Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology

Lindeman, Neal I.; Cagle, Philip T.; Beasley, Mary Beth; Chitale, Dhananjay Arun; Dacic, Sanja; Giaccone, Giuseppe; Jenkins, Robert Brian; Kwiatkowski, David J.; Saldivar, Juan-Sebastian; Squire, Jeremy; Thunnissen, Erik; Ladanyi, Marc

doi:10.1097/jto.0b013e318290868f

Cited by 1,280Lung Cancer Treatments and MutationsCancer Genomics and DiagnosticsLung Cancer Diagnosis and Treatment

Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology

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Lindeman, Neal I., Cagle, Philip T., Beasley, Mary Beth, Chitale, Dhananjay Arun, Dacic, Sanja, Giaccone, Giuseppe, Jenkins, Robert Brian, Kwiatkowski, David J. +4 more·2013·Journal of Thoracic Oncology

DOI 10.1097/jto.0b013e318290868fPMC PMC4159960

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Abstract

OBJECTIVE: To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed. PARTICIPANTS: Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies. EVIDENCE: Three unbiased literature searches of electronic databases were performed to capture articles published published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation. CONSENSUS PROCESS: Initial recommendations were formulated by the cochairs and panel members at a public meeting. Each guideline section was assigned to at least 2 panelists. Drafts were circulated to the writing panel (version 1), advisory panel (version 2), and the public (version 3) before submission (version 4). CONCLUSIONS: The 37 guideline items address 14 subjects, including 15 recommendations (evidence grade A/B). The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitor, respectively, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests. As scientific discoveries and clinical practice outpace the completion of randomized clinical trials, evidence-based guidelines developed by expert practitioners are vital for communicating emerging clinical standards. Already, new treatments targeting genetic alterations in other, less common driver oncogenes are being evaluated in lung cancer, and testing for these may be addressed in future versions of these guidelines.

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Sanger sequencing has relatively low sensitivity, requiring approximately 10% of the mutation allele.
“Sanger sequencing has been performed to detect mutations throughout the exons sequenced (usually exons 18–21), although the sensitivity is relatively low (requiring approximately 10% of the mutation allele).21”
From Not all epidermal growth factor receptor mutations in lung cancer are created equal: Perspectives for individualized treatment strategy (2016) · cites this paper as [21]

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Authors: Lindeman, N. I., Cagle, P. T., Beasley, M. B., Chitale, D. A., Dacic, S., Giaccone, G., Jenkins, R. B., Kwiatkowski, D. J., Saldivar, J.-S., Squire, J., Thunnissen, E., & Ladanyi, M.
Affiliations: Brigham and Women's Hospital (US)
ORCID: Lindeman, Neal I.
Beasley, Mary Beth
Chitale, Dhananjay Arun
Giaccone, Giuseppe
Jenkins, Robert Brian
Kwiatkowski, David J.
Squire, Jeremy
Thunnissen, Erik
Ladanyi, Marc
Venue: Journal of Thoracic Oncology
Publisher: Elsevier BV
Published: 2013-07
Volume: 8
Issue: 7
Pages: 823-859
ISSN: 1556-0864 (ISSN-L)
DOI: 10.1097/jto.0b013e318290868f
PMC: PMC4159960
OpenAlex: W1978236936
Cited by: 1,280
References: 322
Citations by year: 2026: 17 · 2025: 17 · 2024: 33 · 2023: 42 · 2022: 52 · 2021: 81 · 2020: 99 · 2019: 78 · 2018: 135 · 2017: 164 · 2016: 170 · 2015: 167 · 2014: 168 · 2013: 54 · 2012: 1
FWCI: 151.45
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
creativecommons.org/licenses/by-nc-nd/4.0/ (vor, 868 d)
Locations: Journal of Thoracic Oncology (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Pure Amsterdam UMC (publishedVersion)
Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
PubMed Central (acceptedVersion)
Data Archiving and Networked Services (DANS) (submittedVersion)
Funders: National Cancer Institute (P01CA129243)
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Cancer Genomics and Diagnostics
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: lung cancer, EGFR mutation, ALK fusion, tyrosine kinase inhibitors, molecular testing, patient selection, predictive biomarkers, targeted therapy, molecular pathology
MeSH terms: Anaplastic Lymphoma Kinase, Systematic Reviews as Topic, Expert Testimony, Genetic Testing, Humans, International Agencies, Lung Neoplasms, Mutation, Societies, Medical, Biomarkers, Tumor, Gene Rearrangement, Patient Selection, Evidence-Based Medicine, Receptor Protein-Tyrosine Kinases, Protein Kinase Inhibitors, ErbB Receptors

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Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology

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