Evidence map›Paper›PMID 27634691›Full record

ReviewAnnals of oncology : official journal of the European Society for Medical Oncology2016

Statistical controversies in clinical research: prognostic gene signatures are not (yet) useful in clinical practice.

S Michiels, N Ternès, F Rotolo

Abstract readReview
In one paragraph

Review in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

23 citing papers in PubMed.

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  13. Chemotherapy Treatment Considerations in Metastatic Breast Cancer.Journal of the advanced practitioner in oncology · 2021
    Review
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  19. Societal challenges of precision medicine: Bringing order to chaos.European journal of cancer (Oxford, England : 1990) · 2017
    Article
  20. 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

3 authors.

S MichielsGustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif stefan.michiels@gustaveroussy.fr.
N TernèsGustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif.
F RotoloGustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

With the genomic revolution and the era of targeted therapy, prognostic and predictive gene signatures are becoming increasingly important in clinical research. They are expected to assist prognosis assessment and therapeutic decision making. Notwithstanding, an evidence-based approach is needed to bring gene signatures from the laboratory to clinical practice. In early breast cancer, multiple prognostic gene signatures are commercially available without having formally reached the highest levels of evidence-based criteria. We discuss specific concepts for developing and validating a prognostic signature and illustrate them with contemporary examples in breast cancer. When a prognostic signature has not been developed for predicting the magnitude of relative treatment benefit through an interaction effect, it may be wishful thinking to test its predictive value. We propose that new gene signatures be built specifically for predicting treatment effects for future patients and outline an approach for this using a cross-validation scheme in a standard phase III trial. Replication in an independent trial remains essential.

Indexed as

Biomedical ResearchGenomicsPrognosisBreast NeoplasmsDatabases, GeneticFemaleGene Expression Regulation, NeoplasticHumansKaplan-Meier Estimateclinical utilityevidence basedgene signaturepredictiveprognostic

Identifiers

PMID27634691
PMCPMC5178139

What OpenQuestion holds

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LicenceCC BY-NC
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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.