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

Autor: Maria Elena Cazzaniga, Nicla La Verde, Vincenzo Emanuele Chiuri, Marianna Giampaglia, Domenico Bilancia, Alessandra Fabi, Mariangela Ciccarese, A Latorre, Antonio Cusmai, Antonio Febbraro, Luca Moscetti, Evaristo Maiello, L. Petrucelli, L. Lupo, Francesco Giotta, Gennaro Palmiotti, Guido Giordano, Claudio Scavelli, Vito Lorusso, Sante Romito, Elisabetta De Matteis, Giammarco Surico, Maria Morritti, G. Cairo, R. Forcignanò
Přispěvatelé: Ciccarese, M, Fabi, A, Moscetti, L, Cazzaniga, M, Petrucelli, L, Forcignanò, R, Lupo, L, De Matteis, E, Chiuri, V, 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
Rok vydání: 2017
Předmět:
0301 basic medicine
Adult
Cancer Research
medicine.medical_specialty
Drug-Related Side Effects and Adverse Reactions
Receptor
ErbB-2
Population
Breast Neoplasms
Gastroenterology
Disease-Free Survival
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Breast cancer
Exemestane
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Everolimus
education
Adverse effect
Stomatitis
Aged
Neoplasm Staging
Gynecology
Aged
80 and over
education.field_of_study
business.industry
Middle Aged
medicine.disease
Discontinuation
Androstadienes
030104 developmental biology
Oncology
chemistry
Tolerability
Italy
Receptors
Estrogen
030220 oncology & carcinogenesis
Female
everolimus and exemestane (EVE/EXE)
advanced breast cancer (ABC)
multicenter Italian experience
business
Receptors
Progesterone
medicine.drug
Zdroj: Breast cancer research and treatment. 163(3)
ISSN: 1573-7217
Popis: 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.
Databáze: OpenAIRE
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