Evidence map›Paper›PMID 28190252›Full record

Trial reportBreast cancer research and treatment2017

The BIG 2.04 MRC/EORTC SUPREMO Trial: pathology quality assurance of a large phase 3 randomised international clinical trial of postmastectomy radiotherapy in intermediate-risk breast cancer.

J S Thomas, A M Hanby, N Russell, G van Tienhoven, K Riddle, N Anderson, D A Cameron, J M S Bartlett, T Piper, C Cunningham and 3 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Breast cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–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

6 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Review
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.

J S ThomasDepartment of Pathology, Western General Hospital, Edinburgh, EH4 2XU, UK. jeremy.thomas@nhslothian.scot.nhs.uk.ORCID http://orcid.org/0000-0002-4652-610X
A M HanbyLeeds Institute of Cancer and Pathology, St James's University Hospital, Leeds, LS9 7TF, UK.
N RussellDepartment of Radiation Oncology, Netherlands Cancer Institute, Postbus 90203, 1006 BE, Amsterdam, Netherlands.
G van TienhovenAcademic Medical Center, University of Amsterdam, 1105 AZ, Amsterdam, Netherlands.
K RiddleScottish Clinical Trials Research Unit, NHS National Services Scotland, Edinburgh, EH12 9EB, UK.
N AndersonCentre of Population Health Sciences, Edinburgh University Medical School, Edinburgh, EH8 9AG, UK.
D A CameronEdinburgh Cancer Centre, Western General Hospital, Edinburgh, EH4 2XU, UK.
J M S BartlettOntario Institute for Cancer Research, Toronto, ON, M5G0A3, Canada.
T PiperEdinburgh Cancer Centre, Western General Hospital, Edinburgh, EH4 2XU, UK.
C CunninghamEdinburgh Cancer Centre, Western General Hospital, Edinburgh, EH4 2XU, UK.
P CanneyBeatson Oncology Centre, Gartnavel Campus, Glasgow, G12 0YN, UK.
I H KunklerEdinburgh Cancer Centre, Western General Hospital, Edinburgh, EH4 2XU, UK.
SUPREMO Trial Management Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSUPREMO is a phase 3 randomised trial evaluating radiotherapy post-mastectomy for intermediate-risk breast cancer. 1688 patients were enrolled from 16 countries between 2006 and 2013. We report the results of central pathology review carried out for quality assurance. PATIENTS AND

methodsA single recut haematoxylin and eosin (H&E) tumour section was assessed by one of two reviewing pathologists, blinded to the originally reported pathology and patient data. Tumour type, grade and lymphovascular invasion were reviewed to assess if they met the inclusion criteria. Slides from potentially ineligible patients on central review were scanned and reviewed online together by the two pathologists and a consensus reached. A subset of 25 of these cases was double-reported independently by the pathologists prior to the online assessment.

resultsThe major contributors to the trial were the UK (75%) and the Netherlands (10%). There is a striking difference in lymphovascular invasion (LVi) rates (41.6 vs. 15.1% (UK); p = <0.0001) and proportions of grade 3 carcinomas (54.0 vs. 42.0% (UK); p = <0.0001) on comparing local reporting with central review. There was no difference in the locally reported frequency of LVi rates in node-positive (N+) and node-negative (N-) subgroups (40.3 vs. 38.0%; p = 0.40) but a significant difference in the reviewed frequency (16.9 vs. 9.9%; p = 0.004). Of the N- cases, 104 (25.1%) would have been ineligible by initial central review by virtue of grade and/or lymphovascular invasion status. Following online consensus review, this fell to 70 cases (16.3% of N- cases, 4.1% of all cases).

conclusionsThese data have important implications for the design, powering and interpretation of outcomes from this and future clinical trials. If critical pathology criteria are determinants for trial entry, serious consideration should be given to up-front central pathology review.

Indexed as

Breast NeoplasmsFemaleHumansMastectomyNeoplasm GradingObserver VariationTreatment OutcomeBreast cancerClinical trialPathologyQuality assuranceRadiation therapy

Identifiers

PMID28190252
PMCPMC5387007

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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.