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4. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Bilancia, D., Rosati, G., Montesarchio, V., Iaffaioli, R.V., Nasti, G., Daniele, B., Zagonel, V., Lonardi, S., Pella, N., Aprile, G., Pasini, F., Marchetti, Roma P., Romiti, A., Ciuffreda, L., Ferrari, D., Foa, P., Zaniboni, A., Labianca, R., Mosconi, S., Sobrero, A., Bidoli, P., Cazzaniga, M., Beretta, G.D., Corsi, D.C., Cortesi, E., Barni, S., Petrelli, F., Allione, P., D'Arco, A.M., Valmadre, G., Piazza, E., Veltri, E., Ramus, G. Vietti, Giustini, L., Tumulo, S., Cascinu, S., Granetto, C., Testore, F., Giordano, M., Moroni, M., Di Seri, M., Nuzzo, A., Angelelli, L., Gori, S., Farina, G., Aglietta, M., Franchi, R., Comandé, M., Giordani, P., Tonini, G., Bucci, E., Ballestrero, A., Benasso, M., Graiff, C., Bravi, S., Caffo, O., Silva, R.R., Frontini, L., Rota, S., Cozzi, L., Cantore, M., Maiello, E., Cinieri, S., Silvestris, N., Romito, S., Gebbia, V., Banzi, M., Santoro, A., Artioli, F., Mattioli, R., Contu, A., Di Costanzo, F., Leonardi, F., Cavanna, L., Passalacqua, R., Amoroso, D., Sozzi, P., D'Amico, M., Amadori, D., Frassineti, L., Turci, D., Ravaioli, A., Pasquini, E., Gambi, A., Faedi, M., Cruciani, G., Bajetta, E., Di Bartolomeo, M., Gianni, L., Ronzoni, M., Ionta, M.T., Massidda, B., Scartozzi, M., Zampino, M.G., Bochicchio, A.M., Ciarlo, A., Di Leo, A., Frustaci, S., Rangoni, G., Arizzoia, A., Pavesi, L., Verusio, C., Pinotti, G., Iop, A., De Placido, S., Carlomagno, C., Adamo, V., Ficorella, C., Natale, D., Greco, E., Rulli, E., Galli, F., Poli, D., Porcu, L., Torri, V., Rosati, Gerardo, Lonardi, Sara, Galli, Fabio, Di Bartolomeo, Maria, Ronzoni, Monica, Zampino, Maria G., Banzi, Maria, Zaniboni, Alberto, Pasini, Felice, Bozzarelli, Silvia, Garattini, Silvio K., Ferrari, Daris, Montesarchio, Vincenzo, Mambrini, Andrea, Ciuffreda, Libero, Galli, Francesca, Pusceddu, Valeria, Carlomagno, Chiara, Bidoli, Paolo, Amoroso, Domenico, Bochicchio, Anna M., Frassineti, Luca, Corsi, Domenico, Bilancia, Domenico, Pastorino, Alessandro, De Stefano, Alfonso, and Labianca, Roberto

Published
2021
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6. Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial

