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2. The Elapsed Time During a Virtual Reality Treatment for Stressful Procedures. A Pool Analysis on Breast Cancer Patients During Chemotherapy

Author

Chirico, A., D’Aiuto, M., Pinto, M., Milanese, C., Napoli, A, Avino, F., Iodice, G., Russo, G., De Laurentiis, M., Ciliberto, G., Giordano, A., Lucidi, F., Howlett, Robert James, Series editor, Jain, Lakhmi C., Series editor, Pietro, Giuseppe De, editor, Gallo, Luigi, editor, and Howlett, Robert J., editor

Published
2016
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3. Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial

Author

Perrone, F., Nuzzo, F., Di Rella, F., Gravina, A., Iodice, G., Labonia, V., Landi, G., Pacilio, C., Rossi, E., De Laurentiis, M., D'Aiuto, M., Botti, G., Forestieri, V., Lauria, R., De Placido, S., Tinessa, V., Daniele, B., Gori, S., Colantuoni, G., Barni, S., Riccardi, F., De Maio, E., Montanino, A., Morabito, A., Daniele, G., Di Maio, M., Piccirillo, M.C., Signoriello, S., Gallo, C., and de Matteis, A.

Published
2015
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10. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.

Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist

Published
2018

11. PerTe: efficacy and safety of pertuzumab in “real life setting” for the neoadjuvant treatment of HER2-positive breast cancer patients

Author

Cianniello, D., primary, Prudente, A., additional, Caputo, R., additional, Piezzo, M., additional, Riemma, M., additional, Savastano, B., additional, Cocco, S., additional, Licenziato, M., additional, De Stefano, B., additional, Di Gioia, G., additional, Fusco, G., additional, Buonfanti, G., additional, Gravina, A., additional, Landi, G., additional, Di Rella, F., additional, Pacilio, C., additional, Nuzzo, F., additional, Iodice, G., additional, De Laurentiis, M., additional, and Del Prete, S., additional

Published
2017
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13. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

