Abstract
| Lingua originale | English |
|---|---|
| pagine (da-a) | 115-121 |
| Numero di pagine | 7 |
| Rivista | THE BREAST |
| Volume | 35 |
| Stato di pubblicazione | Published - 2017 |
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All Science Journal Classification (ASJC) codes
- Surgery
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Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2â) advanced breast cancer patients: New insights beyond clinical trials. The EVA study. / Gebbia, Vittorio; Valerio, Maria Rosaria; Airoldi, Marta; Ala, Maria; Moretti; Ciccarese; Clivio; Pizzuti, Laura; Capri; Pellegrini; La Verde, Nicla; Pogliani; Pistelli, Mirco; Petrucelli; Gebbia, Vittorio; Fabi; Sartori, Donata; Cicchiello; D'Onofrio, Loretta; Andreis; Cocciolone; Ferzi; Atzori, Francesco; Ferrarini; Ancona, Cristina; Paternò; Cursano; Gervasi; Benedetto, Chiara; Miraglio; Campidoglio; Fotia; Riva; Garrone, Ornella; Cazzaniga; Dester; Guaitoli; Alù; Fotia; Ballerio; Liscia; Bordin; Fumagalli, Alberto; Ferrari, Laura; Licata; Piezzo; Schirone, Alessio; Arcangeli, Valentina; Airoldi; Turletti; Cazzaniga; Butti; Scavelli; Generali; Bajardi, Eugenia; Pedani; Maur; Artale, Salvatore; Blasi, Livio; Butti; Febbraro, Antonio; Porpiglia; Frassoldati; De Laurentiis, Michele; Nicolini; Vici, Patrizia; Ficorella, Corrado; Zambelli, Alberto; Valerio, Maria Rosaria; Michelotti, Andrea; Musolino, Antonino; Torri, Valter; Cazzaniga; Palumbo, Raffaella; Berardi, Rossana; Bianchi, Giulia Valeria; Mentuccia, Lucia; Ancona, Chiara; Arrivas Bajardi, Eugenia; Moretti, Gabriella; Palumbo, Rosa.
In: THE BREAST, Vol. 35, 2017, pag. 115-121.Risultato della ricerca: Article
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TY - JOUR
T1 - Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2â) advanced breast cancer patients: New insights beyond clinical trials. The EVA study
AU - Gebbia, Vittorio
AU - Valerio, Maria Rosaria
AU - Airoldi, Marta
AU - Ala, Maria
AU - Moretti, null
AU - Ciccarese, null
AU - Clivio, null
AU - Pizzuti, Laura
AU - Capri, null
AU - Pellegrini, null
AU - La Verde, Nicla
AU - Pogliani, null
AU - Pistelli, Mirco
AU - Petrucelli, null
AU - Gebbia, Vittorio
AU - Fabi, null
AU - Sartori, Donata
AU - Cicchiello, null
AU - D'Onofrio, Loretta
AU - Andreis, null
AU - Cocciolone, null
AU - Ferzi, null
AU - Atzori, Francesco
AU - Ferrarini, null
AU - Ancona, Cristina
AU - Paternò, null
AU - Cursano, null
AU - Gervasi, null
AU - Benedetto, Chiara
AU - Miraglio, null
AU - Campidoglio, null
AU - Fotia, null
AU - Riva, null
AU - Garrone, Ornella
AU - Cazzaniga, null
AU - Dester, null
AU - Guaitoli, null
AU - Alù, null
AU - Fotia, null
AU - Ballerio, null
AU - Liscia, null
AU - Bordin, null
AU - Fumagalli, Alberto
AU - Ferrari, Laura
AU - Licata, null
AU - Piezzo, null
AU - Schirone, Alessio
AU - Arcangeli, Valentina
AU - Airoldi, null
AU - Turletti, null
AU - Cazzaniga, null
AU - Butti, null
AU - Scavelli, null
AU - Generali, null
AU - Bajardi, Eugenia
AU - Pedani, null
AU - Maur, null
AU - Artale, Salvatore
AU - Blasi, Livio
AU - Butti, null
AU - Febbraro, Antonio
AU - Porpiglia, null
AU - Frassoldati, null
AU - De Laurentiis, Michele
AU - Nicolini, null
AU - Vici, Patrizia
AU - Ficorella, Corrado
AU - Zambelli, Alberto
AU - Valerio, Maria Rosaria
AU - Michelotti, Andrea
AU - Musolino, Antonino
AU - Torri, Valter
AU - Cazzaniga, null
AU - Palumbo, Raffaella
AU - Berardi, Rossana
AU - Bianchi, Giulia Valeria
AU - Mentuccia, Lucia
AU - Ancona, Chiara
AU - Arrivas Bajardi, Eugenia
AU - Moretti, Gabriella
AU - Palumbo, Rosa
PY - 2017
Y1 - 2017
N2 - Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33â83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1â7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4â58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.
AB - Background The BOLERO-2 trial reported efficacy and safety of Everolimus (EVE) and Exemestane (EXE) combination in HR+ advanced breast cancer (ABC) patients. The BALLET trial further evaluated the safety of EVE-EXE in HR+ ABC patients, without reporting efficacy data. Aim of the EVA real-life study was to collect data of efficacy and safety of EVE-EXE combination in the clinical setting, as well as exploring efficacy according to EVE Dose-Intensity (DI) and to previous treatment with Fulvestrant. Patients and methods This study aimed to describe the outcome of ABC pts treated with EVE-EXE combination in terms of median duration of EVE treatment and ORR in a real-life setting. Results From July 2013 to December 2015, the EVA study enrolled 404 pts. Median age was 61 years (33â83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and viscera (33.2%). Median number of previous treatments was 2 (1â7). 43.3% of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4â58.3) in the whole population. No difference was observed in terms of EVE exposure duration according to DI (p for trend = 0.27) or type of previous treatments (p = 0.33). ORR and Disease Control Rate (DCR) were observed in 31.6% and 60.7% of the patients, respectively, with the lowest ORRs confined in CHT pre-treated patients or in those who received the lowest DI of EVE. Grade 3-4 adverse events (AEs) were reported in 37.9% of the patients. Main AEs were: stomatitis (11.2%), non-infectious pneumonitis - NIP (3.8%), anaemia (3.8%) and fatigue (3.2%). Conclusions The EVA study provided new insights in the use of EVE-EVE combination in HR+ ABC pts many years after the publication of the pivotal trial. The combination is safe and the best response could be obtained in patients receiving the full dose of EVE and/or after hormone-therapy as Fulvestrant in ABC.
UR - http://hdl.handle.net/10447/246423
UR - http://www.elsevier-international.com/journals/brst/
M3 - Article
VL - 35
SP - 115
EP - 121
JO - Breast
JF - Breast
SN - 0960-9776
ER -