Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients

a multicenter Italian experience

Mariangela Ciccarese, Alessandra Fabi, Luca Moscetti, Maria Elena Cazzaniga, Luciana Petrucelli, Rosachiara Forcignanò, Laura Isabella Lupo, Elisabetta De Matteis, Vincenzo Emanuele Chiuri, Giuseppe Cairo, Antonio Febbraro, Guido Giordano, Marianna Giampaglia, Domenico Bilancia, Nicla La Verde, Evaristo Maiello, Maria Morritti, Francesco Giotta, Vito Lorusso, Agnese Latorre & 5 others Claudio Scavelli, Sante Romito, Antonio Cusmai, Gennaro Palmiotti, Giammarco Surico

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Aim: This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods: 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results: RR was 29.8% (A), 27.8% (B) (p = 0.953), and not evaluable (C). PFS was 9 months (95% CI 7–11) (A), 10 months (95% CI 9–11) (B), and 5 months (95% CI 2–8) (C), p = 0.956. OS was 38 months (95% CI 24–38) (A), median not reached (B), and 13 months (95% CI 10–25) (C), p = 0.002. Adverse events were stomatitis 57.7% (11.0% grade 3–4), asthenia 46.0% (6.1% grade 3–4), hypercholesterolemia 46.0% (0.6% grade 3–4), and hyperglycemia 35.6% (5.5% grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions: No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.

Original languageEnglish
Pages (from-to)587-594
Number of pages8
JournalBreast Cancer Research and Treatment
Volume163
Issue number3
DOIs
Publication statusPublished - Jun 1 2017

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exemestane
Stomatitis
Hormones
Breast Neoplasms
Population
Asthenia
Hypercholesterolemia
Hyperglycemia
Clinical Trials
Therapeutics
Everolimus

Keywords

  • Breast cancer
  • Dose intensity
  • Everolimus
  • Real-world population
  • Side effects

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients : a multicenter Italian experience. / Ciccarese, Mariangela; Fabi, Alessandra; Moscetti, Luca; Cazzaniga, Maria Elena; Petrucelli, Luciana; Forcignanò, Rosachiara; Lupo, Laura Isabella; De Matteis, Elisabetta; Chiuri, Vincenzo Emanuele; Cairo, Giuseppe; Febbraro, Antonio; Giordano, Guido; Giampaglia, Marianna; Bilancia, Domenico; La Verde, Nicla; Maiello, Evaristo; Morritti, Maria; Giotta, Francesco; Lorusso, Vito; Latorre, Agnese; Scavelli, Claudio; Romito, Sante; Cusmai, Antonio; Palmiotti, Gennaro; Surico, Giammarco.

In: Breast Cancer Research and Treatment, Vol. 163, No. 3, 01.06.2017, p. 587-594.

Research output: Contribution to journalArticle

Ciccarese, M, Fabi, A, Moscetti, L, Cazzaniga, ME, Petrucelli, L, Forcignanò, R, Lupo, LI, De Matteis, E, Chiuri, VE, Cairo, G, Febbraro, A, Giordano, G, Giampaglia, M, Bilancia, D, La Verde, N, Maiello, E, Morritti, M, Giotta, F, Lorusso, V, Latorre, A, Scavelli, C, Romito, S, Cusmai, A, Palmiotti, G & Surico, G 2017, 'Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients: a multicenter Italian experience', Breast Cancer Research and Treatment, vol. 163, no. 3, pp. 587-594. https://doi.org/10.1007/s10549-017-4213-9
Ciccarese, Mariangela ; Fabi, Alessandra ; Moscetti, Luca ; Cazzaniga, Maria Elena ; Petrucelli, Luciana ; Forcignanò, Rosachiara ; Lupo, Laura Isabella ; De Matteis, Elisabetta ; Chiuri, Vincenzo Emanuele ; Cairo, Giuseppe ; Febbraro, Antonio ; Giordano, Guido ; Giampaglia, Marianna ; Bilancia, Domenico ; La Verde, Nicla ; Maiello, Evaristo ; Morritti, Maria ; Giotta, Francesco ; Lorusso, Vito ; Latorre, Agnese ; Scavelli, Claudio ; Romito, Sante ; Cusmai, Antonio ; Palmiotti, Gennaro ; Surico, Giammarco. / Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients : a multicenter Italian experience. In: Breast Cancer Research and Treatment. 2017 ; Vol. 163, No. 3. pp. 587-594.
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abstract = "Aim: This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods: 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results: RR was 29.8{\%} (A), 27.8{\%} (B) (p = 0.953), and not evaluable (C). PFS was 9 months (95{\%} CI 7–11) (A), 10 months (95{\%} CI 9–11) (B), and 5 months (95{\%} CI 2–8) (C), p = 0.956. OS was 38 months (95{\%} CI 24–38) (A), median not reached (B), and 13 months (95{\%} CI 10–25) (C), p = 0.002. Adverse events were stomatitis 57.7{\%} (11.0{\%} grade 3–4), asthenia 46.0{\%} (6.1{\%} grade 3–4), hypercholesterolemia 46.0{\%} (0.6{\%} grade 3–4), and hyperglycemia 35.6{\%} (5.5{\%} grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions: No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.",
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TY - JOUR

