Evidence map›Paper›PMID 26775588›Full record

SynthesisLung cancer (Amsterdam, Netherlands)2016

Problems of variable biomarker evaluation in stratified medicine research--A case study of ERCC1 in non-small-cell lung cancer.

Kinga Malottki, Sanjay Popat, Jonathan J Deeks, Richard D Riley, Andrew G Nicholson, Lucinda Billingham

Open access · hybridAbstract readSystematic Review
In one paragraph

Synthesis in Lung cancer (Amsterdam, Netherlands), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

3 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Observational
  3. 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

6 authors at 5 institutions in 1 country.

Kinga MalottkiCancer Research UK Clinical Trials Unit (CRCTU), MRC Midland Hub for Trials Methodology Research, Institute of Cancer and Genomic Sciences, University of Birmingham, United Kingdom. Electronic address: k.malottki@bham.ac.uk.
Sanjay PopatDepartment of Medicine, Royal Marsden Hospital, London SW3 6JJ, United Kingdom.
Jonathan J DeeksInstitute of Applied Health Research, University of Birmingham, United Kingdom.
Richard D RileyResearch Institute for Primary Care and Health Sciences, Keele University, United Kingdom.
Andrew G NicholsonDepartment of Histopathology, Royal Brompton and Harefield NHS Foundation Trust and National heart and Lung Institute, Imperial College, London, United Kingdom.
Lucinda BillinghamCancer Research UK Clinical Trials Unit (CRCTU), MRC Midland Hub for Trials Methodology Research, Institute of Cancer and Genomic Sciences, University of Birmingham, United Kingdom.
Cancer Research UK Clinical Trials Unit · GBKeele University · GBRoyal Brompton & Harefield NHS Foundation Trust · GBRoyal Marsden Hospital · GBUniversity of Birmingham · GB

Funding

Cancer Research UK 15958Cancer Research UK 17469Medical Research Council G0800808
6 · The paper itself

Abstract

objectivesConsistency of procedures for the evaluation of a predictive biomarker (including sample collection, processing, assay and scoring system) based on adequate evidence is necessary to implement research findings in clinical practice. As a case study we evaluated how a particular predictive biomarker, ERCC1, was assessed in research on platinum-based chemotherapy in non-small-cell lung cancer and what motivated the choice of procedure. MATERIALS AND

methodsA systematic review of studies completed since 2007 and ongoing was undertaken. Questionnaires on details of ERCC1 evaluation procedures and the rationale for their choice were sent to contacts of identified studies.

resultsThirty-three studies of platinum-based chemotherapy in non-small-cell lung cancer using ERCC1 were identified. A reply to the questionnaire was received for 16 studies. Procedures for ERCC1 evaluation varied substantially and included reverse transcriptase quantitative polymerase chain reaction (nine studies), immunohistochemistry (five studies) and other methods (multiple methods-two studies, NER polymorphism-one study). In five studies ERCC1 use was planned, but not undertaken. In nine data was insufficient to identify the procedure. For each assay there was variation across studies in the details of the laboratory techniques, scoring systems and methods for obtaining samples.

conclusionsWe found large variation across studies in ERCC1 evaluation procedures. This will limit the future comparability of results between these different studies. To enable evidence-based clinical practice, consensus is needed on a validated procedure to assess a predictive biomarker in the early phase of research. We believe that ERCC1 is not untypical of biomarkers being investigated for stratified medicine.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Non-Small-Cell LungDNA-Binding ProteinsEndonucleasesEvidence-Based MedicineHumansLung NeoplasmsOrganoplatinum CompoundsTreatment OutcomeBiomarkers, TumorDNA-Binding ProteinsEndonucleasesERCC1 protein, humanOrganoplatinum CompoundsAntineoplastic therapyBiological markersCarcinomaClinical trials as topicDrug therapyERCC1 proteinHumanNon-small-cell lung

Identifiers

PMID26775588
PMCPMC4729317
OpenAlexW2180444265

What OpenQuestion holds

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LicenceCC BY
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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.