PMID- 28711793
OWN - NLM
STAT- MEDLINE
DCOM- 20180528
LR  - 20180528
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Linking)
VI  - 35
DP  - 2017 Oct
TI  - Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive 
      (HR+) human-epidermal-growth-factor negative (HER2-) advanced breast cancer 
      patients: New insights beyond clinical trials. The EVA study.
PG  - 115-121
LID - S0960-9776(17)30515-5 [pii]
LID - 10.1016/j.breast.2017.06.043 [doi]
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 
      (33-83). Main metastatic sites were: bone (69.1%), soft tissue (34.7%) and 
      viscera (33.2%). Median number of previous treatments was 2 (1-7). 43.3% of the 
      pts had received Fulvestrant. Median exposure to EVE was 31.0 weeks (15.4-58.3) 
      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.
CI  - Copyright (c) 2017 Elsevier Ltd. All rights reserved.
FAU - Cazzaniga, M E
AU  - Cazzaniga ME
AD  - Research Unit Phase I Trials, ASST Monza, Monza, Italy; Oncology Unit, ASST 
      Monza, Monza, Italy. Electronic address: marina.cazzaniga@asst-monza.it.
FAU - Airoldi, M
AU  - Airoldi M
AD  - Oncology Unit 2 - Citta della Salute e della Scienza di Torino, Torino, Italy.
FAU - Arcangeli, V
AU  - Arcangeli V
AD  - Oncology Unit Rimini Azienda USL Romagna, Rimini, Italy.
FAU - Artale, S
AU  - Artale S
AD  - Oncology Department, Ospedale di Gallarate ASST Valle Olona, Gallarate, Italy.
FAU - Atzori, F
AU  - Atzori F
AD  - Oncology Unit, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy.
FAU - Ballerio, A
AU  - Ballerio A
AD  - Oncology Unit, ASST della Valle Olona - Presidio Ospedaliero di Saronno, Saronno, 
      Italy.
FAU - Bianchi, G V
AU  - Bianchi GV
AD  - Oncology Unit 1, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
FAU - Blasi, L
AU  - Blasi L
AD  - Oncology Unit, ARNAS Civico Palermo, Palermo, Italy.
FAU - Campidoglio, S
AU  - Campidoglio S
AD  - Oncology Unit, Ospedale Sacro Cuore di Gesu, Fatebenefratelli, Benevento, Italy.
FAU - Ciccarese, M
AU  - Ciccarese M
AD  - Oncology Unit, Ospedale "Vito Fazzi" di Lecce, Lecce, Italy.
FAU - Cursano, M C
AU  - Cursano MC
AD  - Oncology Unit, Universita Campus Bio-Medico, Roma, Italy.
FAU - Piezzo, M
AU  - Piezzo M
AD  - National Cancer Institute "Fondazione Giovanni Pascale", Napoli, Italy.
FAU - Fabi, A
AU  - Fabi A
AD  - Oncology Unit 1, Istituto Regina Elena - IFO, Roma, Italy.
FAU - Ferrari, L
AU  - Ferrari L
AD  - Oncology Unit, ASL di Frosinone Osp. "SS. Trinita", Italy.
FAU - Ferzi, A
AU  - Ferzi A
AD  - Oncology Unit, ASST OVEST Milanese - Presidio di Legnano, Legnano, Italy.
FAU - Ficorella, C
AU  - Ficorella C
AD  - Dipartimento di Scienze Cliniche Applicate e Biotecnologiche (DISCAB) - 
      Universita Degli Studi Dell'Aquila, L'Aquila, Italy.
FAU - Frassoldati, A
AU  - Frassoldati A
AD  - Oncology Unit, Az Ospedaliero Universitaria di Ferrara, Ferrara, Italy.
FAU - Fumagalli, A
AU  - Fumagalli A
AD  - Oncology Unit, Ospedale Moriggia Pelascini, Gravedona, Italy.
FAU - Garrone, O
AU  - Garrone O
AD  - Oncology Unit, A.O. S. Croce e Carle Ospedale di Insegnamento, Cuneo, Italy.
FAU - Gebbia, V
AU  - Gebbia V
AD  - Oncology Unit, Osp. La Maddalena, Palermo, Italy.
FAU - Generali, D
AU  - Generali D
AD  - Brest Unit, ASST di Cremona, Italy.
