Cibiniel L., Masetto I., Cabianca O., Valente A., Caberlotto L., Passoni A., Flumian P., Daniel L., Gion M., Stanziale S., Alborino F., Bortolozzo V., Bacelle L., Bicciato L., Basso D., Navaglia F., Manoni F., Ercolin M., Giubilini F., Imbesi M., Leuci E., Mazzi F., Anelli S., Amore M., Bigi L., Britta W., Anna G. B., Bonatti U., Borziani M., Crosato S., Fabris I., Galluccio R., Galeotti M., Gozzi M., Greco V., Guagnini E., Pagani S., Maccherozzi S., Malvasi R., Marchi F., Melato E., Mazzucchi E., Marzullo F., Pellegrini P., Petrolini N., Volta P., Bonara F., Brusamonti E., Croci R., Flamia I., Fontana F., Losi R., Marchioro R., Raffaini L., Ruju L., Saginario A., Tondelli M., Marrama D., Bernardelli L., Bonacini F., Florindo A., Merli M., Nappo P., Sola L., Tondelli O., Tonna M., Torre M., Tosatti M., Venturelli G., Zampolla D., Bernardi A., Cavalli C., Cigala L., Ciraudo C., Di Bari A., Ferri L., Gombi F., Leurini S., Mandatelli E., Maccaferri S., Oroboncoide M., Pisa B., Ricci C., Poggi E., Zurlini C., Malpeli M., Colla R., Teodori E., Vecchia L., D'Andrea R., Trenti T., Paolini P., Carpeggiani P., Ghigi D., Gagliostro M., Pratelli M., Antonelli A., Battistini L., Bellini F., Bonini E., Capelli C. B. R., DiDomizio C., Drei C., Fucci G., Gualandi A., Grazia M. R., Losi A. M., Mazzoni F. M. P., Marangoni D., Monna G., Morselli M., Oggioni A., Oprandi S., Paganelli W., Passerini M., Piscitelli M., Reggiani G., Rossi G., Salvatori F., Trasforini S., Uslenghi C., Veggetti S., Bartolucci G., Baruffa R., Bertelli R., Borghi L., Ciavarella P., Paltrinieri E., Rizzardi F., Serra P., Suzzi D., Arienti P., Aureli F., Avanzi R., Callegari V., Corsino A., Host P., Michetti R., Rizzo F., Simoncelli P., Soldati E., Succi E., Bertozzi M., Canetti E., Cavicchioli L., Ceccarelli E., Cenni S., Marzola G., Gallina V., Leoni C., Olivieri A., Piccolo E., Ravagli S., Russo R., Tedeschini D., Verenini M., Abram W., Granata V., Curcio A., Guerra G., Granini S., Natali L., Montanari E., Pasi F., Ventura U., Valenti S., Francesca M., Farneti R., Ravagli P., Floris R., Maroncelli O., Volpones G., Casali D., Miceli M., Bencini A., Cellini M., De Biase L., Barbara L., Charles L., Pratesi C., Tanini A., Loparrino R., Ulivelli C., Cussoto C., Dei N., Fumanti E., Pantani M., Zeloni G., Bellini R., Cellesi R., Dorigo N., Gulli P., Ialeggio L., Pisanu M., Rinaldi G., Konze A., Cocchi A., Meneghelli A., Frova M., Monzani E., Zanobio A., Malagoli M., Pagani R., Barbera S., Morganti C., Amade E. S., Brambilla V., Montanari A., Caterina G., Lopez C., Marocchi A., Moletta A., Sberna M., Cascio M. T., and Scarone S.

Abstract

Language production has often been described as impaired in psychiatric diseases such as in psychosis. Nevertheless, little is known about the characteristics of linguistic difficulties and their relation with other cognitive domains in patients with a first episode of psychosis (FEP), either affective or non-affective. To deepen our comprehension of linguistic profile in FEP, 133 patients with FEP (95 non-affective, FEP-NA; 38 affective, FEP-A) and 133 healthy controls (HC) were assessed with a narrative discourse task. Speech samples were systematically analyzed with a well-established multilevel procedure investigating both micro- (lexicon, morphology, syntax) and macro-linguistic (discourse coherence, pragmatics) levels of linguistic processing. Executive functioning and IQ were also evaluated. Both linguistic and neuropsychological measures were secondarily implemented with a machine learning approach in order to explore their predictive accuracy in classifying participants as FEP or HC. Compared to HC, FEP patients showed language production difficulty at both micro- and macro-linguistic levels. As for the former, FEP produced shorter and simpler sentences and fewer words per minute, along with a reduced number of lexical fillers, compared to HC. At the macro-linguistic level, FEP performance was impaired in local coherence, which was paired with a higher percentage of utterances with semantic errors. Linguistic measures were not correlated with any neuropsychological variables. No significant differences emerged between FEP-NA and FEP-A (p≥0.02, after Bonferroni correction). Machine learning analysis showed an accuracy of group prediction of 76.36% using language features only, with semantic variables being the most impactful. Such a percentage was enhanced when paired with clinical and neuropsychological variables. Results confirm the presence of language production deficits already at the first episode of the illness, being such impairment not related to ot

Published
2022

6. Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015–04 (PANGEA-Breast) study

Author

Universidad de Sevilla. Departamento de Medicina, Universidad de Sevilla. Departamento de Bioquímica Médica y Biología Molecular e Inmunología, Cruz Merino, Luis de la, Gion, M., Cruz, J., Alonso-Romero, J. L., Quiroga, V., Moreno, F., Jiménez Cortegana, Carlos, Sánchez Margalet, Víctor, Rojo, F., Universidad de Sevilla. Departamento de Medicina, Universidad de Sevilla. Departamento de Bioquímica Médica y Biología Molecular e Inmunología, Cruz Merino, Luis de la, Gion, M., Cruz, J., Alonso-Romero, J. L., Quiroga, V., Moreno, F., Jiménez Cortegana, Carlos, Sánchez Margalet, Víctor, and Rojo, F.

