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44 results on '"Palumbo, Raffaella"'

5. Identification of a Panel of miRNAs Associated with Resistance to Palbociclib and Endocrine Therapy

Author

Torrisi, Rosalba, primary, Vaira, Valentina, additional, Giordano, Laura, additional, Fernandes, Bethania, additional, Saltalamacchia, Giuseppe, additional, Palumbo, Raffaella, additional, Carnaghi, Carlo, additional, Basilico, Vera, additional, Gentile, Francesco, additional, Masci, Giovanna, additional, De Sanctis, Rita, additional, and Santoro, Armando, additional

Published
2024
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6. 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

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, Bisagni, Giancarlo, 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, De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, 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, Carmela, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, and Perrone, Francesco

Published
2018
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8. EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer

Author

Biganzoli, Laura, Cinieri, Saverio, Berardi, Rossana, Pedersini, Rebecca, McCartney, Amelia, Minisini, Alessandro Marco, Caremoli, Elena Rota, Spazzapan, Simon, Magnolfi, Emanuela, Brunello, Antonella, Risi, Emanuela, Palumbo, Raffaella, Leo, Silvana, Colleoni, Marco, Donati, Sara, De Placido, Sabino, Orlando, Laura, Pistelli, Mirco, Parolin, Veronica, Mislang, Anna, Becheri, Dimitri, Puglisi, Fabio, Sanna, Giuseppina, Zafarana, Elena, Boni, Luca, and Mottino, Giuseppe

Published
2020
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9. Efficacy and activity of treatments after progression from palbociclib plus endocrine therapy in patients with HR+/HER2– metastatic breast cancer: a prospective, monocentric study

Author

Palumbo, Raffaella, primary, Quaquarini, Erica, additional, Saltalamacchia, Giuseppe, additional, Malovini, Alberto, additional, Lapidari, Pietro, additional, Tagliaferri, Barbara, additional, Mollica, Ludovica, additional, Teragni, Cristina Maria, additional, Barletta, Chiara, additional, Locati, Laura Deborah, additional, and Sottotetti, Federico, additional

Published
2023
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11. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study

Author

Arpino, Grazia, Michelotti, Andrea, Truini, Mauro, Montemurro, Filippo, Russo, Stefania, Palumbo, Raffaella, Zamagni, Claudio, Latorre, Agnese, Bruzzese, Dario, Riccardi, Ferdinando, De Laurentiis, Michelino, Beano, Alessandra, Biganzoli, Laura, Zaniboni, Alberto, Laudadio, Lucio, Malagoli, Maria, Bilancia, Domenico, Schettini, Francesco, Giuliano, Mario, Cazzaniga, Marina Elena, and De Placido, Sabino

Published
2016
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12. The prognostic role of variations in tumour markers (CEA, CA15.3) in patients with metastatic breast cancer treated with CDK4/6 inhibitors

Author

Sottotetti, Federico, primary, Ferraris, Elisa, additional, Tagliaferri, Barbara, additional, Palumbo, Raffaella, additional, Quaquarini, Erica, additional, Teragni, Cristina, additional, Balletti, Emanuela, additional, Leli, Claudia, additional, Premoli, Andrea, additional, Mollica, Ludovica, additional, Puglisi, Silvia, additional, Sardi, Silvia, additional, Malovini, Alberto, additional, Pedrazzoli, Paolo, additional, and Bernardo, Antonio, additional

Published
2022
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13. Clinical and Biological Variables Influencing Outcome in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) Treated with Anti-PD-1/PD-L1 Antibodies: A Prospective Multicentre Study

Author

Quaquarini, Erica, primary, Sottotetti, Federico, additional, Agustoni, Francesco, additional, Pozzi, Emma, additional, Malovini, Alberto, additional, Teragni, Cristina Maria, additional, Palumbo, Raffaella, additional, Saltalamacchia, Giuseppe, additional, Tagliaferri, Barbara, additional, Balletti, Emanuela, additional, Rinaldi, Pietro, additional, Canino, Costanza, additional, Pedrazzoli, Paolo, additional, and Bernardo, Antonio, additional

Published
2022
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14. Additional file 2 of EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer

Author

Biganzoli, Laura, Cinieri, Saverio, Berardi, Rossana, Pedersini, Rebecca, McCartney, Amelia, Minisini, Alessandro Marco, Caremoli, Elena Rota, Spazzapan, Simon, Magnolfi, Emanuela, Brunello, Antonella, Risi, Emanuela, Palumbo, Raffaella, Leo, Silvana, Colleoni, Marco, Donati, Sara, Placido, Sabino De, Orlando, Laura, Pistelli, Mirco, Parolin, Veronica, Mislang, Anna, Becheri, Dimitri, Puglisi, Fabio, Sanna, Giuseppina, Zafarana, Elena, Boni, Luca, and Mottino, Giuseppe

Abstract

Additional File 2: Supplementary Table 2 (S2). Distribution of CTCAE G2-3 fatigue and neurotoxicity by age and arm of treatment. Reported as N (%) unless otherwise indicated. Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events.

Published
2020
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15. Additional file 1 of EFFECT: a randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer

Author

Biganzoli, Laura, Cinieri, Saverio, Berardi, Rossana, Pedersini, Rebecca, McCartney, Amelia, Minisini, Alessandro Marco, Caremoli, Elena Rota, Spazzapan, Simon, Magnolfi, Emanuela, Brunello, Antonella, Risi, Emanuela, Palumbo, Raffaella, Leo, Silvana, Colleoni, Marco, Donati, Sara, Placido, Sabino De, Orlando, Laura, Pistelli, Mirco, Parolin, Veronica, Mislang, Anna, Becheri, Dimitri, Puglisi, Fabio, Sanna, Giuseppina, Zafarana, Elena, Boni, Luca, and Mottino, Giuseppe

Abstract

Additional File 1: Supplementary Table 1 (S1). Distribution of AEs by arm in patients aged ≥75 years. Abbreviations: CTCAE, Common Terminology Criteria for Adverse Events; /, grade does not exist for this adverse event; ° grade 5 n=1.

