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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)31877-31887
Number of pages11
JournalOncotarget
Volume9
Issue number61
DOIs
Publication statusPublished - Aug 1 2018

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exemestane
Extravehicular Activity
Breast Neoplasms
Stomatitis
Exanthema
Anemia
Weight Loss
Pneumonia
Everolimus

Keywords

  • Advanced breast cancer
  • Elderly
  • Everolimus
  • Exemestane
  • Hormone-receptor positive

ASJC Scopus subject areas

  • Oncology

Cite this

Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years : New lessons for clinical practice from the EVA study. / Cazzaniga, Marina; Verusio, Claudio; Ciccarese, Mariangela; Fumagalli, Alberto; Sartori, Donata; 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; On behalf of The EVA Study Group, behalf of The EVA Study Group.

In: Oncotarget, Vol. 9, No. 61, 01.08.2018, p. 31877-31887.

Research output: Contribution to journalArticle

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, MC, 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, BOTEVASG 2018, 'Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years: New lessons for clinical practice from the EVA study', Oncotarget, vol. 9, no. 61, pp. 31877-31887. https://doi.org/10.18632/oncotarget.25874
Cazzaniga, Marina ; Verusio, Claudio ; Ciccarese, Mariangela ; Fumagalli, Alberto ; Sartori, Donata ; 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 ; On behalf of The EVA Study Group, behalf of The EVA Study Group. / Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years : New lessons for clinical practice from the EVA study. In: Oncotarget. 2018 ; Vol. 9, No. 61. pp. 31877-31887.
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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.",
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author = "Marina Cazzaniga and Claudio Verusio and Mariangela Ciccarese and Alberto Fumagalli and Donata Sartori and Cristina Ancona and Mario Airoldi and Gabriella Moretti and Corrado Ficorella and Valentina Arcangeli and Lucrezia Diodati and Alberto Zambelli and Antonio Febbraro and Daniele Generali and Mirco Pistelli and Ornella Garrone and Antonino Musolino and Patrizia Vici and Michela Maur and Lucia Mentuccia and {La Verde}, Nicla and Giulia Bianchi and Salvatore Artale and Livio Blasi and Matilde Piezzo and Francesco Atzori and Anna Turletti and Chiara Benedetto and Cursano, {Maria Concetta} and Alessandra Fabi and Vittorio Gebbia and Antonio Schirone and Raffaella Palumbo and Antonella Ferzi and Antonio Frassoldati and Claudio Scavelli and Luca Clivio and Valter Torri and {On behalf of The EVA Study Group}, {behalf of The EVA Study Group}",
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T1 - Everolimus (EVE) and exemestane (EXE) in patients with advanced breast cancer aged ≥ 65 years

T2 - New lessons for clinical practice from the EVA study

AU - Cazzaniga, Marina

AU - Verusio, Claudio

AU - Ciccarese, Mariangela

AU - Fumagalli, Alberto

AU - Sartori, Donata

AU - Ancona, Cristina

AU - Airoldi, Mario

AU - Moretti, Gabriella

AU - Ficorella, Corrado

AU - Arcangeli, Valentina

AU - Diodati, Lucrezia

AU - Zambelli, Alberto

AU - Febbraro, Antonio

AU - Generali, Daniele

AU - Pistelli, Mirco

AU - Garrone, Ornella

AU - Musolino, Antonino

AU - Vici, Patrizia

AU - Maur, Michela

AU - Mentuccia, Lucia

AU - La Verde, Nicla

AU - Bianchi, Giulia

AU - Artale, Salvatore

AU - Blasi, Livio

AU - Piezzo, Matilde

AU - Atzori, Francesco

AU - Turletti, Anna

AU - Benedetto, Chiara

AU - Cursano, Maria Concetta

AU - Fabi, Alessandra

AU - Gebbia, Vittorio

AU - Schirone, Antonio

AU - Palumbo, Raffaella

AU - Ferzi, Antonella

AU - Frassoldati, Antonio

AU - Scavelli, Claudio

AU - Clivio, Luca

AU - Torri, Valter

AU - On behalf of The EVA Study Group, behalf of The EVA Study Group

PY - 2018/8/1

Y1 - 2018/8/1

N2 - 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.

AB - 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.

KW - Advanced breast cancer

KW - Elderly

KW - Everolimus

KW - Exemestane

KW - Hormone-receptor positive

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