Abstract

Background: We evaluated a new chemoimmunotherapy combination based on the anti-PD1 monoclonal antibody pembrolizumab and the pyrimidine antimetabolite gemcitabine in HER2- advanced breast cancer (ABC) patients previously treated in the advanced setting, in order to explore a potential synergism that could eventually obtain long term beneft in these patients. Methods: HER2-negative ABC patients received 21-day cycles of pembrolizumab 200 mg (day 1) and gemcitabine (days 1 and 8). A run-in-phase (6+6 design) was planned with two dose levels (DL) of gemcitabine (1,250 mg/m2 [DL0]; 1,000 mg/m2 [DL1]) to determine the recommended phase II dose (RP2D). The primary objective was objec‑ tive response rate (ORR). Tumor infltrating lymphocytes (TILs) density and PD-L1 expression in tumors and myeloidderived suppressor cells (MDSCs) levels in peripheral blood were analyzed. Results: Fourteen patients were treated with DL0, resulting in RP2D. Thirty-six patients were evaluated during the frst stage of Simon’s design. Recruitment was stopped as statistical assumptions were not met. The median age was 52; 21 (58%) patients had triple-negative disease, 28 (78%) visceral involvement, and 27 (75%)≥2 metastatic locations. Progression disease was observed in 29 patients. ORR was 15% (95% CI, 5–32). Eight patients were treated≥6 months before progression. Fourteen patients reported grade≥3 treatment-related adverse events. Due to the small sample size, we did not fnd any clear association between immune tumor biomarkers and treatment efcacy that could identify a subgroup with higher probability of response or better survival. However, patients that experienced a clini‑ cal beneft showed decreased MDSCs levels in peripheral blood along the treatment. Conclusion: Pembrolizumab 200 mg and gemcitabine 1,250 mg/m2 were considered as RP2D. The objective of ORR was not met; however, 22% patients were on treatment for≥6 months. ABC patients that could beneft of chemoimmunotherapy strategies m