Sabino De Placido, Ciro Gallo, Michelino De Laurentiis, Giancarlo Bisagni, Grazia Arpino, Maria Giuseppa Sarobba, Ferdinando Riccardi, Antonio Russo, Lucia Del Mastro, Alessio Aligi Cogoni, Francesco Cognetti, Stefania Gori, Jennifer Foglietta, Antonio Frassoldati, Domenico Amoroso, Lucio Laudadio, Luca Moscetti, Filippo Montemurro, Claudio Verusio, Antonio Bernardo, Vito Lorusso, Adriano Gravina, Gabriella Moretti, Rossella Lauria, Antonella Lai, Carmela Mocerino, Sergio Rizzo, Francesco Nuzzo, Paolo Carlini, Francesco Perrone, Antonello Accurso, Biagio Agostara, Michele Aieta, Oscar Alabiso, Maria Grazia Alicicco, Dino Amadori, Laura Amaducci, Gianna Amiconi, Giustino Antuzzi, Mara Ardine, Antonio Ardizzoia, Caterina Aversa, Giuseppe Badalamenti, Sandro Barni, Carlo Basurto, Rossana Berardi, Cinzia Bergamasco, Paolo Bidoli, Claudia Bighin, Edoardo Biondi, Corrado Boni, Karen Borgonovo, Mario Botta, Stefano Bravi, Paolo Bruzzi, Giuseppe Buono, Alfredo Butera, Alessia Caldara, Giampiero Candeloro, Claudia Cappelletti, Cinzia Cardalesi, Elisabetta Carfora, Anna Cariello, Francesco Carrozza, Giacomo Cartenì, Michele Caruso, Virginia Casadei, Claudia Casanova, Luigi Castori, Luigi Cavanna, Giovanna Cavazzini, Marina Cazzaniga, Mario Chilelli, Paolo Chiodini, Silvia Chiorrini, Fortunato Ciardiello, Mariangela Ciccarese, Saverio Cinieri, Mario Clerico, Mariarosa Coccaro, Mario Comande, Claudia Corbo, Giuseppina Cortino, Stefania Cusenza, Gennaro Daniele, Alfonso Maria D'arco, Giuliana D'auria, Claudio Dazzi, Carmine De Angelis, Filippo de Braud, Gianfranco De Feo, Andrea De Matteis, Michele De Tursi, Anna Di Blasio, Giuseppe di Lucca, Liberato Di Lullo, Francesca Di Rella, Gianfranco Di Renzo, Pia Di Stefano, Aida Di Stefano, Anna Diana, Sara Donati, Agnese Fabbri, Alessandra Fabi, Marina Faedi, Gabriella Farina, Antonio Farris, Antonio Febbraro, Palma Fedele, Piera Federico, Francesco Ferraù, Gianluigi Ferretti, Antonella Ferro, Irene Floriani, Rosachiara Forcignanò, Samantha Forciniti, Valeria Forestieri, Gianni Fornari, Michela Frisinghelli, Vittorio Fusco, Giulia Gallizzi, Antonio Galvano, Antonio Gambardella, Angelo Gambi, Vittorio Gebbia, Erika Gervasi, Mara Ghilardi, Alice Giacobino, Giovanni Giardina, Francesco Giotta, Sara Giraudi, Mario Giuliano, Antonino Grassadonia, Donatella Grasso, Federica Grosso, Lorenzo Guizzaro, Pasquale Incoronato, Lorena Incorvaia, Giovanni Iodice, Nicla La Verde, Vincenzo Labonia, Gabriella Landi, Agnese Latorre, Vita Leonardi, Alessia Levaggi, Gennaro Limite, Linda Lina Bascialla, Lorenzo Livi, Evaristo Maiello, Daniela Mandelli, Ilaria Marcon, Daniela Menon, Michele Montedoro, Lucia Moraca, Anna Moretti, Maria Grazia Morritti, Patrizia Morselli, Antonella Mura, Silvia Mura, Michela Musacchio, Alberto Muzio, Donato Natale, Clara Natoli, Cinzia Nigro, Cecilia Nisticò, Antonio Nuzzo, Michele Orditura, Laura Orlando, Carmen Pacilio, Giuliano Palumbo, Raffaella Palumbo, Felice Pasini, Emanuela Paterno, Antonio Pazzola, Silvia Pelliccioni, Matilde Pensabene, Davide Perroni, Angela Pesenti Gritti, Fausto Petrelli, Maria Carmela Piccirillo, Graziella Pinotti, Claudia Pogliani, Davide Poli, Sonia Prader, Francesco Recchia, Daniele Rizzi, Carmen Romano, Rosalba Rossello, Chiara Rossini, Giuseppina Salvucci, Valeria Sanna, Alessandra Santini, Silvana Saracchini, Clementina Savastano, Giovanni Scambia, Francesco Schettini, Paola Schiavone, Alessio Schirone, Elena Seles, Simona Signoriello, Giuseppe Signoriello, Rosa Rita Silva, Antonia Silvestri, Vittorio Simeon, Ilaria Spagnoletti, Stefano Tamberi, Cristina Teragni, Verena Thalmann, Renato Thomas, Guglielmo Thomas, Amelia Tienghi, Nicola Tinari, Vincenza Tinessa, Federica Tomei, Giuseppe Tonini, Valter Torri, Divina Traficante, Marianna Tudini, Monica Turazza, Roberto Vignoli, Maria Giuseppa Vitale, Alessandra Zacchia, Pasquale Zagarese, Alda Zanni, Laura Zavallone, Maria Zavettieri, Alessandra Zoboli, De Placido, S., Gallo, C., De Laurentiis, M., Bisagni, G., Arpino, G., Sarobba, M. G., Riccardi, F., Russo, A., Del Mastro, L., Cogoni, A. A., Cognetti, F., Gori, S., Foglietta, J., Frassoldati, A., Amoroso, D., Laudadio, L., Moscetti, L., Montemurro, F., Verusio, C., Bernardo, A., Lorusso, V., Gravina, A., Moretti, G., Lauria, R., Lai, A., Mocerino, C., Rizzo, S., Nuzzo, F., Carlini, P., Perrone, F., Accurso, A., Agostara, B., Aieta, M., Alabiso, O., Alicicco, M. G., Amadori, D., Amaducci, L., Amiconi, G., Antuzzi, G., Ardine, M., Ardizzoia, A., Aversa, C., Badalamenti, G., Barni, S., Basurto, C., Berardi, R., Bergamasco, C., Bidoli, P., Bighin, C., Biondi, E., Boni, C., Borgonovo, K., Botta, M., Bravi, S., Bruzzi, P., Buono, G., Butera, A., Caldara, A., Candeloro, G., Cappelletti, C., Cardalesi, C., Carfora, E., Cariello, A., Carrozza, F., Carteni, G., Caruso, M., Casadei, V., Casanova, C., Castori, L., Cavanna, L., Cavazzini, G., Cazzaniga, M., Chilelli, M., Chiodini, P., Chiorrini, S., Ciardiello, F., Ciccarese, M., Cinieri, S., Clerico, M., Coccaro, M., Comande, M., Corbo, C., Cortino, G., Cusenza, S., Daniele, G., D'Arco, A. M., D'Auria, G., Dazzi, C., De Angelis, C., de Braud, F., De Feo, G., De Matteis, Ma., De Tursi, M., Di Blasio, A., di Lucca, G., Di Lullo, L., Di Rella, F., Di Renzo, G., Di Stefano, P., Di Stefano, A., Diana, A., Donati, S., Fabbri, A., Fabi, A., Faedi, M., Farina, G., Farris, A., Febbraro, A., Fedele, P., Federico, P., Ferrau, F., Ferretti, G., Ferro, A., Floriani, I., Forcignano, R., Forciniti, S., Forestieri, V., Fornari, G., Frisinghelli, M., Fusco, V., Gallizzi, G., Galvano, A., Gambardella, A., Gambi, A., Gebbia, V., Gervasi, E., Ghilardi, M., Giacobino, A., Giardina, G., Giotta, F., Giraudi, S., Giuliano, M., Grassadonia, A., Grasso, D., Grosso, F., Guizzaro, L., Incoronato, P., Incorvaia, L., Iodice, G., La Verde, N., Labonia, V., Landi, G., Latorre, A., Leonardi, V., Levaggi, A., Limite, G., Lina Bascialla, L., Livi, L., Maiello, E., Mandelli, D., Marcon, I., Menon, D., Montedoro, M., Moraca, L., Moretti, A., Morritti, M. G., Morselli, P., Mura, A., Mura, S., Musacchio, M., Muzio, A., Natale, D., Natoli, C., Nigro, C., Nistico, C., Nuzzo, A., Orditura, M., Orlando, L., Pacilio, C., Palumbo, G., Palumbo, R., Pasini, F., Paterno, E., Pazzola, A., Pelliccioni, S., Pensabene, M., Perroni, D., Pesenti Gritti, A., Petrelli, F., Piccirillo, M. C., Pinotti, G., Pogliani, C., Poli, D., Prader, S., Recchia, F., Rizzi, D., Romano, C., Rossello, R., Rossini, C., Salvucci, G., Sanna, V., Santini, A., Saracchini, S., Savastano, C., Scambia, G., Schettini, F., Schiavone, P., Schirone, A., Seles, E., Signoriello, S., Signoriello, G., Silva, R. R., Silvestri, A., Simeon, V., Spagnoletti, I., Tamberi, S., Teragni, C., Thalmann, V., Thomas, R., Thomas, G., Tienghi, A., Tinari, N., Tinessa, V., Tomei, F., Tonini, G., Torri, V., Traficante, D., Tudini, M., Turazza, M., Vignoli, R., Vitale, M. G., Zacchia, A., Zagarese, P., Zanni, A., Zavallone, L., Zavettieri, M., Zoboli, A., De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, Bisagni, Giancarlo, Arpino, Grazia, Sarobba, Maria Giuseppa, Riccardi, Ferdinando, Russo, Antonio, Del Mastro, Lucia, Cogoni, Alessio Aligi, Cognetti, Francesco, Gori, Stefania, Foglietta, Jennifer, Frassoldati, Antonio, Amoroso, Domenico, Laudadio, Lucio, Moscetti, Luca, Montemurro, Filippo, Verusio, Claudio, Bernardo, Antonio, Lorusso, Vito, Gravina, Adriano, Moretti, Gabriella, Lauria, Rossella, Lai, Antonella, Mocerino, Carmen, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, Perrone, Francesco, Accurso, Antonello, Agostara, Biagio, Aieta, Michele, Alabiso, Oscar, Alicicco, Maria Grazia, Amadori, Dino, Amaducci, Laura, Amiconi, Gianna, Antuzzi, Giustino, Ardine, Mara, Ardizzoia, Antonio, Aversa, Caterina, Badalamenti, Giuseppe, Barni, Sandro, Basurto, Carlo, Berardi, Rossana, Bergamasco, Cinzia, Bidoli, Paolo, Bighin, Claudia, Biondi, Edoardo, Boni, Corrado, Borgonovo, Karen, Botta, Mario, Bravi, Stefano, Bruzzi, Paolo, Buono, Giuseppe, Butera, Alfredo, Caldara, Alessia, Candeloro, Giampiero, Cappelletti, Claudia, Cardalesi, Cinzia, Carfora, Elisabetta, Cariello, Anna, Carrozza, Francesco, Cartenì, Giacomo, Caruso, Michele, Casadei, Virginia, Casanova, Claudia, Castori, Luigi, Cavanna, Luigi, Cavazzini, Giovanna, Cazzaniga, Marina, Chilelli, Mario, Chiodini, Paolo, Chiorrini, Silvia, Ciardiello, Fortunato, Ciccarese, Mariangela, Cinieri, Saverio, Clerico, Mario, Coccaro, Mariarosa, Comande, Mario, Corbo, Claudia, Cortino, Giuseppina, Cusenza, Stefania, Daniele, Gennaro, D'arco, Alfonso Maria, D'auria, Giuliana, Dazzi, Claudio, De Angelis, Carmine, de Braud, Filippo, De Feo, Gianfranco, De Matteis, Andrea, De Tursi, Michele, Di Blasio, Anna, di Lucca, Giuseppe, Di Lullo, Liberato, Di Rella, Francesca, Di Renzo, Gianfranco, Di Stefano, Pia, Di Stefano, Aida, Diana, Anna, Donati, Sara, Fabbri, Agnese, Fabi, Alessandra, Faedi, Marina, Farina, Gabriella, Farris, Antonio, Febbraro, Antonio, Fedele, Palma, Federico, Piera, Ferraù, Francesco, Ferretti, Gianluigi, Ferro, Antonella, Floriani, Irene, Forcignanò, Rosachiara, Forciniti, Samantha, Forestieri, Valeria, Fornari, Gianni, Frisinghelli, Michela, Fusco, Vittorio, Gallizzi, Giulia, Galvano, Antonio, Gambardella, Antonio, Gambi, Angelo, Gebbia, Vittorio, Gervasi, Erika, Ghilardi, Mara, Giacobino, Alice, Giardina, Giovanni, Giotta, Francesco, Giraudi, Sara, Giuliano, Mario, Grassadonia, Antonino, Grasso, Donatella, Grosso, Federica, Guizzaro, Lorenzo, Incoronato, Pasquale, Incorvaia, Lorena, Iodice, Giovanni, La Verde, Nicla, Labonia, Vincenzo, Landi, Gabriella, Latorre, Agnese, Leonardi, Vita, Levaggi, Alessia, Limite, Gennaro, Lina Bascialla, Linda, Livi, Lorenzo, Maiello, Evaristo, Mandelli, Daniela, Marcon, Ilaria, Menon, Daniela, Montedoro, Michele, Moraca, Lucia, Moretti, Anna, Morritti, Maria Grazia, Morselli, Patrizia, Mura, Antonella, Mura, Silvia, Musacchio, Michela, Muzio, Alberto, Natale, Donato, Natoli, Clara, Nigro, Cinzia, Nisticò, Cecilia, Nuzzo, Antonio, Orditura, Michele, Orlando, Laura, Pacilio, Carmen, Palumbo, Giuliano, Palumbo, Raffaella, Pasini, Felice, Paterno, Emanuela, Pazzola, Antonio, Pelliccioni, Silvia, Pensabene, Matilde, Perroni, Davide, Pesenti Gritti, Angela, Petrelli, Fausto, Piccirillo, Maria Carmela, Pinotti, Graziella, Pogliani, Claudia, Poli, Davide, Prader, Sonia, Recchia, Francesco, Rizzi, Daniele, Romano, Carmen, Rossello, Rosalba, Rossini, Chiara, Salvucci, Giuseppina, Sanna, Valeria, Santini, Alessandra, Saracchini, Silvana, Savastano, Clementina, Scambia, Giovanni, Schettini, Francesco, Schiavone, Paola, Schirone, Alessio, Seles, Elena, Signoriello, Simona, Signoriello, Giuseppe, Silva, Rosa Rita, Silvestri, Antonia, Simeon, Vittorio, Spagnoletti, Ilaria, Tamberi, Stefano, Teragni, Cristina, Thalmann, Verena, Thomas, Renato, Thomas, Guglielmo, Tienghi, Amelia, Tinari, Nicola, Tinessa, Vincenza, Tomei, Federica, Tonini, Giuseppe, Torri, Valter, Traficante, Divina, Tudini, Marianna, Turazza, Monica, Vignoli, Roberto, Vitale, Maria Giuseppa, Zacchia, Alessandra, Zagarese, Pasquale, Zanni, Alda, Zavallone, Laura, Zavettieri, Maria, Zoboli, Alessandra, Mocerino, Carmela, D'Arco, Alfonso Maria, D'Auria, Giuliana, De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, and Zoboli, A

Subjects
Oncology, Receptor, ErbB-2, Settore MED/06 - Oncologia Medica, letrozole, law.invention, Adjuvant anastrozole, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Exemestane, law, exemestane, tamoxifen, breast cancer, Antineoplastic Combined Chemotherapy Protocols, 030212 general & internal medicine, Aromatase Inhibitors, Letrozole, Hazard ratio, Middle Aged, Receptors, Estrogen, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Receptors, Progesterone, Breast Neoplasm, Human, medicine.drug, medicine.medical_specialty, Socio-culturale, Anastrozole, Breast Neoplasms, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Aromatase Inhibitor, Humans, Aged, Antineoplastic Combined Chemotherapy Protocol, Androstadiene, business.industry, medicine.disease, Androstadienes, chemistry, business, Tamoxifen
Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is registered with the European Clinical Trials Database, number 2006-004018-42, and ClinicalTrials.gov, number NCT00541086. Findings: Between March 9, 2007, and July 31, 2012, 3697 patients were enrolled into the study. After a median follow-up of 60 months (IQR 46–72), 401 disease-free survival events were reported, including 211 (11%) of 1850 patients allocated to the switch strategy and 190 (10%) of 1847 patients allocated to upfront treatment. 5-year disease-free survival was 88·5% (95% CI 86·7–90·0) with the switch strategy and 89·8% (88·2–91·2) with upfront treatment (hazard ratio 0·89, 95% CI 0·73–1·08; p=0·23). 5-year disease-free survival was 90·0% (95% CI 87·9–91·7) with anastrozole (124 events), 88·0% (85·8–89·9) with exemestane (148 events), and 89·4% (87·3 to 91·1) with letrozole (129 events; p=0·24). No unexpected serious adverse reactions or treatment-related deaths occurred. Musculoskeletal side-effects were the most frequent grade 3–4 events, reported in 130 (7%) of 1761 patients who received the switch strategy and 128 (7%) of 1766 patients who received upfront treatment. Grade 1 musculoskeletal events were more frequent with the upfront schedule than with the switch schedule (924 [52%] of 1766 patients vs 745 [42%] of 1761 patients). All other grade 3–4 adverse events occurred in less than 2% of patients in either group. Interpretation: 5 years of treatment with aromatase inhibitors was not superior to 2 years of tamoxifen followed by 3 years of aromatase inhibitors. None of the three aromatase inhibitors was superior to the others in terms of efficacy. Therefore, patient preference, tolerability, and financial constraints should be considered when deciding the optimal treatment approach in this setting. Funding: Italian Drug Agency.

