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4. 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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8. Bone effect of adjuvant tamoxifen, letrozole or letrozole plus zoledronic acid in early-stage breast cancer: the randomized phase 3 HOBOE study

Author

Nuzzo, F., Gallo, C., Lastoria, S., Di Maio, M., Piccirillo, M.C., Gravina, A., Landi, G., Rossi, E., Pacilio, C., Labonia, V., Di Rella, F., Bartiromo, A., Buonfanti, G., De Feo, G., Esposito, G., D'Aniello, R., Maiolino, P., Signoriello, S., De Maio, E., Tinessa, V., Colantuoni, G., De Laurentiis, M., D'Aiuto, M., Di Bonito, M., Botti, G., Giordano, P., Daniele, G., Morabito, A., Normanno, N., de Matteis, A., and Perrone, F.

Published
2012
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17. 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

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

Author

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

Abstract

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

Published
2017

22. EPIRUBICIN vs EPIRUBICIN + CISPLATIN vs EPIRUBICIN + LONIDAMINE vs EPIRUBICIN + CISPLATIN + LONIDAMINE AS FIRST LINE TREATMENT IN ADVANCED BREAST CANCER (BC) PATIENTS. A RANDOMIZED MULTICENTER PHASE III TRIAL WITH A FACTORIAL DESIGN.

Author

Dogliotti, L, Berruti, A, Bitossi, R, Gorzegno, G, Bottini, A, Alquati, P, De Matteis, A, Nuzzo, F, Giardina, B, Danese, S, De Lena, M, Lorusso, V, Farris, A, Sarobba, M G, DeFabiani, E, Spanu, G, Bonazzi, G, Castiglione, F, Bumma, C, Moro, G, and Galletto, L

Published
2000

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

Author

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

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

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

Published
2016

25. Economic Assessment of the Long Term Operation of Nuclear Power Plants: Approaches and Experience

Author

Bakirov, M., Cserhati, A., Dou, Y., Esquivel Estrada, Hercberg, S., Kwon, J.J., Tomšić, Ž., Lee, M.K., Lindbaeck, J.M., Jalal, A.I., Kang, K.-S., Marchena, M.H., Memon, A.M., Nuzzo, F., Pluhar, D., Romanova. A., Savolainen, S., Stenman, K., Sun, Q., Travassos, R.C., Tuomisto, J., Vivalda, C. N, Wandrol, J., and Young, G.G.

Subjects
Nuclear power plant, Economic assessment, long term operation, risks
Abstract

This publication describes the various approaches to the techno–economic assessment of a project for the long term operation of a nuclear power plant in its specific market environment. It examines the process of defining the technical scope required to prolong the operating licences of nuclear power plants and highlights the need for further studies on technical cost drivers and economic assessments in order to better define the cost boundaries of long term operation. Information is also provided on the new IAEA software LTOFIN, which was developed to assist in performing long term operation economic assessments within the process described in the publication.

Published
2018

26. First-Line Chemotherapy for HER-2–Negative Metastatic Breast Cancer Patients Who Received Anthracyclines as Adjuvant Treatment

Author

MORABITO A, PICCIRILLO MC, MONACO K, PACILIO C, NUZZO F, CHIODINI, Paolo, GALLO, Ciro, DE MATTEIS A, PERRONE F, NCI NAPLES BREAST CANCER GROUP, Morabito, A, Piccirillo, Mc, Monaco, K, Pacilio, C, Nuzzo, F, Chiodini, Paolo, Gallo, Ciro, DE MATTEIS, A, Perrone, F, and NCI NAPLES BREAST CANCER, Group

Subjects
Drug, Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Adjuvant chemotherapy, medicine.medical_treatment, media_common.quotation_subject, Breast Neoplasms, Disease-Free Survival, Recurrence, Trastuzumab, Internal medicine, medicine, Humans, Anthracyclines, Neoplasm Metastasis, media_common, Chemotherapy, business.industry, medicine.disease, Metastatic breast cancer, Anti-Bacterial Agents, Treatment Outcome, Clinical research, Chemotherapy, Adjuvant, Liposomes, Female, Taxoids, First line chemotherapy, business, Adjuvant, medicine.drug
Abstract