Published
2020
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16. Patterns of treatment and outcome of palbociclib plus endocrine therapy in hormone receptor-positive/HER2 receptor-negative metastatic breast cancer: a real-world multicentre Italian study

Author

Palumbo, Raffaella, primary, Torrisi, Rosalba, additional, Sottotetti, Federico, additional, Presti, Daniele, additional, Rita Gambaro, Anna, additional, Collovà, Elena, additional, Ferzi, Antonella, additional, Agostinetto, Elisa, additional, Maria Teragni, Cristina, additional, Saltalamacchia, Giuseppe, additional, Tagliaferri, Barbara, additional, Balletti, Emanuela, additional, Bernardo, Antonio, additional, and Quaquarini, Erica, additional

Published
2021
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17. Impact of COVID-19 Outbreak on Cancer Patient Care and Treatment: Data from an Outpatient Oncology Clinic in Lombardy (Italy)

Author

Quaquarini, Erica, primary, Saltalamacchia, Giuseppe, additional, Presti, Daniele, additional, Caldana, Giulia, additional, Tibollo, Valentina, additional, Malovini, Alberto, additional, Palumbo, Raffaella, additional, Teragni, Cristina Maria, additional, Balletti, Emanuela, additional, Mollica, Ludovica, additional, Biscaldi, Elisa, additional, Frascaroli, Mara, additional, Bernardo, Antonio, additional, and Sottotetti, Federico, additional

Published
2020
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18. EFFECT: A randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer

Author

Biganzoli, Laura, primary, Cinieri, Saverio, additional, Berardi, Rossana, additional, Pedersini, Rebecca, additional, McCartney, Amelia, additional, Minisini, Alessandro Marco, additional, Caremoli, Elena Rota, additional, Spazzapan, Simon, additional, Magnolfi, Emanuela, additional, Brunello, Antonella, additional, Risi, Emanuela, additional, Palumbo, Raffaella, additional, Leo, Silvana, additional, Colleoni, Marco, additional, Donati, Sara, additional, De Placido, Sabino, additional, Orlando, Laura, additional, Pistelli, Mirco, additional, Parolin, Veronica, additional, Mislang, Anna, additional, Becheri, Dimitri, additional, Puglisi, Fabio, additional, Sanna, Giuseppina, additional, Zafarana, Elena, additional, Boni, Luca, additional, and Mottino, Giuseppe, additional

Published
2020
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19. Role of androgen receptor expression in early stage ER+/PgR−/HER2– breast cancer

Author

Tagliaferri, Barbara, primary, Quaquarini, Erica, additional, Palumbo, Raffaella, additional, Balletti, Emanuela, additional, Presti, Daniele, additional, Malovini, Alberto, additional, Agozzino, Manuela, additional, Teragni, Cristina Maria, additional, Terzoni, Andrea, additional, Bernardo, Antonio, additional, Villani, Laura, additional, and Sottotetti, Federico, additional

Published
2020
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20. Correction: Everolimus (Eve) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study (Oncotarget (2018) 9:77 (34639-34640) DOI: 10.18632/oncotarget.25874)

Author

Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, Ancona, Chiara, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Michela, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Antonio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, and Clivio, Luca

Subjects
Oncology
Published
2018

22. Patterns of treatment and outcome with 500-mg fulvestrant in postmenopausal women with hormone receptor-positive/HER2-negative metastatic breast cancer: a real-life multicenter Italian experience

Author

Palumbo, Raffaella, primary, Sottotetti, Federico, additional, Quaquarini, Erica, additional, Gambaro, Anna, additional, Ferzi, Antonella, additional, Tagliaferri, Barbara, additional, Teragni, Cristina, additional, Licata, Luca, additional, Serra, Francesco, additional, Lapidari, Pietro, additional, and Bernardo, Antonio, additional

Published
2019
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23. Additional file 1: of Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01â 2014)

Author

Passalacqua, Rodolfo, Lazzarelli, Silvia, Donini, Maddalena, Montironi, Rodolfo, Tambaro, Rosa, Giorgi, Ugo De, Pignata, Sandro, Palumbo, Raffaella, Ceresoli, Giovanni, Conte, Gianluca Del, Tonini, Giuseppe, Morelli, Franco, Nolè, Franco, Panni, Stefano, Rondini, Ermanno, Guida, Annalisa, Zucali, Paolo, Doni, Laura, Iezzi, Elisa, and Caminiti, Caterina

Subjects
neoplasms
Abstract

List of participating centers. Table S1. Stratified analysis of overall survival (OS) and progression-free survival (PFS) according to previous Cisplatin or Carboplatin treatment and to the number of cycles received. (DOCX 46 kb)

Published
2017
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24. Correction 2: Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: new lessons for clinical practice from the EVA study

Author

Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, Valerio, Maria Rosaria, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Michela, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Alessio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, Clivio, Luca, and Torri, Valter

Subjects
Oncology, Correction
Abstract

The present analysis focuses on real-world data of Everolimus-Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years.Data are collected from clinical records and analysed according to age cut-off (65 years; 65 - 69 years and {greater than or equal to} 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel-Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model.From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged {greater than or equal to} 65 years, of whom 87 were {greater than or equal to} 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged {greater than or equal to} 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged {greater than or equal to} 70 years. Five treatment-related deaths were collected (3,2%).EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018
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25. Correction: Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: new lessons for clinical practice from the EVA study

Author

Cazzaniga, Marina, primary, Verusio, Claudio, additional, Ciccarese, Mariangela, additional, Fumagalli, Alberto, additional, Sartori, Donata, additional, Valerio, Maria Rosaria, additional, Airoldi, Mario, additional, Moretti, Gabriella, additional, Ficorella, Corrado, additional, Arcangeli, Valentina, additional, Diodati, Lucrezia, additional, Zambelli, Alberto, additional, Febbraro, Antonio, additional, Generali, Daniele, additional, Pistelli, Mirco, additional, Garrone, Ornella, additional, Musolino, Antonino, additional, Vici, Patrizia, additional, Maur, Michela, additional, Mentuccia, Lucia, additional, La Verde, Nicla, additional, Bianchi, Giulia, additional, Artale, Salvatore, additional, Blasi, Livio, additional, Piezzo, Matilde, additional, Atzori, Francesco, additional, Turletti, Anna, additional, Benedetto, Chiara, additional, Cursano, Maria Concetta, additional, Fabi, Alessandra, additional, Gebbia, Vittorio, additional, Schirone, Alessio, additional, Palumbo, Raffaella, additional, Ferzi, Antonella, additional, Frassoldati, Antonio, additional, Scavelli, Claudio, additional, Clivio, Luca, additional, and Torri on behalf of The EVA Study Group, Valter, additional