Published
2018

14. Weekly docetaxel versus CMF as adjuvant chemotherapy for older women with early breast cancer: final results of the randomized phase III ELDA trial

Author

G. Botti, Carmen Pacilio, Ferdinando Riccardi, Massimiliano D’Aiuto, F. Di Rella, Maria Carmela Piccirillo, F. Perrone, Rossella Lauria, Ciro Gallo, M. Di Maio, Agnese Montanino, Vincenza Tinessa, G. Landi, Bruno Daniele, Sandro Barni, Simona Signoriello, Valeria Forestieri, Elisa Rossi, Francesco Nuzzo, Giovanni Iodice, E. De Maio, Adriano Gravina, G. Colantuoni, Gennaro Daniele, Stefania Gori, A. De Matteis, S. De Placido, Alessandro Morabito, V. Labonia, M. De Laurentiis, Perrone, F, Nuzzo, F, Di Rella, F, Gravina, A, Iodice, G, Labonia, V, Landi, G, Pacilio, C, Rossi, E, De Laurentiis, M, D'Aiuto, M, Botti, G, Forestieri, V, Lauria, R, De Placido, S, Tinessa, V, Daniele, B, Gori, S, Colantuoni, G, Barni, S, Riccardi, F, De Maio, E, Montanino, A, Morabito, A, Daniele, G, Di Maio, M, Piccirillo, Mc, Signoriello, Simona, Gallo, Ciro, de Matteis, A., Nuzzo, F., Di Rella, F., Gravina, A., Iodice, G., Labonia, V., Landi, G., Pacilio, C., Rossi, E., De Laurentiis, M., D'Aiuto, M., Botti, G., Forestieri, V., Lauria, R., De Placido, S., Tinessa, V., Daniele, B., Gori, S., Colantuoni, G., Barni, S., Riccardi, F., De Maio, E., Montanino, A., Morabito, A., Daniele, G., Di Maio, M., Piccirillo, M. C., Signoriello, S., Gallo, C., and De Matteis, Ma.

Subjects
Oncology, medicine.medical_treatment, Ductal, Antineoplastic Combined Chemotherapy Protocols, CMF, docetaxel, Breast, Adjuvant, Medicine (all), Carcinoma, Ductal, Breast, Hazard ratio, Hematology, Prognosis, Chemotherapy regimen, Survival Rate, Local, Docetaxel, Chemotherapy, Adjuvant, Taxoids, Female, Fluorouracil, Breast Neoplasm, Human, medicine.drug, medicine.medical_specialty, Randomized phase III trial, Cyclophosphamide, Prognosi, Breast Neoplasms, elderly, Lobular, Follow-Up Studie, Breast cancer, breast cancer, Taxoid, Internal medicine, Mucositis, medicine, Chemotherapy, Humans, Survival rate, Aged, Neoplasm Staging, Antineoplastic Combined Chemotherapy Protocol, business.industry, Carcinoma, medicine.disease, Carcinoma, Lobular, Neoplasm Recurrence, Methotrexate, Elderly, Follow-Up Studies, Neoplasm Grading, Neoplasm Recurrence, Local, business
Abstract

Evidence on adjuvant chemotherapy for elderly early breast cancer patients is poor, due to the low number of phase 3 trials. ELDA shows that weekly docetaxel does not prolong DFS compared with standard CMF and worsens quality of life. Non-hematological toxicity is worse with weekly docetaxel. Age, comorbidities and functioning geriatric scales may be predictive of non-hematological side effects. Background Evidence on adjuvant chemotherapy in older women with breast cancer is poor. We tested whether weekly docetaxel is more effective than standard chemotherapy. Patients and methods We carried out a multicenter, randomized phase III study. Women aged 65–79, operated for breast cancer, with average to high risk of recurrence, were allocated 1 : 1 to CMF (cyclophosphamide 600 mg/m², methotrexate 40 mg/m², fluorouracil 600 mg/m², days 1, 8) or docetaxel (35 mg/m2 days 1, 8, 15) every 4 weeks, for four or six cycles according to hormone receptor status. Primary end point was disease-free survival (DFS). A geriatric assessment was carried out. Quality of life (QoL) was assessed with EORTC C-30 and BR-23 questionnaires. Results From July 2003 to April 2011, 302 patients were randomized and 299 (152 allocated CMF and 147 docetaxel) were eligible. After 70-month median follow-up, 109 DFS events were observed. Unadjusted hazard ratio (HR) of DFS for docetaxel versus CMF was 1.21 [95% confidence interval (CI) 0.83–1.76,P = 0.32]; DFS estimate at 5 years was 0.69 with CMF and 0.65 with docetaxel. HR of death was 1.34 (95% CI 0.80–2.22,P = 0.26). There was no interaction between treatment arms and geriatric scales measuring patients' ability or comorbidities. Hematological toxicity, mucositis and nausea were worse with CMF; allergy, fatigue, hair loss, onychopathy, dysgeusia, diarrhea, abdominal pain, neuropathy, cardiac and skin toxicity were worse with docetaxel. One death was attributed to CMF and two to docetaxel. Increasing age, impairment in instrumental daily living activities, number of comorbidities and docetaxel treatment were independently associated with severe nonhematological toxicity. QoL was worse with docetaxel for nausea-vomiting, appetite loss, diarrhea, body image, future perspective, treatment side-effects and hair loss items. Conclusions Weekly docetaxel is not more effective than standard CMF as adjuvant treatment of older women with breast cancer and worsens QoL and toxicity. ClinicalTrials.gov NCT00331097.

Published
2015

15. WHICH PROBLEMATICS IN THA AFTER ACETABULAR FRACTURES: EXPERIENCE OF 38 CASES

Author

Fabio Zanchini, Antonio Piscopo, Luigi Aurelio Nasto, Davide Piscopo, Alessia Boemio, Stefano Cacciapuoti, Giuseppe Iodice, Valerio Cipolloni, Federico Fusini, Zanchini, F., Piscopo, A., Nasto, L. A., Piscopo, D., Boemio, A., Cacciapuoti, S., Iodice, G., Cipolloni, V., and Fusini, F.

Subjects
total hip arthroplasty, acetabular fracture, Paprosky classification, Orthopedics and Sports Medicine, General, aseptic necrosi, posttraumatic hip arthrosi
Abstract

Background Within a timeframe of 8 years (2008-2016), 38 patients have undergone total hip replacement surgery for coxarthrosis or aseptic necrosis secondary to acetabulum fractures. Materials and Methods The study included 27 males and 11 females between 42 and 70 years of age, all of whom came from other institutions. The follow-up period ranged between a minimum of 4.6 and a maximum of 9.7 years. Results At the final follow-up, all patients were evaluated using the Merle D’Aubigne and Pastel model. Optimal results were found in all the cases. Three patients benefited from surgical revisitation with implant exchange following infection and one/two state reimplatation at seven, fourtheen et twenty-seven months respectively. Two patients benefited from cotyle revision due to chronic instability of the implant. Conclusions The scope of the study was to present all the possible surgical difficulties that can come up with prosthetic implants. More particularly, hip implants after acetabulum fractures qualifies as a “difficult primary implant”.

Published
2022

16. Full Digital Surgery-First, Skeletal Anchorage and Aligners Approach to Correct a Gummy Smile and Class II Malocclusion with Mandibular Retrusion and Deviation

Author

Mario Santagata, Gianpaolo Tartaro, Giorgio Iodice, Salvatore D'Amato, Iodice, G., Tartaro, G., Santagata, M., and D'Amato, S.

Subjects
medicine.medical_specialty, Technology, QH301-705.5, medicine.medical_treatment, QC1-999, 3-dimensional diagnosis and treatment plan, Adult age, Gummy smile, medicine, skeletal anchorage, General Materials Science, aligner, Biology (General), Instrumentation, QD1-999, Fluid Flow and Transfer Processes, Dental occlusion, business.industry, Process Chemistry and Technology, Physics, General Engineering, medicine.disease, Engineering (General). Civil engineering (General), Chin, Computer Science Applications, Surgery, surgery-first, Chemistry, medicine.anatomical_structure, Mandibular Retrusion, Mandibular deficiency, Malocclusion, TA1-2040, Splint (medicine), business
Abstract

Background: The demand for interdisciplinary orthodontic treatment has increased significantly in the past few years, especially in adult patients. This kind of treatment requires careful clinical management, as consequence of the possible complications and limits related to adult age. However, the use of skeletal anchorage and three-dimensional (3D) digital technology has deeply revolutionised diagnostic planning and treatment strategies. Methods: A fully digital approach to the treatment of a Class II patient with a gummy smile and mandibular deficiency and deviation, consisting of initial surgery followed by the use of aligners and skeletal anchorage, is described. Results: The 3D, fully digital pre-evaluation enabled clinicians to accurately and reliably plan the surgical procedure and subsequent orthodontics, including the individualised positioning of stabilisation plates and a splint for maxillary and chin surgical movements. This allowed for the improvement of the patient’s facial aesthetics and dental occlusion without the use of visible orthodontic appliances or the occurrence of pre-surgical aesthetic worsening. Conclusions: This approach could be very effective for adult patients seeking aesthetic treatment options for facial and dental aesthetic improvement.

