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

Vittorio Gebbia, Maria Rosaria Valerio, Marta Airoldi, Maria Ala, Moretti, Ciccarese, Clivio, Laura Pizzuti, Capri, Pellegrini, Nicla La Verde, Pogliani, Mirco Pistelli, Petrucelli, Vittorio Gebbia, Fabi, Donata Sartori, Cicchiello, Loretta D'Onofrio, AndreisCocciolone, Ferzi, Francesco Atzori, Ferrarini, Cristina Ancona, Paternò, Cursano, Gervasi, Chiara Benedetto, Miraglio, Campidoglio, Fotia, Riva, Ornella Garrone, Cazzaniga, Dester, Guaitoli, Alù, Fotia, Ballerio, Liscia, Bordin, Alberto Fumagalli, Laura Ferrari, Licata, Piezzo, Alessio Schirone, Valentina Arcangeli, Airoldi, Turletti, Cazzaniga, Butti, Scavelli, Generali, Eugenia Bajardi, Pedani, Maur, Salvatore Artale, Livio Blasi, Butti, Antonio Febbraro, Porpiglia, Frassoldati, Michele De Laurentiis, Nicolini, Patrizia Vici, Corrado Ficorella, Alberto Zambelli, Maria Rosaria Valerio, Andrea Michelotti, Antonino Musolino, Valter Torri, Cazzaniga, Raffaella Palumbo, Rossana Berardi, Giulia Valeria Bianchi, Lucia Mentuccia, Chiara Ancona, Eugenia Arrivas Bajardi, Gabriella Moretti, Rosa Palumbo

Risultato della ricerca: Article

8 Citazioni (Scopus)

Abstract

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.
Lingua originaleEnglish
pagine (da-a)115-121
Numero di pagine7
RivistaTHE BREAST
Volume35
Stato di pubblicazionePublished - 2017

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exemestane
Extravehicular Activity
Epidermal Growth Factor
Clinical Trials
Hormones
Breast Neoplasms
Safety
Everolimus

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

Gebbia, V, Valerio, MR, Airoldi, M, Ala, M, Moretti, Ciccarese, Clivio, Pizzuti, L, Capri, Pellegrini, La Verde, N, Pogliani, Pistelli, M, Petrucelli, Gebbia, V, Fabi, Sartori, D, Cicchiello, D'Onofrio, L, Andreis, Cocciolone, Ferzi, Atzori, F, Ferrarini, Ancona, C, Paternò, Cursano, Gervasi, Benedetto, C, Miraglio, Campidoglio, Fotia, Riva, Garrone, O, Cazzaniga, Dester, Guaitoli, Alù, Fotia, Ballerio, Liscia, Bordin, Fumagalli, A, Ferrari, L, Licata, Piezzo, Schirone, A, Arcangeli, V, Airoldi, Turletti, Cazzaniga, Butti, Scavelli, Generali, Bajardi, E, Pedani, Maur, Artale, S, Blasi, L, Butti, Febbraro, A, Porpiglia, Frassoldati, De Laurentiis, M, Nicolini, Vici, P, Ficorella, C, Zambelli, A, Valerio, MR, Michelotti, A, Musolino, A, Torri, V, Cazzaniga, Palumbo, R, Berardi, R, Bianchi, GV, Mentuccia, L, Ancona, C, Arrivas Bajardi, E, Moretti, G & Palumbo, R 2017, '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', THE BREAST, vol. 35, pagg. 115-121.
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. / 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. In: THE BREAST. 2017 ; Vol. 35. pagg. 115-121.
@article{bb1cf2dfc0d34f9d874fa65284a09ac8,
title = "Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2{\^a}) advanced breast cancer patients: New insights beyond clinical trials. The EVA study",
abstract = "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 (33{\^a}83). Main metastatic sites were: bone (69.1{\%}), soft tissue (34.7{\%}) and viscera (33.2{\%}). Median number of previous treatments was 2 (1{\^a}7). 43.3{\%} of the pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4{\^a}58.3) 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.",
author = "Vittorio Gebbia and Valerio, {Maria Rosaria} and Marta Airoldi and Maria Ala and Moretti and Ciccarese and Clivio and Laura Pizzuti and Capri and Pellegrini and {La Verde}, Nicla and Pogliani and Mirco Pistelli and Petrucelli and Vittorio Gebbia and Fabi and Donata Sartori and Cicchiello and Loretta D'Onofrio and Andreis and Cocciolone and Ferzi and Francesco Atzori and Ferrarini and Cristina Ancona and Patern{\`o} and Cursano and Gervasi and Chiara Benedetto and Miraglio and Campidoglio and Fotia and Riva and Ornella Garrone and Cazzaniga and Dester and Guaitoli and Al{\`u} and Fotia and Ballerio and Liscia and Bordin and Alberto Fumagalli and Laura Ferrari and Licata and Piezzo and Alessio Schirone and Valentina Arcangeli and Airoldi and Turletti and Cazzaniga and Butti and Scavelli and Generali and Eugenia Bajardi and Pedani and Maur and Salvatore Artale and Livio Blasi and Butti and Antonio Febbraro and Porpiglia and Frassoldati and {De Laurentiis}, Michele and Nicolini and Patrizia Vici and Corrado Ficorella and Alberto Zambelli and Valerio, {Maria Rosaria} and Andrea Michelotti and Antonino Musolino and Valter Torri and Cazzaniga and Raffaella Palumbo and Rossana Berardi and Bianchi, {Giulia Valeria} and Lucia Mentuccia and Chiara Ancona and {Arrivas Bajardi}, Eugenia and Gabriella Moretti and Rosa Palumbo",
year = "2017",
language = "English",
volume = "35",
pages = "115--121",
journal = "Breast",
issn = "0960-9776",
publisher = "Churchill Livingstone",

}

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 -