Published
2018
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26. 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, Sabino, primary, Gallo, Ciro, additional, De Laurentiis, Michelino, additional, Bisagni, Giancarlo, additional, Arpino, Grazia, additional, Sarobba, Maria Giuseppa, additional, Riccardi, Ferdinando, additional, Russo, Antonio, additional, Del Mastro, Lucia, additional, Cogoni, Alessio Aligi, additional, Cognetti, Francesco, additional, Gori, Stefania, additional, Foglietta, Jennifer, additional, Frassoldati, Antonio, additional, Amoroso, Domenico, additional, Laudadio, Lucio, additional, Moscetti, Luca, additional, Montemurro, Filippo, additional, Verusio, Claudio, additional, Bernardo, Antonio, additional, Lorusso, Vito, additional, Gravina, Adriano, additional, Moretti, Gabriella, additional, Lauria, Rossella, additional, Lai, Antonella, additional, Mocerino, Carmela, additional, Rizzo, Sergio, additional, Nuzzo, Francesco, additional, Carlini, Paolo, additional, Perrone, Francesco, additional, Accurso, Antonello, additional, Agostara, Biagio, additional, Aieta, Michele, additional, Alabiso, Oscar, additional, Alicicco, Maria Grazia, additional, Amadori, Dino, additional, Amaducci, Laura, additional, Amiconi, Gianna, additional, Antuzzi, Giustino, additional, Ardine, Mara, additional, Ardizzoia, Antonio, additional, Aversa, Caterina, additional, Badalamenti, Giuseppe, additional, Barni, Sandro, additional, Basurto, Carlo, additional, Berardi, Rossana, additional, Bergamasco, Cinzia, additional, Bidoli, Paolo, additional, Bighin, Claudia, additional, Biondi, Edoardo, additional, Boni, Corrado, additional, Borgonovo, Karen, additional, Botta, Mario, additional, Bravi, Stefano, additional, Bruzzi, Paolo, additional, Buono, Giuseppe, additional, Butera, Alfredo, additional, Caldara, Alessia, additional, Candeloro, Giampiero, additional, Cappelletti, Claudia, additional, Cardalesi, Cinzia, additional, Carfora, Elisabetta, additional, Cariello, Anna, additional, Carrozza, Francesco, additional, Cartenì, Giacomo, additional, Caruso, Michele, additional, Casadei, Virginia, additional, Casanova, Claudia, additional, Castori, Luigi, additional, Cavanna, Luigi, additional, Cavazzini, Giovanna, additional, Cazzaniga, Marina, additional, Chilelli, Mario, additional, Chiodini, Paolo, additional, Chiorrini, Silvia, additional, Ciardiello, Fortunato, additional, Ciccarese, Mariangela, additional, Cinieri, Saverio, additional, Clerico, Mario, additional, Coccaro, Mariarosa, additional, Comande, Mario, additional, Corbo, Claudia, additional, Cortino, Giuseppina, additional, Cusenza, Stefania, additional, Daniele, Gennaro, additional, D'arco, Alfonso Maria, additional, D'auria, Giuliana, additional, Dazzi, Claudio, additional, De Angelis, Carmine, additional, de Braud, Filippo, additional, De Feo, Gianfranco, additional, De Matteis, Andrea, additional, De Tursi, Michele, additional, Di Blasio, Anna, additional, di Lucca, Giuseppe, additional, Di Lullo, Liberato, additional, Di Rella, Francesca, additional, Di Renzo, Gianfranco, additional, Di Stefano, Pia, additional, Di Stefano, Aida, additional, Diana, Anna, additional, Donati, Sara, additional, Fabbri, Agnese, additional, Fabi, Alessandra, additional, Faedi, Marina, additional, Farina, Gabriella, additional, Farris, Antonio, additional, Febbraro, Antonio, additional, Fedele, Palma, additional, Federico, Piera, additional, Ferraù, Francesco, additional, Ferretti, Gianluigi, additional, Ferro, Antonella, additional, Floriani, Irene, additional, Forcignanò, Rosachiara, additional, Forciniti, Samantha, additional, Forestieri, Valeria, additional, Fornari, Gianni, additional, Frisinghelli, Michela, additional, Fusco, Vittorio, additional, Gallizzi, Giulia, additional, Galvano, Antonio, additional, Gambardella, Antonio, additional, Gambi, Angelo, additional, Gebbia, Vittorio, additional, Gervasi, Erika, additional, Ghilardi, Mara, additional, Giacobino, Alice, additional, Giardina, Giovanni, additional, Giotta, Francesco, additional, Giraudi, Sara, additional, Giuliano, Mario, additional, Grassadonia, Antonino, additional, Grasso, Donatella, additional, Grosso, Federica, additional, Guizzaro, Lorenzo, additional, Incoronato, Pasquale, additional, Incorvaia, Lorena, additional, Iodice, Giovanni, additional, La Verde, Nicla, additional, Labonia, Vincenzo, additional, Landi, Gabriella, additional, Latorre, Agnese, additional, Leonardi, Vita, additional, Levaggi, Alessia, additional, Limite, Gennaro, additional, Lina Bascialla, Linda, additional, Livi, Lorenzo, additional, Maiello, Evaristo, additional, Mandelli, Daniela, additional, Marcon, Ilaria, additional, Menon, Daniela, additional, Montedoro, Michele, additional, Moraca, Lucia, additional, Moretti, Anna, additional, Morritti, Maria Grazia, additional, Morselli, Patrizia, additional, Mura, Antonella, additional, Mura, Silvia, additional, Musacchio, Michela, additional, Muzio, Alberto, additional, Natale, Donato, additional, Natoli, Clara, additional, Nigro, Cinzia, additional, Nisticò, Cecilia, additional, Nuzzo, Antonio, additional, Orditura, Michele, additional, Orlando, Laura, additional, Pacilio, Carmen, additional, Palumbo, Giuliano, additional, Palumbo, Raffaella, additional, Pasini, Felice, additional, Paterno, Emanuela, additional, Pazzola, Antonio, additional, Pelliccioni, Silvia, additional, Pensabene, Matilde, additional, Perroni, Davide, additional, Pesenti Gritti, Angela, additional, Petrelli, Fausto, additional, Piccirillo, Maria Carmela, additional, Pinotti, Graziella, additional, Pogliani, Claudia, additional, Poli, Davide, additional, Prader, Sonia, additional, Recchia, Francesco, additional, Rizzi, Daniele, additional, Romano, Carmen, additional, Rossello, Rosalba, additional, Rossini, Chiara, additional, Salvucci, Giuseppina, additional, Sanna, Valeria, additional, Santini, Alessandra, additional, Saracchini, Silvana, additional, Savastano, Clementina, additional, Scambia, Giovanni, additional, Schettini, Francesco, additional, Schiavone, Paola, additional, Schirone, Alessio, additional, Seles, Elena, additional, Signoriello, Simona, additional, Signoriello, Giuseppe, additional, Silva, Rosa Rita, additional, Silvestri, Antonia, additional, Simeon, Vittorio, additional, Spagnoletti, Ilaria, additional, Tamberi, Stefano, additional, Teragni, Cristina, additional, Thalmann, Verena, additional, Thomas, Renato, additional, Thomas, Guglielmo, additional, Tienghi, Amelia, additional, Tinari, Nicola, additional, Tinessa, Vincenza, additional, Tomei, Federica, additional, Tonini, Giuseppe, additional, Torri, Valter, additional, Traficante, Divina, additional, Tudini, Marianna, additional, Turazza, Monica, additional, Vignoli, Roberto, additional, Vitale, Maria Giuseppa, additional, Zacchia, Alessandra, additional, Zagarese, Pasquale, additional, Zanni, Alda, additional, Zavallone, Laura, additional, Zavettieri, Maria, additional, and Zoboli, Alessandra, additional