FAU - La Verde, N
AU  - La Verde N
AD  - Oncology Unit, ASST Fatebenefratelli Sacco, Milano, Italy.
FAU - Maur, M
AU  - Maur M
AD  - Oncology and Haematology Department, A.O.U Policlinico di Modena, Modena, Italy.
FAU - Michelotti, A
AU  - Michelotti A
AD  - Oncology Unit I, Ospedale S. Chiara, Azienda Ospedaliero Universitaria Pisana, 
      Pisa, Italy.
FAU - Moretti, G
AU  - Moretti G
AD  - Oncology Unit, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy.
FAU - Musolino, A
AU  - Musolino A
AD  - Oncology Unit, Azienda Ospedaliero-Universitaria di Parma, Parma, Italy.
FAU - Palumbo, R
AU  - Palumbo R
AD  - Oncology Unit, IRCCS ICS Maugeri, Pavia, Italy.
FAU - Pistelli, M
AU  - Pistelli M
AD  - Oncology Unit, AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi, Ancona, 
      Italy.
FAU - Porpiglia, M
AU  - Porpiglia M
AD  - Oncology Unit, Presidio Ospedaliero S. Anna, Torino, Italy.
FAU - Sartori, D
AU  - Sartori D
AD  - Oncology Unit, AULSS 3, Mirano, Italy.
FAU - Scavelli, C
AU  - Scavelli C
AD  - Oncology Unit, Ospedale "S. Cuore di Gesu", Gallipoli, Italy.
FAU - Schirone, A
AU  - Schirone A
AD  - Oncology Department, Istituto Scientifico Romagnolo per lo Studio e la Cura dei 
      Tumori (IRST) IRCCS, Meldola, Italy.
FAU - Turletti, A
AU  - Turletti A
AD  - Oncology Unit, Ospedale Martini della ASL "Citta di Torino", Torino, Italy.
FAU - Valerio, M R
AU  - Valerio MR
AD  - Oncology Department, Policlinico di Palermo Paolo Giaccone, Palermo, Italy.
FAU - Vici, P
AU  - Vici P
AD  - Oncology Unit, Istituto Nazionale Tumori Regina Elena - IFO, Roma, Italy.
FAU - Zambelli, A
AU  - Zambelli A
AD  - Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
FAU - Clivio, L
AU  - Clivio L
AD  - IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
FAU - Torri, V
AU  - Torri V
AD  - IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Milano, Italy.
CN  - on behalf of
CN  - EVA Study Group
LA  - eng
PT  - Journal Article
DEP - 20170713
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Androstadienes)
RN  - 9HW64Q8G6G (Everolimus)
RN  - EC 2.7.10.1 (ERBB2 protein, human)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - NY22HMQ4BX (exemestane)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Androstadienes/*administration & dosage
MH  - Breast Neoplasms/*drug therapy/*metabolism/pathology
MH  - Everolimus/*administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Metastasis
MH  - Neoplasm Staging
MH  - Receptor, ErbB-2/*metabolism
OTO - NOTNLM
OT  - Advanced breast cancer
OT  - Dose-intensity
OT  - Everolimus
OT  - Fulvestrant
OT  - Hormone-receptor positive
FIR - Alu, M
IR  - Alu M
IRAD- Oncologia Medica ARNAS Civico Palermo, Italy.
FIR - Ancona, C
IR  - Ancona C
IRAD- Dipartimento di oncologia, Policlinico di Palermo, Paolo Giaccone, PA, Italy.
FIR - Andreis, D
IR  - Andreis D
IRAD- Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la 
      Cura dei Tumori (IRST) IRCCS, Meldola, Italy.
FIR - Bajardi, E
IR  - Bajardi E
IRAD- La Maddalena Palermo, Italy.
FIR - Benedetto, C
IR  - Benedetto C
IRAD- Presidio Ospedaliero S. Anna, Torino, Italy.
FIR - Berardi, R
IR  - Berardi R
IRAD- Universita Politecnica delle Marche - AOU Ospedali Riuniti Umberto I-G.M. 
      Lancisi-G. Salesi, Ancona, Italy.
FIR - Bordin, E
IR  - Bordin E
IRAD- Ospedale Martini della ASL "Citta di Torino", Italy.
FIR - Butti, C
IR  - Butti C
IRAD- Dipartimento di Oncologia Ospedale di Gallarate ASST Valle Olona, Italy.
FIR - Capri, G
IR  - Capri G
IRAD- Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale Tumori, Milano, Italy.