Author

Ostuzzi, G, Gastaldon, C, Tettamanti, M, Cartabia, M, Monti, I, Aguglia, A, Aguglia, E, Bartoli, F, Callegari, C, Canozzi, A, Carbone, E, Carrà, G, Caruso, R, Cavallotti, S, Chiappini, S, Colasante, F, Compri, B, D'Agostino, A, De Fazio, P, de Filippis, R, Gari, M, Ielmini, M, Ingrosso, G, Mammarella, S, Martinotti, G, Rodolico, A, Roncone, R, Sterzi, E, Tarsitani, L, Tiberto, E, Todini, L, Amaddeo, F, D'Avanzo, B, Barbato, A, Barbui, C, Alessi, M, Avincola, G, Bachi, B, Bernasconi, G, Birgillito, A, Bisso, E, Bonora, S, Calabrese, A, Callovini, T, Canestro, A, Canonico, S, Capogrosso, C, Carosielli, D, Caselli, I, Cavaleri, D, Cavallotto, C, Cesca, M, Chiarenza, C, Cioni, R, Coloccini, S, Cruciata, M, Cumerlato, C, De Filippis, R, De Palma, M, Del Vecchio, S, Della Rocca, B, Di Natale, C, D'Onofrio, E, Espa, I, Fior, G, Gancitano, M, Giordano, B, Giusti, L, Grassi, L, Guzzi, P, Isella, C, Lax, A, Marano, L, Marconi, F, Marella, M, Metelli, A, Michencig, G, Miuli, A, Moncada, A, Morello, P, Moretti, F, Morreale, M, Mosca, A, Nasti, C, Nosé, M, Ogheri, F, Oresti, M, Ornaghi, A, Palpella, D, Pancheri, C, Papola, D, Passeri, S, Pettorusso, M, Piacenti, S, Pinucci, I, Pugliese, V, Purgato, M, Rania, M, Robbi, F, Romito, S, Ronchi, B, Roselli, V, Segura-Garcia, C, Signorelli, M, Simonelli, G, Sociali, A, Sturiale, S, Tambelli, A, Todesco, B, Trabucco, A, Turrini, G, Villa, V, Wiedenmann, F, Zambuto, L, Zanini, E, Zannini, C, Zerbinati, L, Ostuzzi, Giovanni, Gastaldon, Chiara, Tettamanti, Mauro, Cartabia, Massimo, Monti, Igor, Aguglia, Andrea, Aguglia, Eugenio, Bartoli, Francesco, Callegari, Camilla, Canozzi, Andrea, Carbone, Elvira Anna, Carrà, Giuseppe, Caruso, Rosangela, Cavallotti, Simone, Chiappini, Stefania, Colasante, Fabrizio, Compri, Beatrice, D'Agostino, Armando, De Fazio, Pasquale, de Filippis, Renato, Gari, Matteo, Ielmini, Marta, Ingrosso, Gianmarco, Mammarella, Silvia, Martinotti, Giovanni, Rodolico, Alessandro, Roncone, Rita, Sterzi, Enrico, Tarsitani, Lorenzo, Tiberto, Elisa, Todini, Liliana, Amaddeo, Francesco, D'Avanzo, Barbara, Barbato, Angelo, Barbui, Corrado, Alessi, Maria Chiara, Avincola, Gabriele, Bachi, Bianca, Bernasconi, Gianna, Birgillito, Andrea, Bisso, Emanuele, Bonora, Stefano, Calabrese, Angela, Callovini, Tommaso, Canestro, Aurelia, Canonico, Salvo, Capogrosso, Chiara Alessandra, Carbone, Elvira, Carosielli, Doriana, Caselli, Ivano, Cavaleri, Daniele, Cavallotto, Clara, Cesca, Marco, Chiarenza, Cecilia, Cioni, Riccardo Matteo, Coloccini, Sara, Cruciata, Marco, Cumerlato, Claudia, De Filippis, Renato, De Palma, Manuela, Del Vecchio, Sasha, Della Rocca, Bianca, Di Natale, Chiara, D'Onofrio, Ettore, Espa, Irene, Fior, Giulia, Gancitano, Marta, Giordano, Barbara, Giusti, Laura, Grassi, Luigi, Guzzi, Pierluca, Isella, Celeste, Lax, Annamaria, Marano, Leonardo, Marconi, Federico, Marella, Marco, Metelli, Alessia, Michencig, Giulia, Miuli, Andrea, Moncada, Alessandro, Morello, Pietro, Moretti, Federico, Morreale, Marco, Mosca, Alessio, Nasti, Christian, Nosé, Michela, Ogheri, Filippo, Oresti, Margherita, Ornaghi, Alessandra, Palpella, Dario, Pancheri, Corinna, Papola, Davide, Passeri, Silvia, Pettorusso, Mauro, Piacenti, Susanna, Pinucci, Irene, Pugliese, Valentina, Purgato, Marianna, Rania, Marianna, Robbi, Federica, Romito, Samantha, Ronchi, Barbara, Roselli, Valentina, Segura-Garcia, Cristina, Signorelli, Maria Salvina, Simonelli, Gabriele, Sociali, Antonella, Sturiale, Serena, Tambelli, Antonio, Todesco, Beatrice, Trabucco, Alice, Turrini, Giulia, Villa, Veronica, Wiedenmann, Federico, Zambuto, Luca, Zanini, Elisa, Zannini, Chiara, Zerbinati, Luigi, Ostuzzi, G, Gastaldon, C, Tettamanti, M, Cartabia, M, Monti, I, Aguglia, A, Aguglia, E, Bartoli, F, Callegari, C, Canozzi, A, Carbone, E, Carrà, G, Caruso, R, Cavallotti, S, Chiappini, S, Colasante, F, Compri, B, D'Agostino, A, De Fazio, P, de Filippis, R, Gari, M, Ielmini, M, Ingrosso, G, Mammarella, S, Martinotti, G, Rodolico, A, Roncone, R, Sterzi, E, Tarsitani, L, Tiberto, E, Todini, L, Amaddeo, F, D'Avanzo, B, Barbato, A, Barbui, C, Alessi, M, Avincola, G, Bachi, B, Bernasconi, G, Birgillito, A, Bisso, E, Bonora, S, Calabrese, A, Callovini, T, Canestro, A, Canonico, S, Capogrosso, C, Carosielli, D, Caselli, I, Cavaleri, D, Cavallotto, C, Cesca, M, Chiarenza, C, Cioni, R, Coloccini, S, Cruciata, M, Cumerlato, C, De Filippis, R, De Palma, M, Del Vecchio, S, Della Rocca, B, Di Natale, C, D'Onofrio, E, Espa, I, Fior, G, Gancitano, M, Giordano, B, Giusti, L, Grassi, L, Guzzi, P, Isella, C, Lax, A, Marano, L, Marconi, F, Marella, M, Metelli, A, Michencig, G, Miuli, A, Moncada, A, Morello, P, Moretti, F, Morreale, M, Mosca, A, Nasti, C, Nosé, M, Ogheri, F, Oresti, M, Ornaghi, A, Palpella, D, Pancheri, C, Papola, D, Passeri, S, Pettorusso, M, Piacenti, S, Pinucci, I, Pugliese, V, Purgato, M, Rania, M, Robbi, F, Romito, S, Ronchi, B, Roselli, V, Segura-Garcia, C, Signorelli, M, Simonelli, G, Sociali, A, Sturiale, S, Tambelli, A, Todesco, B, Trabucco, A, Turrini, G, Villa, V, Wiedenmann, F, Zambuto, L, Zanini, E, Zannini, C, Zerbinati, L, Ostuzzi, Giovanni, Gastaldon, Chiara, Tettamanti, Mauro, Cartabia, Massimo, Monti, Igor, Aguglia, Andrea, Aguglia, Eugenio, Bartoli, Francesco, Callegari, Camilla, Canozzi, Andrea, Carbone, Elvira Anna, Carrà, Giuseppe, Caruso, Rosangela, Cavallotti, Simone, Chiappini, Stefania, Colasante, Fabrizio, Compri, Beatrice, D'Agostino, Armando, De Fazio, Pasquale, de Filippis, Renato, Gari, Matteo, Ielmini, Marta, Ingrosso, Gianmarco, Mammarella, Silvia, Martinotti, Giovanni, Rodolico, Alessandro, Roncone, Rita, Sterzi, Enrico, Tarsitani, Lorenzo, Tiberto, Elisa, Todini, Liliana, Amaddeo, Francesco, D'Avanzo, Barbara, Barbato, Angelo, Barbui, Corrado, Alessi, Maria Chiara, Avincola, Gabriele, Bachi, Bianca, Bernasconi, Gianna, Birgillito, Andrea, Bisso, Emanuele, Bonora, Stefano, Calabrese, Angela, Callovini, Tommaso, Canestro, Aurelia, Canonico, Salvo, Capogrosso, Chiara Alessandra, Carbone, Elvira, Carosielli, Doriana, Caselli, Ivano, Cavaleri, Daniele, Cavallotto, Clara, Cesca, Marco, Chiarenza, Cecilia, Cioni, Riccardo Matteo, Coloccini, Sara, Cruciata, Marco, Cumerlato, Claudia, De Filippis, Renato, De Palma, Manuela, Del Vecchio, Sasha, Della Rocca, Bianca, Di Natale, Chiara, D'Onofrio, Ettore, Espa, Irene, Fior, Giulia, Gancitano, Marta, Giordano, Barbara, Giusti, Laura, Grassi, Luigi, Guzzi, Pierluca, Isella, Celeste, Lax, Annamaria, Marano, Leonardo, Marconi, Federico, Marella, Marco, Metelli, Alessia, Michencig, Giulia, Miuli, Andrea, Moncada, Alessandro, Morello, Pietro, Moretti, Federico, Morreale, Marco, Mosca, Alessio, Nasti, Christian, Nosé, Michela, Ogheri, Filippo, Oresti, Margherita, Ornaghi, Alessandra, Palpella, Dario, Pancheri, Corinna, Papola, Davide, Passeri, Silvia, Pettorusso, Mauro, Piacenti, Susanna, Pinucci, Irene, Pugliese, Valentina, Purgato, Marianna, Rania, Marianna, Robbi, Federica, Romito, Samantha, Ronchi, Barbara, Roselli, Valentina, Segura-Garcia, Cristina, Signorelli, Maria Salvina, Simonelli, Gabriele, Sociali, Antonella, Sturiale, Serena, Tambelli, Antonio, Todesco, Beatrice, Trabucco, Alice, Turrini, Giulia, Villa, Veronica, Wiedenmann, Federico, Zambuto, Luca, Zanini, Elisa, Zannini, Chiara, and Zerbinati, Luigi

Abstract

Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01–2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depress

Published
2024

9. Heterogeneity of KRAS, NRAS, BRAF and PIK3CA mutations in metastatic colorectal cancer and potential effects on therapy in the CAPRI GOIM trial

Author

Normanno, N., Rachiglio, A.M., Lambiase, M., Martinelli, E., Fenizia, F., Esposito, C., Roma, C., Troiani, T., Rizzi, D., Tatangelo, F., Botti, G., Maiello, E., Colucci, G., Ciardiello, F., Giuliani, F., Simone, G., Febbraro, A., Tommaselli, E., Cinieri, S., Criscuolo, M., Perrino, A., Rinaldi, A., Bordonaro, R., Manusia, M., Romito, S., Bufo, P., Cartenì, G., Biglietto, M., Nappi, O., Cardarelli, A., Montesarchio, E., Micheli, P., Nasti, G., Chicchinelli, N., Iannaccone, A., Russo, A., Cabibi, D., Giaccone, P., Barone, C., Rindi, G., Tonini, G., Onetti Muda, A., Perrone, G., Latiano, T., Graziano, P., Pisconti, S., and Sebastio, A.

Published
2015
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10. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., Torri V., Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., and Torri V.

Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study. Results: Older patients compared with younger ones presented more frequently an Eastern Cooperative Oncology Group performance status equal to 1 (10.5% vs 3.3%, p < 0.001), a greater number of right-sided tumours (40.9% vs 26.6%, p < 0.001), and were at higher clinical risk (37.2% vs 33.2%, p = 0.062). The treatments were almost identical in the two cohorts (p = 0.965). We found a greater proportion of dose reductions (46.7% vs 41.4%, p = 0.018), treatment interruptions (26.1% vs 19.3%, p < 0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p = 0.033) in the older patients. The multivariable analysis of the TTR did not indicate a statistically significant effect of age (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 0.98–1.44; p = 0.082). The HR comparing older with younger patients was 1.34 (95% CI: 1.12–1.59; p = 0.001) for DFS, 1.58 (95% CI: 1.26–1.99; p < 0.001) for OS, and 1.28 (95% CI: 0.96–1.70; p = 0.089) for CSS. Conclusions: Worse prognostic factors and reduced treatment compliance have a negative impact on the efficacy of oxaliplatin-based adjuvant therapy in older patients.