The treatment decision for patients with metastatic breast cancer who have received anthracyclines within the course of adjuvant chemotherapy is troublesome, particularly if trastuzumab and hormonal treatment are not indicated. In the first part of this review we discuss the value of retreatment with anthracyclines, a topicthathasbeenindirectlyevaluatedbyretrospective studies with conflicting results and within a small phase III trial with a negative outcome. Evidence on liposomal anthracyclinesisalsoreviewed.Inthesecondpartofthe review, alternative options of first-line chemotherapy are discussed. These include taxanes as single agents, taxanesincombinationwithothercytotoxicdrugs,combinationswithoutanthracyclinesandtaxanes,andinnovative treatments including target-based agents. Both the amount and the quality of evidence on these treatments are poor. Few phase III studies are available and most of them have been performed with registrative aims sponsored by the companies who own the winning drug. Beyond indications derived from such studies, there is a great need for more clinical research in this setting. The Oncologist 2007;12:1288 –1298

Published
2007
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27. Is epirubicin effective in first-line chemotherapy of metastatic breast cancer (MBC) after an epirubicin-containing adjuvant treatment? A single centre phase III trial

Author

PACILIO C, MORABITO A, NUZZO F, GRAVINA A, LABONIA V, LANDI G, ROSSI E, MAIO E, DI MAIO M, D'AIUTO G, BOTTI G, NORMANNO N, CHIODINI, Paolo, GALLO, Ciro, PERRONE, F, DE MATTEIS A, NCI NAPLES BREAST CANCER GROUP, Pacilio, C, Morabito, A, Nuzzo, F, Gravina, A, Labonia, V, Landi, G, Rossi, E, De, Maio, E, DI MAIO, M, D'Aiuto, G, Botti, G, Normanno, N, Chiodini, Paolo, Gallo, Ciro, Perrone, F, DE MATTEIS, A, and NCI NAPLES BREAST CANCER, Group

Subjects
Adult, Oncology, Cancer Research, medicine.medical_specialty, Anthracycline, medicine.medical_treatment, Breast Neoplasms, Docetaxel, Metastasis, Breast cancer, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Clinical Studies, Humans, Medicine, Neoplasm Metastasis, adjuvant anthracyclines, skin and connective tissue diseases, Neoadjuvant therapy, randomised trials, Chemotherapy, Antibiotics, Antineoplastic, business.industry, Middle Aged, medicine.disease, Survival Analysis, epirubicin, Metastatic breast cancer, Female, Taxoids, metastatic breast cancer, Neoplasm Recurrence, Local, business, medicine.drug, Epirubicin
Abstract

The aim of the study was to demonstrate the superiority of docetaxel and epirubicin vs docetaxel alone as first-line therapy in metastatic breast cancer patients pretreated with adjuvant or neoadjuvant epirubicin. We compared single agent docetaxel 100 mg m−2 (D) with the combination of docetaxel 80 mg m−2 and epirubicin 75 mg m−2 (ED). The response rate (72 vs 79%), the progression-free survival (median 9 vs 11 months) and the overall survival (median 18 vs 21 months) were not significantly different between the ED (n=26) and D arms (n=25), respectively. Leucopaenia, nausea and stomatitis were significantly worse with ED. In conclusion, epirubicin should not be administered in combination with taxanes in metastatic breast cancer patients relapsed after an anthracycline-based adjuvant or neoadjuvant therapy.

Published
2006
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28. The HOBOE-2 multicenter randomized phase III trial in premenopausal patients with hormone-receptor positive early breast cancer comparing triptorelin plus either tamoxifen or letrozole or letrozole + zoledronic acid

Author

Perrone, F., primary, De Laurentiis, M., additional, de Placido, S., additional, Orditura, M., additional, Cinieri, S., additional, Riccardi, F., additional, Ribecco, A.S., additional, Putzu, C., additional, Del Mastro, L., additional, Rossi, E., additional, Daniele, B., additional, Mosconi, A.M., additional, Di Rella, F., additional, Landi, G., additional, Nuzzo, F., additional, Pacilio, C., additional, Lauria, R., additional, Arenare, L., additional, Piccirillo, M.C., additional, and Gallo, C., additional

Published
2018
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29. Phase 3 randomized study of adjuvant anastrozole (A), exemestane (E) or letrozole (L) with or without tamoxifen (T) in postmenopausal women with hormone-responsive (HR) breast cancer. The FATA-GIM3 trial