Published
2023

7. Language production impairments in patients with a first episode of psychosis

Author

Gargano G., Caletti E., Perlini C., Turtulici N., Bellani M., Bonivento C., Garzitto M., Siri F. M., Longo C., Bonetto C., Cristofalo D., Scocco P., Semrov E., Preti A., Lazzarotto L., Gardellin F., Lasalvia A., Ruggeri M., Marini A., Brambilla P., Bertani M. E., Bissoli S., De Santi K., Lunardi S., Negretto V., Poli S., Tosato S., Zamboni M. G., Ballarin M., De Girolamo G., Fioritti A., Neri G., Pileggi F., Rucci P., Chiavetto L. B., Scasselatti C., Zanardini R., Bertoldo A., Marinelli V., Rambaldelli G., Bardella S., Lamonaca D., Lunardon M., Magnabosco R., Martucci M., Nicolau S., Nifosi F., Pavanati M., Rossi M., Piazza C., Piccione G., Sala A., Sale A., Stefani B., Zotos S., Balbo M., Boggian I., Ceccato E., Dall'Agnola R., Girotto B., Goss C., Leoni R., Mai A., Pasqualini A., Roccato S., Rossi A., Strizzolo S., Urbani A., Aldi F., Bianchi B., Cappellari P., Conti R., De Battisti L., Lazzarin E., Merlin S., Migliorini G., Pozzan T., Sarto L., Visona S., Brazzoli A., Campi A., Carmagnani R., Giambelli S., Gianella A., Lunardi L., Madaghiele D., Maestrelli P., Paiola L., Posteri E., Viola L., Zamberlan V., Zenari M., Zanoni M., Bonadonna G., Bonomo M., Santonastaso P., Cremonese C., Veronese A., Anderle P., Angelozzi A., Baron I. A. G., Candeago E. B. F., Castelli F., Chieco M., Di Costanzo E., Derossi M., Doriguzzi M., Galvano O., Lattanzi M., Lezzi R., Marcato M., Marcolin A., Marini F., Matranga M., Scalabrin D., Zucchetto M., Zadro F., Austoni G., Bianco M., Bordino F., Dario F., De Risio A., Gatto A., Grana S., Favero E., Franceschini A., Friederici S., Marangon V., Pascolo M., Ramon L., Zambolin S., Riolo R., Buffon A., Di Bortolo E., Fortin S., Matarrese F., Mogni S., Codemo N., Russi A., Silvestro A., Turella E., Viel P., Dominoni A., Andreose L., Boemio M., Bressan L., Cabbia A., Canesso E., Cian R., Dal Piccol C., Pasqua M. M. D., Di Prisco A., Mantellato L., Luison M., Morgante S., Santi M., Sacillotto M., Scabbio M., Sponga P., Sguotto M., Stach F., Vettorato M., Martinello G., Dassie F., Marino S., Cibiniel L., Masetto I., Cabianca O., Valente A., Caberlotto L., Passoni A., Flumian P., Daniel L., Gion M., Stanziale S., Alborino F., Bortolozzo V., Bacelle L., Bicciato L., Basso D., Navaglia F., Manoni F., Ercolin M., Giubilini F., Imbesi M., Leuci E., Mazzi F., Anelli S., Amore M., Bigi L., Britta W., Anna G. B., Bonatti U., Borziani M., Crosato S., Fabris I., Galluccio R., Galeotti M., Gozzi M., Greco V., Guagnini E., Pagani S., Maccherozzi S., Malvasi R., Marchi F., Melato E., Mazzucchi E., Marzullo F., Pellegrini P., Petrolini N., Volta P., Bonara F., Brusamonti E., Croci R., Flamia I., Fontana F., Losi R., Marchioro R., Raffaini L., Ruju L., Saginario A., Tondelli M., Marrama D., Bernardelli L., Bonacini F., Florindo A., Merli M., Nappo P., Sola L., Tondelli O., Tonna M., Torre M., Tosatti M., Venturelli G., Zampolla D., Bernardi A., Cavalli C., Cigala L., Ciraudo C., Di Bari A., Ferri L., Gombi F., Leurini S., Mandatelli E., Maccaferri S., Oroboncoide M., Pisa B., Ricci C., Poggi E., Zurlini C., Malpeli M., Colla R., Teodori E., Vecchia L., D'Andrea R., Trenti T., Paolini P., Carpeggiani P., Ghigi D., Gagliostro M., Pratelli M., Antonelli A., Battistini L., Bellini F., Bonini E., Capelli C. B. R., DiDomizio C., Drei C., Fucci G., Gualandi A., Grazia M. R., Losi A. M., Mazzoni F. M. P., Marangoni D., Monna G., Morselli M., Oggioni A., Oprandi S., Paganelli W., Passerini M., Piscitelli M., Reggiani G., Rossi G., Salvatori F., Trasforini S., Uslenghi C., Veggetti S., Bartolucci G., Baruffa R., Bertelli R., Borghi L., Ciavarella P., Paltrinieri E., Rizzardi F., Serra P., Suzzi D., Arienti P., Aureli F., Avanzi R., Callegari V., Corsino A., Host P., Michetti R., Rizzo F., Simoncelli P., Soldati E., Succi E., Bertozzi M., Canetti E., Cavicchioli L., Ceccarelli E., Cenni S., Marzola G., Gallina V., Leoni C., Olivieri A., Piccolo E., Ravagli S., Russo R., Tedeschini D., Verenini M., Abram W., Granata V., Curcio A., Guerra G., Granini S., Natali L., Montanari E., Pasi F., Ventura U., Valenti S., Francesca M., Farneti R., Ravagli P., Floris R., Maroncelli O., Volpones G., Casali D., Miceli M., Bencini A., Cellini M., De Biase L., Barbara L., Charles L., Pratesi C., Tanini A., Loparrino R., Ulivelli C., Cussoto C., Dei N., Fumanti E., Pantani M., Zeloni G., Bellini R., Cellesi R., Dorigo N., Gulli P., Ialeggio L., Pisanu M., Rinaldi G., Konze A., Cocchi A., Meneghelli A., Frova M., Monzani E., Zanobio A., Malagoli M., Pagani R., Barbera S., Morganti C., Amade E. S., Brambilla V., Montanari A., Caterina G., Lopez C., Marocchi A., Moletta A., Sberna M., Cascio M. T., Scarone S., Gargano, G, Caletti, E, Perlini, C, Turtulici, N, Bellani, M, Bonivento, C, Garzitto, M, Siri, F, Longo, C, Bonetto, C, Cristofalo, D, Scocco, P, Semrov, E, Preti, A, Lazzarotto, L, Gardellin, F, Lasalvia, A, Ruggeri, M, Marini, A, Brambilla, P, Bertani, M, Bissoli, S, De Santi, K, Lunardi, S, Negretto, V, Poli, S, Tosato, S, Zamboni, M, Ballarin, M, De Girolamo, G, Fioritti, A, Neri, G, Pileggi, F, Rucci, P, Chiavetto, L, Scasselatti, C, Zanardini, R, Bertoldo, A, Marinelli, V, Rambaldelli, G, Bardella, S, Lamonaca, D, Lunardon, M, Magnabosco, R, Martucci, M, Nicolau, S, Nifosi, F, Pavanati, M, Rossi, M, Piazza, C, Piccione, G, Sala, A, Sale, A, Stefani, B, Zotos, S, Balbo, M, Boggian, I, Ceccato, E, Dall'Agnola, R, Girotto, B, Goss, C, Leoni, R, Mai, A, Pasqualini, A, Roccato, S, Rossi, A, Strizzolo, S, Urbani, A, Aldi, F, Bianchi, B, Cappellari, P, Conti, R, De Battisti, L, Lazzarin, E, Merlin, S, Migliorini, G, Pozzan, T, Sarto, L, Visona, S, Brazzoli, A, Campi, A, Carmagnani, R, Giambelli, S, Gianella, A, Lunardi, L, Madaghiele, D, Maestrelli, P, Paiola, L, Posteri, E, Viola, L, Zamberlan, V, Zenari, M, Zanoni, M, Bonadonna, G, Bonomo, M, Santonastaso, P, Cremonese, C, Veronese, A, Anderle, P, Angelozzi, A, Baron, I, Candeago, E, Castelli, F, Chieco, M, Di Costanzo, E, Derossi, M, Doriguzzi, M, Galvano, O, Lattanzi, M, Lezzi, R, Marcato, M, Marcolin, A, Marini, F, Matranga, M, Scalabrin, D, Zucchetto, M, Zadro, F, Austoni, G, Bianco, M, Bordino, F, Dario, F, De Risio, A, Gatto, A, Grana, S, Favero, E, Franceschini, A, Friederici, S, Marangon, V, Pascolo, M, Ramon, L, Zambolin, S, Riolo, R, Buffon, A, Di Bortolo, E, Fortin, S, Matarrese, F, Mogni, S, Codemo, N, Russi, A, Silvestro, A, Turella, E, Viel, P, Dominoni, A, Andreose, L, Boemio, M, Bressan, L, Cabbia, A, Canesso, E, Cian, R, Dal Piccol, C, Pasqua, M, Di Prisco, A, Mantellato, L, Luison, M, Morgante, S, Santi, M, Sacillotto, M, Scabbio, M, Sponga, P, Sguotto, M, Stach, F, Vettorato, M, Martinello, G, Dassie, F, Marino, S, Cibiniel, L, Masetto, I, Cabianca, O, Valente, A, Caberlotto, L, Passoni, A, Flumian, P, Daniel, L, Gion, M, Stanziale, S, Alborino, F, Bortolozzo, V, Bacelle, L, Bicciato, L, Basso, D, Navaglia, F, Manoni, F, Ercolin, M, Giubilini, F, Imbesi, M, Leuci, E, Mazzi, F, Anelli, S, Amore, M, Bigi, L, Britta, W, Anna, G, Bonatti, U, Borziani, M, Crosato, S, Fabris, I, Galluccio, R, Galeotti, M, Gozzi, M, Greco, V, Guagnini, E, Pagani, S, Maccherozzi, S, Malvasi, R, Marchi, F, Melato, E, Mazzucchi, E, Marzullo, F, Pellegrini, P, Petrolini, N, Volta, P, Bonara, F, Brusamonti, E, Croci, R, Flamia, I, Fontana, F, Losi, R, Marchioro, R, Raffaini, L, Ruju, L, Saginario, A, Tondelli, M, Marrama, D, Bernardelli, L, Bonacini, F, Florindo, A, Merli, M, Nappo, P, Sola, L, Tondelli, O, Tonna, M, Torre, M, Tosatti, M, Venturelli, G, Zampolla, D, Bernardi, A, Cavalli, C, Cigala, L, Ciraudo, C, Di Bari, A, Ferri, L, Gombi, F, Leurini, S, Mandatelli, E, Maccaferri, S, Oroboncoide, M, Pisa, B, Ricci, C, Poggi, E, Zurlini, C, Malpeli, M, Colla, R, Teodori, E, Vecchia, L, D'Andrea, R, Trenti, T, Paolini, P, Carpeggiani, P, Ghigi, D, Gagliostro, M, Pratelli, M, Antonelli, A, Battistini, L, Bellini, F, Bonini, E, Capelli, C, Didomizio, C, Drei, C, Fucci, G, Gualandi, A, Grazia, M, Losi, A, Mazzoni, F, Marangoni, D, Monna, G, Morselli, M, Oggioni, A, Oprandi, S, Paganelli, W, Passerini, M, Piscitelli, M, Reggiani, G, Rossi, G, Salvatori, F, Trasforini, S, Uslenghi, C, Veggetti, S, Bartolucci, G, Baruffa, R, Bertelli, R, Borghi, L, Ciavarella, P, Paltrinieri, E, Rizzardi, F, Serra, P, Suzzi, D, Arienti, P, Aureli, F, Avanzi, R, Callegari, V, Corsino, A, Host, P, Michetti, R, Rizzo, F, Simoncelli, P, Soldati, E, Succi, E, Bertozzi, M, Canetti, E, Cavicchioli, L, Ceccarelli, E, Cenni, S, Marzola, G, Gallina, V, Leoni, C, Olivieri, A, Piccolo, E, Ravagli, S, Russo, R, Tedeschini, D, Verenini, M, Abram, W, Granata, V, Curcio, A, Guerra, G, Granini, S, Natali, L, Montanari, E, Pasi, F, Ventura, U, Valenti, S, Francesca, M, Farneti, R, Ravagli, P, Floris, R, Maroncelli, O, Volpones, G, Casali, D, Miceli, M, Bencini, A, Cellini, M, De Biase, L, Barbara, L, Charles, L, Pratesi, C, Tanini, A, Loparrino, R, Ulivelli, C, Cussoto, C, Dei, N, Fumanti, E, Pantani, M, Zeloni, G, Bellini, R, Cellesi, R, Dorigo, N, Gulli, P, Ialeggio, L, Pisanu, M, Rinaldi, G, Konze, A, Cocchi, A, Meneghelli, A, Frova, M, Monzani, E, Zanobio, A, Malagoli, M, Pagani, R, Barbera, S, Morganti, C, Amade, E, Brambilla, V, Montanari, A, Caterina, G, Lopez, C, Marocchi, A, Moletta, A, Sberna, M, Cascio, M, and Scarone, S

