Safety of everolimus plus exemestane in patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer: results of phase IIIb BALLET trial in Spain
Clin. transl. oncol. (Print)
; 20(6): 753-760, jun. 2018. tab
Artigo
em Inglês
| IBECS
| ID: ibc-173624
Biblioteca responsável:
ES1.1
Localização: BNCS
ABSTRACT
Background:
Everolimus with exemestane has shown promising activity in patients with hormone-receptor (HR)-positive HER2-negative endocrine-resistant advanced breast cancer. It is necessary, therefore, to characterize the safety profile of this new combination in the real-world clinical setting and in the broadest possible population. Patients andmethods:
Post-menopausal women with HR-positive HER2-negative advanced breast cancer progressing after prior non-steroidal aromatase inhibitors (NSAIs) were included. The objectives of this analysis were to evaluate the safety profile of this combination in a subset of Spanish patients in the BALLET trial and to characterize grade 3 and 4 adverse events (AEs) in routine clinical practice in Spain.Results:
Between September 2012 and July 2013, 429 patients (20% of the overall study population) were included in the BALLET study in 52 hospitals in Spain, of whom 100 (23%) were ≥ 70 years. The median treatment duration was 3.14 and 3.03 months for exemestane and everolimus, respectively. The most common reasons for discontinuation of treatment were local reimbursement of everolimus (43%), followed by disease progression (31%) and the incidence of AEs (15%). The most frequent AEs causing permanent discontinuation were pneumonitis (4%), asthenia (2%) and stomatitis (2%). Overall, 87% of patients experienced at least one AE of any grade, 30% of patients at least one grade 3 AE and 2% of patients a grade 4 AE.Conclusion:
The safety profile in Spanish patients of the BALLET trial is consistent with the results obtained in the overall population of the trial, as well as in previous clinical trialsRESUMEN
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Coleções:
Bases de dados nacionais
/
Espanha
Base de dados:
IBECS
Assunto principal:
Neoplasias da Mama
/
Receptor ErbB-2
/
Everolimo
/
Androstadienos
Limite:
Feminino
/
Humanos
Idioma:
Inglês
Revista:
Clin. transl. oncol. (Print)
Ano de publicação:
2018
Tipo de documento:
Artigo
Instituição/País de afiliação:
Carlos Haya University Hospital/Spain
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Central University Hospital of Asturias/Spain
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General University Hospital of Castellón/Spain
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Hospital Universitario 12 de Octubre/Spain
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Instituto Valenciano de Oncología/Spain
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Lozano Blesa University Hospital/Spain
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Novartis Oncology/Spain
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Ramón y Cajal University Hospital/Spain
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San Carlos University Hospital/Spain
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Vall dHebron University Hospital/Spain