Author

De Placido, S., primary, Gallo, C., additional, De Laurentiis, M., additional, Bisagni, G., additional, Arpino, G., additional, Sarobba, M.G., additional, Riccardi, F., additional, Russo, A., additional, Del Mastro, L., additional, Cogoni, A., additional, Cognetti, F., additional, Gori, S., additional, Frassoldati, A., additional, Amoroso, D., additional, Laudadio, L., additional, Moscetti, L., additional, Montemurro, F., additional, Nuzzo, F., additional, Carlini, P., additional, and Perrone, F., additional

Published
2017
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30. 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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31. Abstract P4-22-13: Everolimus plus trastuzumab and paclitaxel as first-line therapy in women with HER2+ advanced breast cancer: Overall survival results from BOLERO-1

Author

Yardley, D, primary, Hurvitz, S, additional, Jiang, Z-f, additional, Toi, M, additional, Burris, H, additional, Buyse, M, additional, Slamon, D, additional, Makhson, A, additional, Elsaid, A, additional, Lerzo, G, additional, Hellerstedt, B, additional, Nuzzo, F, additional, Sohn, J, additional, Manzyuk, L, additional, Cabaribere, D, additional, Lincy, J, additional, Weimann, A, additional, Noel-Baron, F, additional, Pacaud, L, additional, and Andre, F, additional

Published
2017
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32. Valutazione dell'impatto della dermatite atomica sui pazienti in età pediatrica e sui loro caregiver

Author

Nuzzo F, Boccia L., CANTONE, Daniela, Nuzzo, F, Cantone, Daniela, and Boccia, L.

Subjects
relazione affettiva, qualità della vita, dermatite atopica
Abstract

Numerosi studi hanno evidenziato che la dermatite atopica (DA) dell’infanzia ha un impatto, oltre che sulla qualità della vita del piccolo paziente, anche su quella della sua famiglia. Questa ricerca è stata progettata allo scopo di valutare anche l’impatto della DA del bambino sullo stress psicofisico e sull’accordo di coppia del genitore-caregiver. Sono stati somministrati 4 questionari a 60 genitori-caregiver di bambini affetti da DA e 2 questionari a 60 genitori-caregiver di bambini sani. I risultati sono in linea con la letteratura scientifica, in più sono emersi nuovi dati relativamente all’impatto della DA sul genitore-caregiver del bambino affetto.

Published
2013

33. Meta-analysis applied to operations management: summarizing the results of empirical research.

Author

Forza, C. and Nuzzo, F. Di

Subjects
META-analysis, MANAGEMENT
Abstract

The writing of every new management study should include an enquiry into previous, related investigations. This approach helps to build up a comprehensive picture of the phenomena being considered. Researchers working in isolation tend to repeat past mistakes and rarely achieve much progress. Progress in management sciences comes from building on the efforts of those who have already worked on the subject. Research synthesis is therefore an important task in the theory building/theory testing process. In recent years, quantitative research synthesis (meta-analysis) has gained increasing acceptance. Meta-analysis offers a powerful set of tools for extracting quantitative information from a body of related research. It has already been applied in the fields of archaeology, astronomy, chemistry, education, geophysical science, psychology and public policy. However, it seems suitable even for management researchers since quantitative research is becoming more accepted in management disciplines. The aim of this study is to identify the conditions of applicability of quantitative methods in summarizing past research by drawing overall conclusions from many separate studies. Meta-analysis will be applied to a specific topic of operations management (OM): the link between JIT levers and manufacturing performance with particular reference to time performance. More specifically, an application of meta-analysis will be made with reference to two of the main steps towards the development of an empirically-tested theory: testing the adequacy of the measurement of variables and testing the linkages between the variables. The preliminary application of meta-analysis to OM has revealed distinct potential. However, in order for this potential to be fully exploited, a set of conditions should be established when publishing empirical research in operations management, in order to simplify the comparison of different studies which are related to the same issue. This recommendation is presented together with the final results of the present study. [ABSTRACT FROM AUTHOR]

Published
1998
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35. health economics The effect of financial difficulties on clinical outcomes in Italian cancer patients: A pooled analysis of 16 academic prospective clinical trials

Author

Perrone, F., primary, Jommi, C., additional, Di Maio, M., additional, Gimigliano, A., additional, Gridelli, C., additional, Pignata, S., additional, Ciardiello, F., additional, Nuzzo, F., additional, de Matteis, A., additional, Del Mastro, L., additional, Bryce, J., additional, Daniele, G., additional, Morabito, A., additional, Piccirillo, M.C., additional, Rocco, G., additional, Guizzaro, L., additional, and Gallo, C., additional

