Evidence map›Paper›PMID 21986093›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2012

Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial.

B Ejlertsen, J Aldridge, K V Nielsen, M M Regan, K L Henriksen, A E Lykkesfeldt, S Müller, R D Gelber, K N Price, B B Rasmussen and 3 more

Registry-linked trialOpen access · bronzeAbstract readEvaluation StudyMulticenter Study
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00004205 (A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor), which is not on this map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.4field-weighted citation impact, top 11% 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.

NCT00004205 phase3completednot on this map

A Phase III Study to Evaluate Letrozole as Adjuvant Endocrine Therapy for Postmenopausal Women With Receptor (ER and/or PgR) Positive Tumors

TypeinterventionalSponsorETOP IBCSG Partners FoundationRan1998 to 2016Enrolled8,028ConditionsBreast CancerArmsletrozole, tamoxifen citrate
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 23 citations in OpenAlex.

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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

13 authors at 7 institutions in 3 countries.

B EjlertsenDanish Breast Cancer Cooperative Group Statistical Center; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: ejlertsen@rh.dk.
J AldridgeInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA.
K V NielsenDako A/S, Glostrup, Denmark.
M M ReganInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA; Department of Biostatistics, Harvard School of Public Health; Department of Medicine, Harvard Medical School, Boston, USA.
K L HenriksenDepartment of Breast Cancer Research, Institute of Cancer Biology, Danish Cancer Society, Copenhagen, Denmark.
A E LykkesfeldtDepartment of Breast Cancer Research, Institute of Cancer Biology, Danish Cancer Society, Copenhagen, Denmark.
S MüllerDako A/S, Glostrup, Denmark.
R D GelberInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA; Department of Biostatistics, Harvard School of Public Health; Department of Medicine, Harvard Medical School, Boston, USA; International Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, USA.
K N PriceInternational Breast Cancer Study Group Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, USA; International Breast Cancer Study Group Statistical Center, Frontier Science and Technology Research Foundation, Boston, USA.
B B RasmussenDepartment of Pathology, Herlev Hospital, Copenhagen University Hospital, Herlev, Denmark.
G VialeDivision of Pathology and Laboratory Medicine, International Breast Cancer Study Group Pathology Review Office, European Institute of Oncology, University of Milan, Milan, Italy.
H MouridsenDanish Breast Cancer Cooperative Group Statistical Center; Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Danish Breast Cancer Cooperative Group the BIG 1-98 Collaborative Group and the International Breast Cancer Study Group
Dana-Farber Cancer Institute · USDanish Cancer Society · DKGlostrup Hospital · DKCopenhagen University Hospital · DKEuropean Institute of Oncology · ITHerlev Hospital · DKRigshospitalet · DK

Funding

IBCSG STATISTICAL CENTER--A BREAST CANCER STUDY RESOURCEU24CA075362 · NCI · DANA-FARBER CANCER INSTITUTE · PI REGAN, MEREDITH M · 1997 to 2015
$7.5M
NCI NIH HHS CA-75362NCI NIH HHS U24 CA075362
6 · The paper itself

Abstract

backgroundEstrogen Receptor 1 (ESR1) aberrations may be associated with expression of estrogen receptor (ER) or progesterone receptor (PgR), human epidermal growth factor receptor-2 (HER2) or Ki-67 labeling index and prognosis. PATIENTS AND

methodsESR1 was assessed in 1129 (81%) of 1396 postmenopausal Danish women with early breast cancer randomly assigned to receive 5 years of letrozole, tamoxifen or a sequence of these agents in the Breast International Group 1-98 trial and who had ER ≥ 1% after central review.

resultsBy FISH, 13.6% of patients had an ESR1-to-Centromere-6 (CEN-6) ratio ≥ 2 (amplified), and 4.2% had ESR1-to-CEN-6 ratio <0.8 (deleted). Deletion of ESR1 was associated with significantly lower levels of ER (P < 0.0001) and PgR (P = 0.02) and more frequent HER2 amplification. ESR1 deletion or amplification was associated with higher-Ki-67 than ESR1-normal tumors. Overall, there was no evidence of heterogeneity of disease-free survival (DFS) or in treatment effect according to ESR1 status. However, significant differences in DFS were observed for subsets based on a combination of ESR1 and HER2 status (P = 0.02).

conclusionsESR1 aberrations were associated with HER2 status, Ki-67 labeling index and ER and PgR levels. When combined with HER2, ESR1 may be prognostic but should not be used for endocrine treatment selection in postmenopausal women with endocrine-responsive early breast cancer.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Agents, HormonalBiomarkers, TumorBreast NeoplasmsCarcinomaCohort StudiesDenmarkEstrogen Receptor alphaFemaleHumansMiddle AgedNeoplasm StagingPostmenopausePredictive Value of TestsAntineoplastic Agents, HormonalBiomarkers, TumorESR1 protein, humanEstrogen Receptor alpha

Identifiers

PMID21986093
PMCPMC3335246
OpenAlexW2158354974

What OpenQuestion holds

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Registered trials

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.