Published
2021

17. Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy

Author

Fabio Alivernini, Gerardo Botti, Fabio Lucidi, Carla Milanese, Patrizia Maiorano, Giovanni Iodice, Antonio Giordano, Michelino De Laurentiis, Giovan Giacomo Giordano, Giuseppe De Pietro, Luigi Gallo, Andrea Chirico, Paola Indovina, Chirico, A., Maiorano, P., Indovina, P., Milanese, C., Giordano, G. G., Alivernini, F., Iodice, G., Gallo, L., De Pietro, G., Lucidi, F., Botti, G., De Laurentiis, M., and Giordano, A.

Subjects
0301 basic medicine, Adult, medicine.medical_specialty, Music therapy, Adolescent, Physiology, cybersickne, music therapy, Clinical Biochemistry, Psychological intervention, mood states, Breast Neoplasms, chemotherapy, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Breast cancer, breast cancer, Quality of life, Distraction, mood state, medicine, Humans, anxiety, cybersickness, virtual reality, Aged, business.industry, Mood Disorders, Cell Biology, Middle Aged, medicine.disease, 030104 developmental biology, Mood, 030220 oncology & carcinogenesis, Cohort, Physical therapy, Quality of Life, Anxiety, Female, medicine.symptom, business
Abstract

Psychological distress is a common consequence of breast cancer diagnosis and treatment and could further exacerbate therapy side effects. Interventions increasing treatment tolerance are crucial to improve both patients' quality of life and adherence to therapies. Virtual reality (VR) has emerged as an effective distraction tool for different medical procedures. Here, we assessed the efficacy of immersive and interactive VR in alleviating chemotherapy-related psychological distress in a cohort of Italian breast cancer patients, also comparing its effects with those of music therapy (MT). Thirty patients were included in the VR group, 30 in the MT group, and 34 in the control group, consisting of patients receiving standard care during chemotherapy. Our data suggest that both VR and MT are useful interventions for alleviating anxiety and for improving mood states in breast cancer patients during chemotherapy. Moreover, VR seems more effective than MT in relieving anxiety, depression, and fatigue.

Published
2020
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18. Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial

Author

Emanuela Rossi, Francesca Di Rella, Carlo Putzu, Francesco Perrone, Rossella Lauria, Lucia Del Mastro, Gennaro Daniele, Vittorio Simeon, Vincenza Tinessa, Ermelinda De Maio, Sabino De Placido, G. Landi, Sandro Barni, Francesco Nuzzo, Saverio Cinieri, Giovanni Iodice, Andrea de Matteis, Nicola Normanno, A. Fabbri, Carmen Pacilio, Laura Arenare, Maria Carmela Piccirillo, Toni Ibrahim, Valeria Forestieri, Angela Stefania Ribecco, Adriano Gravina, Ciro Gallo, Stefania Gori, Anna Maria Mosconi, Ferdinando Riccardi, Michele Orditura, Michelino De Laurentiis, Perrone, Francesco, De Laurentiis, Michelino, De Placido, Sabino, Orditura, Michele, Cinieri, Saverio, Riccardi, Ferdinando, Ribecco, Angela Stefania, Putzu, Carlo, Del Mastro, Lucia, Rossi, Emanuela, Tinessa, Vincenza, Mosconi, Anna Maria, Nuzzo, Francesco, Di Rella, Francesca, Gravina, Adriano, Iodice, Giovanni, Landi, Gabriella, Pacilio, Carmen, Forestieri, Valeria, Lauria, Rossella, Fabbri, Agnese, Ibrahim, Toni, De Maio, Ermelinda, Barni, Sandro, Gori, Stefania, Simeon, Vittorio, Arenare, Laura, Daniele, Gennaro, Piccirillo, Maria Carmela, Normanno, Nicola, de Matteis, Andrea, Gallo, Ciro, Perrone, F., De Laurentiis, M., De Placido, S., Orditura, M., Cinieri, S., Riccardi, F., Ribecco, A. S., Putzu, C., Del Mastro, L., Rossi, E., Tinessa, V., Mosconi, A. M., Nuzzo, F., Di Rella, F., Gravina, A., Iodice, G., Landi, G., Pacilio, C., Forestieri, V., Lauria, R., Fabbri, A., Ibrahim, T., De Maio, E., Barni, S., Gori, S., Simeon, V., Arenare, L., Daniele, G., Piccirillo, M. C., Normanno, N., de Matteis, A., and Gallo, C.

Subjects
0301 basic medicine, Cancer Research, Time Factors, Gastroenterology, Zoledronic Acid, 0302 clinical medicine, Breast cancer, Antineoplastic Combined Chemotherapy Protocols, education.field_of_study, Triptorelin Pamoate, Bone Density Conservation Agents, Aromatase Inhibitors, Letrozole, Hazard ratio, Estrogen Antagonists, Middle Aged, Triptorelin, Oncology, Italy, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Adjuvant endocrine treatment, Aromatase inhibitors, Breast cancer, Phase 3, Premenopausal patients, Zoledronic acid, Disease Progression, Female, medicine.drug, Adult, medicine.medical_specialty, Population, Breast Neoplasms, Phase 3, Adjuvant endocrine treatment, Disease-Free Survival, 03 medical and health sciences, Internal medicine, medicine, Humans, education, Premenopausal patients, business.industry, Ovary, Premenopausal patient, Cancer, Aromatase inhibitor, medicine.disease, Tamoxifen, 030104 developmental biology, Zoledronic acid, Premenopause, business
Abstract

Aim The aim of the study is to analyse whether letrozole (L) and zoledronic acid plus L (ZL) are more effective than tamoxifen (T) as adjuvant endocrine treatment of premenopausal patients with breast cancer with hormone receptor–positive (HR+) tumours. Patients and methods In a phase 3 trial, 1065 premenopausal patients with HR + early breast cancer received triptorelin to suppress ovarian function and were randomly assigned (1:1:1) to adjuvant T, L or ZL for 5 years. Cancer recurrence, second breast or non-breast cancer and death were considered events for the intention-to-treat disease-free survival (DFS) analysis. Results With a 64-month median follow-up and 134 reported events, the disease-free rate at 5 years was 85.4%, 93.2% and 93.3% with T, L and ZL, respectively (overall P = 0.008). The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70 (95% CI, 0.44 to 1.12; P = 0.22) with ZL vs L. With 36 deaths, there was no significant difference in overall survival (P = 0.14). Treatment was stopped for toxicity or refusal in 7.3%, 7.3% and 16.6% patients, and in the safety population, grade 3–4 side-effects were reported in 4.2%, 6.9% and 9.1% patients treated with T, L or ZL, respectively. Conclusion HOBOE study shows that in premenopausal patients with early breast cancer undergoing ovarian function suppression with triptorelin, ZL significantly improves DFS, while worsening compliance and toxicity, as compared with T. ( NCT00412022 )

Published
2019

19. Progression-Free Survival and Overall Survival of CDK 4/6 Inhibitors Plus Endocrine Therapy in Metastatic Breast Cancer: A Systematic Review and Meta-Analysis

Author

Francesca Di Rella, Paolo Chiodini, Carmen Pacilio, Giovanni Iodice, Michelino De Laurentiis, Daniela Cianniello, Matilde Pensabene, Giuseppina Fusco, Germira Di Gioia, Stefania Cocco, Vincenzo Di Lauro, Roberta Caputo, Francesco Nuzzo, Michela Piezzo, Maria Antonietta Riemma, Piezzo, M., Chiodini, P., Riemma, M., Cocco, S., Caputo, R., Cianniello, D., Di Gioia, G., Di Lauro, V., Di Rella, F., Fusco, G., Iodice, G., Nuzzo, F., Pacilio, C., Pensabene, M., and De Laurentiis, M.

Subjects
0301 basic medicine, Oncology, Review, CDK4/6 inhibitor, lcsh:Chemistry, 0302 clinical medicine, Neoplasm Metastasis, subgroup analysis, lcsh:QH301-705.5, Spectroscopy, Hazard ratio, General Medicine, Prognosis, Metastatic breast cancer, Computer Science Applications, Survival Rate, 030220 oncology & carcinogenesis, Meta-analysis, epidemiology, Female, metastatic breast cancer, medicine.medical_specialty, Antineoplastic Agents, Hormonal, medicine.drug_class, overall survival, therapies, Breast Neoplasms, Palbociclib, Hormone receptor, Catalysis, Inorganic Chemistry, Subgroup analysi, CDK4/6 inhibitors, 03 medical and health sciences, Internal medicine, medicine, cancer, Humans, Progression-free survival, Physical and Theoretical Chemistry, Protein Kinase Inhibitors, Molecular Biology, Survival analysis, Aromatase inhibitor, hormone therapy, business.industry, Organic Chemistry, hormone receptors, Cyclin-Dependent Kinase 4, Cancer, Cyclin-Dependent Kinase 6, medicine.disease, 030104 developmental biology, lcsh:Biology (General), lcsh:QD1-999, business
Abstract

The introduction of CDK4/6 inhibitors in combination with endocrine therapy (ET) represents the most relevant advance in the management of hormone receptor (HR) positive, HER2-negative metastatic breast cancer over the last few years. This meta-analysis of randomized controlled trials (RCTs) is aimed to better characterize the efficacy of CDK4/6 inhibitors in some relevant subgroups and to test heterogeneity between different compounds with a particular focus on their ability to improve overall survival (OS). Pooled estimates of hazard ratios (HRs) were computed for progression-free survival (PFS), OS, and objective response rate (ORR) analysis in predefined subgroups to better understand treatment effect concerning specific patients’ characteristics. To estimate the absolute benefit in terms of PFS, pooled survival curves were generated by pooling the data of all trials. A total of eight RCTs were included. Adding a CDK4/6 inhibitor to ET is beneficial in terms of PFS, irrespective of the presence or not of visceral metastases, the number of metastatic sites, and the length of the treatment-free interval (TFI). The addition of CDK4/6 inhibitors produces a significant OS improvement, both in aromatase inhibitor (AI)-sensitive (HR 0.75, 95% CI) and AI-resistant patients (HR 0.77, 95% CI [0.67–0.89]). Pooled data from each single drug show that palbociclib remains the only class member not showing a statistically significant HR for OS (HR 0.83, 95% CI [0.68–1.02]).

