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

F. Cicchiello, F. Riva, M. E. Cazzaniga, F. Pedani, M. Nicolini, C. Butti, N. Liscia, C. Pogliani, G. Capri, M. Alù, A. Febbraro, L. Petrucelli, L. D'Onofrio, D. Pellegrini, L. Mentuccia, V. Cocciolone, E. Miraglio, E. Bajardi, M. Dester, E. PaternòG. Guaitoli, I. Ferrarini, E. Gervasi, L. Licata, C. Benedetto, D. Andreis, E. Bordin, C. Ancona, L. Pizzuti, V. Fotia, R. Berardi, M. E. Cazzaniga, M. Airoldi, V. Arcangeli, S. Artale, F. Atzori, A. Ballerio, G. V. Bianchi, L. Blasi, S. Campidoglio, M. Ciccarese, M. C. Cursano, M. Piezzo, A. Fabi, L. Ferrari, A. Ferzi, C. Ficorella, A. Frassoldati, A. Fumagalli, on behalf of, The EVA Study Group

Research output: Contribution to journalArticle

8 Citations (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 (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.

Original languageEnglish
Pages (from-to)115-121
Number of pages7
JournalBreast
Volume35
DOIs
Publication statusPublished - Oct 1 2017

Fingerprint

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

Keywords

  • Advanced breast cancer
  • Dose-intensity
  • Everolimus
  • Fulvestrant
  • Hormone-receptor positive

ASJC Scopus subject areas

  • Surgery

Cite this

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. / Cicchiello, F.; Riva, F.; Cazzaniga, M. E.; Pedani, F.; Nicolini, M.; Butti, C.; Liscia, N.; Pogliani, C.; Capri, G.; Alù, M.; Febbraro, A.; Petrucelli, L.; D'Onofrio, L.; Pellegrini, D.; Mentuccia, L.; Cocciolone, V.; Miraglio, E.; Bajardi, E.; Dester, M.; Paternò, E.; Guaitoli, G.; Ferrarini, I.; Gervasi, E.; Licata, L.; Benedetto, C.; Andreis, D.; Bordin, E.; Ancona, C.; Pizzuti, L.; Fotia, V.; Berardi, R.; Cazzaniga, M. E.; Airoldi, M.; Arcangeli, V.; Artale, S.; Atzori, F.; Ballerio, A.; Bianchi, G. V.; Blasi, L.; Campidoglio, S.; Ciccarese, M.; Cursano, M. C.; Piezzo, M.; Fabi, A.; Ferrari, L.; Ferzi, A.; Ficorella, C.; Frassoldati, A.; Fumagalli, A.; on behalf of; The EVA Study Group.

In: Breast, Vol. 35, 01.10.2017, p. 115-121.