Published
2021

13. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, Gerardo, primary, Lonardi, Sara, additional, Galli, Fabio, additional, Di Bartolomeo, Maria, additional, Ronzoni, Monica, additional, Zampino, Maria G., additional, Banzi, Maria, additional, Zaniboni, Alberto, additional, Pasini, Felice, additional, Bozzarelli, Silvia, additional, Garattini, Silvio K., additional, Ferrari, Daris, additional, Montesarchio, Vincenzo, additional, Mambrini, Andrea, additional, Ciuffreda, Libero, additional, Galli, Francesca, additional, Pusceddu, Valeria, additional, Carlomagno, Chiara, additional, Bidoli, Paolo, additional, Amoroso, Domenico, additional, Bochicchio, Anna M., additional, Frassineti, Luca, additional, Corsi, Domenico, additional, Bilancia, Domenico, additional, Pastorino, Alessandro, additional, De Stefano, Alfonso, additional, Labianca, Roberto, additional, Bilancia, D., additional, Rosati, G., additional, Montesarchio, V., additional, Iaffaioli, R.V., additional, Nasti, G., additional, Daniele, B., additional, Zagonel, V., additional, Lonardi, S., additional, Pella, N., additional, Aprile, G., additional, Pasini, F., additional, Marchetti, Roma P., additional, Romiti, A., additional, Ciuffreda, L., additional, Ferrari, D., additional, Foa, P., additional, Zaniboni, A., additional, Labianca, R., additional, Mosconi, S., additional, Sobrero, A., additional, Bidoli, P., additional, Cazzaniga, M., additional, Beretta, G.D., additional, Corsi, D.C., additional, Cortesi, E., additional, Barni, S., additional, Petrelli, F., additional, Allione, P., additional, D'Arco, A.M., additional, Valmadre, G., additional, Piazza, E., additional, Veltri, E., additional, Ramus, G. Vietti, additional, Giustini, L., additional, Tumulo, S., additional, Cascinu, S., additional, Granetto, C., additional, Testore, F., additional, Giordano, M., additional, Moroni, M., additional, Di Seri, M., additional, Nuzzo, A., additional, Angelelli, L., additional, Gori, S., additional, Farina, G., additional, Aglietta, M., additional, Franchi, R., additional, Comandé, M., additional, Giordani, P., additional, Tonini, G., additional, Bucci, E., additional, Ballestrero, A., additional, Benasso, M., additional, Graiff, C., additional, Bravi, S., additional, Caffo, O., additional, Silva, R.R., additional, Frontini, L., additional, Rota, S., additional, Cozzi, L., additional, Cantore, M., additional, Maiello, E., additional, Cinieri, S., additional, Silvestris, N., additional, Romito, S., additional, Gebbia, V., additional, Banzi, M., additional, Santoro, A., additional, Artioli, F., additional, Mattioli, R., additional, Contu, A., additional, Di Costanzo, F., additional, Leonardi, F., additional, Cavanna, L., additional, Passalacqua, R., additional, Amoroso, D., additional, Sozzi, P., additional, D'Amico, M., additional, Amadori, D., additional, Frassineti, L., additional, Turci, D., additional, Ravaioli, A., additional, Pasquini, E., additional, Gambi, A., additional, Faedi, M., additional, Cruciani, G., additional, Bajetta, E., additional, Di Bartolomeo, M., additional, Gianni, L., additional, Ronzoni, M., additional, Ionta, M.T., additional, Massidda, B., additional, Scartozzi, M., additional, Zampino, M.G., additional, Bochicchio, A.M., additional, Ciarlo, A., additional, Di Leo, A., additional, Frustaci, S., additional, Rangoni, G., additional, Arizzoia, A., additional, Pavesi, L., additional, Verusio, C., additional, Pinotti, G., additional, Iop, A., additional, De Placido, S., additional, Carlomagno, C., additional, Adamo, V., additional, Ficorella, C., additional, Natale, D., additional, Greco, E., additional, Rulli, E., additional, Galli, F., additional, Poli, D., additional, Porcu, L., additional, and Torri, V., additional

Published
2021
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15. Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study

Author

Conte, P., Frassoldati, A., Bisagni, G., Brandes, A. A., Donadio, M., Garrone, O., Piacentini, F., Cavanna, L., Giotta, F., Aieta, M., Gebbia, V., Molino, A., Musolino, A., Ferro, A., Maltoni, R., Danese, S., Zamagni, C., Rimanti, A., Cagossi, K., Russo, A., Pronzato, P., Giovanardi, F., Moretti, G., Lombardo, L., Schirone, A., Beano, A., Amaducci, L., Bajardi, E. A., Vicini, R., Balduzzi, S., D'Amico, R., Guarneri, Falci C, V., Giarratano, T, Mcmahon, L, De Salvo GL, Dieci, Mv, Maiorana, A, Ficarra, G, Caggia, F, Grisolia, D, Bartolini, S, Lorusso, V, Ardito, R, Tartarone, A, Vanella, P, Taverniti, C, Porpiglia, M, Spanu, Pg, Biglia, N, Andreis, D, Piancastelli, A, Fedeli, A, Parra, Hs, Gambaro, Ar, Romito, S, Malossi, A, Gori, S, Miglietta, L, Del Mastro, L, Amoroso, D, Mansutti, M, Generali, D, Prati, G, Bertolini, A, Berardi, R, Zanni, A, Cottafavi, L, Bologna, A, Naso, G, Pancotti, A, Farci, D, Zoboli, A, Silva, R, Laudadio, L, Bordonaro, R, Marenco, D, Dongiovanni, V, Baldini, E, Saggia, C, Gorzegno, G, Cariello, A, Biganzoli, L, Rampello, E., Conte P., Frassoldati A., Bisagni G., Brandes A.A., Donadio M., Garrone O., Piacentini F., Cavanna L., Giotta F., Aieta M., Gebbia V., Molino A., Musolino A., Ferro A., Maltoni R., Danese S., Zamagni C., Rimanti A., Cagossi K., Russo A., Pronzato P., Giovanardi F., Moretti G., Lombardo L., Schirone A., Beano A., Amaducci L., Bajardi E.A., Vicini R., Balduzzi S., D'Amico R., and Guarneri V.

Subjects
Oncology, Time Factors, Adjuvant, Breast cancer, Cardiac safety, De-escalated treatment, Trastuzumab, Settore MED/06 - Oncologia Medica, Receptor, ErbB-2, medicine.medical_treatment, Anthracycline, 030204 cardiovascular system & hematology, Breast cancer, Antineoplastic Agents, Immunological, ErbB-2, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Anthracyclines, skin and connective tissue diseases, Adjuvant, Mastectomy, Cardiac safety, De-escalated treatment, Hazard ratio, Hematology, Middle Aged, Chemotherapy regimen, Bridged-Ring Compound, Immunological, Local, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Taxoids, Trastuzumab, adjuvant, breast cancer, cardiac safety, de-escalated treatment, Breast Neoplasm, Human, Receptor, medicine.drug, Adult, Bridged-Ring Compounds, medicine.medical_specialty, Time Factor, Socio-culturale, Breast Neoplasms, Antineoplastic Agents, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Taxoid, Internal medicine, medicine, Humans, Chemotherapy, Risk factor, Aged, Neoplasm Staging, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Cardiotoxicity, Neoplasm Recurrence, Neoplasm Recurrence, Local, business
Abstract

