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
| Autor: | Noelia Martínez-Jañez, E. Martínez de Dueñas, F. Carabantes, L. Murillo, José A. García-Sáenz, R. Fonseca, Joaquín Gavilá, Eva Ciruelos, Maria Vidal, Yolanda Fernández, A. Beliera |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Oncology Adult Cancer Research medicine.medical_specialty Receptor ErbB-2 Population Breast Neoplasms 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Exemestane Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Invasiveness Everolimus Neoplasm Metastasis Adverse effect education Aged Aged 80 and over education.field_of_study business.industry General Medicine Middle Aged medicine.disease Prognosis Metastatic breast cancer Discontinuation Clinical trial Androstadienes Survival Rate 030104 developmental biology chemistry Receptors Estrogen 030220 oncology & carcinogenesis Population study Female Safety business Receptors Progesterone medicine.drug Follow-Up Studies |
| Zdroj: | CLINICAL & TRANSLATIONAL ONCOLOGY r-FISABIO. Repositorio Institucional de Producción Científica instname r-FISABIO: Repositorio Institucional de Producción Científica Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| ISSN: | 1699-3055 1699-048X |
| Popis: | 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 and methods 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 trials. |
| Databáze: | OpenAIRE |
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