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

• Published in: Clinical & translational oncology 2018-06, Vol.20 (6), p.753-760
• Main Authors: Ciruelos, E., Vidal, M., Martínez de Dueñas, E., Martínez-Jáñez, N., Fernández, Y., García-Sáenz, J. A., Murillo, L., Carabantes, F., Beliera, A., Fonseca, R., Gavilá, J.
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Androstadienes - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast Neoplasms - drug therapy; Breast Neoplasms - pathology; Everolimus - administration & dosage; Female; Follow-Up Studies; Humans; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Invasiveness; Neoplasm Metastasis; Oncology; Prognosis; Receptor, ErbB-2 - metabolism; Receptors, Estrogen - metabolism; Receptors, Progesterone - metabolism; Research Article; Safety; Survival Rate
• ISSN: 1699-048X; 1699-3055
• DOI: 10.1007/s12094-017-1784-1

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.