Background: Chemotherapy plus 1-year trastuzumab is the standard adjuvant treatment of HER2-positive breast cancer. The efficacy of less extended trastuzumab exposure is under investigation. The short-HER study was aimed to assess the non-inferiority of 9 weeks versus 1 year of adjuvant trastuzumab combined with chemotherapy. Patients and methods: HER2-positive breast cancer patients with node-positive or, if node negative, with at least one risk factor (pT>2 cm, G3, lympho-vascular invasion, Ki-67 > 20%, age 35 years, or hormone receptor negativity) were randomly assigned to receive sequential anthracycline-taxane combinations plus 1-year trastuzumab (arm A, long) or plus 9 weeks trastuzumab (arm B, short). This study was designed as a non-inferiority trial with disease-free survival (DFS) as primary end point. A DFS hazard ratio (HR)

Published
2018
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17. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Carteni, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, Cn, Procopio, G, Falcone, A, Roila, F, Cascinu, S, Tirelli, U, Giustini, L, Sobrero, A, Cappuzzo, F, Tortora, G, Tassinari, D, Passalacqua, R, Pazzola, A, Surico, G, Maio, M, Benedetti, G, Barone, C, Adamo, V, Ricevuto, E, De Censi, A, Spada, M, Tonini, G, Pinto, C, Ciuffreda, L, Ruggeri, Em, Bengala, C, Scotti, V, Fagnani, D, Bonetti, A, Mitterer, M, Castiglione, F, Bidoli, P, Ferrau, F, Crino, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Favaretto, A, Di Costanzo, F, Fasola, G, Merlano, M, Artioli, F, Di Leo, A, Romito, S, Maestri, A, Giorgio, Cg, Ionta, Mt, Verderame, F, Zampa, G, Numico, G, Minelli, M, Tagliaferri, P, Foa, P, Palmiotti, G, De Placido, S, Mattioli, R, Iuliano, F, Defraia, E, Siena, S, Clerico, M, Salvagno, L, Ceresoli, Gl, Bernardo, A, Di Lieto, M, Moroni, M, Maisano, M, Scartozzi, M, Scagliotti, G, Soraru, M, Pepe, S, Scaltriti, A, Gebbia, V, Testa, E, Lorusso, V, Bordonaro, R, De Signoribus, G, Tedde, N, Santoro, A, Francini, G, Aondio, G, De Giorgi, U., Carteni, G., Giannarelli, D., Basso, U., Galli, L., Cortesi, E., Caserta, C., Pignata, S., Sabbatini, R., Bearz, A., Buti, S., Lo Re, G., Berruti, A., Bracarda, S., Cognetti, F., Rastelli, F., Fornarini, G., Porta, C., Turci, D., Sternberg, C. N., Procopio, G., Falcone, A., Roila, F., Cascinu, S., Tirelli, U., Giustini, L., Sobrero, A., Cappuzzo, F., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., Maio, M., Benedetti, G., Barone, C., Adamo, V., Ricevuto, E., De Censi, A., Spada, M., Tonini, G., Pinto, C., Ciuffreda, L., Ruggeri, E. M., Bengala, C., Scotti, V., Fagnani, D., Bonetti, A., Mitterer, M., Castiglione, F., Bidoli, P., Ferrau, F., Crino, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Favaretto, A., Di Costanzo, F., Fasola, G., Merlano, M., Artioli, F., Di Leo, A., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M. T., Verderame, F., Zampa, G., Numico, G., Minelli, M., Tagliaferri, P., Foa, P., Palmiotti, G., De Placido, S., Mattioli, R., Iuliano, F., Defraia, E., Siena, S., Clerico, M., Salvagno, L., Ceresoli, G. L., Bernardo, A., Di Lieto, M., Moroni, M., Maisano, M., Scartozzi, M., Scagliotti, G., Soraru, M., Pepe, S., Scaltriti, A., Gebbia, V., Testa, E., Lorusso, V., Bordonaro, R., De Signoribus, G., Tedde, N., Santoro, A., Francini, G., Aondio, G., De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, and Bidoli, P

Subjects
0301 basic medicine, Male, expanded access programme, nivolumab, real-world experience, renal cell cancer, Antineoplastic Agent, 0302 clinical medicine, Antineoplastic Agents, Immunological, 80 and over, Sunitinib, Medicine, Urology, Aged, 80 and over, Sulfonamides, Brain Neoplasms, Kidney Neoplasm, Common Terminology Criteria for Adverse Events, Middle Aged, Kidney Neoplasms, Progression-Free Survival, Survival Rate, Everolimu, Immunological, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Retreatment, Female, Nivolumab, medicine.drug, Human, Adult, medicine.medical_specialty, Indazoles, metastatic renal cancer, Response Evaluation Criteria in Solid Tumor, Antineoplastic Agents, Bone Neoplasms, Bone Neoplasm, expanded access programme, nivolumab, real-world experience, renal cell cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Agents, Immunological, Bone Neoplasms, Brain Neoplasms, Carcinoma, Renal Cell, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Pyrimidines, Response Evaluation Criteria in Solid Tumors, Retreatment, Sulfonamides, Sunitinib, Survival Rate, Sulfonamide, Pazopanib, Brain Neoplasm, 03 medical and health sciences, Aged, Carcinoma, Renal Cell, Everolimus, Humans, Pyrimidines, Internal medicine, Progression-free survival, Survival rate, business.industry, Carcinoma, Renal Cell, 030104 developmental biology, Pyrimidine, Expanded access, business
Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

18. Business for Ocean Sustainability

Author

Totaro, L., Fumagalli, F., Daminelli, R., Santicoli, C., Perin, G., De Silvio, G., Perrini, F., Pogutz, S., Romito, S., Saputo, A., and Sardá, Rafael

Subjects
education
Published
2020

21. Everolimus Plus Exemestane in Advanced Breast Cancer: Safety Results of the BALLET Study on Patients Previously Treated Without and with Chemotherapy in the Metastatic Setting

Author

Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, Piovano P, Ionta MT, Bighin C, Sartori D, Frassoldati A, Cazzaniga ME, Riccardi F, Testore F, Vici P, Barone CA, Schirone A, Piacentini F, Nolè F, Molino A, Latini L, Simoncini EL, Roila F, Cognetti F, Nuzzo F, Foglietta J, Minisini AM, Goffredo F, Portera G, Ascione G, Mariani G, Cazzaniga M, contributor, Generali, D, Montemurro, F, Bordonaro, R, Mafodda, A, Romito, S, Michelotti, A, Piovano, P, Ionta, M, Bighin, C, Sartori, D, Frassoldati, A, Cazzaniga, M, Riccardi, F, Testore, F, Vici, P, Barone, C, Schirone, A, Piacentini, F, Nolè, F, Molino, A, Latini, L, Simoncini, E, Roila, F, Cognetti, F, Nuzzo, F, Foglietta, J, Minisini, A, Goffredo, F, Portera, G, Ascione, G, Mariani, G, Contributor, Generali, Daniele, Montemurro, F., Bordonaro, R., Mafodda, A., Romito, S., Michelotti, A., Piovano, P., Ionta, M. T., Bighin, C., Sartori, D., Frassoldati, A., Cazzaniga, M. E., Riccardi, F., Testore, F., Vici, P., Barone, C. A. ., Schirone, Alice, Piacentini, F., Nolè, F., Molino, A., Latini, L., Simoncini, E. L., Roila, F., Cognetti, Francesca, Nuzzo, Federica, Foglietta, J., Minisini, A. M., Goffredo, F., Portera, G., Ascione, G., and Mariani, G.

