Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: Guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology Journal Article


Authors: Lindeman, N. I.; Cagle, P. T.; Aisner, D. L.; Arcila, M. E.; Beasley, M. B.; Bernicker, E. H.; Colasacco, C.; Dacic, S.; Hirsch, F. R.; Kerr, K.; Kwiatkowski, D. J.; Ladanyi, M.; Nowak, J. A.; Sholl, L.; Temple-Smolkin, R.; Solomon, B.; Souter, L. H.; Thunnissen, E.; Tsao, M. S.; Ventura, C. B.; Wynes, M. W.; Yatabe, Y.
Article Title: Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: Guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology
Abstract: Context: In 2013, an evidence-based guideline was published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology to set standards for the molecular analysis of lung cancers to guide treatment decisions with targeted inhibitors. New evidence has prompted an evaluation of additional laboratory technologies, targetable genes, patient populations, and tumor types for testing. Objective: To systematically review and update the 2013 guideline to affirm its validity; to assess the evidence of new genetic discoveries, technologies, and therapies; and to issue an evidence-based update. Design: The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology convened an expert panel to develop an evidence-based guideline to help define the key questions and literature search terms, review abstracts and full articles, and draft recommendations. Results: Eighteen new recommendations were drafted. The panel also updated 3 recommendations from the 2013 guideline. Conclusions: The 2013 guideline was largely reaffirmed with updated recommendations to allow testing of cytology samples, require improved assay sensitivity, and recommend against the use of immunohistochemistry for EGFR testing. Key new recommendations include ROS1 testing for all adenocarcinoma patients; the inclusion of additional genes (ERBB2, MET, BRAF, KRAS, and RET) for laboratories that perform next-generation sequencing panels; immunohistochemistry as an alternative to fluorescence in situ hybridization for ALK and/or ROS1 testing; use of 5% sensitivity assays for EGFR T790M mutations in patients with secondary resistance to EGFR inhibitors; and the use of cell-free DNA to “rule in” targetable mutations when tissue is limited or hard to obtain. © 2018 College of American Pathologists, American Society for Investigative Pathology, Association for Molecular Pathology, and the International Association for the Study of Lung Cancer
Keywords: immunohistochemistry; gene mutation; cancer recurrence; patient selection; cancer patient; sensitivity and specificity; quality control; cytology; gene; gene overexpression; consensus; gene amplification; epidermal growth factor receptor; epidermal growth factor receptor 2; evidence based practice; lung cancer; practice guideline; tumor marker; protein tyrosine kinase inhibitor; lung adenocarcinoma; fluorescence in situ hybridization; gene rearrangement; systematic review; immunomodulation; threonine; immunomodulating agent; egfr gene; oncogene k ras; k ras protein; health care organization; genetic screening; b raf kinase; methionine; predictive value; epidermal growth factor receptor kinase inhibitor; scatter factor receptor; braf gene; oncogene neu; randomized controlled trial (topic); molecular diagnosis; ret gene; met gene; next generation sequencing; alk gene; ros1 gene; human; priority journal; article
Journal Title: Journal of Thoracic Oncology
Volume: 13
Issue: 3
ISSN: 1556-0864
Publisher: Elsevier Inc.  
Date Published: 2018-03-01
Start Page: 323
End Page: 358
Language: English
DOI: 10.1016/j.jtho.2017.12.001
PROVIDER: scopus
PUBMED: 29396253
DOI/URL:
Notes: Article -- Export Date: 2 April 2018 -- Source: Scopus
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MSK Authors
  1. Marc Ladanyi
    971 Ladanyi
  2. Maria Eugenia Arcila
    414 Arcila
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