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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

  • Epidemiology
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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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Authors and Affiliations

  1. Medical Oncology Unit, “Vito Fazzi” Hospital, Lecce, Italy

    Mariangela Ciccarese, Luciana Petrucelli, Rosachiara Forcignanò, Laura Isabella Lupo, Elisabetta De Matteis, Vincenzo Emanuele Chiuri, Giuseppe Cairo & Giammarco Surico

  2. Department of Medical Oncology, “Regina Elena” National Cancer Institute, Rome, Italy

    Alessandra Fabi

  3. Department of Oncology/Haemathology, University Hospital, Modena, Italy

    Luca Moscetti

  4. Oncology Department, “AO S. Gerardo”, Monza, Italy

    Maria Elena Cazzaniga

  5. Medical Oncology Unit, “Sacro Cuore di Gesù Fatebenefratelli” Hospital, Benevento, Italy

    Antonio Febbraro & Guido Giordano

  6. Medical Oncology Unit, “S. Carlo” Hospital, Potenza, Italy

    Marianna Giampaglia & Domenico Bilancia

  7. Department of Oncology, “ASST Fatebenefratelli Sacco”, Milan, Italy

    Nicla La Verde

  8. Department of Medical Oncology, “Casa Sollievo Della Sofferenza” Hospital, San Giovanni Rotondo, FG, Italy

    Evaristo Maiello & Maria Morritti

  9. Department of Medical Oncology, “Giovanni Paolo II” Institute, Bari, Italy

    Francesco Giotta, Vito Lorusso & Agnese Latorre

  10. Medical Oncology Unit, “S. Cuore di Gesù” Hospital, Gallipoli, LE, Italy

    Claudio Scavelli

  11. Oncology Unit, “Ospedali Riuniti” Hospital, Foggia, Italy

    Sante Romito

  12. Oncology Unit, “Di Venere” Hospital, Bari, Italy

    Antonio Cusmai & Gennaro Palmiotti

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  1. Mariangela Ciccarese
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Corresponding author

Correspondence to Mariangela Ciccarese.

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Ciccarese, M., Fabi, A., Moscetti, L. et al. 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 Res Treat 163, 587–594 (2017). https://doi.org/10.1007/s10549-017-4213-9

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