Evidence map›Paper›PMID 21960707›Full record

GuidelineJournal of the National Cancer Institute2011

Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group.

Mitch Dowsett, Torsten O Nielsen, Roger A'Hern, John Bartlett, R Charles Coombes, Jack Cuzick, Matthew Ellis, N Lynn Henry, Judith C Hugh, Tracy Lively and 12 more

2 registry-linked trialsAbstract readPractice Guideline
In one paragraph

Guideline in Journal of the National Cancer Institute, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 850 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
850citing papers in PubMed, 2 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.

NCT01830244 phase2unknown statusnot on this mapstarted 2013, after this paper: background citation

Tailored Neoadjuvant Epirubicin and Cyclophosphamide (EC) and Nanoparticle Albumin Bound (Nab) Paclitaxel for Newly Diagnosed Breast Cancer

TypeinterventionalSponsorBarwon HealthRan2013 to 2020Enrolled60ConditionsBreast CancerArmsNab-Paclitaxel
NCT02347163 phase2terminatednot on this mapstarted 2015, after this paper: background citation

A Multicenter, Single-arm, Phase II Study to Evaluate the Activity of Pre-operative Zoledronate in Triple Negative Breast Cancer Patients, According to p53 Level

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2015 to 2018Enrolled22ConditionsBreast CancerArmsZoledronate
3 · Its place in the literature

Who cites it

850 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Trial
  4. A Co-clinical Trial of Exercise Therapy in Breast Cancer Prevention.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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790 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.

Mitch DowsettDepartment of Biochemistry, Royal Marsden Hospital and Breakthrough Breast Cancer Centre, Fulham Road, London, UK. mitch.dowsett@icr.ac.uk
Torsten O Nielsen
Roger A'Hern
John Bartlett
R Charles Coombes
Jack Cuzick
Matthew Ellis
N Lynn Henry
Judith C Hugh
Tracy Lively
Lisa McShane
Soon Paik
Frederique Penault-Llorca
Ljudmila Prudkin
Meredith Regan
Janine Salter
Christos Sotiriou
Ian E Smith
Giuseppe Viale
Jo Anne Zujewski
Daniel F Hayes
International Ki-67 in Breast Cancer Working Group

Funding

Breast Cancer Now BREAST CANCER NOW RESEARCH CENTRECancer Research UK
6 · The paper itself

Abstract

Uncontrolled proliferation is a hallmark of cancer. In breast cancer, immunohistochemical assessment of the proportion of cells staining for the nuclear antigen Ki67 has become the most widely used method for comparing proliferation between tumor samples. Potential uses include prognosis, prediction of relative responsiveness or resistance to chemotherapy or endocrine therapy, estimation of residual risk in patients on standard therapy and as a dynamic biomarker of treatment efficacy in samples taken before, during, and after neoadjuvant therapy, particularly neoadjuvant endocrine therapy. Increasingly, Ki67 is measured in these scenarios for clinical research, including as a primary efficacy endpoint for clinical trials, and sometimes for clinical management. At present, the enormous variation in analytical practice markedly limits the value of Ki67 in each of these contexts. On March 12, 2010, an international panel of investigators with substantial expertise in the assessment of Ki67 and in the development of biomarker guidelines was convened in London by the co-chairs of the Breast International Group and North American Breast Cancer Group Biomarker Working Party to consider evidence for potential applications. Comprehensive recommendations on preanalytical and analytical assessment, and interpretation and scoring of Ki67 were formulated based on current evidence. These recommendations are geared toward achieving a harmonized methodology, create greater between-laboratory and between-study comparability, and allow earlier valid applications of this marker in clinical practice.

Indexed as

Antineoplastic Agents, HormonalAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantClinical Trials as TopicFemaleHumansImmunohistochemistryKi-67 AntigenNeoadjuvant TherapyPredictive Value of TestsPrognosisProtein Array AnalysisReproducibility of ResultsAntineoplastic Agents, HormonalBiomarkers, TumorKi-67 Antigen

Identifiers

PMID21960707
PMCPMC3216967

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.