Published
2020
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20. Effect of post-printing curing time on cytotoxicity of direct printed aligners: A pilot study.

Author

Iodice G, Ludwig B, Polishchuk E, Petruzzelli R, Di Cunto R, Husam S, and Farella M

Subjects
Humans, Pilot Projects, Time Factors, Gingiva cytology, Materials Testing, Cells, Cultured, Saliva, Orthodontic Appliances, Cell Proliferation drug effects, Fibroblasts drug effects, Printing, Three-Dimensional, Cell Survival drug effects
Abstract

Introduction: The aim of this in vitro study was to examine the potential impact of different curing times of 3D-printed orthodontic aligners on their cytotoxicity., Method: Some 60 samples of aligner material were directly 3D printed using Tera Harz TC-85 DAC resin and randomly allocated to three different curing time groups (14, 24 and 50 min). Zendura FLX samples were used as control. The samples were incubated in saliva for 14 days, and then the supernatant was collected. Human gingival fibroblasts (HGF-1)-CRL2014 were used to evaluate potential cytotoxicity. Furthermore, HGF-1 cells were plated on the samples as well as on a glass control sample. After 72 h of growth, their viability was tested., Results: Compared with the glass, only the 50-min curing time markedly reduced fibroblast cell growth. Additionally, a negative linear trend was observed between curing time and fibroblast growth. In comparison with the aligner control group, all samples, including the aligner control samples, exhibited a significant reduction in the viability of human fibroblasts when exposed to saliva., Conclusions: 3D directly printed aligners showed a cytotoxic effect similar to that of thermoformed conventional aligners in terms of fibroblasts growth. A linear trend was found between curing time and cells growth, indicating that directly printed aligners could exhibit higher cytotoxicity if exposed to a longer curing time. This dependence on curing time underscores the importance of following a strict manufacturing process., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2024
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21. Prevalence of psychosocial findings and their correlation with TMD symptoms in an adult population sample.

Author

Iodice G, Michelotti A, D'Antò V, Martina S, Valletta R, and Rongo R

Subjects
Humans, Female, Male, Adult, Prevalence, Pain Measurement, Facial Pain psychology, Middle Aged, Depression epidemiology, Depression psychology, Surveys and Questionnaires, Temporomandibular Joint Disorders psychology, Temporomandibular Joint Disorders complications
Abstract

Background and Aim: Some studies suggested an association between Temporomandibular Disorders (TMD) and psychosocial status, but most of them are focused on samples of patients looking for treatment or present limits of sample representativeness. The aim of the present study was to evaluate the psychosocial status in a large sample of adult population, further than to assess its association to TMD symptoms, oral behaviours, and self-reported facial trauma., Results: the study sample included 4299 subjects older than 18 years randomly recruited from general population in public spaces during their daily life (1700 Males, 2599 Females mean ± SD age = 40.4 ± 18.1). Psychosocial status and pain-related disability were assessed by means of Patient Health Questionnaire 4 (PHQ-4) and Graded Chronic Pain Scale (GCPS). TMD symptoms were assessed by RDC/TMD and validated screening tools for TMD pain. Oral Behaviours Checklist was used to investigate on oral behaviours. Logistic regression model was used to evaluate the association of the psychosocial status, TMD symptoms, trauma, and oral behaviours. The association was tested using both univariate and multivariate models. The PHQ4 evaluation showed a severe impairment in 4.6% of our sample, moderate in 18.8% and mild in 32.5%. We found a Characteristic Pain Intensity (CPI) level and Interference Score greater that 30 respectively in 36.2% and 22.2% of the study sample. The GCPS status revealed a high disability with severe limitation in 2.5% of the sample, high disability with moderate limitation in 7.0%, low disability high pain intensity in 7.4% and low disability low pain intensity in 37.8%. Anxiety and depression's levels were significantly associated with gender, TMD pain, coexistence of TMD Pain and sound, and oral behaviours. GCPS status was significantly associated with age, TMD Pain, coexistence of TMD pain and sound, trauma, and oral behaviours., Conclusions: In the general population, psychosocial impairment is associated to TMD pain, female gender, and report of oral behaviours. Hence, in adults with TMD accompanied by pain, psychosocial status should also be evaluated., (© 2024. The Author(s).)

Published
2024
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22. Alzheimer's disease CSF biomarkers correlate with early pathology and alterations in neuronal and glial gene expression.

Author

Ropri AS, Lam TG, Kalia V, Buchanan HM, Bartosch AMW, Youth EHH, Xiao H, Ross SK, Jain A, Chakrabarty JK, Kang MS, Boyett D, Spinazzi EF, Iodice G, McGovern RA, Honig LS, Brown LM, Miller GW, McKhann GM, and Teich AF

Subjects
Humans, Female, Male, Aged, Neurons pathology, Neurofilament Proteins cerebrospinal fluid, Proteomics, Hydrocephalus, Normal Pressure cerebrospinal fluid, Hydrocephalus, Normal Pressure pathology, Hydrocephalus, Normal Pressure genetics, Gene Expression genetics, Middle Aged, Alzheimer Disease cerebrospinal fluid, Alzheimer Disease pathology, Alzheimer Disease genetics, Biomarkers cerebrospinal fluid, Amyloid beta-Peptides cerebrospinal fluid, Neuroglia pathology, Neuroglia metabolism, tau Proteins cerebrospinal fluid
Abstract

Introduction: Normal pressure hydrocephalus (NPH) patients undergoing cortical shunting frequently show early Alzheimer's disease (AD) pathology on cortical biopsy, which is predictive of progression to clinical AD. The objective of this study was to use samples from this cohort to identify cerebrospinal fluid  (CSF) biomarkers for AD-related central nervous system (CNS) pathophysiologic changes using tissue and fluids with early pathology, free of post mortem artifact., Methods: We analyzed Simoa, proteomic, and metabolomic CSF data from 81 patients with previously documented pathologic and transcriptomic changes., Results: AD pathology on biopsy correlates with CSF β-amyloid-42/40, neurofilament light chain (NfL), and phospho-tau-181(p-tau181)/β-amyloid-42, while several gene expression modules correlate with NfL. Proteomic analysis highlights seven core proteins that correlate with pathology and gene expression changes on biopsy, and metabolomic analysis of CSF identifies disease-relevant groups that correlate with biopsy data., Discussion: As additional biomarkers are added to AD diagnostic panels, our work provides insight into the CNS pathophysiology these markers are tracking., Highlights: AD CSF biomarkers correlate with CNS pathology and transcriptomic changes. Seven proteins correlate with CNS pathology and gene expression changes. Inflammatory and neuronal gene expression changes correlate with YKL-40 and NPTXR, respectively. CSF metabolomic analysis identifies pathways that correlate with biopsy data. Fatty acid metabolic pathways correlate with β-amyloid pathology., (© 2024 The Author(s). Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.)

Published
2024
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23. Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study.

Author

Caminiti C, Maglietta G, Arenare L, Di Liello R, Migliaccio G, Barberio D, De Laurentiis M, Di Rella F, Nuzzo F, Pacilio C, Iodice G, Orditura M, Ciardiello F, Di Bella S, Cavanna L, Porta C, Giovanardi F, Ripamonti CI, Bilancia D, Aprile G, Ruelle T, Diodati F, Piccirillo MC, Iannelli E, Pinto C, and Perrone F

Subjects
Humans, Female, Middle Aged, Prospective Studies, Aged, Adult, Drug-Related Side Effects and Adverse Reactions psychology, Surveys and Questionnaires, Self Report, Reproducibility of Results, Breast Neoplasms psychology, Patient Reported Outcome Measures, Psychometrics, Quality of Life
Abstract

Patients' self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients. Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients' reporting of side-effects. We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors. The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions. Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires. In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer. The study is registered on clinicaltrials.gov (NCT04416672)., Competing Interests: Declaration of competing interest Michelino De Laurentiis declares: honoraria or consultation fees for speaker, consultancy or advisory roles from Eli Lilly, Seagen, Therapeutics, GSK, Roche, Novartis, Genetic, Pfizer, Pierre Fabre, MSD, Menarini Stemline, Sophos Biotech, Max Farma, Celltrion Healthcare, Gilead, Daiichi Sankyo; institutional financial interests, financial support for clinical trials or contracted research, from: Novartis, Pierre Fabre, Pfizer, Roche, Stemline Therapeutics. Fortunato Ciardiello declares: honoraria or consultation fees for speaker, consultancy or advisory roles from Amgen, Merck KGaA, MSD, Pierre Fabre, Pfizer, Roche, Servier; institutional financial interests, financial support for clinical trials or contracted research, from: Amgen, Merck KGaA, MSD, Pierre Fabre, Pfizer, Roche, Servier. Lugi Cavanna declares honoraria from Roche and Pfizer. Filippo Giovanardi declares honoraria from Eli Lilly, AstraZeneca, Roche, Seagen, Novartis. Maria Carmela Piccirillo declares: honoraria for speaker activities from Astellas, Pfizer, Ipsen, Astrazeneca; financial support to institutional research activities from AstraZeneca, Bayer, Roche. Francesco Perrone declares: institutional grants or contracts from Roche, Bayer, AstraZeneca, Pfizer, Incyte, Tesaro/GSK, Merck; consulting fees from Bayer, Pierre Fabre, Astra Zeneca, Incyte, Ipsen, Clovis, Astellas, Sanofi, Roche, Pfizer; leadership in scientific society: President of AIOM 2023–2025. All the other authors declares no competing interests., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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25. WHICH PROBLEMATICS IN THA AFTER ACETABULAR FRACTURES: EXPERIENCE OF 38 CASES.