Subjects
Language Disorders, Multidisciplinary, Comprehension, Humans, Language, Neuropsychological Tests, Psychotic Disorders, Psychosis, Language Disorder, Psychosis, Language, Cognition, Neuropsychology, Cognition, Neuropsychology, Neuropsychological Test, Settore MED/25 - Psichiatria, Human
Abstract

Language production has often been described as impaired in psychiatric diseases such as in psychosis. Nevertheless, little is known about the characteristics of linguistic difficulties and their relation with other cognitive domains in patients with a first episode of psychosis (FEP), either affective or non-affective. To deepen our comprehension of linguistic profile in FEP, 133 patients with FEP (95 non-affective, FEP-NA; 38 affective, FEP-A) and 133 healthy controls (HC) were assessed with a narrative discourse task. Speech samples were systematically analyzed with a well-established multilevel procedure investigating both micro- (lexicon, morphology, syntax) and macro-linguistic (discourse coherence, pragmatics) levels of linguistic processing. Executive functioning and IQ were also evaluated. Both linguistic and neuropsychological measures were secondarily implemented with a machine learning approach in order to explore their predictive accuracy in classifying participants as FEP or HC. Compared to HC, FEP patients showed language production difficulty at both micro- and macro-linguistic levels. As for the former, FEP produced shorter and simpler sentences and fewer words per minute, along with a reduced number of lexical fillers, compared to HC. At the macro-linguistic level, FEP performance was impaired in local coherence, which was paired with a higher percentage of utterances with semantic errors. Linguistic measures were not correlated with any neuropsychological variables. No significant differences emerged between FEP-NA and FEP-A (p≥0.02, after Bonferroni correction). Machine learning analysis showed an accuracy of group prediction of 76.36% using language features only, with semantic variables being the most impactful. Such a percentage was enhanced when paired with clinical and neuropsychological variables. Results confirm the presence of language production deficits already at the first episode of the illness, being such impairment not related to other cognitive domains. The high accuracy obtained by the linguistic set of features in classifying groups support the use of machine learning methods in neuroscience investigations.

Published
2022

9. Pembrolizumab in combination with tocilizumab in high-risk hospitalized patients with COVID-19 (COPERNICO): A randomized proof-of-concept phase II study

Author

Sánchez-Conde M, Vizcarra P, Pérez-García JM, Gion M, Martialay MP, Taboada J, Alonso-Fernández A, Sampayo-Cordero M, Malfettone A, Tena I, Torre S, Llombart-Cussac A, and Cortés J

Subjects
SARS-CoV-2 infection, COVID-19, Tocilizumab, Pembrolizumab
Abstract

OBJECTIVES: Severe COVID-19 is associated with immune dysregulation and hyperinflammation (lymphocyte exhaustion and elevated interleukin 6. Pembrolizumab (P; immune-activating anti-programmed cell death-1 antibody) plus tocilizumab (TCZ; anti- interleukin 6 receptor antibody) might interrupt the hyperinflammation and restore cellular immunocompetence. We assessed the efficacy and safety of P + TCZ + standard of care (SOC) in high-risk, hospitalized patients with COVID-19 pneumonia without mechanical ventilation. METHODS: Randomized, controlled, open-label, phase II trial in patients with severe SARS-CoV-2 infection to assess the hospitalization period to discharge. RESULTS: A total of 12 patients were randomized (P + TCZ + SOC, n = 7; SOC, n = 5). Nine (75%) were males, with a median age of 68 (41-79) years. The median time to discharge for P + TCZ + SOC and SOC was 10 and 47.5 days (P = 0.03), with zero (n = 1 patient had P-related grade 5 myositis) and two COVID-19-related deaths, respectively. CONCLUSION: The addition of P and TCZ to SOC reduced the hospitalization period, with higher and faster discharges without sequelae than SOC alone.

Published
2022

10. Trastuzumab Deruxtecan in Patients with Central Nervous System Involvement from HER2-Positive Breast Cancer: The DEBBRAH Trial

Author

Pérez-García JM, Batista MV, Cortez P, Ruiz-Borrego M, Cejalvo JM, de la Haba-Rodriguez J, Garrigós L, Racca F, Servitja S, Blanch S, Gion M, Nave M, Fernández-Abad M, Martinez-Bueno A, Llombart-Cussac A, Sampayo-Cordero M, Malfettone A, Cortés J, and Braga S

Subjects
advanced breast cancer, brain metastases, Trastuzumab deruxtecan, HER2-positive, T-DXd
Abstract