FIR - Cicchiello, F
IR  - Cicchiello F
IRAD- Oncology Unit, ASST Monza, Monza, Italy.
FIR - Cocciolone, V
IR  - Cocciolone V
IRAD- Dipartimento di Scienze Cliniche Applicate e Biotecnologiche (DISCAB) - 
      Universita Degli Studi Dell'Aquila, Italy.
FIR - Dester, M
IR  - Dester M
IRAD- SS Multidisciplinare di Patologia Mammaria - ASST di Cremona, Italy.
FIR - D'Onofrio, L
IR  - D'Onofrio L
IRAD- Oncologia Medica Universita Campus Bio-Medico, Roma, Italy.
FIR - Febbraro, A
IR  - Febbraro A
IRAD- UO Oncologia, Ospedale Sacro Cuore di Gesu, Fatebenefratelli, Benevento, Italy.
FIR - Ferrarini, I
IR  - Ferrarini I
IRAD- UO Oncologia Medica I - Ospedale S. Chiara - Azienda Ospedaliero Universitaria 
      Pisana, Italy.
FIR - Fotia, V
IR  - Fotia V
IRAD- Oncologia Medica ASST Papa Giovanni XXIII, Bergamo, Italy.
FIR - Gervasi, E
IR  - Gervasi E
IRAD- Oncologia Medica - IRCCS Arcispedale S. Maria Nuova Reggio, Emilia, Italy.
FIR - Guaitoli, G
IR  - Guaitoli G
IRAD- DAI di Oncologia ed Ematologia, A.O.U Policlinico di Modena, Italy.
FIR - Licata, L
IR  - Licata L
IRAD- IRCCS ICS Maugeri, Pavia, Italy.
FIR - Liscia, N
IR  - Liscia N
IRAD- Oncologia Medica, Azienda Ospedaliero Universitaria di Cagliari, Italy.
FIR - Mentuccia, L
IR  - Mentuccia L
IRAD- U.O.C. di Oncologia Medica ASL di Frosinone Osp., "SS. Trinita" - Sora (FR), 
      Italy.
FIR - Miraglio, E
IR  - Miraglio E
IRAD- A.O. S. Croce e Carle Ospedale di Insegnamento, Cuneo, Italy.
FIR - Nicolini, M
IR  - Nicolini M
IRAD- U.O. di Oncologia Rimini Azienda USL Romagna, Italy.
FIR - Paterno, E
IR  - Paterno E
IRAD- ASST Fatebenefratelli Sacco, Milano, Italy.
FIR - Pedani, F
IR  - Pedani F
IRAD- S.C. Oncologia Medica 2 - Citta della Salute e della Scienza di Torino, Italy.
FIR - Pellegrini, D
IR  - Pellegrini D
IRAD- Divisione di Oncologia Medica 1, Istituto Regina Elena - IFO, Italy.
FIR - Petrucelli, L
IR  - Petrucelli L
IRAD- Unita' Operativa di Oncologia, Ospedale "Vito Fazzi" di, Lecce, Italy.
FIR - De Laurentiis, M
IR  - De Laurentiis M
IRAD- National Cancer Institute "Fondazione Giovanni Pascale", Italy.
FIR - Pizzuti, L
IR  - Pizzuti L
IRAD- Istituto Nazionale Tumori Regina Elena, Italy.
FIR - Pogliani, C
IR  - Pogliani C
IRAD- ASST della Valle Olona - Presidio Ospedaliero di Saronno - SC di Oncologia 
      Medica, Italy.
FIR - Riva, F
IR  - Riva F
IRAD- Oncology Unit, ASST Monza, Monza, Italy.
EDAT- 2017/07/18 06:00
MHDA- 2018/05/29 06:00
CRDT- 2017/07/17 06:00
PHST- 2017/04/10 00:00 [received]
PHST- 2017/06/12 00:00 [revised]
PHST- 2017/06/29 00:00 [accepted]
PHST- 2017/07/18 06:00 [pubmed]
PHST- 2018/05/29 06:00 [medline]
PHST- 2017/07/17 06:00 [entrez]
AID - S0960-9776(17)30515-5 [pii]
AID - 10.1016/j.breast.2017.06.043 [doi]
PST - ppublish
SO  - Breast. 2017 Oct;35:115-121. doi: 10.1016/j.breast.2017.06.043. Epub 2017 Jul 13.