Subjects
0301 basic medicine, Oncology, Cancer Research, Advanced breast cancer, Everolimus, Hormone-receptor positive, Real life, Safety, medicine.medical_treatment, chemistry.chemical_compound, 0302 clinical medicine, Exemestane, Antineoplastic Combined Chemotherapy Protocols, Medicine, Neoplasm Metastasis, Aged, 80 and over, advanced breast cancer, everolimus, hormone-receptor positive, real life, safety, Middle Aged, Metastatic breast cancer, Everolimu, Italy, 030220 oncology & carcinogenesis, Female, medicine.drug, Hormone‐receptor positive, Adult, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, Socio-culturale, Breast Neoplasms, Everolimus Plus Exemestane, Advanced Breast Cancer, BALLET Study, 03 medical and health sciences, Breast cancer, Internal medicine, Post-hoc analysis, Breast Cancer, Humans, Adverse effect, Aged, Chemotherapy, business.industry, medicine.disease, Androstadienes, Regimen, 030104 developmental biology, chemistry, business
Abstract

BACKGROUND: The BALLET study was an open-label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). PATIENTS AND METHODS: One thousand one hundred and fifty-one Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). RESULTS: One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus-related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus-related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. CONCLUSION: Real-life data of the Italian patients BALLET-related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. The Oncologist 2017;22:1-8Implications for Practice: With the advent of new targeted agents for advanced or metastatic breast cancer, multiple lines of therapy may be possible, and components of the combined regimens can overlap from one line to another. Thus, it is important to assess even the potential of cumulative and additive toxic effects among the drugs. Previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane. The continuous monitoring of the safety signals of this drug combination from general clinical practice is important, in particular for stomatitis.

Published
2016

22. Idiopathic delayed-onset edema surrounding deep brain stimulation leads: Insights from a case series and systematic literature review

Author

de Cuba, C. M. K. E., Albanese, Antonini, Angelo, Cossu, A., Deuschl, G., Eleopra, G., Galati, R., Hoffmann, A., Knudsen, C. F. E., Landi, K., Lanotte, A., Marcante, M. M. R., Mosch, A., Pilleri, A., Reich, M., Ricchi, M. M., Rinaldo, V., Romito, S., Saba, L. M., Sacristan, F. S., Schuurman, H. E., Trezza, P. R., van den Munckhof, A., Volkmann, P., Zibetti, J., Contarino, M., and Marcante, Andrea

Subjects
Male, medicine.medical_specialty, Complications, Deep brain stimulation, Neurology, medicine.medical_treatment, Brain Edema, Databases, 03 medical and health sciences, Delayed onset, Edema, Databases, Bibliographic, Deep Brain Stimulation, Female, Humans, Magnetic Resonance Imaging, Middle Aged, Retrospective Studies, Geriatrics and Gerontology, Neurology (clinical), 0302 clinical medicine, medicine, 030212 general & internal medicine, Bibliographic, business.industry, Pathophysiology, Surgery, Settore MED/26 - NEUROLOGIA, Systematic review, Etiology, medicine.symptom, Complication, business, 030217 neurology & neurosurgery
Abstract

Introduction Deep brain stimulation (DBS) is effective for some neurological and psychiatric conditions. Idiopathic delayed-onset edema (IDE) surrounding the leads has been anecdotally reported. The etiology, predisposing factors and prognosis of this complication are unknown. We present a multicenter case series of patients with IDE, and a systematic literature review, aimed at defining the pathophysiology and identifying appropriate treatment strategies. Methods IDE was defined as edema along the DBS lead, occurring ≥72 h postoperatively, in absence of trauma, vascular events or infection. Information on patients with IDE was collected in a standardized way. A systematic search was performed in Pubmed. Results Twelve new patients presenting with 14 episodes of IDE are described. From the literature, 38 patients were identified. No common surgical aspects or patient-related factors were identified as risk predictors for the onset of IDE. Symptoms included deterioration of the stimulation effect, seizures and focal neurological signs. Although the condition is self-limiting, with symptoms resolution in 28.5 days on average, three patients underwent surgical revision and seven received antibiotics. Conclusions IDE is a rare complication of DBS procedures, presenting from few days to months after surgery. Symptoms can be mild and not-specific, and the condition is self-limiting. The diagnosis of IDE is made after exclusion of vascular events or infections. The pathophysiology is still unexplained. The recognition of this complication can help avoiding unnecessary surgical procedures (system explantation) and antibiotic treatment.

Published
2016
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23. Everolimus plus exemestane in advanced breast cancer: Safety results of the BALLET study on patients previously treatedwithout and with chemotherapy in the metastatic setting

Author

Generali, D, Montemurro, F, Bordonaro, R, Mafodda, A, Romito, S, Michelotti, A, Piovano, P, Ionta, M, Bighin, C, Sartori, D, Frassoldati, A, Cazzaniga, M, Riccardi, F, Testore, F, Vici, P, Barone, C, Schirone, A, Piacentini, F, Nolè, F, Molino, A, Latini, L, Simoncini, E, Roila, F, Cognetti, F, Nuzzo, F, Foglietta, J, Minisini, A, Goffredo, F, Portera, G, Ascione, G, Mariani, G, Contributor, Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, Piovano P, Ionta MT, Bighin C, Sartori D, Frassoldati A, Cazzaniga ME, Riccardi F, Testore F, Vici P, Barone CA, Schirone A, Piacentini F, Nolè F, Molino A, Latini L, Simoncini EL, Roila F, Cognetti F, Nuzzo F, Foglietta J, Minisini AM, Goffredo F, Portera G, Ascione G, Mariani G, Cazzaniga M, contributor, Generali, D, Montemurro, F, Bordonaro, R, Mafodda, A, Romito, S, Michelotti, A, Piovano, P, Ionta, M, Bighin, C, Sartori, D, Frassoldati, A, Cazzaniga, M, Riccardi, F, Testore, F, Vici, P, Barone, C, Schirone, A, Piacentini, F, Nolè, F, Molino, A, Latini, L, Simoncini, E, Roila, F, Cognetti, F, Nuzzo, F, Foglietta, J, Minisini, A, Goffredo, F, Portera, G, Ascione, G, Mariani, G, Contributor, Generali D, Montemurro F, Bordonaro R, Mafodda A, Romito S, Michelotti A, Piovano P, Ionta MT, Bighin C, Sartori D, Frassoldati A, Cazzaniga ME, Riccardi F, Testore F, Vici P, Barone CA, Schirone A, Piacentini F, Nolè F, Molino A, Latini L, Simoncini EL, Roila F, Cognetti F, Nuzzo F, Foglietta J, Minisini AM, Goffredo F, Portera G, Ascione G, Mariani G, Cazzaniga M, and contributor

Abstract

Background. The BALLET study was an open-label, multicenter, expanded access study designed to allow treatment with everolimus plus exemestane in postmenopausal women with hormone receptor-positive metastatic breast cancer progressed following prior endocrine therapy. A post hoc analysis to evaluate if previous chemotherapy in the metastatic setting affects the safety profile of the combination regimen of everolimus and exemestane was conducted on the Italian subset, as it represented the major part of the patients enrolled (54%). Patients and Methods. One thousand one hundred and fiftyone Italian patients were included in the present post hoc analysis, which focused on two sets of patients: patients who never received chemotherapy in the metastatic setting (36.1%) and patients who received at least one chemotherapy treatment in the metastatic setting (63.9%). Results. One thousand one hundred and sixteen patients (97.0%) prematurely discontinued the study drug, and the main reasons reported were disease progression (39.1%), local reimbursement of everolimus (31.1%), and adverse events (AEs) (16.1%). The median duration of study treatment exposure was 139.5 days for exemestane and 135.0 days for everolimus. At least one AE was experienced by 92.5% of patients. The incidence of everolimus-related AEs was higher (83.9%) when compared with those that occurred with exemestane (29.1%), and the most commonly reported everolimus-related AE was stomatitis (51.3%). However, no significant difference in terms of safety related to the combination occurred between patients without and with chemotherapy in the metastatic setting. Conclusion. Real-life data of the Italian patients BALLET-related cohort were an adequate setting to state that previous chemotherapy did not affect the safety profile of the combination regimen of everolimus and exemestane.