BACKGROUND: Trastuzumab deruxtecan (T-DXd) has shown durable antitumor activity in pretreated patients with HER2-positive advanced breast cancer (ABC), but its efficacy has not yet been evaluated in patients with active brain metastases (BMs). DEBBRAH aims to assess T-DXd in patients with HER2-positive or HER2-low ABC and central nervous system involvement.; METHODS: This ongoing, five-cohort, phase II study (NCT04420598) enrolled patients with pretreated HER2-positive or HER2-low ABC with stable, untreated, or progressing BMs and/or leptomeningeal carcinomatosis. Here, we report findings from HER2-positive ABC patients with non-progressing BMs after local therapy (n=8; cohort 1), asymptomatic untreated BMs (n=4; cohort 2), or progressing BMs after local therapy (n=9; cohort 3). Patients received 5.4mg/kg T-DXd intravenously once every 21 days. The primary endpoint was 16-week progression-free survival (PFS) for cohort 1 and intracranial overall response rate (ORR-IC) for cohorts 2 and 3.; RESULTS: As of October 20, 2021, 21 patients received T-DXd. In cohort 1, 16-week PFS rate was 87.5% (95%CI, 47.3-99.7; P

Published
2022

13. Recommendations for the implementation of BRCA1/2 testing in ovarian cancer patients: From tumor to germline analysis. Joint document from SIBioC, AIOM, SIGU, SIAPEC-IAP

Author

Barberis, M, Bella, M, Buttitta, F, Capoluongo, E, Carrera, P, Colombo, N, Cortesi, L, Genuardi, M, Gion, M, Gori, S, Guarneri, V, Verde, N, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Russo, A, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Barberis M., Bella M. A., Buttitta F., Capoluongo E., Carrera P., Colombo N., Cortesi L., Genuardi M., Gion M., Gori S., Guarneri V., Verde N. L., Lorusso D., Marchetti A., Marchetti P., Normanno N., Pasini B., Pensabene M., Pignata S., Radice P., Ricevuto E., Russo A., Sapino A., Tagliaferri P., Tassone P., Trevisiol C., Truini M., Varesco L., Barberis, M, Bella, M, Buttitta, F, Capoluongo, E, Carrera, P, Colombo, N, Cortesi, L, Genuardi, M, Gion, M, Gori, S, Guarneri, V, Verde, N, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Russo, A, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Barberis M., Bella M. A., Buttitta F., Capoluongo E., Carrera P., Colombo N., Cortesi L., Genuardi M., Gion M., Gori S., Guarneri V., Verde N. L., Lorusso D., Marchetti A., Marchetti P., Normanno N., Pasini B., Pensabene M., Pignata S., Radice P., Ricevuto E., Russo A., Sapino A., Tagliaferri P., Tassone P., Trevisiol C., Truini M., and Varesco L.

Abstract

Since the approval of the first poly adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi), olaparib for platinum-sensitive relapsed high grade ovarian cancer, with either germline or somatic BRCA1/2 deleterious variants, the strategies for BRCA1/2 testing are dynamically changing. In fact, along with germline assay, patients are now tested for tumor BRCA1/2 also above all for treatment decisions. In fact, it is reported as by tumor BRCA analysis we can identify 3–9% more mutated women which can therefore benefit from PARPi therapy. Although this new type of approach looks like challenging, in particular due to the technical and analytical difficulties regarding low quality DNA deriving from formalin-fixed paraffin-embedded specimens, the new CE-IVD on NGS-based pipelines, can overcome these issues, allowing specialized molecular laboratories to ensure high quality results and perform the best test settings. Nevertheless, each new NGS pipeline (CE-IVD or in house) should be validated using peculiar samples along with commercially available reference and certified materials, before being introduced in routine settings. The validation set should be appropriately chosen in order to provide unequivocal data regarding robustness of each NGS tBRCA pipeline. Therefore, in order to harmonize the patient and laboratory path, a group of Italian Scientific Societies [Italian Society of Clinical Chemistry (SIBioC), Italian Association of Medical Oncology (AIOM), Italian Association of Clinical Pathology (SIAPEC), Italian Society of Human Genetics (SIGU)] provided the present recommendations which are aimed to guide all professionals (oncologists, gynaecologists, clinical and laboratory geneticists, clinical molecular biologists and pathologists). The intersociety group is confident that the present paper can offer all ovarian cancer women a well-organized pathway of diagnosis and treatment.

Published
2019

14. 330TiP Trastuzumab deruxtecan (T-DXd; DS-8201) in HER2-positive (HER2+) and HER2-low expressing (HER-LE) metastatic breast cancer (MBC) with brain metastases (BM) and/or leptomeningeal carcinomatosis (LMC): DEBBRAH

Author

Vaz Batista, M., primary, Pérez-Garcia, J.M., additional, Llombart Cussac, A., additional, Cortez, P., additional, Ruiz Borrego, M., additional, De La Haba, J., additional, Cejalvo, J.M., additional, Racca, F., additional, Servitja, S., additional, Blanch, S., additional, Lema, L., additional, Galàn Garmaje, M., additional, Fernández-Abad, M., additional, Fernández, A., additional, Iranzo, V., additional, González-Santiago, S., additional, Gion, M., additional, Nave, M., additional, Cortés, J., additional, and Braga, S., additional

Published
2021
Full Text
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15. 336TiP Ipatasertib plus non-taxane chemotherapy for metastatic triple-negative breast cancer (TNBC): Pathfinder trial

Author

Llombart Cussac, A., primary, Soberino, J., additional, Gion, M., additional, Bermejo, B., additional, Martinez- Garcia, M., additional, Braga, S., additional, Cardoso, F., additional, Vieira, C., additional, Lopez-Miranda, E., additional, Sampayo, M., additional, Malfettone, A., additional, Cortés, J., additional, and Pérez-Garcia, J.M., additional

Published
2021
Full Text
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16. Surrogate endpoints for early-stage breast cancer: a review of the state of the art, controversies, and future prospects

Author

Gion M, Perez-Garcia J, Llombart-Cussac A, Sampayo-Cordero M, Cortes J, and Malfettone A

Subjects
intermediate endpoints, pathological complete response, neoadjuvant therapy, early breast cancer, surrogate markers, breast cancer subtypes
Abstract