Published
2018
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27. Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01–2014)

Author

Passalacqua, Rodolfo, primary, Lazzarelli, Silvia, additional, Donini, Maddalena, additional, Montironi, Rodolfo, additional, Tambaro, Rosa, additional, De Giorgi, Ugo, additional, Pignata, Sandro, additional, Palumbo, Raffaella, additional, Ceresoli, Giovanni Luca, additional, Del Conte, Gianluca, additional, Tonini, Giuseppe, additional, Morelli, Franco, additional, Nolè, Franco, additional, Panni, Stefano, additional, Rondini, Ermanno, additional, Guida, Annalisa, additional, Zucali, Paolo Andrea, additional, Doni, Laura, additional, Iezzi, Elisa, additional, and Caminiti, Caterina, additional

Published
2017
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30. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life

Author

Palumbo,Raffaella, Sottotetti,Federico, Trifirò,Giuseppe, Piazza,Elena, Ferzi,Antonella, Gambaro,Anna, Spinapolice,Elena Giulia, Pozzi,Emma, Tagliaferri,Barbara, Teragni,Cristina, Bernardo,Antonio, Palumbo,Raffaella, Sottotetti,Federico, Trifirò,Giuseppe, Piazza,Elena, Ferzi,Antonella, Gambaro,Anna, Spinapolice,Elena Giulia, Pozzi,Emma, Tagliaferri,Barbara, Teragni,Cristina, and Bernardo,Antonio

Abstract

Raffaella Palumbo,1 Federico Sottotetti,1 Giuseppe Trifirò,2 Elena Piazza,3 Antonella Ferzi,4 Anna Gambaro,3 Elena Giulia Spinapolice,2 Emma Pozzi,1 Barbara Tagliaferri,1 Cristina Teragni,1 Antonio Bernardo1 1Departmental Unit of Oncology, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy; 2Unit of Nuclear Medicine, IRCCS Fondazione Salvatore Maugeri, Pavia, Italy; 3Medical Oncology Luigi Sacco Hospital, Milano, Italy; 4Medical Oncology, Legnano Hospital, Legnano, Italy Background: A prospective, multicenter trial was undertaken to assess the activity, safety, and quality of life of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer (MBC).Patients and methods: Fifty-two women with HER2-negative MBC who were candidates for second-line chemotherapy for the metastatic disease were enrolled and treated at three centers in Northern Italy. All patients had previously received taxane-based chemotherapy in the adjuvant or first-line metastatic setting. Single-agent nab-paclitaxel was given at the dose of 260 mg/m2 as a 30-minute intravenous infusion on day 1 each treatment cycle, which lasted 3 weeks, in the outpatient setting. No steroid or antihistamine premedication was provided. Treatment was stopped for documented disease progression, unacceptable toxicity, or patient refusal.Results: All of the enrolled patients were evaluable for the study endpoints. The objective response rate was 48% (95% CI, 31.5%–61.3%) and included complete responses from 13.5%. Disease stabilization was obtained in 19 patients and lasted >6 months in 15 of them; the overall clinical benefit rate was 77%. The median time to response was 70 days (range 52–86 days). The median progression-free survival time was 8.9 months (95% CI, 8.0–11.6 months, range 5–21+ months). The median overall survival point has not yet been reached. Toxicities were expecte

Published
2015

31. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study

Author

Arpino, Grazia, primary, Michelotti, Andrea, additional, Truini, Mauro, additional, Montemurro, Filippo, additional, Russo, Stefania, additional, Palumbo, Raffaella, additional, Zamagni, Claudio, additional, Latorre, Agnese, additional, Bruzzese, Dario, additional, Riccardi, Ferdinando, additional, De Laurentiis, Michelino, additional, Beano, Alessandra, additional, Biganzoli, Laura, additional, Zaniboni, Alberto, additional, Laudadio, Lucio, additional, Malagoli, Maria, additional, Bilancia, Domenico, additional, Schettini, Francesco, additional, Giuliano, Mario, additional, Cazzaniga, Marina Elena, additional, and De Placido, Sabino, additional

Published
2015
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33. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) as second-line chemotherapy in HER2-negative, taxane-pretreated metastatic breast cancer patients: prospective evaluation of activity, safety, and quality of life

Author

Palumbo, Raffaella, primary, Sottotetti, Federico, additional, Trifirò, Giuseppe, additional, Piazza, Elena, additional, Ferzi, Antonella, additional, Gambaro, Anna, additional, Spinapolice, Elena Giulia, additional, Pozzi, Emma, additional, Tagliaferri, Barbara, additional, Teragni, Cristina, additional, and Bernardo, Antonio, additional

Published
2015
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34. Fulvestrant and trastuzumab in patients with luminal HER2-positive advanced breast cancer (ABC): an Italian real-world experience (HERMIONE 9)

Author

Laura Pizzuti, Laura Cortesi, Barbara Tagliaferri, Armando Santoro, Patrizia Vici, A. Gambaro, Rita De Sanctis, Raffaella Palumbo, Alessandra Fabi, Vita Leonardi, Rosalba Torrisi, Maria Rosaria Valerio, Rossana Gueli, Marina Elena Cazzaniga, Giulia Bianchi, Torrisi, R, Palumbo, R, De Sanctis, R, Vici, P, Bianchi, G, Cortesi, L, Leonardi, V, Gueli, R, Fabi, A, Valerio, M, Gambaro, A, Tagliaferri, B, Pizzuti, L, Cazzaniga, M, Santoro, A, Torrisi, Rosalba, Palumbo, Raffaella, De Sanctis, Rita, Vici, Patrizia, Bianchi, Giulia Valeria, Cortesi, Laura, Leonardi, Vita, Gueli, Rossana, Fabi, Alessandra, Valerio, Maria Rosaria, Gambaro, Anna Rita, Tagliaferri, Barbara, Pizzuti, Laura, Cazzaniga, Marina Elena, and Santoro, Armando

Subjects
HER2 positive, Oncology, Cancer Research, medicine.medical_specialty, Settore MED/06 - Oncologia Medica, Receptor, ErbB-2, Advanced breast, Breast Neoplasms, Breast cancer, Maintenance therapy, Trastuzumab, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Fulvestrant, Retrospective Studies, Hormone receptor positive, business.industry, Cancer, Middle Aged, medicine.disease, Italy, Cohort, Advanced breast cancer, Female, Pertuzumab, business, medicine.drug
Abstract