Published
2017

24. Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients: a multicenter Italian experience

Author

Ciccarese, M, Fabi, A, Moscetti, L, Cazzaniga, M, Petrucelli, L, Forcignanò, R, Lupo, L, De Matteis, E, Chiuri, V, Cairo, G, Febbraro, A, Giordano, G, Giampaglia, M, Bilancia, D, La Verde, N, Maiello, E, Morritti, M, Giotta, F, Lorusso, V, Latorre, A, Scavelli, C, Romito, S, Cusmai, A, Palmiotti, G, Surico, Ciccarese M, Fabi A, Moscetti L, Cazzaniga M, Petrucelli L, Forcignanò R, Lupo LI, De Matteis E, Chiuri VE, Cairo G, Febbraro A, Giordano G, Giampaglia M, Bilancia D, La Verde N, Maiello E, Morritti M, Giotta F, Lorusso V, Latorre A, Scavelli C, Romito S, Cusmai A, Palmiotti G, Ciccarese, M, Fabi, A, Moscetti, L, Cazzaniga, M, Petrucelli, L, Forcignanò, R, Lupo, L, De Matteis, E, Chiuri, V, Cairo, G, Febbraro, A, Giordano, G, Giampaglia, M, Bilancia, D, La Verde, N, Maiello, E, Morritti, M, Giotta, F, Lorusso, V, Latorre, A, Scavelli, C, Romito, S, Cusmai, A, Palmiotti, G, Surico, Ciccarese M, Fabi A, Moscetti L, Cazzaniga M, Petrucelli L, Forcignanò R, Lupo LI, De Matteis E, Chiuri VE, Cairo G, Febbraro A, Giordano G, Giampaglia M, Bilancia D, La Verde N, Maiello E, Morritti M, Giotta F, Lorusso V, Latorre A, Scavelli C, Romito S, Cusmai A, and Palmiotti G

Abstract

Aim: This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods: 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results: RR was 29.8% (A), 27.8% (B) (p = 0.953), and not evaluable (C). PFS was 9 months (95% CI 7–11) (A), 10 months (95% CI 9–11) (B), and 5 months (95% CI 2–8) (C), p = 0.956. OS was 38 months (95% CI 24–38) (A), median not reached (B), and 13 months (95% CI 10–25) (C), p = 0.002. Adverse events were stomatitis 57.7% (11.0% grade 3–4), asthenia 46.0% (6.1% grade 3–4), hypercholesterolemia 46.0% (0.6% grade 3–4), and hyperglycemia 35.6% (5.5% grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions: No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.

Published
2017

27. Adjuvant chemotherapy with epirubicin, leucovorin, 5-fluorouracil and etoposide regimen in resected gastric cancer patients: a randomized phase III trial by the Gruppo Oncologico Italia Meridionale (GOIM 9602 Study)

Author

DE VITA, Ferdinando, GIULIANI F, ORDITURA, Michele, MAIELLO E, GALIZIA, Gennaro, DI MARTINO, Natale, MONTEMURRO F, CARTEN G, MANZIONE L, ROMITO S, GEBBIA V, CIARDIELLO, Fortunato, CATALANO, G, COLUCCI G, GRUPPO ONCOLOGICO ITALIA MERIDIONALE, DE VITA F, GIULIANI F, ORDITURA M, MAIELLO E, GALIZIA G, DI MARTINO N, MONTEMURRO F, CARTENI G, MANZIONE L, ROMITO S, GEBBIA V, CIARDIELLO F, CATALANO G, COLUCCI G, GRUPPO ONCOLOGICO ITALIA MERIDIONALE, DE VITA, Ferdinando, Giuliani, F, Orditura, Michele, Maiello, E, Galizia, Gennaro, DI MARTINO, Natale, Montemurro, F, Carten, G, Manzione, L, Romito, S, Gebbia, V, Ciardiello, Fortunato, Catalano, G, Colucci, G, and GRUPPO ONCOLOGICO ITALIA, Meridionale

Subjects
Adjuvant chemotherapy
Abstract

Adjuvant chemotherapy

Published
2007

28. Management of Italian patients with advanced non-small-cell lung cancer after second-line treatment: results of the longitudinal phase of the LIFE observational study

Author

De Marinis, Filippo, Ardizzoni, Andrea, Fontanini, Gabriella, Grossi, Francesco, Cappuzzo, Federico, Novello, Silvia, Santo, Antonio, Lorusso, Vito, Cortinovis, Diego, Iurlaro, Monica, Galetta, Domenico, Gridelli, Cesare, Pedrazzoli P, Siena S, Alabiso O, Bilancia D, Cinieri S, Cartenì G, Fasola G, Ferraù F, Milella M, Contu A, Giuffrida D, Illiano A, Ravaioli A, Zaniboni A, Bettini A, Caprioli A, Longo F, Cruciani G, Defraia E, Favaretto A, Amadori D, Clerico M, Di Costanzo F, Gamucci T, Caruso M, Iacobelli S, Pinotti G, Pozzessere D, Maiello E, Marchetti P, Passalacqua R, Pavesi L, Tortora G, Aglietta M, Brandes A, Ciuffreda L, Daniele B, Demichelis C, Romito S, Tamberi S, Barni S, Barbieri F, Giordano M, Bracarda S, Crinò L, Marzano N, Merlano M, Numico G., BIANCO, ROBERTO, De Marinis, Filippo, Ardizzoni, Andrea, Fontanini, Gabriella, Grossi, Francesco, Cappuzzo, Federico, Novello, Silvia, Santo, Antonio, Lorusso, Vito, Cortinovis, Diego, Iurlaro, Monica, Galetta, Domenico, Gridelli, Cesare, Pedrazzoli, P, Siena, S, Alabiso, O, Bilancia, D, Cinieri, S, Cartenì, G, Fasola, G, Ferraù, F, Milella, M, Contu, A, Giuffrida, D, Illiano, A, Ravaioli, A, Zaniboni, A, Bettini, A, Caprioli, A, Longo, F, Cruciani, G, Defraia, E, Favaretto, A, Amadori, D, Clerico, M, Di Costanzo, F, Gamucci, T, Caruso, M, Iacobelli, S, Pinotti, G, Pozzessere, D, Maiello, E, Marchetti, P, Passalacqua, R, Pavesi, L, Tortora, G, Aglietta, M, Bianco, Roberto, Brandes, A, Ciuffreda, L, Daniele, B, Demichelis, C, Romito, S, Tamberi, S, Barni, S, Barbieri, F, Giordano, M, Bracarda, S, Crinò, L, Marzano, N, Merlano, M, and Numico, G.