Drug approval for early-stage breast cancer (EBC) has been historically granted in the context of registration trials based on adequate outcomes such as disease-free survival and overall survival. Improvements in long-term outcomes have made it more difficult to demonstrate the clinical benefit of a new cancer drug in large, randomized, comparative clinical trials. Therefore, the use of surrogate endpoints rather than traditional measures allows for cancer drug trials to proceed with smaller sample sizes and shorter follow-up periods, which reduces drug development time. Among surrogate endpoints for breast cancer, the increase in pathological complete response (pCR) rates was considered appropriate for accelerated drug approval. The association between pCR and long-term outcomes was strongest in patients with aggressive tumor subtypes, such as triple-negative and human epidermal growth factor receptor 2 (HER2)-positive/hormone receptor-negative breast cancers. Whereas in hormone receptor-positive/HER2-negative EBC, the most accepted surrogate markers for endocrine therapy-based trials include changes in Ki67 and the preoperative endocrine prognostic index. Beyond the classic endpoints, further prognostic tools are required to provide EBC patients with individualized and effective therapies, and the neoadjuvant setting provides an excellent platform for drug development and biomarker discovery. Nowadays, the availability of multigene signatures is offering a standardized quantitative and reproducible tool to potentiate the efficacy of standard treatment for high-risk patients and develop de-escalated treatments for patients at lower risk of relapse. In this article, we first evaluate the surrogacies used for long-term outcomes and the underlying evidence supporting the use of each surrogate endpoint for the accelerated or regular drug approval process in EBC. Next, we provide an overview of the most recent studies and innovative strategies in a (neo)adjuvant setting as a platform to accelerate new drug approval. Finally, we highlight some clinical trials aimed at tailoring systemic treatment of EBC using prognosis-related factors or early biomarkers of drug sensitivity or resistance.

Published
2021

19. Recommendations for the implementation of BRCA1/2 testing in ovarian cancer patients: From tumor to germline analysis. Joint document from SIBioC, AIOM, SIGU, SIAPEC-IAP

Author

Barberis M., Bella M. A., Buttitta F., Capoluongo E., Carrera P., Colombo N., Cortesi L., Genuardi M., Gion M., Gori S., Guarneri V., Verde N. L., Lorusso D., Marchetti A., Marchetti P., Normanno N., Pasini B., Pensabene M., Pignata S., Radice P., Ricevuto E., Russo A., Sapino A., Tagliaferri P., Tassone P., Trevisiol C., Truini M., Varesco L., Barberis, M, Bella, M, Buttitta, F, Capoluongo, E, Carrera, P, Colombo, N, Cortesi, L, Genuardi, M, Gion, M, Gori, S, Guarneri, V, Verde, N, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Russo, A, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, and Varesco, L

Subjects
BRCA2 protein, BRCA1 protein
Abstract

Since the approval of the first poly adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi), olaparib for platinum-sensitive relapsed high grade ovarian cancer, with either germline or somatic BRCA1/2 deleterious variants, the strategies for BRCA1/2 testing are dynamically changing. In fact, along with germline assay, patients are now tested for tumor BRCA1/2 also above all for treatment decisions. In fact, it is reported as by tumor BRCA analysis we can identify 3–9% more mutated women which can therefore benefit from PARPi therapy. Although this new type of approach looks like challenging, in particular due to the technical and analytical difficulties regarding low quality DNA deriving from formalin-fixed paraffin-embedded specimens, the new CE-IVD on NGS-based pipelines, can overcome these issues, allowing specialized molecular laboratories to ensure high quality results and perform the best test settings. Nevertheless, each new NGS pipeline (CE-IVD or in house) should be validated using peculiar samples along with commercially available reference and certified materials, before being introduced in routine settings. The validation set should be appropriately chosen in order to provide unequivocal data regarding robustness of each NGS tBRCA pipeline. Therefore, in order to harmonize the patient and laboratory path, a group of Italian Scientific Societies [Italian Society of Clinical Chemistry (SIBioC), Italian Association of Medical Oncology (AIOM), Italian Association of Clinical Pathology (SIAPEC), Italian Society of Human Genetics (SIGU)] provided the present recommendations which are aimed to guide all professionals (oncologists, gynaecologists, clinical and laboratory geneticists, clinical molecular biologists and pathologists). The intersociety group is confident that the present paper can offer all ovarian cancer women a well-organized pathway of diagnosis and treatment.

Published
2019

31. BRCA1/2 molecular assay for ovarian cancer patients: A survey through Italian departments of oncology and molecular and genomic diagnostic laboratories

Author

Capoluongo, E, Verde, N, Barberis, M, Bella, M, Buttitta, F, Carrera, P, Colombo, N, Cortesi, L, Gion, M, Guarneri, V, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Russo, A, Gori, S, Capoluongo, Ettore, Verde, Nicla La, Barberis, Massimo, Bella, Maria Angela, Buttitta, Fiamma, Carrera, Paola, Colombo, Nicoletta, Cortesi, Laura, Gion, Massimo, Guarneri, Valentina, Lorusso, Domenica, Marchetti, Antonio, Marchetti, Paolo, Normanno, Nicola, Pasini, Barbara, Pensabene, Matilde, Pignata, Sandro, Radice, Paolo, Ricevuto, Enrico, Sapino, Anna, Tagliaferri, Pierosandro, Tassone, Pierfrancesco, Trevisiol, Chiara, Truini, Mauro, Varesco, Liliana, Russo, Antonio, Gori, Stefania, Capoluongo, E, Verde, N, Barberis, M, Bella, M, Buttitta, F, Carrera, P, Colombo, N, Cortesi, L, Gion, M, Guarneri, V, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Russo, A, Gori, S, Capoluongo, Ettore, Verde, Nicla La, Barberis, Massimo, Bella, Maria Angela, Buttitta, Fiamma, Carrera, Paola, Colombo, Nicoletta, Cortesi, Laura, Gion, Massimo, Guarneri, Valentina, Lorusso, Domenica, Marchetti, Antonio, Marchetti, Paolo, Normanno, Nicola, Pasini, Barbara, Pensabene, Matilde, Pignata, Sandro, Radice, Paolo, Ricevuto, Enrico, Sapino, Anna, Tagliaferri, Pierosandro, Tassone, Pierfrancesco, Trevisiol, Chiara, Truini, Mauro, Varesco, Liliana, Russo, Antonio, and Gori, Stefania

Abstract

In Italy, 5200 new ovarian cancers were diagnosed in 2018, highlighting an increasing need to test women for BRCA1/2. The number of labs offering this test is continuously increasing. The aim of this study was to show the results coming from the intersociety survey coordinated by four different Clinical and Laboratory Italian Scientific Societies (AIOM, SIAPEC-IAP, SIBIOC, and SIGU). A multidisciplinary team belonging to the four scientific societies drew up two different questionnaires: One was targeted toward all Italian Departments of Medical Oncology, and the second toward laboratories of clinical molecular biology. This survey was implemented from September 2017 to March 2018. Seventy-seven out of 305 (25%) Departments of Medical Oncology filled our survey form. Indeed, 59 molecular laboratories were invited. A total of 41 laboratories (70%) filled in the questionnaire. From 2014 to 2017, 16 new molecular laboratories were activated. A total of 12,559 tests were performed in the year 2016, with a mean of 339 tests and a median of 254 tests per laboratory, showing a glimpse of an extreme low number of tests performed per year by some laboratories. In terms of the type and number of professionals involved in the pre- and post-test counseling, results among the onco-genetic team were heterogeneous. Our data show that the number of laboratories providing BRCA1/2 germline assays is significantly increased with further implementation of the somatic test coming soon. The harmonization of the complete laboratory diagnostic path should be encouraged, particularly in order to reduce the gap between laboratories with high and low throughput.