Purpose: The most appropriate therapy for HR + /HER2-positive (HER2 +) advanced breast cancer (ABC) is a matter of debate. Co-targeting of both receptors represents an attractive strategy to overcome the cross-talk between them. Methods: The HERMIONE 9 is an observational retrospective multicentric study which aimed to describe the clinical outcome of patients with HR + /HER2 + ABC who received the combination of Fulvestrant (F) and Trastuzumab (T) as part of their routine treatment at 10 Italian Institutions. Results: Eighty-seven patients were included. Median age was 63 (range, 35–87) years. The median number of previous treatments was 3 (range, 0–10) and F and T were administered as ≥ 3rd line in 67 patients. Among the 86 evaluable patients, 6 (6.9%) achieved CR, 18 (20.7%) PR, and 44 (50.6%) had SD ≥ 24 weeks with an overall CBR of 78.2%. At a median follow-up of 33.6 months, mPFS of the entire cohort was 12.9 months (range, 2.47–128.67). No difference was observed in mPFS between patients treated after progression or as maintenance therapy (mPFS 12.9 and 13.9 months in 64 and 23 patients, respectively), neither considering the number of previous treatment lines (≤ 3 or < 3). Conclusion: The combination of F and T was active in this cohort at poor prognosis and deserves further investigations possibly in combination with pertuzumab in patients with high ER expression.

Published
2021
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35. EFFECT: A randomized phase II study of efficacy and impact on function of two doses of nab-paclitaxel as first-line treatment in older women with advanced breast cancer

Author

Antonella Brunello, Silvana Leo, Emanuela Magnolfi, Sabino De Placido, Raffaella Palumbo, Alessandro Marco Minisini, Elena Rota Caremoli, Elena Zafarana, Sara Donati, Emanuela Risi, Anna Rachelle Mislang, Giuseppe Mottino, Luca Boni, Dimitri Becheri, Rossana Berardi, Mirco Pistelli, Fabio Puglisi, Amelia McCartney, Rebecca Pedersini, Laura Biganzoli, Veronica Parolin, Simon Spazzapan, Giuseppina Sanna, Saverio Cinieri, Marco Colleoni, Laura Orlando, Biganzoli, Laura, Cinieri, Saverio, Berardi, Rossana, Pedersini, Rebecca, Mccartney, Amelia, Minisini, Alessandro Marco, Caremoli, Elena Rota, Spazzapan, Simon, Magnolfi, Emanuela, Brunello, Antonella, Risi, Emanuela, Palumbo, Raffaella, Leo, Silvana, Colleoni, Marco, Donati, Sara, De Placido, Sabino, Orlando, Laura, Pistelli, Mirco, Parolin, Veronica, Mislang, Anna, Becheri, Dimitri, Puglisi, Fabio, Sanna, Giuseppina, Zafarana, Elena, Boni, Luca, and Mottino, Giuseppe

Subjects
Phases of clinical research, law.invention, Efficacy, 0302 clinical medicine, Breast cancer, Randomized controlled trial, law, Functional decline, Clinical endpoint, Age Factor, Older adult, Aged, 80 and over, Age Factors, Prognosis, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Survival Rate, 030220 oncology & carcinogenesis, Older adults, Metastatic, Female, Breast Neoplasm, Research Article, Human, medicine.medical_specialty, Paclitaxel, Prognosi, Breast Neoplasms, Nab-paclitaxel, lcsh:RC254-282, 03 medical and health sciences, Albumins, Internal medicine, medicine, Humans, Neoplasm Invasiveness, Progression-free survival, Adverse effect, Survival rate, Aged, Neoplasm Staging, Neoplasm Invasivene, Dose-Response Relationship, Drug, Toxicity, business.industry, Albumin, medicine.disease, Antineoplastic Agents, Phytogenic, business
Abstract

Background Limited data are available regarding the use of nab-paclitaxel in older patients with breast cancer. A weekly schedule is recommended, but there is a paucity of evidence regarding the optimal dose. We evaluated the efficacy of two different doses of weekly nab-paclitaxel, with a specific focus on their corresponding impact on patient function, in order to address the lack of data specifically relating to the older population. Methods EFFECT is an open-label, phase II trial wherein 160 women with advanced breast cancer aged ≥ 65 years were enrolled from 15 institutions within Italy. Patients were randomly assigned 1:1 to receive nab-paclitaxel 100 mg/m2 (arm A) or 125 mg/m2 (arm B) on days 1, 8, and 15 on a 28-day cycle, as first-line treatment for advanced disease. The primary endpoint was event-free survival (EFS), wherein an event was defined as disease progression (PD), functional decline (FD), or death. In each arm, the null hypothesis that the median EFS would be ≤ 7 months was tested against a one-sided alternative according to the Brookmeyer Crowley test. Secondary endpoints included objective response rate (ORR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety. Results After a median follow-up of 32.6 months, 140 events were observed in 158 evaluable patients. Median EFS was 8.2 months (90% CI, 5.9–8.9; p = 0.188) in arm A vs 8.3 months (90% CI, 6.2–9.7, p = 0.078) in arm B. Progression-free survival, overall survival, and response rates were similar in both groups. A higher percentage of dose reductions and discontinuations due to adverse events (AEs) was noted in arm B. The most frequently reported non-haematological AEs were fatigue (grade [G] 2–3 toxicity occurrence in arm A vs B, 43% and 51%, respectively) and peripheral neuropathy (G2–3 arm A vs B, 19% and 38%, respectively). Conclusion Pre-specified outcomes were similar in both treatment arms. However, 100 mg/m2 was significantly better tolerated with fewer neurotoxicity-related events, representing a more feasible dose to be recommended for older patients with advanced disease. Trial registration EudraCT, 2012-002707-18. Registered on June 4, 2012. NIH ClinicalTrials.gov, NCT02783222. Retrospectively registered on May 26, 2016.

Published
2020
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36. Correction: Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: new lessons for clinical practice from the EVA study

Author

Michela Maur, Maria Concetta Cursano, A. Ferzi, Chiara Benedetto, Luca Clivio, Salvatore Artale, Matteo Valerio, Livio Blasi, A Fumagalli, Ornella Garrone, Daniele Generali, Alberto Zambelli, Lucia Mentuccia, Mariangela Ciccarese, Claudio Verusio, D Sartori, Mario Airoldi, M Piezzo, Antonio Febbraro, Antonio Frassoldati, Alessio Schirone, Claudio Scavelli, Mirco Pistelli, Francesco Atzori, Raffaella Palumbo, A. Fabi, A. Turletti, G. Moretti, Antonino Musolino, Patrizia Vici, Torri, Giulia Bianchi, N La Verde, Corrado Ficorella, L Diodati, Gebbia, Marina Elena Cazzaniga, Arcangeli, Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, Valerio, Maria Rosaria, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Matilde, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Alessio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, Clivio, Luca, and Torri On Behalf Of The Eva Study Group, Valter

Subjects
Oncology, advanced breast cancer, medicine.medical_specialty, Everolimus, business.industry, Advanced breast, Cancer, Correction, medicine.disease, clinical practice, Clinical Practice, chemistry.chemical_compound, Everolimu, Exemestane, chemistry, Internal medicine, medicine, In patient, business, medicine.drug
Abstract

[This corrects the article DOI: 10.18632/oncotarget.25874.].