Author

Zanchini F, Piscopo A, Nasto LA, Piscopo D, Boemio A, Cacciapuoti S, Iodice G, Cipolloni V, and Fusini F

Abstract

Background: Within a timeframe of 8 years (2008-2016), 38 patients have undergone total hip replacement surgery for coxarthrosis or aseptic necrosis secondary to acetabulum fractures., Materials and Methods: The study included 27 males and 11 females between 42 and 70 years of age, all of whom came from other institutions. The follow-up period ranged between a minimum of 4.6 and a maximum of 9.7 years., Results: At the final follow-up, all patients were evaluated using the Merle D'Aubigne and Pastel model. Optimal results were found in all the cases. Three patients benefited from surgical revisitation with implant exchange following infection and one/two state reimplatation at seven, fourtheen et twenty-seven months respectively. Two patients benefited from cotyle revision due to chronic instability of the implant., Conclusions: The scope of the study was to present all the possible surgical difficulties that can come up with prosthetic implants. More particularly, hip implants after acetabulum fractures qualifies as a "difficult primary implant"., Competing Interests: The authors certify that they have NO affiliations with or involvement in any organization or entity with any financial interest (such as honoraria; educational grants; participation in speakers’ bureaus; membership, employment, consultancies, stock ownership, or other equity interest; and expert testimony or patent-licensing arrangements), or non-financial interest (such as personal or professional relationships, affiliations, knowledge or beliefs) in the subject matter or materials discussed in this manuscript.

Published
2022
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26. Accuracy of direct insertion of TADs in the anterior palate with respect to a 3D-assisted digital insertion virtual planning.

Author

Iodice G, Nanda R, Drago S, Repetto L, Tonoli G, Silvestrini-Biavati A, and Migliorati M

Subjects
Cone-Beam Computed Tomography, Humans, Imaging, Three-Dimensional methods, Palate diagnostic imaging, Orthodontic Anchorage Procedures methods
Abstract

Background: Direct and 3D-assisted methods are an available alternative when inserting temporary anchorage devices (TADs) in the anterior palate for orthodontic anchorage. This study aimed to evaluate the differences between a planned insertion versus a direct method on digital models., Settings and Sample Population: Seventy TADs were inserted by the direct insertion method in 35 patients who needed palatal TADs for orthodontic anchorage. For each patient, placement was independently planned by the superimposition of lateral cephalograms and corresponding plaster models. After mini-implant placement, impressions were taken with scanbodies. For the measurement of both linear and angle deviations, virtual planning models and postoperative oral scans were compared using 3D software for automatic surface registration and calculations., Results: Comparing TADs positioned by the direct method and the digitally planned method, a mean linear distance was found of 2.54 ± 1.51 mm in the occlusal view and 2.41 ± 1.33 mm in the sagittal view. No significant difference has been found between TADs positioned in the right and left palatal sides. A mean distance of 7.65 ± 2.16 mm was found between the tip of the digitally planned TAD and the central incisors root apex., Conclusions: Both direct and 3D-assisted TAD insertion methods are safe and accurate in the anterior palate. However, the use of insertion guides facilitates TAD insertion, allowing less-experienced clinicians to use palatal implants., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2022
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27. Talimogene Laherparepvec: Moving From First-In-Class to Best-In-Class.

Author

Kaufman HL, Shalhout SZ, and Iodice G

Abstract

Talimogene laherparepvec (T-VEC) is a modified oncolytic herpes Simplex virus, type 1 (HSV-1) encoding granulocyte-macrophage colony stimulating factor (GM-CSF). T-VEC is adapted for selective replication in melanoma cells and GM-CSF was expressed to augment host anti-tumor immunity. T-VEC is indicated for the local treatment of melanoma recurrent after primary surgery and is the first-in-class oncolytic virus to achieve approval by the FDA in 2015. This review will describe the progress made in advancing T-VEC to the most appropriate melanoma patients, expansion to patients with non-melanoma cancers and clinical trial results of T-VEC combination studies. Further, strategies to identify predictive biomarkers of therapeutic response to T-VEC will be discussed. Finally, a brief outline of high-priority future directions for investigation of T-VEC and other promising oncolytic viruses will set the stage for a best-in-class oncolytic virus to bring the maximum benefit of this emerging class of anti-cancer agents to patients with cancer., Competing Interests: HK and GI were employed by Ankyra Therapeutics. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer HW declared a shared affiliation, with no collaboration, with the authors to the handling editor at the time of the review., (Copyright © 2022 Kaufman, Shalhout and Iodice.)

Published
2022
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28. An immune response characterizes early Alzheimer's disease pathology and subjective cognitive impairment in hydrocephalus biopsies.

Author

Huang W, Bartosch AM, Xiao H, Maji S, Youth EHH, Flowers X, Leskinen S, Tomljanovic Z, Iodice G, Boyett D, Spinazzi E, Menon V, McGovern RA, McKhann GM, and Teich AF

Subjects
Age of Onset, Aged, Aged, 80 and over, Alzheimer Disease genetics, Alzheimer Disease immunology, Alzheimer Disease pathology, Astrocytes immunology, Astrocytes pathology, Biopsy, Cerebral Cortex cytology, Cerebral Cortex immunology, Cognitive Dysfunction diagnosis, Cognitive Dysfunction genetics, Cognitive Dysfunction pathology, Female, Humans, Hydrocephalus, Normal Pressure genetics, Hydrocephalus, Normal Pressure pathology, Hydrocephalus, Normal Pressure surgery, Male, Microglia immunology, Microglia pathology, Neuropsychological Tests, RNA-Seq, Retrospective Studies, Alzheimer Disease complications, Cerebral Cortex pathology, Cognitive Dysfunction immunology, Gene Regulatory Networks immunology, Hydrocephalus, Normal Pressure immunology
Abstract

Early Alzheimer's disease (AD) pathology can be found in cortical biopsies taken during shunt placement for Normal Pressure Hydrocephalus. This represents an opportunity to study early AD pathology in living patients. Here we report RNA-seq data on 106 cortical biopsies from this patient population. A restricted set of genes correlate with AD pathology in these biopsies, and co-expression network analysis demonstrates an evolution from microglial homeostasis to a disease-associated microglial phenotype in conjunction with increasing AD pathologic burden, along with a subset of additional astrocytic and neuronal genes that accompany these changes. Further analysis demonstrates that these correlations are driven by patients that report mild cognitive symptoms, despite similar levels of biopsy β-amyloid and tau pathology in comparison to patients who report no cognitive symptoms. Taken together, these findings highlight a restricted set of microglial and non-microglial genes that correlate with early AD pathology in the setting of subjective cognitive decline., (© 2021. The Author(s).)

Published
2021
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29. Progression-Free Survival and Overall Survival of CDK 4/6 Inhibitors Plus Endocrine Therapy in Metastatic Breast Cancer: A Systematic Review and Meta-Analysis.

Author

Piezzo M, Chiodini P, Riemma M, Cocco S, Caputo R, Cianniello D, Di Gioia G, Di Lauro V, Rella FD, Fusco G, Iodice G, Nuzzo F, Pacilio C, Pensabene M, and De Laurentiis M

Subjects
Breast Neoplasms drug therapy, Breast Neoplasms enzymology, Female, Humans, Neoplasm Metastasis, Prognosis, Survival Rate, Antineoplastic Agents, Hormonal therapeutic use, Breast Neoplasms mortality, Cyclin-Dependent Kinase 4 antagonists & inhibitors, Cyclin-Dependent Kinase 6 antagonists & inhibitors, Protein Kinase Inhibitors therapeutic use
Abstract

The introduction of CDK4/6 inhibitors in combination with endocrine therapy (ET) represents the most relevant advance in the management of hormone receptor (HR) positive, HER2-negative metastatic breast cancer over the last few years. This meta-analysis of randomized controlled trials (RCTs) is aimed to better characterize the efficacy of CDK4/6 inhibitors in some relevant subgroups and to test heterogeneity between different compounds with a particular focus on their ability to improve overall survival (OS). Pooled estimates of hazard ratios (HRs) were computed for progression-free survival (PFS), OS, and objective response rate (ORR) analysis in predefined subgroups to better understand treatment effect concerning specific patients' characteristics. To estimate the absolute benefit in terms of PFS, pooled survival curves were generated by pooling the data of all trials. A total of eight RCTs were included. Adding a CDK4/6 inhibitor to ET is beneficial in terms of PFS, irrespective of the presence or not of visceral metastases, the number of metastatic sites, and the length of the treatment-free interval (TFI). The addition of CDK4/6 inhibitors produces a significant OS improvement, both in aromatase inhibitor (AI)-sensitive (HR 0.75, 95% CI) and AI-resistant patients (HR 0.77, 95% CI [0.67-0.89]). Pooled data from each single drug show that palbociclib remains the only class member not showing a statistically significant HR for OS (HR 0.83, 95% CI [0.68-1.02]).

Published
2020
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30. Virtual reality and music therapy as distraction interventions to alleviate anxiety and improve mood states in breast cancer patients during chemotherapy.

