Evidence map›Paper›PMID 24362951›Full record

Trial reportBreast cancer research and treatment2014

Everolimus plus exemestane as first-line therapy in HR⁺, HER2⁻ advanced breast cancer in BOLERO-2.

J Thaddeus Beck, Gabriel N Hortobagyi, Mario Campone, Fabienne Lebrun, Ines Deleu, Hope S Rugo, Barbara Pistilli, Norikazu Masuda, Lowell Hart, Bohuslav Melichar and 9 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
47citing papers in PubMed, 2 pooled it
8.3field-weighted citation impact, top 2% 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

47 citing papers in PubMed, 2 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
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  4. Trial
  5. 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.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
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  19. The immunomodulatory effects of endocrine therapy in breast cancer.Journal of experimental & clinical cancer research : CR · 2021
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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

19 authors at 16 institutions in 9 countries.

J Thaddeus BeckHighlands Oncology Group, 3232 N. North Hills Blvd, Fayetteville, AR, 72703, USA, tbeck@hogonc.com.
Gabriel N Hortobagyi
Mario Campone
Fabienne Lebrun
Ines Deleu
Hope S Rugo
Barbara Pistilli
Norikazu Masuda
Lowell Hart
Bohuslav Melichar
Shaker Dakhil
Matthias Geberth
Martina Nunzi
Daniel Y C Heng
Thomas Brechenmacher
Mona El-Hashimy
Shyanne Douma
Francois Ringeisen
Martine Piccart
Institut Jules Bordet · BENovartis (United States) · USCancer Center of Kansas · USFlorida Cancer Specialists & Research Institute · USHighlands Oncology Group · USInstitut de Cancérologie de l'Ouest · FRNovartis (France) · FRNovartis (Switzerland) · CHOsaka National Hospital · JPPalacký University Olomouc · CZPraxis für Hämatologie und Onkologie · DEThe University of Texas MD Anderson Cancer Center · USUniversity of Calgary · CAUniversity of California, San Francisco · USUniversity of Macerata · ITVlaamse Vereniging voor Obstetrie en Gynaecolo · BE

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

The present exploratory analysis examined the efficacy, safety, and quality-of-life effects of everolimus (EVE) + exemestane (EXE) in the subgroup of patients in BOLERO-2 whose last treatment before study entry was in the (neo)adjuvant setting. In BOLERO-2, patients with hormone-receptor-positive (HR(+)), human epidermal growth factor receptor-2-negative (HER2(-)) advanced breast cancer recurring/progressing after a nonsteroidal aromatase inhibitor (NSAI) were randomly assigned (2:1) to receive EVE (10 mg/day) + EXE (25 mg/day) or placebo (PBO) + EXE. The primary endpoint was progression-free survival (PFS) by local assessment. Overall, 137 patients received first-line EVE + EXE (n = 100) or PBO + EXE (n = 37). Median PFS by local investigator assessment nearly tripled to 11.5 months with EVE + EXE from 4.1 months with PBO + EXE (hazard ratio = 0.39; 95 % CI 0.25-0.62), while maintaining quality of life. This was confirmed by central assessment (15.2 vs 4.2 months; hazard ratio = 0.32; 95 % CI 0.18-0.57). The marked PFS improvement in patients receiving EVE + EXE as first-line therapy for disease recurrence during or after (neo)adjuvant NSAI therapy supports the efficacy of this combination in the first-line setting. Furthermore, the results highlight the potential benefit of early introduction of EVE + EXE in the management of HR(+), HER2(-) advanced breast cancer in postmenopausal patients.

Indexed as

AgedAged, 80 and overAndrostadienesAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsClinical Trials as TopicDisease-Free SurvivalEverolimusFemaleHumansKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasms, Hormone-DependentReceptors, EstrogenReceptors, ProgesteroneAndrostadienesEverolimusexemestaneReceptors, EstrogenReceptors, ProgesteroneSirolimus

Identifiers

PMID24362951
PMCPMC3907668
OpenAlexW1982234365

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.