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, International Association for the Study of Lung Cancer, Association for Molecular Pathology, and American Society for Investigative Pathology |
| Keywords: | patient selection; cancer patient; consensus; evidence based practice; lung cancer; practice guideline; protein tyrosine kinase inhibitor; cancer genetics; lung adenocarcinoma; systematic review; pathologist; molecular pathology; molecularly targeted therapy; next generation sequencing; human; article |
| Journal Title: | Journal of Molecular Diagnostics |
| Volume: | 20 |
| Issue: | 2 |
| ISSN: | 1525-1578 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2018-03-01 |
| Start Page: | 129 |
| End Page: | 159 |
| Language: | English |
| DOI: | 10.1016/j.jmoldx.2017.11.004 |
| PROVIDER: | scopus |
| PUBMED: | 29398453 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 April 2018 -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work