PMID- 29116433
OWN - NLM
STAT- MEDLINE
DCOM- 20180926
LR  - 20181113
IS  - 1699-3055 (Electronic)
IS  - 1699-048X (Linking)
VI  - 20
IP  - 6
DP  - 2018 Jun
TI  - 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.
PG  - 753-760
LID - 10.1007/s12094-017-1784-1 [doi]
AB  - 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.
FAU - Ciruelos, E
AU  - Ciruelos E
AUID- ORCID: 0000-0002-2796-1042
AD  - Departamento de Oncologia Medica, Hospital Universitario 12 de Octubre, Avda. De 
      Cordoba, s/n, 28041, Madrid, Spain. eva.ciruelos@gmail.com.
FAU - Vidal, M
AU  - Vidal M
AD  - Vall d'Hebron University Hospital, Barcelona, Spain.
AD  - Clinic Hospital, Barcelona, Spain.
FAU - Martinez de Duenas, E
AU  - Martinez de Duenas E
AD  - General University Hospital of Castellon, Castello de la Plana, Spain.
FAU - Martinez-Janez, N
AU  - Martinez-Janez N
AD  - Ramon y Cajal University Hospital, Madrid, Spain.
FAU - Fernandez, Y
AU  - Fernandez Y
AD  - Central University Hospital of Asturias, Oviedo, Spain.
FAU - Garcia-Saenz, J A
AU  - Garcia-Saenz JA
AD  - San Carlos University Hospital, Madrid, Spain.
FAU - Murillo, L
AU  - Murillo L
AD  - Lozano Blesa University Hospital, Zaragoza, Spain.
FAU - Carabantes, F
AU  - Carabantes F
AD  - Carlos Haya University Hospital, Malaga, Spain.
FAU - Beliera, A
AU  - Beliera A
AD  - Novartis Oncology, Madrid, Spain.
FAU - Fonseca, R
AU  - Fonseca R
AD  - Novartis Oncology, Madrid, Spain.
FAU - Gavila, J
AU  - Gavila J
AD  - Instituto Valenciano de Oncologia, Valencia, Spain.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20171107
PL  - Italy
TA  - Clin Transl Oncol
JT  - Clinical & translational oncology : official publication of the Federation of 
      Spanish Oncology Societies and of the National Cancer Institute of Mexico
JID - 101247119
RN  - 0 (Androstadienes)
RN  - 0 (Receptors, Estrogen)
RN  - 0 (Receptors, Progesterone)
RN  - 9HW64Q8G6G (Everolimus)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - NY22HMQ4BX (exemestane)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Androstadienes/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Breast Neoplasms/*drug therapy/pathology
MH  - Everolimus/administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Middle Aged
MH  - Neoplasm Invasiveness
MH  - Neoplasm Metastasis
MH  - Prognosis
MH  - Receptor, ErbB-2/*metabolism
MH  - Receptors, Estrogen/*metabolism
MH  - Receptors, Progesterone/*metabolism
MH  - Safety
MH  - Survival Rate
OTO - NOTNLM
OT  - Aromatase inhibitors
OT  - Breast neoplasm
OT  - Endocrine therapy
OT  - Post-menopausal women
OT  - Targeted therapy
EDAT- 2017/11/09 06:00
MHDA- 2018/09/27 06:00
CRDT- 2017/11/09 06:00
PHST- 2017/05/30 00:00 [received]
PHST- 2017/10/20 00:00 [accepted]
PHST- 2017/11/09 06:00 [pubmed]
PHST- 2018/09/27 06:00 [medline]
PHST- 2017/11/09 06:00 [entrez]
AID - 10.1007/s12094-017-1784-1 [pii]
AID - 10.1007/s12094-017-1784-1 [doi]
PST - ppublish
SO  - Clin Transl Oncol. 2018 Jun;20(6):753-760. doi: 10.1007/s12094-017-1784-1. Epub 
      2017 Nov 7.