Document Detail

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.
MedLine Citation:
PMID:  23562183     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: To establish evidence-based recommendations for the molecular analysis of lung cancers 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 published articles 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.
Neal I Lindeman; Philip T Cagle; Mary Beth Beasley; Dhananjay Arun Chitale; Sanja Dacic; Giuseppe Giaccone; Robert Brian Jenkins; David J Kwiatkowski; Juan-Sebastian Saldivar; Jeremy Squire; Erik Thunnissen; Marc Ladanyi; College of American Pathologists International Association for the Study of Lung Cancer and Association for Molecular Pathology
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Publication Detail:
Type:  Guideline; Journal Article     Date:  2013-04-04
Journal Detail:
Title:  The Journal of molecular diagnostics : JMD     Volume:  15     ISSN:  1943-7811     ISO Abbreviation:  J Mol Diagn     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-24     Completed Date:  2014-02-13     Revised Date:  2014-07-31    
Medline Journal Info:
Nlm Unique ID:  100893612     Medline TA:  J Mol Diagn     Country:  United States    
Other Details:
Languages:  eng     Pagination:  415-53     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 College of American Pathologists, American Society for Investigative Pathology, Association for Molecular Pathology, and the International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
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MeSH Terms
Disease-Free Survival
Lung Neoplasms / diagnosis*,  drug therapy*,  genetics,  pathology
Oncogene Proteins, Fusion / genetics
Randomized Controlled Trials as Topic
Receptor Protein-Tyrosine Kinases / antagonists & inhibitors,  genetics*
Receptor, Epidermal Growth Factor / antagonists & inhibitors,  biosynthesis,  genetics*
Grant Support
Reg. No./Substance:
0/Oncogene Proteins, Fusion; EC protein, human; EC Protein-Tyrosine Kinases; EC, Epidermal Growth Factor; EC lymphoma kinase
Comment In:
J Mol Diagn. 2013 Jul;15(4):413-4   [PMID:  23791446 ]
Erratum In:
J Mol Diagn. 2013 Sep;15(5):730

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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