Published
2016
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36. The effect of financial difficulties on clinical outcomes in Italian cancer patients: a pooled analysis of 16 academic prospective clinical trials

Author

Perrone, F., primary, Jommi, C., additional, Di Maio, M., additional, Gimigliano, A., additional, Gridelli, C., additional, Pignata, S., additional, Ciardiello, F., additional, Nuzzo, F., additional, de Matteis, A., additional, Del Mastro, L., additional, Bryce, J., additional, Daniele, G., additional, Morabito, A., additional, Piccirillo, M.C., additional, Rocco, G., additional, Guizzaro, L., additional, and Gallo, C., additional

Published
2016
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37. LBA14_PR - The HOBOE-2 multicenter randomized phase III trial in premenopausal patients with hormone-receptor positive early breast cancer comparing triptorelin plus either tamoxifen or letrozole or letrozole + zoledronic acid

Author

Perrone, F., De Laurentiis, M., de Placido, S., Orditura, M., Cinieri, S., Riccardi, F., Ribecco, A.S., Putzu, C., Del Mastro, L., Rossi, E., Daniele, B., Mosconi, A.M., Di Rella, F., Landi, G., Nuzzo, F., Pacilio, C., Lauria, R., Arenare, L., Piccirillo, M.C., and Gallo, C.

Published
2018
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42. 2* - Phase 3 randomized study of adjuvant anastrozole (A), exemestane (E) or letrozole (L) with or without tamoxifen (T) in postmenopausal women with hormone-responsive (HR) breast cancer. The FATA-GIM3 trial

Author

De Placido, S., Gallo, C., De Laurentiis, M., Bisagni, G., Arpino, G., Sarobba, M.G., Riccardi, F., Russo, A., Del Mastro, L., Cogoni, A., Cognetti, F., Gori, S., Frassoldati, A., Amoroso, D., Laudadio, L., Moscetti, L., Montemurro, F., Nuzzo, F., Carlini, P., and Perrone, F.

Published
2017
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43. Breast cancer screening: characteristics and results of the Italian programmes in the Italian group for planning and evaluating breast cancer screening programmes (GISMa)

Author

GIORDANO, LARA, BIANCO, ANGELO RAFFAELE, DE PLACIDO, SABINO, SODANO, ANTONIO, Giorgi D., Fasolo G., Segnan N., Rosselli Del Turco M., Pini M. T., Nuzzo F., Perrone F., Giordano, Lara, Giorgi, D., Fasolo, G., Segnan, N., Rosselli Del Turco, M., Bianco, ANGELO RAFFAELE, DE PLACIDO, Sabino, Sodano, Antonio, Pini, M. T., Nuzzo, F., and Perrone, F.

Published
1996

46. Weekly Docetaxel (Wd) Vs Cmf As Adjuvant Chemotherapy for Elderly Early Breast Cancer (Ebc) Patients (Pts): Final Results from the Randomised Phase 3 Elda Trial

Author

Perrone, F., primary, Nuzzo, F., additional, Di Rella, F., additional, Gravina, A., additional, Landi, G., additional, Pacilio, C., additional, De Laurentiis, M., additional, De Placido, S., additional, Forestieri, V., additional, Gargiulo, P., additional, Daniele, B., additional, Tinessa, V., additional, Gori, S., additional, Colantuoni, G., additional, Barni, S., additional, Riccardi, F., additional, Piccirillo, M.C., additional, Di Maio, M., additional, Gallo, C., additional, and De Matteis, A., additional

Published
2014
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47. Symptomatic Toxicities Experienced During Anti-Cancer Treatment: Comparison of Patients' and Physicians' Reporting in Three Randomized Controlled Trials (Rcts)

Author

Di Maio, M., primary, Piccirillo, M.C., additional, Daniele, G., additional, Nuzzo, F., additional, Gridelli, C., additional, Gebbia, V., additional, Ciardiello, F., additional, De Placido, S., additional, Ceribelli, A., additional, Favaretto, A., additional, De Matteis, A., additional, Feld, R., additional, Butts, C.A., additional, Leighl, N.B., additional, Morabito, A., additional, Bryce, J., additional, Signoriello, S., additional, Gallo, C., additional, and Perrone, F., additional

Published
2014
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