Evidence map›Paper›PMID 29116433›Full record

Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2018

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.

E Ciruelos, M Vidal, E Martínez de Dueñas, N Martínez-Jáñez, Y Fernández, J A García-Sáenz, L Murillo, F Carabantes, A Beliera, R Fonseca and 1 more

Abstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.0field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 10 institutions in 1 country.

E CiruelosDepartamento de Oncología Médica, Hospital Universitario 12 de Octubre, Avda. De Córdoba, s/n, 28041, Madrid, Spain. eva.ciruelos@gmail.com.ORCID http://orcid.org/0000-0002-2796-1042
M VidalVall d'Hebron University Hospital, Barcelona, Spain.
E Martínez de DueñasGeneral University Hospital of Castellón, Castelló de la Plana, Spain.
N Martínez-JáñezRamón y Cajal University Hospital, Madrid, Spain.
Y FernándezCentral University Hospital of Asturias, Oviedo, Spain.
J A García-SáenzSan Carlos University Hospital, Madrid, Spain.
L MurilloLozano Blesa University Hospital, Zaragoza, Spain.
F CarabantesCarlos Haya University Hospital, Málaga, Spain.
A BelieraNovartis Oncology, Madrid, Spain.
R FonsecaNovartis Oncology, Madrid, Spain.
J GaviláInstituto Valenciano de Oncología, Valencia, Spain.
Novartis (Spain) · ESFundación Instituto Valenciano de Oncología · ESHospital Clínic de Barcelona · ESHospital Clínico San Carlos · ESHospital Clínico Universitario Lozano Blesa · ESHospital Doctor José Molina Orosa · ESHospital General Universitari de Castelló · ESHospital Universitario 12 De Octubre · ESHospital Universitario Central de Asturias · ESInstituto Cajal · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEverolimus 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

methodsPost-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.

resultsBetween 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.

conclusionThe 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.

Indexed as

AdultAgedAged, 80 and overAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsErb-b2 Receptor Tyrosine KinasesEverolimusFemaleFollow-Up StudiesHumansMiddle AgedNeoplasm InvasivenessNeoplasm MetastasisPrognosisReceptors, EstrogenAndrostadienesErb-b2 Receptor Tyrosine KinasesEverolimusexemestaneReceptors, EstrogenReceptors, ProgesteroneAromatase inhibitorsBreast neoplasmEndocrine therapyPost-menopausal womenTargeted therapy

Identifiers

PMID29116433
OpenAlexW2767252854

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.