Published
2018

37. 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

38. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study

Author

Cazzaniga, M., Verusio, C., Ciccarese, M., Fumagalli, A., Sartori, D., Ancona, C., Airoldi, M., Moretti, G., Ficorella, C., Arcangeli, V., Diodati, L., Zambelli, A., Febbraro, A., Generali, D., Pistelli, M., Garrone, O., Musolino, A., Vici, P., Maur, M., Mentuccia, L., La Verde, N., Bianchi, G., Artale, S., Blasi, L., Piezzo, M., Atzori, F., Turletti, A., Benedetto, C., Cursano, M. C., Fabi, A., Gebbia, V., Schirone, A., Palumbo, R., Ferzi, A., Frassoldati, A., Scavelli, C., Clivio, L., Torri, V., On behalf of The EVA Study Group, Cazzaniga, Marina, Verusio, Claudio, Ciccarese, Mariangela, Fumagalli, Alberto, Sartori, Donata, D'Ancona, Cristina, Airoldi, Mario, Moretti, Gabriella, Ficorella, Corrado, Arcangeli, Valentina, Diodati, Lucrezia, Zambelli, Alberto, Febbraro, Antonio, Generali, Daniele, Pistelli, Mirco, Garrone, Ornella, Musolino, Antonino, Vici, Patrizia, Maur, Michela, Mentuccia, Lucia, La Verde, Nicla, Bianchi, Giulia, Artale, Salvatore, Blasi, Livio, Piezzo, Matilde, Atzori, Francesco, Turletti, Anna, Benedetto, Chiara, Cursano, Maria Concetta, Fabi, Alessandra, Gebbia, Vittorio, Schirone, Antonio, Palumbo, Raffaella, Ferzi, Antonella, Frassoldati, Antonio, Scavelli, Claudio, Clivio, Luca, Torri, Valter, Cazzaniga, M, Verusio, C, Ciccarese, M, Fumagalli, A, Sartori, D, Ancona, C, Airoldi, M, Moretti, G, Ficorella, C, Arcangeli, V, Diodati, L, Zambelli, A, Febbraro, A, Generali, D, Pistelli, M, Garrone, O, Musolino, A, Vici, P, Maur, M, Mentuccia, L, La Verde, N, Bianchi, G, Artale, S, Blasi, L, Piezzo, M, Atzori, F, Turletti, A, Benedetto, C, Cursano, M, Fabi, A, Gebbia, V, Schirone, A, Palumbo, R, Ferzi, A, Frassoldati, A, Scavelli, C, Clivio, L, Torri, V, On behalf of The EVA Study, G, Cazzaniga M., Verusio C., Ciccarese M., Fumagalli A., Sartori D., Valerio MR., Airoldi M., Moretti G., Ficorella C., Arcangeli V., Diodati L., Zambelli A., Febbraro A., Generali D., Pistelli M., Garrone O., Musolino A., Vici P., Maur M., Mentuccia L., La Verde N., Bianchi G., Artale S., Blasi L., Piezzo M., Atzori F., Turletti A., Benedetto C., Cursano M.C., Fabi A., Gebbia V., Schirone A., Palumbo R., Ferzi A., Frassoldati A., Scavelli C., Clivio L., Torri V., and On behalf of The EVA Study Group

Subjects
medicine.medical_specialty, Socio-culturale, Hormone-receptor positive, Exemestane, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Breast cancer, Elderly, Weight loss, Internal medicine, Advanced breast cancer, Everolimus, Oncology, medicine, 030212 general & internal medicine, Stomatitis, Pneumonitis, business.industry, Cancer, medicine.disease, Rash, Everolimu, chemistry, 030220 oncology & carcinogenesis, MED/06 - ONCOLOGIA MEDICA, medicine.symptom, business, Research Paper, medicine.drug
Abstract

BACKGROUND: The present analysis focuses on real-world data of Everolimus- Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years. METHODS: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and [greater than or equal to] 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel- Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model. RESULTS: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged [greater than or equal to] 65 years, of whom 87 were [greater than or equal to] 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged [greater than or equal to] 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (> 7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged [greater than or equal to] 70 years. Five treatment-related deaths were collected (3,2%). CONCLUSIONS: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones.

Published
2018

39. Demographic, tumor and clinical features of clinical trials versus clinical practice patients with HER2-positive early breast cancer: results of a prospective study

Author

Grazia Arpino, Claudio Zamagni, Ferdinando Riccardi, Laura Biganzoli, Mario Giuliano, Alessandra Beano, Michelino De Laurentiis, Lucio Laudadio, Sabino De Placido, Dario Bruzzese, Andrea Michelotti, Stefania Russo, Francesco Schettini, Domenico Bilancia, Alberto Zaniboni, Mauro Truini, Marina Cazzaniga, Maria Malagoli, Filippo Montemurro, Raffaella Palumbo, A. Latorre, Arpino, Grazia, Michelotti, Andrea, Truini, Mauro, Montemurro, Filippo, Russo, Stefania, Palumbo, Raffaella, Zamagni, Claudio, Latorre, Agnese, Bruzzese, Dario, Riccardi, Ferdinando, DE LAURENTIIS, Michelino, Beano, Alessandra, Biganzoli, Laura, Zaniboni, Alberto, Laudadio, Lucio, Malagoli, Maria, Bilancia, Domenico, Schettini, Francesco, Giuliano, Mario, Cazzaniga, Marina Elena, DE PLACIDO, Sabino, Arpino, G, Michelotti, A, Truini, M, Montemurro, F, Russo, S, Palumbo, R, Zamagni, C, Latorre, A, Bruzzese, D, Riccardi, F, De Laurentiis, M, Beano, A, Biganzoli, L, Zaniboni, A, Laudadio, L, Malagoli, M, Bilancia, D, Schettini, F, Giuliano, M, Cazzaniga, M, and De Placido, S