T1 - Dose intensity and efficacy of the combination of everolimus and exemestane (EVE/EXE) in a real-world population of hormone receptor-positive (ER+/PgR+), HER2-negative advanced breast cancer (ABC) patients

T2 - a multicenter Italian experience

AU - Ciccarese, Mariangela

AU - Fabi, Alessandra

AU - Moscetti, Luca

AU - Cazzaniga, Maria Elena

AU - Petrucelli, Luciana

AU - Forcignanò, Rosachiara

AU - Lupo, Laura Isabella

AU - De Matteis, Elisabetta

AU - Chiuri, Vincenzo Emanuele

AU - Cairo, Giuseppe

AU - Febbraro, Antonio

AU - Giordano, Guido

AU - Giampaglia, Marianna

AU - Bilancia, Domenico

AU - La Verde, Nicla

AU - Maiello, Evaristo

AU - Morritti, Maria

AU - Giotta, Francesco

AU - Lorusso, Vito

AU - Latorre, Agnese

AU - Scavelli, Claudio

AU - Romito, Sante

AU - Cusmai, Antonio

AU - Palmiotti, Gennaro

AU - Surico, Giammarco

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Aim: This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods: 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results: RR was 29.8% (A), 27.8% (B) (p = 0.953), and not evaluable (C). PFS was 9 months (95% CI 7–11) (A), 10 months (95% CI 9–11) (B), and 5 months (95% CI 2–8) (C), p = 0.956. OS was 38 months (95% CI 24–38) (A), median not reached (B), and 13 months (95% CI 10–25) (C), p = 0.002. Adverse events were stomatitis 57.7% (11.0% grade 3–4), asthenia 46.0% (6.1% grade 3–4), hypercholesterolemia 46.0% (0.6% grade 3–4), and hyperglycemia 35.6% (5.5% grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions: No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.

AB - Aim: This retrospective analysis focused on the effect of treatment with EVE/EXE in a real-world population outside of clinical trials. We examined the efficacy of this combination in terms of PFS and RR related to dose intensity (5 mg daily versus 10 mg daily) and tolerability. Methods: 163 HER2-negative ER+/PgR+ ABC patients, treated with EVE/EXE from May 2011 to March 2016, were included in the analysis. The primary endpoints were the correlation between the daily dose and RR and PFS, as well as an evaluation of the tolerability of the combination. Secondary endpoints were RR, PFS, and OS according to the line of treatment. Patients were classified into three different groups, each with a different dose intensity of everolimus (A, B, C). Results: RR was 29.8% (A), 27.8% (B) (p = 0.953), and not evaluable (C). PFS was 9 months (95% CI 7–11) (A), 10 months (95% CI 9–11) (B), and 5 months (95% CI 2–8) (C), p = 0.956. OS was 38 months (95% CI 24–38) (A), median not reached (B), and 13 months (95% CI 10–25) (C), p = 0.002. Adverse events were stomatitis 57.7% (11.0% grade 3–4), asthenia 46.0% (6.1% grade 3–4), hypercholesterolemia 46.0% (0.6% grade 3–4), and hyperglycemia 35.6% (5.5% grade 3–4). The main reason for discontinuation/interruption was grade 2–3 stomatitis. Conclusions: No correlation was found between dose intensity (5 vs. 10 mg labeled dose) and efficacy in terms of RR and PFS. The tolerability of the higher dose was poor in our experience, although this had no impact on efficacy.

KW - Breast cancer

KW - Dose intensity

KW - Everolimus

KW - Real-world population

KW - Side effects

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