Evidence map›Paper›PMID 25248157›Full record

ArticlePloS one2014

Accurate identification of ALK positive lung carcinoma patients: novel FDA-cleared automated fluorescence in situ hybridization scanning system and ultrasensitive immunohistochemistry.

Esther Conde, Ana Suárez-Gauthier, Amparo Benito, Pilar Garrido, Rosario García-Campelo, Michele Biscuola, Luis Paz-Ares, David Hardisson, Javier de Castro, M Carmen Camacho and 13 more

Abstract 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 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
–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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Updated guidelines for predictive biomarker testing in advanced non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Guideline
  2. Pooled it
  3. JTO clinical and research reports · 2024
    Article
  4. Article
  5. A narrative review of methods for the identification ofTranslational lung cancer research · 2023
    Review
  6. New update to the guidelines on testing predictive biomarkers in non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Article
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  16. ALK alterations and inhibition in lung cancer.Seminars in cancer biology · 2017
    Review
  17. Article
  18. Article
  19. Significance and evaluation of anaplastic lymphoma kinase by immunohistochemistry in non-small cell lung cancer.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2016
    Article
  20. FluorescenceOncology letters · 2016
    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

23 authors.

Esther CondeLaboratorio de Dianas Terapéuticas, Centro Integral Oncológico "Clara Campal", Hospital Universitario Madrid Sanchinarro, Universidad San Pablo-CEU, Madrid, Spain.
Ana Suárez-GauthierLaboratorio de Dianas Terapéuticas, Centro Integral Oncológico "Clara Campal", Hospital Universitario Madrid Sanchinarro, Universidad San Pablo-CEU, Madrid, Spain.
Amparo BenitoHospital Ramón y Cajal, Madrid, Spain.
Pilar GarridoHospital Ramón y Cajal, Madrid, Spain.
Rosario García-CampeloC.H.U. A Coruña, La Coruña, Spain.
Michele BiscuolaHospital Virgen del Rocío, Sevilla, Spain.
Luis Paz-AresHospital Virgen del Rocío, Sevilla, Spain.
David HardissonIdiPAZ (Hospital La Paz Institute for Health Research), University Hospital La Paz, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.
Javier de CastroIdiPAZ (Hospital La Paz Institute for Health Research), University Hospital La Paz, Faculty of Medicine, Autonomous University of Madrid, Madrid, Spain.
M Carmen CamachoHospital Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.
Delvys Rodriguez-AbreuHospital Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain.
Ihab AbdulkaderC.H.U. Santiago de Compostela, Santiago de Compostela, Spain.
Josep RamirezHospital Clinic, Barcelona, Spain.
Noemí ReguartHospital Clinic, Barcelona, Spain.
Marta SalidoHospital del Mar-Parc de Salut Mar, Barcelona, Spain.
Lara PijuánHospital del Mar-Parc de Salut Mar, Barcelona, Spain.
Edurne ArriolaHospital del Mar-Parc de Salut Mar, Barcelona, Spain.
Julián SanzHospital Clínico San Carlos, Madrid, Spain.
Victoria FolguerasHospital Central de Asturias, Oviedo, Spain.
Noemí VillanuevaHospital Central de Asturias, Oviedo, Spain.
Javier Gómez-RománHospital Marqués de Valdecilla, Santander, Spain.
Manuel HidalgoOncology Department, Centro Integral Oncológico "Clara Campal", Hospital Universitario Madrid Sanchinarro, Universidad San Pablo-CEU, Madrid, Spain.
Fernando López-RíosLaboratorio de Dianas Terapéuticas, Centro Integral Oncológico "Clara Campal", Hospital Universitario Madrid Sanchinarro, Universidad San Pablo-CEU, Madrid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBased on the excellent results of the clinical trials with ALK-inhibitors, the importance of accurately identifying ALK positive lung cancer has never been greater. However, there are increasing number of recent publications addressing discordances between FISH and IHC. The controversy is further fuelled by the different regulatory approvals. This situation prompted us to investigate two ALK IHC antibodies (using a novel ultrasensitive detection-amplification kit) and an automated ALK FISH scanning system (FDA-cleared) in a series of non-small cell lung cancer tumor samples.

methodsForty-seven ALK FISH-positive and 56 ALK FISH-negative NSCLC samples were studied. All specimens were screened for ALK expression by two IHC antibodies (clone 5A4 from Novocastra and clone D5F3 from Ventana) and for ALK rearrangement by FISH (Vysis ALK FISH break-apart kit), which was automatically captured and scored by using Bioview's automated scanning system.

resultsAll positive cases with the IHC antibodies were FISH-positive. There was only one IHC-negative case with both antibodies which showed a FISH-positive result. The overall sensitivity and specificity of the IHC in comparison with FISH were 98% and 100%, respectively.

conclusionsThe specificity of these ultrasensitive IHC assays may obviate the need for FISH confirmation in positive IHC cases. However, the likelihood of false negative IHC results strengthens the case for FISH testing, at least in some situations.

Indexed as

Anaplastic Lymphoma KinaseAntibodiesAutomation, LaboratoryCarcinoma, Non-Small-Cell LungGene RearrangementHumansImmunohistochemistryIn Situ Hybridization, FluorescenceLung NeoplasmsReceptor Protein-Tyrosine KinasesSensitivity and SpecificityTranslocation, GeneticUnited StatesUnited States Food and Drug AdministrationALK protein, humanAnaplastic Lymphoma KinaseAntibodiesReceptor Protein-Tyrosine Kinases

Identifiers

PMID25248157
PMCPMC4172507

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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.