Research output: Contribution to journalArticle

Cicchiello, F, Riva, F, Cazzaniga, ME, Pedani, F, Nicolini, M, Butti, C, Liscia, N, Pogliani, C, Capri, G, Alù, M, Febbraro, A, Petrucelli, L, D'Onofrio, L, Pellegrini, D, Mentuccia, L, Cocciolone, V, Miraglio, E, Bajardi, E, Dester, M, Paternò, E, Guaitoli, G, Ferrarini, I, Gervasi, E, Licata, L, Benedetto, C, Andreis, D, Bordin, E, Ancona, C, Pizzuti, L, Fotia, V, Berardi, R, Cazzaniga, ME, Airoldi, M, Arcangeli, V, Artale, S, Atzori, F, Ballerio, A, Bianchi, GV, Blasi, L, Campidoglio, S, Ciccarese, M, Cursano, MC, Piezzo, M, Fabi, A, Ferrari, L, Ferzi, A, Ficorella, C, Frassoldati, A, Fumagalli, A, on behalf of & The EVA Study Group 2017, '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', Breast, vol. 35, pp. 115-121. https://doi.org/10.1016/j.breast.2017.06.043
Cicchiello, F. ; Riva, F. ; Cazzaniga, M. E. ; Pedani, F. ; Nicolini, M. ; Butti, C. ; Liscia, N. ; Pogliani, C. ; Capri, G. ; Alù, M. ; Febbraro, A. ; Petrucelli, L. ; D'Onofrio, L. ; Pellegrini, D. ; Mentuccia, L. ; Cocciolone, V. ; Miraglio, E. ; Bajardi, E. ; Dester, M. ; Paternò, E. ; Guaitoli, G. ; Ferrarini, I. ; Gervasi, E. ; Licata, L. ; Benedetto, C. ; Andreis, D. ; Bordin, E. ; Ancona, C. ; Pizzuti, L. ; Fotia, V. ; Berardi, R. ; Cazzaniga, M. E. ; Airoldi, M. ; Arcangeli, V. ; Artale, S. ; Atzori, F. ; Ballerio, A. ; Bianchi, G. V. ; Blasi, L. ; Campidoglio, S. ; Ciccarese, M. ; Cursano, M. C. ; Piezzo, M. ; Fabi, A. ; Ferrari, L. ; Ferzi, A. ; Ficorella, C. ; Frassoldati, A. ; Fumagalli, A. ; on behalf of ; The EVA Study Group. / 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. In: Breast. 2017 ; Vol. 35. pp. 115-121.
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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 (33–83). 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.",
keywords = "Advanced breast cancer, Dose-intensity, Everolimus, Fulvestrant, Hormone-receptor positive",
author = "F. Cicchiello and F. Riva and Cazzaniga, {M. E.} and F. Pedani and M. Nicolini and C. Butti and N. Liscia and C. Pogliani and G. Capri and M. Al{\`u} and A. Febbraro and L. Petrucelli and L. D'Onofrio and D. Pellegrini and L. Mentuccia and V. Cocciolone and E. Miraglio and E. Bajardi and M. Dester and E. Patern{\`o} and G. Guaitoli and I. Ferrarini and E. Gervasi and L. Licata and C. Benedetto and D. Andreis and E. Bordin and C. Ancona and L. Pizzuti and V. Fotia and R. Berardi and Cazzaniga, {M. E.} and M. Airoldi and V. Arcangeli and S. Artale and F. Atzori and A. Ballerio and Bianchi, {G. V.} and L. Blasi and S. Campidoglio and M. Ciccarese and Cursano, {M. C.} and M. Piezzo and A. Fabi and L. Ferrari and A. Ferzi and C. Ficorella and A. Frassoldati and A. Fumagalli and {on behalf of} and {The EVA Study Group}",
year = "2017",
month = "10",
day = "1",
doi = "10.1016/j.breast.2017.06.043",
language = "English",
volume = "35",
pages = "115--121",
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TY - JOUR

T1 - Efficacy and safety of Everolimus and Exemestane in hormone-receptor positive (HR+) human-epidermal-growth-factor negative (HER2−) advanced breast cancer patients

T2 - New insights beyond clinical trials. The EVA study

AU - Cicchiello, F.

AU - Riva, F.

AU - Cazzaniga, M. E.

AU - Pedani, F.

AU - Nicolini, M.

AU - Butti, C.

AU - Liscia, N.

AU - Pogliani, C.

AU - Capri, G.

AU - Alù, M.

AU - Febbraro, A.

AU - Petrucelli, L.

AU - D'Onofrio, L.

AU - Pellegrini, D.

AU - Mentuccia, L.

AU - Cocciolone, V.

AU - Miraglio, E.

AU - Bajardi, E.

AU - Dester, M.

AU - Paternò, E.

AU - Guaitoli, G.

AU - Ferrarini, I.

AU - Gervasi, E.

AU - Licata, L.

AU - Benedetto, C.

AU - Andreis, D.

AU - Bordin, E.

AU - Ancona, C.

AU - Pizzuti, L.

AU - Fotia, V.

AU - Berardi, R.

AU - Cazzaniga, M. E.

AU - Airoldi, M.

AU - Arcangeli, V.

AU - Artale, S.

AU - Atzori, F.

AU - Ballerio, A.

AU - Bianchi, G. V.

AU - Blasi, L.

AU - Campidoglio, S.

AU - Ciccarese, M.

AU - Cursano, M. C.

AU - Piezzo, M.

AU - Fabi, A.

AU - Ferrari, L.

AU - Ferzi, A.

AU - Ficorella, C.

AU - Frassoldati, A.

AU - Fumagalli, A.

AU - on behalf of

AU - The EVA Study Group

PY - 2017/10/1

Y1 - 2017/10/1

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 (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.

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.

KW - Advanced breast cancer

KW - Dose-intensity

KW - Everolimus

KW - Fulvestrant

KW - Hormone-receptor positive

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