Subjects
Adult, Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Breast Neoplasms, Clinical practice, Adjuvant therapy, law.invention, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Meta-Analysis as Topic, Randomized controlled trial, law, Trastuzumab, Internal medicine, HER2, medicine, Humans, 030212 general & internal medicine, Practice Patterns, Physicians', skin and connective tissue diseases, Prospective cohort study, neoplasms, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, clinical trials, clinical practice, early breast cancer, Hematology, business.industry, Early breast cancer, General Medicine, Middle Aged, medicine.disease, Clinical Practice, Clinical trial, Italy, 030220 oncology & carcinogenesis, Physical therapy, Female, business, medicine.drug
Abstract

Background: Several randomized clinical trials (RCTs) have demonstrated the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancer (BC). However, RCT patients may not invariably be representative of patients routinely seen in clinical practice (CP). To address this issue, we compared the clinical and tumor features of RCT and CP patients with HER2-positive BC. Patients and methods: From January to December 2012, 650 consecutive patients with HER2-positive early BC, treated in 36 different types of Italian healthcare facilities, were enrolled in this study. Age, treatment, tumor size (T), nodes (N), grade (G), estrogen receptor (ER) and progesterone receptor (PgR) status were prospectively collected in these CP patients. The same data were extracted from the main adjuvant trastuzumab RCTs and pooled using the random-effects model of DerSimonian and Laird. RCT and CP patients were compared by using the Cochran Q statistics. Results: Versus RCT patients, CP patients were more likely to be older than 50years (65 vs. 49%; p2cm (T≥2cm 39 vs. 59%; p&nbsp

Published
2016

40. Tolerability and Preliminary Outcomes of Adjuvant T-DM1 in HER2-Positive Breast Cancer After Neoadjuvant Therapy: The ATD Study.

Author

Krasniqi E, Filomeno L, Arcuri T, Di Lisa FS, Astone A, Cutigni C, Foglietta J, Nunzi M, Rossi R, Minelli M, Meattini I, Visani L, Scialino J, Livi L, Moscetti L, Marchetti P, Botticelli A, Paris I, Pavese F, D'Angelo T, Sini V, Stani S, Valerio MR, Grassadonia A, Tinari N, Mazzotta M, Vergati M, D'Auria G, Gamucci T, D'Onofrio L, Gasparro S, Roselli A, Fulvi A, Ferretti G, Torchia A, Giordano M, Greco F, Pantano F, Tonini G, Fabbri A, Bria E, Garufi G, Fiorio E, Raffaele M, Pistelli M, Berardi R, Saltarelli R, Kayal R, Ferranti FR, Cannita K, Irelli A, D'Ostilio N, De Rossi C, Palumbo R, Cariello A, Sanguineti G, Calabrò F, Pizzuti L, Barba M, Botti C, Pelle F, Cappelli S, Cavicchi F, Puccica I, Villanucci A, Sperduti I, Ciliberto G, and Vici P

Abstract

Background/objectives: HER2-positive breast cancer (HER2 + BC) is an aggressive subtype, with neoadjuvant treatment (NAT) aiming to achieve a pathological complete response (pCR) to improve long-term outcomes. Trastuzumab emtansine (T-DM1) has been established as the standard of care in the adjuvant setting for HER2 + BC patients who do not obtain pCR. The ATD study aimed to evaluate the real-world tolerability of T-DM1 in this setting. The secondary objective was to assess the effectiveness., Methods: This was a multicenter, retrospective study across 24 Italian oncology centers, including 410 patients with HER2 + BC treated with adjuvant T-DM1 following a lack of pCR after NAT. Patient characteristics, NAT regimens, and surgical outcomes were recorded. Tolerability was assessed by documenting adverse events (AEs) according to the CTCAE (v5.0). Preliminary effectiveness was evaluated in terms of relapse-free survival (RFS) and overall survival (OS)., Results: Overall, 228 patients (55.6%) experienced at least one AE related to T-DM1, with 4.9% experiencing grade 3 or higher AEs. The most common AEs were hepatotoxicity (18.5%) and thrombocytopenia (17.6%). T-DM1 was discontinued in 10.0% of patients due to toxicity. After a median follow-up of 25 months, 31 relapse events (7.6%) and 22 deaths (5.4%) were reported. The preliminary incidence of RFS and OS events was similar between patients who completed the T-DM1 course and those who discontinued it early., Conclusions: T-DM1 demonstrated a manageable safety profile, and the adverse events were consistent with those reported in randomized trials. The data are not yet sufficient to allow for a formal analysis of RFS and OS, and long-term follow-up is required.

Published
2024
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41. Efficacy and activity of treatments after progression from palbociclib plus endocrine therapy in patients with HR + /HER2 - metastatic breast cancer: a prospective, monocentric study.

Author

Palumbo R, Quaquarini E, Saltalamacchia G, Malovini A, Lapidari P, Tagliaferri B, Mollica L, Teragni CM, Barletta C, Locati LD, and Sottotetti F

Abstract

Background: Breast cancer is the most frequent tumour worldwide, and the HR + /HER2 - subtype is the most common. For this tumour type, endocrine therapy (ET) is the mainstay of treatment. The association of ET and CDK4/6 inhibitors (CDK4/6i) represents the gold standard for first-line or second-line therapies. However, the optimal therapeutic strategy after CDK4/6i progression is still a matter of debate, with several randomized clinical trials still ongoing., Patients and Methods: This is an observational, prospective, real-world study including women with HR + /HER2 - metastatic breast cancer progressing to palbociclib plus ET. Patients received either ET or chemotherapy (CT). The primary objective was the evaluation of efficacy of the different therapeutic strategies after palbociclib in terms of median progression-free survival 2. Secondary objectives were the activity of therapeutic strategies measured with the clinical benefit rate, evaluation of the parameters used for the treatment choice, and progression-free survival 1 related to palbociclib plus ET treatment., Results: Overall, 48 patients (median age 53, range 33-78 years) were included. The median progression-free survival 2 was of 5 months in the overall cohort (95% CI 4-48 months) with a statistically significant difference between the two therapeutic strategies adopted (ET versus CT, 10 months versus 5 months, respectively). Regarding secondary objectives, the clinical benefit rate was 55.2% in the CT cohort and 50% in ET. Moreover, women treated with CT had a greater number of visceral metastases and a shorter median progression-free survival 1 than patients who received ET., Conclusions: ET and CT represent two possible therapeutic alternatives for patients progressing on CDK4/6i plus ET. The choice is based on clinical parameters, with a potential preference for ET., Competing Interests: Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest relevant to this manuscript. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at: https://www.drugsincontext.com/wp-content/uploads/2023/11/dic.2023-7-5-COI.pdf, (Copyright © 2024 Palumbo R, Quaquarini E, Saltalamacchia G, Malovini A, Lapidari P, Tagliaferri B, Mollica L, Teragni CM, Barletta C, Locati LD, Sottotetti F.)