Author

Chirico A, Maiorano P, Indovina P, Milanese C, Giordano GG, Alivernini F, Iodice G, Gallo L, De Pietro G, Lucidi F, Botti G, De Laurentiis M, and Giordano A

Subjects
Adolescent, Adult, Aged, Anxiety pathology, Breast Neoplasms pathology, Breast Neoplasms psychology, Female, Humans, Middle Aged, Mood Disorders pathology, Quality of Life, Virtual Reality, Young Adult, Anxiety therapy, Breast Neoplasms drug therapy, Mood Disorders therapy, Music Therapy
Abstract

Psychological distress is a common consequence of breast cancer diagnosis and treatment and could further exacerbate therapy side effects. Interventions increasing treatment tolerance are crucial to improve both patients' quality of life and adherence to therapies. Virtual reality (VR) has emerged as an effective distraction tool for different medical procedures. Here, we assessed the efficacy of immersive and interactive VR in alleviating chemotherapy-related psychological distress in a cohort of Italian breast cancer patients, also comparing its effects with those of music therapy (MT). Thirty patients were included in the VR group, 30 in the MT group, and 34 in the control group, consisting of patients receiving standard care during chemotherapy. Our data suggest that both VR and MT are useful interventions for alleviating anxiety and for improving mood states in breast cancer patients during chemotherapy. Moreover, VR seems more effective than MT in relieving anxiety, depression, and fatigue., (© 2020 Wiley Periodicals, Inc.)

Published
2020
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31. Long-term eribulin treatment in patients with a single kidney and retroperitoneal liposarcoma.

Author

Tober N, Gentile M, and Iodice G

Subjects
Aged, Aged, 80 and over, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Duration of Therapy, Furans administration & dosage, Furans adverse effects, Humans, Ketones administration & dosage, Ketones adverse effects, Liposarcoma diagnosis, Magnetic Resonance Imaging, Male, Nephrectomy, Positron Emission Tomography Computed Tomography, Retroperitoneal Neoplasms diagnosis, Tomography, X-Ray Computed, Treatment Outcome, Antineoplastic Agents therapeutic use, Furans therapeutic use, Ketones therapeutic use, Liposarcoma complications, Liposarcoma drug therapy, Retroperitoneal Neoplasms complications, Retroperitoneal Neoplasms drug therapy, Solitary Kidney complications
Abstract

Retroperitoneal sarcomas are extremely rare malignant tumors. The most common type of sarcomas arising in the retroperitoneum are liposarcomas, occurring mostly in the sixth and seventh decades of life. The only potentially curative approach to liposarcomas is the complete surgical resection of the tumor with negative microscopic margins. However, retroperitoneal liposarcomas exhibit a propensity for local recurrence and distant metastasis despite the negative surgical margins, thus requiring additional therapy. Eribulin demonstrated a benefit in terms of overall survival in patients with advanced or metastatic liposarcoma. We report two cases of patients, both submitted to concomitant right nephrectomy, who experienced a long-lasting control of recurrent retroperitoneal liposarcoma before being submitted to eribulin-based therapeutic regimens (23 and 24 treatment cycles completed, respectively).

Published
2020
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32. Biological Effects of Anodic Oxidation on Titanium Miniscrews: An In Vitro Study on Human Cells.

Author

Iodice G, Perinetti G, Ludwig B, Polishchuk EV, and Polishchuk RS

Abstract

This controlled in vitro study compared the effects of varying the thickness of a TiO 2 layer on cellular activity using commercially available miniscrew samples with identical surface features to derive information with direct clinical impact. Titanium grade V plates with four different thicknesses of TiO 2 layer/color were used: absent/gray (Control group), 40-50 nm/pink (Pink group), 130 nm/gold (Gold group) and 140 nm/rosé (Rosé group). In vitro experiments used Saos-2 cells and included cell growth analysis, phospho-Histone H3 and procollagen I staining, cell viability analysis, and a cell migration assay at 12, 24, 40 and to 48 h. Few differences were seen among the groups, with no clear behavior of cellular activity according to the TiO 2 thickness. The Control group showed a greater cell count. Phospho-Histone H3 staining was similar among the groups and procollagen I staining was greater in the Rosé group. Cell viability analysis showed a significant difference for live cell counts (greater in the Rosé group) and no difference for the dead cell counts. The cell migration assay showed a delay for the Rosé group up to 40 h, where full repopulation of cell-free areas was obtained at 48 h. The results suggest that the TiO 2 layers of the commercial miniscrews have minimal biological effects, including cytotoxicity, with possibly negligible or minimal clinical implications., Competing Interests: The authors declare no conflict of interest.

Published
2019
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33. Intracystic papillary breast carcinoma with DCIS in a man: a case report.

Author

Esposito E, Di Bonito M, Iodice G, Avino F, Donzelli I, Fucito A, Melucci MT, Saponara R, Siani C, Tortoriello R, Rinaldo M, and di Giacomo R

Abstract

Here we report a case of 50-mm lump within the left breast in a 56-year-old man. The patient underwent left total mastectomy and sentinel node biopsy. The pathology report showed low-grade intracystic papillary breast carcinoma surrounded by ductal carcinoma in situ. Sentinel node biopsy was negative. The patient was prescribed five years tamoxifen., Competing Interests: Conflicts of Interest: Both authors have completed the ICMJE uniform disclosure form (available at http://dx.doi.org/10.21037/tcr.2019.09.40). The focused issue “Rare Tumors of the Breast” was commissioned by the editorial office without any funding or sponsorship. EE served as the unpaid Guest Editor for the focused issue and serves as the unpaid editorial board member of Translational Cancer Research from May 2018 to Apr 2020. The authors have no other conflicts of interest to declare., (2019 Translational Cancer Research. All rights reserved.)

Published
2019
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34. Adjuvant zoledronic acid and letrozole plus ovarian function suppression in premenopausal breast cancer: HOBOE phase 3 randomised trial.

Author

Perrone F, De Laurentiis M, De Placido S, Orditura M, Cinieri S, Riccardi F, Ribecco AS, Putzu C, Del Mastro L, Rossi E, Tinessa V, Mosconi AM, Nuzzo F, Di Rella F, Gravina A, Iodice G, Landi G, Pacilio C, Forestieri V, Lauria R, Fabbri A, Ibrahim T, De Maio E, Barni S, Gori S, Simeon V, Arenare L, Daniele G, Piccirillo MC, Normanno N, de Matteis A, and Gallo C

Subjects
Adult, Antineoplastic Combined Chemotherapy Protocols adverse effects, Aromatase Inhibitors adverse effects, Bone Density Conservation Agents adverse effects, Breast Neoplasms mortality, Breast Neoplasms physiopathology, Chemotherapy, Adjuvant, Disease Progression, Disease-Free Survival, Estrogen Antagonists adverse effects, Female, Humans, Italy, Letrozole adverse effects, Middle Aged, Ovary physiopathology, Tamoxifen adverse effects, Time Factors, Triptorelin Pamoate adverse effects, Zoledronic Acid adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Aromatase Inhibitors therapeutic use, Bone Density Conservation Agents therapeutic use, Breast Neoplasms drug therapy, Estrogen Antagonists therapeutic use, Letrozole therapeutic use, Ovary drug effects, Premenopause, Tamoxifen therapeutic use, Triptorelin Pamoate therapeutic use, Zoledronic Acid therapeutic use
Abstract

Aim: The aim of the study is to analyse whether letrozole (L) and zoledronic acid plus L (ZL) are more effective than tamoxifen (T) as adjuvant endocrine treatment of premenopausal patients with breast cancer with hormone receptor-positive (HR+) tumours., Patients and Methods: In a phase 3 trial, 1065 premenopausal patients with HR + early breast cancer received triptorelin to suppress ovarian function and were randomly assigned (1:1:1) to adjuvant T, L or ZL for 5 years. Cancer recurrence, second breast or non-breast cancer and death were considered events for the intention-to-treat disease-free survival (DFS) analysis., Results: With a 64-month median follow-up and 134 reported events, the disease-free rate at 5 years was 85.4%, 93.2% and 93.3% with T, L and ZL, respectively (overall P = 0.008). The hazard ratio for a DFS event was 0.52 (95% confidence interval [CI], 0.34 to 0.80; P = 0.003) with ZL vs T, 0.72 (95% CI, 0.48 to 1.07; P = 0.06) with L vs T and 0.70 (95% CI, 0.44 to 1.12; P = 0.22) with ZL vs L. With 36 deaths, there was no significant difference in overall survival (P = 0.14). Treatment was stopped for toxicity or refusal in 7.3%, 7.3% and 16.6% patients, and in the safety population, grade 3-4 side-effects were reported in 4.2%, 6.9% and 9.1% patients treated with T, L or ZL, respectively., Conclusion: HOBOE study shows that in premenopausal patients with early breast cancer undergoing ovarian function suppression with triptorelin, ZL significantly improves DFS, while worsening compliance and toxicity, as compared with T. (NCT00412022)., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Published
2019
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35. Prevalence of temporomandibular disorder pain, jaw noises and oral behaviours in an adult Italian population sample.

Author

Iodice G, Cimino R, Vollaro S, Lobbezoo F, and Michelotti A

Subjects
Adult, Facial Pain, Female, Humans, Prevalence, Self Report, Somatoform Disorders, Temporomandibular Joint Disorders
Abstract

To evaluate the prevalence of temporomandibular disorder pain (TMD-pain), temporomandibular joint (TMJ) noises, oral behaviours in an Italian adult population sample, their possible association with gender, oral behaviours, self-reported facial trauma and orthodontic treatment. Subjects older than 18 years were recruited from general population in public spaces during their daily life. A specific questionnaire was developed to collect data on TMD-pain, TMJ noises, oral behaviours, orthodontic treatment and facial trauma. A total of 4299 subjects were included in the study. The most common symptom in the sample was TMJ clicking (30.7%), followed by TMD-pain (16.3%) and TMJ crepitus (10.3%). Oral behaviours were reported in 29% of the sample; 43.6% of the sample reported a previous or ongoing orthodontic treatment. TMD-pain and TMJ clicking were significantly associated to gender, oral behaviours and a positive history of previous facial trauma. Crepitus was significantly associated to oral behaviours, facial trauma and higher age. Ongoing orthodontic treatment was significantly associated to TMD-pain and TMJ sounds. In a general Italian adult population sample, TMD-pain is associated to female gender and is less prevalent than TMJ clicking. TMDs are associated to trauma and oral behaviours., (© 2019 John Wiley & Sons Ltd.)

