Evidence map›Paper›PMID 24586842›Full record

ArticlePloS one2014

Clinical validation of a PCR assay for the detection of EGFR mutations in non-small-cell lung cancer: retrospective testing of specimens from the EURTAC trial.

Susana Benlloch, Maria Luisa Botero, Jordi Beltran-Alamillo, Clara Mayo, Ana Gimenez-Capitán, Itziar de Aguirre, Cristina Queralt, Jose Luis Ramirez, Santiago Ramón y Cajal, Barbara Klughammer and 10 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.1field-weighted citation impact, top 6% 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

22 citing papers in PubMed, 37 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Using cfDNA and ctDNA as Oncologic Markers: A Path to Clinical Validation.International journal of molecular sciences · 2023
    Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Budget Impact Analysis ofDiagnostics (Basel, Switzerland) · 2020
    Article
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  19. Article
  20. Targeted treatment of mutatedLung Cancer (Auckland, N.Z.) · 2014
    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

20 authors at 3 institutions in 2 countries.

Susana BenllochPangaea Biotech SL, Barcelona, Spain.
Maria Luisa BoteroPangaea Biotech SL, Barcelona, Spain.
Jordi Beltran-AlamilloPangaea Biotech SL, Barcelona, Spain.
Clara MayoPangaea Biotech SL, Barcelona, Spain.
Ana Gimenez-CapitánPangaea Biotech SL, Barcelona, Spain.
Itziar de AguirreMedical Oncology Service-ICO, Hospital Germans Trias i Pujol, Badalona, Spain.
Cristina QueraltMedical Oncology Service-ICO, Hospital Germans Trias i Pujol, Badalona, Spain.
Jose Luis RamirezMedical Oncology Service-ICO, Hospital Germans Trias i Pujol, Badalona, Spain.
Santiago Ramón y CajalPangaea Biotech SL, Barcelona, Spain ; Pathology Department, Vall d'Hebron, University Hospital, Universidad Autónoma de Barcelona, Barcelona, Spain.
Barbara KlughammerF. Hoffmann-La Roche, Basel, Switzerland.
Mariette SchlegelF. Hoffmann-La Roche, Basel, Switzerland.
Walter BordognaF. Hoffmann-La Roche, Basel, Switzerland.
David ChenGenentech, South San Francisco, California, United States of America.
Guili ZhangRoche Molecular Systems, Pleasanton, California, United States of America.
Barbara KovachRoche Molecular Systems, Pleasanton, California, United States of America ; Roche Molecular Systems, Pleasanton, California, United States of America.
Felice ShiehRoche Molecular Systems, Pleasanton, California, United States of America ; Roche Molecular Systems, Pleasanton, California, United States of America.
John F PalmaRoche Molecular Systems, Pleasanton, California, United States of America.
Lin WuRoche Molecular Systems, Pleasanton, California, United States of America.
H Jeffrey LawrenceRoche Molecular Systems, Pleasanton, California, United States of America ; Roche Molecular Systems, Pleasanton, California, United States of America.
Miquel TaronPangaea Biotech SL, Barcelona, Spain ; Medical Oncology Service-ICO, Hospital Germans Trias i Pujol, Badalona, Spain.
Hospital Universitari Germans Trias i Pujol · ESRoche (Switzerland) · CHUniversitat Autònoma de Barcelona · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The EURTAC trial demonstrated that the tyrosine kinase inhibitor (TKI) erlotinib was superior to chemotherapy as first-line therapy for advanced non-small cell lung cancers (NSCLC) that harbor EGFR activating mutations in a predominantly Caucasian population. Based on EURTAC and several Asian trials, anti-EGFR TKIs are standard of care for EGFR mutation-positive NSCLC. We sought to validate a rapid multiplex EGFR mutation assay as a companion diagnostic assay to select patients for this therapy. Samples from the EURTAC trial were prospectively screened for EGFR mutations using a combination of laboratory-developed tests (LDTs), and tested retrospectively with the cobas EGFR mutation test (EGFR PCR test). The EGFR PCR test results were compared to the original LDT results and to Sanger sequencing, using a subset of specimens from patients screened for the trial. Residual tissue was available from 487 (47%) of the 1044 patients screened for the trial. The EGFR PCR test showed high concordance with LDT results with a 96.3% overall agreement. The clinical outcome of patients who were EGFR-mutation detected by the EGFR PCR test was very similar to the entire EURTAC cohort. The concordance between the EGFR PCR test and Sanger sequencing was 90.6%. In 78.9% of the discordant samples, the EGFR PCR test result was confirmed by a sensitive deep sequencing assay. This retrospective study demonstrates the clinical utility of the EGFR PCR test in the accurate selection of patients for anti-EGFR TKI therapy. The EGFR PCR test demonstrated improved performance relative to Sanger sequencing.

Indexed as

Carcinoma, Non-Small-Cell LungErbB ReceptorsErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedMutationPolymerase Chain ReactionProspective StudiesProtein Kinase InhibitorsQuinazolinesRetrospective StudiesSequence Analysis, DNAEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideProtein Kinase InhibitorsQuinazolines

Identifiers

PMID24586842
PMCPMC3934888
OpenAlexW2050619780

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.