Evidence map›Paper›PMID 33369635›Full record

ArticleJournal of the National Cancer Institute2021

Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group.

Torsten O Nielsen, Samuel C Y Leung, David L Rimm, Andrew Dodson, Balazs Acs, Sunil Badve, Carsten Denkert, Matthew J Ellis, Susan Fineberg, Margaret Flowers and 12 more

Abstract read
In one paragraph

Article in Journal of the National Cancer Institute, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 426 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
426citing papers in PubMed, 3 pooled it
–field-weighted citation impact
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

426 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Guideline
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  5. Neoadjuvant Abemaciclib plus Letrozole Versus Chemotherapy in Patients with HR+/HER2- Highly Proliferative Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
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  7. FOXC1 Expression Predicts Capecitabine Efficacy in Patients with Triple-Negative Breast Cancer from the GEICAM_CIBOMA Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
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366 more citing papers are in PubMed but not listed here.

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

22 authors.

Torsten O NielsenDepartment of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.ORCID 0000-0003-3769-2517
Samuel C Y LeungDepartment of Pathology and Laboratory Medicine, University of British Columbia, Vancouver, BC, Canada.ORCID 0000-0003-0138-7254
David L RimmDepartment of Pathology, Yale University School of Medicine, New Haven, CT, USA.ORCID 0000-0001-5820-4397
Andrew DodsonThe UK National External Quality Assessment Scheme for Immunocytochemistry and In-Situ Hybridisation, London, UK.ORCID 0000-0002-7443-2362
Balazs AcsDepartment of Oncology and Pathology, Cancer Centre Karolinska (CCK), Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-0972-4633
Sunil BadveIndiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, USA.ORCID 0000-0001-8861-9980
Carsten DenkertPhilipps University Marburg and University Hospital Marburg, Marburg, Germany.ORCID 0000-0002-2249-0982
Matthew J EllisLester and Sue Smith Breast Center, Baylor College of Medicine, Houston, TX, USA.ORCID 0000-0002-8467-8534
Susan FinebergMontefiore Medical Center and the Albert Einstein College of Medicine, Bronx, NY, USA.ORCID 0000-0002-4769-7875
Margaret FlowersBreast Cancer Research Foundation, New York, NY, USA.
Hans H KreipeMedical School Hannover, Institute of Pathology, Hannover, Germany.ORCID 0000-0003-0708-1790
Anne-Vibeke LaenkholmDepartment of Surgical Pathology, Zealand University Hospital, Slagelse, Denmark.
Hongchao PanNuffield Department of Population Health, University of Oxford, Oxford, UK.ORCID 0000-0001-9777-195X
Frédérique M Penault-LlorcaDepartment of Pathology, Centre Jean Perrin and Université d'Auvergne, Clermont-Ferrand, France.ORCID 0000-0002-4279-5492
Mei-Yin PolleyDepartment of Public Health Sciences, University of Chicago Biological Sciences, Chicago, IL, USA.ORCID 0000-0003-0106-0323
Roberto SalgadoDepartment of Pathology, GasthuisZusters Antwerpen / Hospital Network Antwerp (GZA-ZNA), Antwerp, Belgium.
Ian E SmithBreast Unit, Royal Marsden Hospital, London, UK.
Tomoharu SugieDepartment of Surgery, Kansai Medical University, Shinmachi, Hirakata City, Osaka Prefecture, Japan.ORCID 0000-0002-0712-7069
John M S BartlettDiagnostic Development Program, Ontario Institute for Cancer Research, Toronto, ON, Canada.ORCID 0000-0002-0347-3888
Lisa M McShaneBiometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.ORCID 0000-0001-8195-3206
Mitch DowsettBreast Cancer Now Toby Robins Research Centre, Institute of Cancer Research, London, UK.ORCID 0000-0003-4122-744X
Daniel F HayesUniversity of Michigan Rogel Cancer Center, Ann Arbor, MI, USA.ORCID 0000-0003-3620-7575

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

Ki67 immunohistochemistry (IHC), commonly used as a proliferation marker in breast cancer, has limited value for treatment decisions due to questionable analytical validity. The International Ki67 in Breast Cancer Working Group (IKWG) consensus meeting, held in October 2019, assessed the current evidence for Ki67 IHC analytical validity and clinical utility in breast cancer, including the series of scoring studies the IKWG conducted on centrally stained tissues. Consensus observations and recommendations are: 1) as for estrogen receptor and HER2 testing, preanalytical handling considerations are critical; 2) a standardized visual scoring method has been established and is recommended for adoption; 3) participation in and evaluation of quality assurance and quality control programs is recommended to maintain analytical validity; and 4) the IKWG accepted that Ki67 IHC as a prognostic marker in breast cancer has clinical validity but concluded that clinical utility is evident only for prognosis estimation in anatomically favorable estrogen receptor-positive and HER2-negative patients to identify those who do not need adjuvant chemotherapy. In this T1-2, N0-1 patient group, the IKWG consensus is that Ki67 5% or less, or 30% or more, can be used to estimate prognosis. In conclusion, analytical validity of Ki67 IHC can be reached with careful attention to preanalytical issues and calibrated standardized visual scoring. Currently, clinical utility of Ki67 IHC in breast cancer care remains limited to prognosis assessment in stage I or II breast cancer. Further development of automated scoring might help to overcome some current limitations.

Indexed as

Breast NeoplasmsBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunohistochemistryKi-67 AntigenPrognosisReceptors, EstrogenBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesKi-67 AntigenReceptors, Estrogen

Identifiers

PMID33369635
PMCPMC8487652

What OpenQuestion holds

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Registered trials

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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.