Published
2019

32. Recommendations for the implementation of BRCA testing in ovarian cancer patients and their relatives

Author

Gori, S, Barberis, M, Bella, M, Buttitta, F, Capoluongo, E, Carrera, P, Colombo, N, Cortesi, L, Genuardi, M, Gion, M, Guarneri, V, Incorvaia, L, La Verde, N, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Russo, A, Bella, MA, Pasini B, Gori, S, Barberis, M, Bella, M, Buttitta, F, Capoluongo, E, Carrera, P, Colombo, N, Cortesi, L, Genuardi, M, Gion, M, Guarneri, V, Incorvaia, L, La Verde, N, Lorusso, D, Marchetti, A, Marchetti, P, Normanno, N, Pasini, B, Pensabene, M, Pignata, S, Radice, P, Ricevuto, E, Sapino, A, Tagliaferri, P, Tassone, P, Trevisiol, C, Truini, M, Varesco, L, Russo, A, Bella, MA, and Pasini B

Abstract

The current availability of new Poly(ADP-ribose) Polymerase (PARP)-inhibitors for the treatment of ovarian cancer patients independently of the presence of a BRCA pathogenic variant, together with the validation of somatic test for the analysis of BRCA1/2 genes, involves the need to optimise the guidelines for BRCA testing. The AIOM-SIGU-SIBIOC-SIAPEC-IAP Italian Scientific Societies, in this position paper, recommend the implementation of BRCA testing with 2 main objectives: the first is the identification of ovarian cancer patients with higher probability of benefit from specific anticancer treatments (test for response to therapy); the second goal, through BRCA testing in the family members of ovarian cancer patients, is the identification of carriers of pathogenic variant, who have inheredited predisposition to cancer development (test for cancer risk). These individuals with increased risk of cancer, should be encouraged to participate in dedicated high-risk surveillance clinics and specific risk-reducing measures (primary and/or secondary prevention programs).

Published
2019

39. The role of HE4 in ovarian cancer follow-up: A review

Author

Piovano, E, Attamante, L, Macchi, C, Cavallero, C, Romagnolo, C, Maggino, T, Landoni, F, Gadducci, A, Sartori, E, Gion, M, Zola, P, Piovano E., Attamante L., Macchi C., Cavallero C., Romagnolo C., Maggino T., Landoni F., Gadducci A., Sartori E., Gion M., Zola P., Piovano, E, Attamante, L, Macchi, C, Cavallero, C, Romagnolo, C, Maggino, T, Landoni, F, Gadducci, A, Sartori, E, Gion, M, Zola, P, Piovano E., Attamante L., Macchi C., Cavallero C., Romagnolo C., Maggino T., Landoni F., Gadducci A., Sartori E., Gion M., and Zola P.

Abstract

Objective: The aim of this review was to analyze the state of the art about HE4 and follow-up in patients treated for ovarian cancer. Methods: A literature search was conducted in the MEDLINE database using the key words "HE4" and "ovarian cancer" and "recurrence" or "relapse" or "follow up." Results: Seven of 28 clinical studies were selected. Four studies were prospective, and all of them were based on a small number of patients (8Y73 women). A failure of HE4 levels to normalize at completion of standard therapy may indicate a poor prognosis, thus suggesting the need of a closer follow-up. Moreover, HE4 showed better sensibility and specificity in the diagnosis of ovarian cancer recurrence with respect to CA-125, being also an earlier indicator of the relapse with a lead time of 5 to 8 months. HE4 showed a better performance in this setting if performed in association with other markers (CA-125, CA-72.4). HE4 seems to be an independent predictive factor for the surgical outcome at secondary cytoreductive surgery and to maintain its prognostic role even after the recurrence. Conclusions: These preliminary data start to suggest a superiority of HE4 over CA-125 in the detection of ovarian cancer recurrence. Moreover, the prognostic role of HE4 could help clinicians to personalize the follow-up program, whereas its predictive role could be useful to plan the treatment of the relapse. The role of HE4 in ovarian cancer follow-up deserves to be further investigated in prospective randomized multicentric studies.

Published
2014

41. Three-monthly dynamic evaluation of CEA and CA15-3 and 18-FDG PET vs usual practice in the follow-up of early breast cancer patients: a prospective, multicenter, randomized trial (KRONOS – Patient-Oriented New Surveillance-Study Italy)

Author

Barbieri, E., primary, Gion, M., additional, Mariani, L., additional, Stieber, P., additional, Rubino, D., additional, Fanti, S., additional, Baum, R., additional, Wirtz, R., additional, Bernardi, A., additional, Cacciari, N., additional, Quercia, S., additional, Lenzi, M., additional, Cubelli, M., additional, Pizzirani, C., additional, Carapelle, M., additional, Pagliaro, M., additional, Tomasini, S., additional, Toracchio, S., additional, and Zamagni, C., additional

Published
2017
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42. Abstract OT3-05-01: Three-monthly dynamic evaluation of CEA and CA15-3 (followed by 18-FDG PET) vs usual practice in the follow-up of early breast cancer (BC) patients (pts): A prospective randomized trial (KRONOS-patient-oriented new surveillance study, Italy)

Author

Zamagni, C, primary, Gion, M, additional, Mariani, L, additional, Stieber, P, additional, Quercia, S, additional, Rubino, D, additional, Bernardi, A, additional, Cacciari, N, additional, Fini, A, additional, Lenzi, M, additional, Minichillo, S, additional, Pizzirani, C, additional, Pagliaro, M, additional, Tomasini, S, additional, and Barbieri, E, additional

Published
2017
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43. Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK)

Author

McShane, LM, Altman, DG, Sauerbrei, W, Taube, SE, Gion, M, Clark, GM, and Grp, SSNCI-EORTC

Subjects
Research design, Cancer Research, medicine.medical_specialty, Pathology, Biomedical Research, media_common.quotation_subject, Alternative medicine, Information Dissemination, MEDLINE, Guidelines as Topic, Context (language use), law.invention, Breast cancer, Randomized controlled trial, law, Neoplasms, Biomarkers, Tumor, Humans, Medicine, Quality (business), Medical physics, Generalizability theory, Intensive care medicine, media_common, Tumor marker, business.industry, General Medicine, Guideline, Prognosis, medicine.disease, Surgery, Oncology, Research Design, business
Abstract

Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons why multiple studies of the same marker lead to differing conclusions. A variety of methodological problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, preplanned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines provide helpful suggestions on how to present data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.