Published
2019
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36. Metastasectomy following incomplete response to high-dose interleukin-2.

Author

Hughes T, Broucek J, Iodice G, Bommareddy PK, Basu S, and Kaufman HL

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Carcinoma, Renal Cell pathology, Dose-Response Relationship, Drug, Female, Humans, Kidney Neoplasms pathology, Male, Melanoma pathology, Middle Aged, Neoplasm Metastasis, Retrospective Studies, Young Adult, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell surgery, Interleukin-2 administration & dosage, Kidney Neoplasms drug therapy, Kidney Neoplasms surgery, Melanoma drug therapy, Melanoma surgery
Abstract

Objective: To evaluate our experience with metastasectomy following partial response or stable disease after treatment with high-dose interleukin-2 (HD IL-2)., Methods: A total of 305 patients with metastatic renal cell carcinoma or melanoma treated with HD IL-2 over a 12-year period were reviewed. Age, objective response, and overall survival data were evaluated using standard RECIST criteria and Kaplan-Meier estimates., Results: The average age was 55.3 years (range, 15-85) and 245 (80.3%) patients had melanoma and 60 (19.7%) had renal cell carcinoma. The objective response rate to IL-2 for all patients was 13.6% and median survival was 16.8 months. Complete follow-up data were available for 236 patients with 147 (62.3%) progressing after treatment and 8 (3.3%) with a complete response. Incomplete responses were seen in 81 (34.3%) patients, including 57 (24.2%) patients with stable disease and 24 (10.1%) with partial responses. Of these 81 incomplete responders, 15 (18.5%) underwent subsequent metastasectomy. Patients without surgery had overall survival of 38.2 months and median survival has not yet been reached in those who underwent metastasectomy (P = 0.026)., Conclusion: The data support prospective evaluation of metastasectomy following incomplete therapeutic responses to immunotherapy and defines a new role for surgical resection following IL-2 and perhaps other immunotherapy regimens., (© 2017 Wiley Periodicals, Inc.)

Published
2018
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37. Eribulin for metastatic breast cancer (MBC) treatment: a retrospective, multicenter study based in Campania, south Italy (Eri-001 trial).

Author

Orditura M, Gravina A, Riccardi F, Diana A, Mocerino C, Leopaldi L, Fabozzi A, Giordano G, Nettuno R, Incoronato P, Barzelloni ML, Caputo R, Pisano A, Grimaldi G, Genua G, Montesarchio V, Barbato E, Iodice G, Lieto E, Procaccini E, Mabilia R, Febbraro A, Laurentiis M, and Ciardiello F

Abstract

Background: On the basis of the results of two pivotal phase III clinical trials, eribulin mesylate is currently approved in EU for the treatment of advanced breast cancer (aBC) in patients who have previously received an anthracycline and a taxane in either the adjuvant or the metastatic setting, and at least one chemotherapeutic regimen for metastatic disease., Methods: In our study, we investigated the efficacy and tolerability of eribulin as second or further line chemotherapy in 137 women affected by aBC., Results: Eribulin as monotherapy provided benefit in terms of progression-free survival (PFS), response rate (RR) and disease control rate (DCR) independently of its use as second or late-line therapy. The overall RR and DCR were 17.5% and 64%, respectively. In particular, DCR and overall RR were 50% and 13.6%, 65.4% and 21.1%, 70.4% and 14.8% and 66.7% and 16.7% in second, third, fourth and further lines of treatment, respectively. Median PFS (mPFS) according to the line of therapy was 5.7, 6.3, 4.5 and 4.0 months in patients treated with eribulin in second, third, fourth and over the fourth line, respectively. No significant difference in terms of mPFS was found between the various BC subtypes. Overall, eribulin resulted safe and most adverse events were of grade 1 or 2 and easily manageable. Grades 3-4 toxicities were neutropaenia and neurotoxicity., Conclusions: With the limitations due to the observational nature of our findings, eribulin was shown to be an effective and safe therapeutic option in heavily pretreated patients with aBC., Competing Interests: Competing interests: None declared.

Published
2017
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38. Long-term treatment with eribulin in heavily pretreated women with metastatic breast cancer: a case series.

Author

Morritti M, Iodice G, Melaccio A, D'Onofrio L, Bergnolo P, Boglione A, Comandone A, Molinaro P, and Garigliano D

Subjects
Adult, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Biomarkers, Tumor, Female, Furans administration & dosage, Furans adverse effects, Humans, Ketones administration & dosage, Ketones adverse effects, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Positron-Emission Tomography, Retreatment, Tomography, X-Ray Computed, Treatment Outcome, Antineoplastic Agents therapeutic use, Breast Neoplasms diagnosis, Breast Neoplasms drug therapy, Furans therapeutic use, Ketones therapeutic use
Abstract

During the last decades, much effort has been made to develop and test treatments for advanced/metastatic breast cancer (MBC) able to prolong survival and improve patients' quality of life. In this regard, eribulin represents one of the most recent and interesting discoveries. This tubulin-targeting chemotherapy demonstrated a survival benefit in MBC women who progressed after at least two prior lines of chemotherapy for the treatment of metastatic disease (prior therapies should have included an anthracycline and a taxane, in either adjuvant or metastatic setting). Here, we described five cases of heavily pretreated MBC patients who experienced long-lasting control of disease with eribulin.

Published
2017
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39. Association between posterior crossbite, skeletal, and muscle asymmetry: a systematic review.

Author

Iodice G, Danzi G, Cimino R, Paduano S, and Michelotti A

Subjects
Bite Force, Electromyography, Humans, Malocclusion pathology, Mandible physiopathology, Mastication physiology, Masticatory Muscles pathology, Malocclusion physiopathology, Masticatory Muscles physiopathology
Abstract

Background: Of the various malocclusions, unilateral posterior crossbite has often been associated to skeletal and muscular asymmetrical growth and function., Objective: To assess, by systematically reviewing the literature, the association between unilateral posterior crossbite (UPCB) and morphological and/or functional asymmetries (i.e. skeletal, masticatory muscle electromyographic (EMG) performance, bite force, muscle thickness, and chewing cycle asymmetries)., Materials and Methods: A literature survey covering the period from January 1965 to June 2015 was performed. Two reviewers extracted the data independently and assessed the quality of the studies., Results: The search strategy resulted in 2184 citations, of which 45 met the inclusion criteria. The scientific and methodological quality of these studies was medium-low, irrespective of the association reported. In several studies, posterior crossbite is reported to be associated to asymmetries in mandibular skeletal growth, EMG activity, and the chewing cycle. Fewer data are available on bite force and masticatory muscle thickness., Conclusions: The relationship between unilateral posterior crossbite and skeletal asymmetry is still unresolved. To date, most of the studies available report a skeletal asymmetric growth. EMG activity of masticatory muscles is different between crossbite and non-crossbite sides. Subjects with UPCB show smaller bite force than non-crossbite subjects. There is no consistency of studies reporting masticatory muscle thickness asymmetry in UPCB subjects. UPCB is associated to an increase in the reverse chewing cycle. The literature available on the subject is of medium-low scientific and methodological quality, irrespective of the association reported. Further investigations with higher sample size, well-defined diagnostic criteria, rigorous scientific methodologies, and long-term control are needed., (© The Author 2016. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Published
2016
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40. The prognostic significance of stable disease following high-dose interleukin-2 (IL-2) treatment in patients with metastatic melanoma and renal cell carcinoma.

Author

Hughes T, Klairmont M, Broucek J, Iodice G, Basu S, and Kaufman HL

Subjects
Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell secondary, Female, Follow-Up Studies, Humans, Immunotherapy, Kidney Neoplasms mortality, Kidney Neoplasms pathology, Male, Melanoma mortality, Melanoma secondary, Middle Aged, Neoplasm Metastasis, Neoplasm Staging, Prognosis, Remission Induction, Retrospective Studies, Survival Rate, Antineoplastic Agents therapeutic use, Carcinoma, Renal Cell drug therapy, Interleukin-2 therapeutic use, Kidney Neoplasms drug therapy, Melanoma drug therapy
Abstract

High-dose interleukin-2 (HD IL-2) is an approved immunotherapy agent for metastatic melanoma and renal cell carcinoma resulting in objective responses in 15-20 % of patients. An additional subset of patients achieves stable disease, and the natural history of these patients has not been well documented. We hypothesized that stable disease following HD IL-2 is associated with a survival advantage. To explore this hypothesis, a retrospective chart review of 305 patients diagnosed with metastatic melanoma or renal cell carcinoma treated with HD IL-2 was conducted. Patient characteristics, response based on standard RECIST criteria and overall survival were analyzed using the Kaplan-Meier method and associations with clinical response were compared using a log-rank test. Two hundred and forty-five patients had melanoma and 60 had renal cell carcinoma. Of these, 217 had complete data available for analysis. Fifty-nine percentage had progressive disease (PD), 26 % had stable disease (SD) and 15 % had an objective complete (CR) or partial response (PR). Median overall survival was 16.8 months for all patients with available survival data; patients with PD had a median survival of 7.9 months compared to 38.2 months for stable disease, while the median has not been reached for those with objective responses. This retrospective data support an association between overall survival and stable disease, suggesting that clinical benefit may be underestimated for patients treated with HD IL-2. The data further support the use of disease control rate (CR + PR + SD) as a more meaningful endpoint for future clinical studies of tumor immunotherapy, including future studies of HD IL-2.

Published
2015
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