Subjects
Oncology, Male, Cancer Research, Lung Neoplasms, medicine.medical_treatment, Longitudinal Studie, medicine.disease_cause, NSCLC, Antineoplastic Agent, Chemotherapy, EGFR, Erlotinib, Third-line, Cohort Studies, Carcinoma, Non-Small-Cell Lung, 80 and over, Anaplastic lymphoma kinase, Anaplastic Lymphoma Kinase, Longitudinal Studies, Non-Small-Cell Lung, DOCETAXEL, Aged, 80 and over, Proto-Oncogene Protein, Tumor, CHEMOTHERAPY, Middle Aged, OPEN-LABEL, Receptor Protein-Tyrosine Kinase, ErbB Receptors, Italy, Cohort, Disease Progression, Female, KRAS, CLINICAL-PRACTICE GUIDELINES, medicine.drug, Human, Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, ERLOTINIB, Antineoplastic Agents, Proto-Oncogene Proteins p21(ras), Erlotinib Hydrochloride, Internal medicine, Proto-Oncogene Proteins, medicine, Biomarkers, Tumor, Humans, Lung cancer, Aged, III TRIAL, business.industry, Carcinoma, Quinazoline, 3RD-LINE THERAPY, Receptor Protein-Tyrosine Kinases, medicine.disease, ras Protein, 1ST-LINE TREATMENT, FOLLOW-UP, Clinical trial, Lung Neoplasm, Mutation, Quinazolines, ras Proteins, Observational study, Receptor, Epidermal Growth Factor, Cohort Studie, business, Biomarkers
Abstract

Introduction/Background Patients with advanced NSCLC who experience disease progression after second-line therapy might receive further active treatment. LIFE was an Italian cohort multicenter observational study composed of a cross-sectional and a longitudinal phase. Patients and Methods In the longitudinal phase, described here, the primary aim was to determine the proportion of patients receiving third-line therapy among those who received second-line active treatment according to clinical practice. The proportion of patients receiving further treatment lines was also estimated. Results The longitudinal phase was conducted between January and August 2012. Of 464 patients who began second-line therapy outside of clinical trials within the baseline evaluation, 56 (12.1%) were still receiving second-line therapy at the end of the observation period and 17 (3.7%) withdrew during or after second-line therapy. Of the remaining 391 patients, 158 (40.4%) received third-line treatment outside of clinical trials: 93 received a third-line chemotherapy and 65 a targeted agent. The main reason for interrupting third-line treatment was disease progression or death. During the same observation period, 25 of 113 patients who completed a third-line therapy received a fourth line of treatment. From diagnosis of NSCLC to the end of observation, biomarkers were tested in 323 patients (59.7%): epidermal growth factor receptor mutations in 315 (58.2%), Kirsten rat sarcoma 2 viral oncogene homolog (KRAS) mutations in 83 (15.3%) and Anaplastic lymphoma kinase (ALK) translocation in 84 (15.5%). Conclusion In Italian clinical practice, the proportion of patients with advanced NSCLC receiving more than 2 treatment lines of therapy is not negligible.

Published
2014

30. Negative prognostic factors and resulting clinical outcome in patients (pts) with metastatic renal cell carcinoma (mRCC) included in the Italian nivolumab expanded access program (EAP)

Author

Bracarda, S., primary, Galli, L., additional, Maruzzo, M., additional, Lo Re, G., additional, Buti, S., additional, Favaretto, A., additional, Costanzo, F.D., additional, Sacco, C., additional, Merlano, M., additional, Mucciarini, C., additional, Zafarana, E., additional, Romito, S., additional, Maestri, A., additional, Giannitto Giorgio, C., additional, Ionta, M.T., additional, Turci, D., additional, De Giorgi, U., additional, Procopio, G., additional, Cortesi, E., additional, and Porta, C., additional

Published
2017
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31. Analysis of liquid biopsies from metastatic colorectal carcinoma (mCRC) patients (pts) enrolled in the CAPRI GOIM clinical trial

Author

Normanno, N., primary, Esposito Abate, R., additional, Lambiase, M., additional, Forgione, L., additional, Cardone, C., additional, Iannaccone, A., additional, Sacco, A., additional, Rachiglio, A.M., additional, Martinelli, E., additional, Rizzi, D., additional, Pisconti, S., additional, Cartenì, G., additional, Bordonaro, R., additional, Troiani, T., additional, Giuliani, F., additional, Leo, S., additional, Romito, S., additional, Rinaldi, A., additional, Maiello, E., additional, and Ciardiello, F., additional

Published
2017
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32. Abstract P4-22-17: Safety of the combination of everolimus plus exemestane in the Italian cohort of patients enrolled in the expanded access “BALLET” study

Author

Generali, D, primary, Bordonaro, R, additional, Febbraro, A, additional, Madoffa, A, additional, Romito, S, additional, Michelotti, A, additional, Savastano, C, additional, Mariani, G, additional, Tondini, C, additional, Piovano, P, additional, Iona, MT, additional, Bighin, C, additional, Roviello, G, additional, Ascione, G, additional, Goffredo, F, additional, Sartori, D, additional, Frassoldati, A, additional, and Simoncini, E, additional

Published
2017
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33. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., Signoriello, G., Bilancia, D., Dinota, A., Rosati, G., Germano, D., Lamberti, A., Pontillo, V., Brancacio, L., Crispino, C., Esposito, M., Battiloro, C., Tufano, G., Cioffi, A., Guardasole, V., Angelini, V., Guidetti, G., Renda, F., Romano, F., Volpintesta, A., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., Zonato, S., Cabiddu, M., Raina, A., D'Aprile, M., Pistillucci, G., Porcile, G., Ostellino, O., Vinante, O., Azzarello, G., Gebbia, V., Borsellino, N., Testa, A., Gasparini, G., Morabito, A., Gattuso, D., Romito, S., Carrozza, F., Fava, S., Calcagno, A., Grimi, E., Bertetto, O., Ciuffreda, L., Parello, G., Maiorino, L., Santoro, A., Santoro, M., Failla, G., Aiello, R. A., Bearz, A., Sorio, R., Scalone, S., Clerici, M., Bollina, R., Belloni, P., Sacco, C., Sibau, A., Adamo, V., Altavilla, G., Scimone, A., Spatafora, M., Bellia, V., Hopps, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., Pari, F., Aitini, E., Pedicini, T., Febbraro, A., Zollo, C., Di Costanzo, F., Bartolucci, R., Gasperoni, S., Gaion, F., Palazzolo, G., Galligioni, E., Caffo, O., Cortesi, E., D'Auria, G., Curcio, C., Vasta, M., Bumma, C., Celano, A., Bretti, S., Nettis, G., Anselmo, A., Mattioli, R., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003
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34. Prevalence and treatment of cancer pain in Italian oncological wards centres: a cross-sectional survey

Author

MERCADANTE, S, ROILA, F, BERRETTO, O, LABIANCA, R, CASILINI, S, BOTTERO, G, TROVA, V, CASCINU, S, DI VITO, F, LORUSSO, V, TROCCOLI, G, ENDRIZZI, L, DANIELE, B, MARTONI, A, MARINI, G, VITELLO, S, ROMITO, S, SBALZARINI, G, SERRAVEZZA, G, MANENTE, P, MOLICA, S, PALAZZO, S, PRANTERA, T, MERLANO, M, DI GIROLAMO, G, AMADORI, D, SOBRERO, A, ALGERI, R, BRETTI, S, GRECO, E, D'APRILE, M, FORCIGNANO, C, BONETTI, A, AITINI, E, PIAZZA, E, PIVA, L, TABBIADON, D, CARTENI', G, CATALANO, G, ALABISO, O, LANDRISCINA, G, DOGLIOTTI, L, FILIPPELLI, G, BERTE', R, RICCI, S, MANZIONE, L, IACONO, C, MARANGOLO, M., GEBBIA, Nicolo', PALMERI, Sergio, MERCADANTE, S, ROILA, F, BERRETTO, O, LABIANCA, R, CASILINI, S, BOTTERO, G, TROVA, V, CASCINU, S, DI VITO, F, LORUSSO, V, TROCCOLI, G, ENDRIZZI, L, DANIELE, B, MARTONI, A, MARINI, G, VITELLO, S, ROMITO, S, SBALZARINI, G, SERRAVEZZA, G, MANENTE, P, MOLICA, S, PALAZZO, S, PRANTERA, T, MERLANO, M, DI GIROLAMO, G, AMADORI, D, SOBRERO, A, ALGERI, R, BRETTI, S, GRECO, E, D'APRILE, M, FORCIGNANO, C, BONETTI, A, AITINI, E, PIAZZA, E, PIVA, L, TABBIADON, D, CARTENI', G, CATALANO, G, ALABISO, O, LANDRISCINA, G, DOGLIOTTI, L, GEBBIA, N, PALMERI, S, FILIPPELLI, G, BERTE', R, RICCI, S, MANZIONE, L, IACONO, C, and MARANGOLO, M

