Evidence map›Paper›PMID 28222072›Full record

Trial reportBritish journal of cancer2017

Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial.

S E Pinder, A F Campbell, J M S Bartlett, A Marshall, D Allen, M Falzon, J A Dunn, A Makris, L Hughes-Davies, R C Stein

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.5field-weighted citation impact, top 39% 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

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. Article
  3. Observational
  4. Article
  5. A Root Cause Analysis Into the High Error Rate in Clinical Immunohistochemistry.Applied immunohistochemistry & molecular morphology : AIMM
    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

10 authors at 5 institutions in 2 countries.

S E PinderDivision of Cancer Studies, King's College London, Guy's Hospital, Great Maze Pond, London SE1 9RT, UK.
A F CampbellWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Campus, Coventry CV4 7AL, UK.
J M S BartlettOntario Institute of Cancer Research, Toronto, Ontario M5G 0A3, Canada.
A MarshallWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Campus, Coventry CV4 7AL, UK.
D AllenUCL-Advanced Diagnostics, University College London, 21 University Street, London WC1E 6JJ, UK.
M FalzonDepartment of Pathology, University College London Hospitals, 235, Euston Road, London NW1 2BU, UK.
J A DunnWarwick Clinical Trials Unit, University of Warwick, Gibbet Hill Campus, Coventry CV4 7AL, UK.
A MakrisDepartment of Clinical Oncology, Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, HA6 2RN, UK.
L Hughes-DaviesOncology Centre, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
R C SteinDepartment of Oncology, University College London Hospitals, London NW1 2PG, UK.
University College Hospital · GBGuy's Hospital · GBMount Vernon Hospital · GBOntario Institute for Cancer Research · CAUniversity of Warwick · GB

Funding

Department of Health 10/34/01
6 · The paper itself

Abstract

backgroundThere is limited data on results of central re-testing of samples from patients with invasive breast cancer categorised in their local hospital laboratories as oestrogen receptor (ER) positive and human epidermal growth factor receptor homologue 2 (HER2) negative.

methodsThe Optimal Personalised Treatment of early breast cancer usIng Multiparameter Analysis preliminary study (OPTIMA prelim) was the feasibility phase of a randomised controlled trial to validate the use of multiparameter assay-directed chemotherapy decisions in the UK National Health Service (NHS). Eligibility criteria included ER positivity and HER2 negativity. Central re-testing of receptor status was mandatory.

resultsOf the 431 patients tested centrally, discrepant results between central and local laboratory results were identified in only 19 (4.4%; 95% confidence interval 2.5-6.3%) patients (with 21 tumours). On central review, seven patients had cancers that were ER-negative (1.6%) and 13 (3.0%) patients with 15 tumours had HER2-positive disease, including one tumour discrepant for both biomarkers.

conclusionsCentral re-testing of receptor status of invasive breast cancers in the UK NHS setting shows a high level of reproducibility in categorising tumours as ER-positive and HER2-negative, and raises questions regarding the cost effectiveness and clinical value of central re-testing in this sub-group of breast cancers in this setting.

Indexed as

AdultAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantDecision Support Systems, ClinicalErb-b2 Receptor Tyrosine KinasesFeasibility StudiesFemaleFollow-Up StudiesHumansImmunoenzyme TechniquesMedical Laboratory ScienceNeoplasm InvasivenessNeoplasm StagingPrognosisBiomarkers, TumorERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesReceptors, Estrogen

Identifiers

PMID28222072
PMCPMC5379140
OpenAlexW2590708113

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
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.