Published
2024
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42. Role of androgen receptor expression in early stage ER+/PgR-/HER2- breast cancer.

Author

Tagliaferri B, Quaquarini E, Palumbo R, Balletti E, Presti D, Malovini A, Agozzino M, Teragni CM, Terzoni A, Bernardo A, Villani L, and Sottotetti F

Abstract

Background: Progesterone receptor (PgR) negative breast cancer (BC) is an aggressive subtype with poor prognosis and reduced response to endocrine treatments. Several studies have suggested that androgen receptor (AR) expression is associated with a favorable tumor biology, longer recurrence free survival (RFS), and overall survival. In the literature no data exist regarding the role of AR expression in early stage estrogen receptor (ER)+/PgR- BCs. The aim of this study was to evaluate the prognostic role of AR expression in this setting., Patients and Methods: This is a monocentric retrospective study in which 208 patients who underwent surgical intervention for ER+/PgR-/Human Epidermal growth factor Receptor 2 (HER2)- BC were included. The primary objective was to analyze the relationship between AR expression and RFS., Results: At a median follow-up of 77 months, 75 patients (36%) had a disease relapse (all sites included). AR expression was significantly higher in patients who did not relapse compared with those who relapsed with an impact on RFS (hazard ratio [HR] = 0.99, p  = 0.025). Patients with AR expression ⩾80% had a lower risk of relapse compared with those with AR <80% (HR = 0.53, p  = 0.008). In addition, breast tumors with higher AR expression had good biological features (low ki67 and nuclear grade) compared with BCs with lower AR expression, at least partly explaining the different outcome., Conclusions: The results of this study support the potential prognostic role of AR in patients with ER+/PgR- BCs and may contribute to the identification of subgroups of high-risk patients., Competing Interests: Conflict of interest statement: The authors declare that there is no conflict of interest., (© The Author(s), 2020.)

Published
2020
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43. Is There Still a Role for Endocrine Therapy Alone in HR+/HER2- Advanced Breast Cancer Patients? Results from the Analysis of Two Data Sets of Patients Treated with High-Dose Fulvestrant as First-Line Therapy in the Real-World Setting: The EVA and GIM-13 AMBRA Studies.

Author

Cazzaniga ME, Verusio C, Ciccarese M, Fumagalli A, Sartori D, Valerio MR, Airoldi M, Moretti G, Ficorella C, Gianni L, Michelotti A, Zambelli A, Febbraro A, Generali D, Pistelli M, Garrone O, Musolino A, Vici P, Maur M, Mentuccia L, La Verde N, Bianchi GV, Artale S, Blasi L, De Laurentiis M, Atzori F, Turletti A, Porpiglia M, Santini D, Fabi A, Gebbia V, Schirone A, Palumbo R, Ferzi A, Frassoldati A, Scavelli C, Clivio L, Giordano M, Donadio M, Biganzoli L, Del Mastro L, Bisagni G, Livi L, Natoli C, Montemurro F, Riccardi F, Romagnoli E, Marchetti P, Torri V, Pronzato P, and Mustacchi G

Abstract

Background: Different studies suggest that fulvestrant 500 mg every 28 days (HD-FUL) could be an active treatment in HR+ advanced breast cancer (ABC) patients even treated with aromatase inhibitors in the adjuvant setting. The aim of this analysis is to describe the outcome of ABC patients treated with HD-FUL as first-line treatment in terms of median duration of treatment and the overall response rate in a real-world setting., Methods: For the purpose of the present analysis, we considered two data sets of HR+ ABC patients collected in Italy between 2012 and 2015 (EVA and GIM-13 AMBRA studies)., Results: Eighty-one and 91 patients have been identified from the two data sets. The median age was 63 years (range 35-82) for the EVA and 57.8 years (range 35.0-82.3) for the AMBRA patients. ORRs were 23.5 and 24.3% in the whole population, 26.9% in the patients with bone only, and 21.8 and 21.4% in those with visceral metastases. The median duration of HD-FUL was 11.6 months (range 1-48) and 12.4 months (range 2.9-70.0) in the two data sets, respectively., Conclusion: These data suggest that HD-FUL should still continue to play a significant role as first-line therapy in HR+ ABC patients., Competing Interests: The Authors declare that they have no conflict of interest., (Copyright © 2019 by S. Karger AG, Basel.)

Published
2020
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44. Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: new lessons for clinical practice from the EVA study.

Author

Cazzaniga M, Verusio C, Ciccarese M, Fumagalli A, Sartori D, Valerio MR, Ancona C, Airoldi M, Moretti G, Ficorella C, Arcangeli V, Diodati L, Zambelli A, Febbraro A, Generali D, Pistelli M, Garrone O, Musolino A, Vici P, Maur M, Mentuccia L, La Verde N, Bianchi G, Artale S, Blasi L, Piezzo M, Atzori F, Turletti A, Benedetto C, Cursano MC, Fabi A, Gebbia V, Schirone A, Palumbo R, Ferzi A, Frassoldati A, Scavelli C, Clivio L, and Torri On Behalf Of The Eva Study Group V

Abstract

Background: The present analysis focuses on real-world data of Everolimus-Exemestane in advanced HR+ve, HER2-ve elderly breast cancer patients (aged 65 years) included in the EVA study, with unique findings in those aged 70 years., Methods: Data are collected from clinical records and analysed according to age cut-off (< 65 years; 65 - 69 years and {greater than or equal to} 70 years). Relationship of analyzed variables with response were tested by mean of a Mantel-Haenszel chi square test. Time to event analysis was described by Kaplan Meier approach and association with baseline characteristics was analysed by stratified log-rank test and proportional hazard model., Results: From July 2013 to December 2015, the EVA study enrolled overall 404 pts. 154 patients out of 404 (38,1%) were aged {greater than or equal to} 65 years, of whom 87 were {greater than or equal to} 70 years. Median duration of EVE treatment was 28.5 weeks (95% CI 19.0 - 33.8) in patients aged 65-69 years and 24,4 weeks (95% CI 19,2 - 33,2) in those aged {greater than or equal to} 70 years. Fewer patients aged 65 years received the highest EVE Dose-Intensity (>7.5 mg/day) in comparison to younger patients (49,6% vs. 66,8%). Grade 3-4 toxicities occurred to 55 patients (35,7%), mainly stomatitis (10,9%), rash (5,8%) and non-infectious pneumonitis (NIP) (3,6%). Some toxicities, such as weight loss and anaemia were peculiarly observed in patients aged {greater than or equal to} 70 years. Five treatment-related deaths were collected (3,2%)., Conclusions: EVE-EXE combination remains one of the potential treatments in HR+ patients also for elderly ones., Competing Interests: CONFLICTS OF INTEREST The Authors declare that they have no conflicts of interest.

Published
2018
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