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/06 - Oncologia Medica, Cross-sectional study, Pain medicine, MEDLINE, Pain, Severity of Illness Index, Neoplasms, Oncology Service, Hospital, Epidemiology, Severity of illness, medicine, Prevalence, Humans, Aged, Aged, 80 and over, Primary Health Care, business.industry, Cancer pain,Epidemiology,Opioids, Nursing research, Physicians, Family, Middle Aged, Large sample, Analgesics, Opioid, Cross-Sectional Studies, Oncology, Italy, Family medicine, Health Care Surveys, Physical therapy, Female, Cancer pain, business
Abstract

The aim of this national cross-sectional survey was to draw information on pain prevalence and intensity from a large sample of patients who were admitted to oncologic centres for different reasons and to evaluate the pain treatment and possible influencing factors.A total of 2,655 patients completed the study. Nine hundred and one patients (34%) reported pain.Higher pain levels were observed in inpatients, in the presence of bone metastases, and with low levels of Eastern Cooperative Oncology Group status. The number of patients receiving strong opioids increased with the highest levels of pain. However, a significant part of patients with moderate-severe pain were not receiving appropriate medication, patients being predominantly administered non-opioid drugs. General practitioners' attitudes did not negatively influence the opioid prescription.The results of this survey indicate a need for continuing educational and informative program in pain management for oncologists and more generally for any physician dealing with cancer patients.

Published
2008

40. Abstract P4-13-15: Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real world population of hormone receptor positive advanced breast cancer: A multicenter Italian experience

Author

Forcignanò, R, primary, Petrucelli, L, additional, Cazzaniga, ME, additional, Lupo, LI, additional, Chiuri, VE, additional, Cairo, G, additional, De Matteis, E, additional, Febbraro, A, additional, Giordano, G, additional, Campidoglio, S, additional, Fabi, A, additional, Giampaglia, M, additional, Bilancia, D, additional, La Verde, N, additional, Maiello, E, additional, Morritti, M, additional, Giotta, F, additional, Lorusso, V, additional, Scavelli, C, additional, Romito, S, additional, Cusmai, A, additional, Palmiotti, G, additional, Tornesello, A, additional, and Ciccarese, M, additional

Published
2016
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42. Mitoxantrone + Prednisone versus Taxotere + Prednisone nel trattamento del carcinoma prostatico ormonorefrattario (cpor ). Studio randomizzato di fase II del Gruppo Oncologico dell’Italia Meridionale (GOIM ). VII CONGRESSO NAZIONALE G.O.I.M. ROMA 23-25 Giugno 2004

Author

GIOTTA F, MANZIONE L, LORUSSO V, CARUSO M, FORTUNATO S, ROMANO R. A, ROMITO S, DURINI E, BRUNETTI C, COLUCCI G., GEBBIA, Vittorio, VALERIO, Maria Rosaria, GIOTTA F, MANZIONE L, LORUSSO V, CARUSO M, FORTUNATO S, ROMANO R A, ROMITO S, GEBBIA V, VALERIO MR, DURINI E, BRUNETTI C, and COLUCCI G

Published
2004

43. A pilot trial with clenbuterol in SBMA

Author

Querin, G., D Ascenzo, C., Morandi, L., Mazzini, L., Silani, V., JESSICA MANDRIOLI, Raimondi, M., Romito, S., Marcello, N., Angelini, C., Pegoraro, E., and Sorarù, G.

Published
2012

45. 887P - Negative prognostic factors and resulting clinical outcome in patients (pts) with metastatic renal cell carcinoma (mRCC) included in the Italian nivolumab expanded access program (EAP)

Author

Bracarda, S., Galli, L., Maruzzo, M., Lo Re, G., Buti, S., Favaretto, A., Costanzo, F.D., Sacco, C., Merlano, M., Mucciarini, C., Zafarana, E., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M.T., Turci, D., De Giorgi, U., Procopio, G., Cortesi, E., and Porta, C.

Published
2017
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47. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancerreceiving chemotherapy: a prognostic analysis of the multicenter Italian lungcancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolo, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, Vincenzo, Altavilla, Giuseppe, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, E, D'Auria, G, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, and Cazzaniga, M.

Published
2005

48. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferraù, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolò, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, V, Altavilla, G, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, Enrico, D'Auria, Giuliana, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, Cazzaniga, M., MAIONE P, PERRONE F, GALLO C, MANZIONE L, PIANTEDOSI F, BARBERA S, CIGOLARI, ROSETTI F, PIAZZA E, ROBBIATI SF, BERTETTO O, NOVELLO S, MIGLIORINO MR, FAVARETTO A, SPATAFORA M, FERRAU F, FRONTINI L, BEARZ A, REPETTO L, GRIDELLI C, BARLETTA E, BARZELLONI ML, IAFFAIOLI RV, DE MAIO E, DI MAIO M, DE FEO G, SIGORIELLO G, CHIODINI P, CIOFFI A, GUARDASOLE V, ANGELINI V, ROSSI A, BILANCIA, GERMANO D, LAMBERTI A, PONTILLO V, BRANCACCIO L, RENDA F, ROMANO F, ESANI G, GAMBARO A, VINANTE O, AZZARELLO G, CLERICI M, BOLLINA R, BELLONI P, SANNICOLO M, CIUFFREDA L, PARELLO G, CABIDDU M, SACCO C, SIBAU A, PORCILE G, CASTIGLIONE F, OSTELLINO O, MONFARDINI S, STEFANI M, SCAGLIOTTI G, SELVAGGI G, DE MARINIS F, MARTELLI O, GASPARINI G, MORABITO A, GATTUSO D, COLUCCI G, GALETTA D, GIOTTA F, GEBBIA V, ET AL, Maione, P, Perrone, F, Gallo, Ciro, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, and Gridelli, C.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Activities of daily living, Health Status, carcinoma, Vinblastine, Vinorelbine, Deoxycytidine, older people, Quality of life, Instrumental activitie, Carcinoma, Non-Small-Cell Lung, Internal medicine, Activities of Daily Living, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Aged, 80 and over, validation, Proportional hazards model, business.industry, QLQ-C30, Age Factors, Cancer, clinical trial, Prognosis, medicine.disease, Gemcitabine, Comorbidity, humanities, comorbidity, Oncology, Quartile, Quality of Life, Physical therapy, impact, Geriatric oncology, Female, business, Randomized-trial, medicine.drug
Abstract

Purpose To study the prognostic value for overall survival of baseline assessment of functional status, comorbidity, and quality of life (QoL) in elderly patients with advanced non—small-cell lung cancer treated with chemotherapy. Patients and Methods Data from 566 patients enrolled onto the phase III randomized Multicenter Italian Lung Cancer in the Elderly Study (MILES) study were analyzed. Functional status was measured as activities of daily living (ADL) and instrumental ADL (IADL). The presence of comorbidity was assessed with a checklist of 33 items; items 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 (EORTC QLQ-C30) were used to estimate QoL. ADL was dichotomized as none versus one or more dependency. For IADL and QoL, three categories were defined using first and third quartiles as cut points. Comorbidity was summarized using the Charlson scale. Analysis was performed by Cox model, and stratified by treatment arm. Results Better values of baseline QoL (P = .0003) and IADL (P = .04) were significantly associated with better prognosis, whereas ADL (P = .44) and Charlson score (P = .66) had no prognostic value. Performance status 2 (P = .006) and a higher number of metastatic sites (P = .02) also predicted shorter overall survival. Conclusions Pretreatment global QoL and IADL scores, but not ADL and comorbidity, have significant prognostic value for survival of elderly patients with advanced non—small-cell lung cancer who were treated with chemotherapy. Using these scores in clinical practice might improve prognostic prediction for treatment planning.

Published
2005

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