Published
2005

44. Experimental validation of specificity of the SCCA-IgM assay in patients with cirrhosis

Author

Zuin, J., Veggiani, G., Pengo, Paolo, Gallotta, A., Biasiolo, A., Tono, N., Gatta, A., Pontisso, P., Toth, R., Cerin, D., Frecer, V., Meo, S., Gion, M., Fassina, G., Beneduce, L., Zuin, J., Veggiani, G., Pengo, Paolo, Gallotta, A., Biasiolo, A., Tono, N., Gatta, A., Pontisso, P., Toth, R., Cerin, D., Frecer, V., Meo, S., Gion, M., Fassina, G., and Beneduce, L.

Subjects
diagnostic assay, immunesurveillance, autoantibodies, hepatocellular carcinoma immune complexes, natural IgM, hepatocellular carcinoma immune complexe, autoantibodie, cancer biomarker, cell carcinoma antigen-immunoglobulin M
Published
2010

45. Chromogranin A as a marker of neuroendocrine neoplasia: an Italian Multicenter Study

Author

Zatelli, M. C., DELLE FAVE, Gianfranco, Torta, M., Leon, A., Ambrosio, M. R., Gion, M., Tomassetti, P., De Braud, F., Delle, Fave, G., Dogliotti, L., Degli Uberti, E. C., Italian Cromanet Working Group, Zatelli M., Torta M., Leon A., Ambrosio M., Gion M., Tomassetti P., De Braud F., Delle Fave G., Dogliotti L., and degli Uberti E.C.

Subjects
Adult, Male, endocrine system, Cancer Research, medicine.medical_specialty, Pathology, Endocrinology, Diabetes and Metabolism, Enzyme-Linked Immunosorbent Assay, Neuroendocrine tumors, Gastroenterology, Endocrinology, Internal medicine, Positive predicative value, Active disease, medicine, Biomarkers, Tumor, Humans, In patient, Gastrointestinal Neoplasms, Neuroendocrine neoplasia, biology, business.industry, Chromogranin A, Middle Aged, medicine.disease, Pancreatic Neoplasms, Neuroendocrine Tumors, Oncology, Multicenter study, Italy, biology.protein, Female, business
Abstract

Elevated circulating chromogranin A (CgA) levels are found in neuroendocrine tumors (NETs), but the diagnostic usefulness of this marker is still debatable. To assess the role of CgA for the diagnosis of gastroenteropancreatic (GEP) NETs and the identification of metastatic patients, an Italian multicenter observational study has been performed. CgA was evaluated in 202 GEP NET patients by IRMA and ELISA. The cutoffs for diagnosis and presence of metastases were identified by receiver-operating characteristic (ROC) curve. We found good correlation between IRMA and ELISA. The ROC analysis identified a cutoff of 53 ng/ml for IRMA and 16 U/l for ELISA as discriminating between controls and patients with active disease (sensitivity 71.3 and 84%; specificity 71 and 85% respectively). Metastases were present in 123 patients, having significantly higher CgA levels than patients without metastases. ROC analysis identified a cutoff of 146 ng/ml for IRMA and 67.3 U/l for ELISA as discriminating between patients with and without metastases (sensitivity 57 and 63.3%; specificity 55.6 and 71.4% respectively). For pancreatic NETs positive and negative predictive values were 84 and 78% respectively (90% specificity and 68% sensitivity). We found lower CgA levels in patients with extensive metastatic spread than in those with liver metastases only. These data assess the role of CgA evaluation in GEP NETs, and demonstrate that higher CgA levels associate with metastatic disease, confirming that CgA levels can provide a helpful practical biochemical marker for the clinical management of NETs, but with low sensitivity and specificity.

Published
2007

47. Human and entomological surveillance of West Nile fever, dengue and chikungunya in Veneto Region, Italy, 2010-2012

Author

Bisoffi, Zeno, Capelli, G, Angheben, A, Giobbia, M, Conforto, M, Franzetti, M, Cattelan, Am, Raise, E, Rovere, P, Mulatti, P, Montarsi, F, Drago, A, Barzon, L, Napoletano, G, Zanella, F, Pozza, F, Russo, F, Rosi, P, Palù, G, Bisoffi, Z, Summer Fever Study Group, Concia, Ercole, Francavilla, E, Marranconi, F, Pellizzer, G, Scotton, P, Sgarabotto, D, Brugnaro, P, Del Bravo, P, Ferretto, R, Masini, G, Mondardini, V, Viviani, F, Piovesan, C, Postiglione, C, Cattai, M, Conti, A, Cusinato, R, Degani, M, Forti, A, Franchin, E, Gion, M, Marcante, R, Modolo, E, Pacenti, M, Rassu, M, Rigoli, R, Scarin, M, and Tonolli, Elisabetta

Subjects
Adult, Male, Veterinary medicine, Aedes albopictus, Adolescent, viruses, Dengue virus, Biology, medicine.disease_cause, West Nile, Dengue fever, Dengue, Young Adult, Culex pipiens, medicine, Animals, Humans, Chikungunya, Horses, Alphavirus infection, Aged, Aged, 80 and over, Travel, Surveillance, Alphavirus Infections, Outbreak, virus diseases, Dengue Virus, Middle Aged, medicine.disease, biology.organism_classification, Virology, Insect Vectors, Infectious Diseases, Culicidae, Italy, Epidemiological Monitoring, Chikungunya Fever, Female, Horse Diseases, Chikungunya virus, West Nile virus, Malaria, West Nile Fever, Research Article
Abstract

Background Since 2010 Veneto region (North-Eastern Italy) planned a special integrated surveillance of summer fevers to promptly identify cases of West Nile Fever (WNF), dengue (DENV) and chikungunya (CHIKV). The objectives of this study were (i) To increase the detection rate of imported CHIKV and DENV cases in travellers from endemic areas and promptly identify potential autochthonous cases.(ii) To detect autochthonous cases of WNF, besides those of West Nile Neuroinvasive Disease (WNND) that were already included in a national surveillance. Methods Human surveillance: a traveler who had returned within the previous 15 days from endemic countries, with fever >38°C, absence of leucocytosis (leukocyte count 38°C for

Published
2013

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