Neal I Lindeman1, Philip T Cagle2, Dara L Aisner3, Maria E Arcila4, Mary Beth Beasley5, Eric H Bernicker6, Carol Colasacco7, Sanja Dacic8, Fred R Hirsch9, Keith Kerr10, David J Kwiatkowski11, Marc Ladanyi12, Jan A Nowak13, Lynette Sholl14, Robyn Temple-Smolkin15, Benjamin Solomon16, Lesley H Souter17, Erik Thunnissen18, Ming S Tsao19, Christina B Ventura7, Murry W Wynes20, Yasushi Yatabe21. 1. Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: nlindeman@partners.org. 2. Department of Pathology and Genomic Medicine, Houston Methodist Hospital, Houston, Texas. 3. Department of Pathology, University of Colorado School of Medicine, Denver, New York. 4. Diagnostic and Molecular Pathology Laboratory, Memorial Sloan Kettering Cancer Center, New York, New York. 5. Department of Pathology & Medicine, Pulmonary, Critical Care and Sleep Medicine, New York, New York. 6. Cancer Center, Houston Methodist Hospital, Houston, Texas. 7. Pathology and Laboratory Quality Center, College of American Pathologists, Northfield, Illinois. 8. Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania. 9. Department of Medicine and Pathology, University of Colorado, Denver, New York. 10. Department of Pathology, University of Aberdeen, Aberdeen, Scotland. 11. Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. 12. Molecular Diagnostics Service, Memorial Sloan Kettering Cancer Center, New York, New York. 13. Department of Molecular Pathology, Roswell Park Cancer Institute, Buffalo, New York. 14. Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts. 15. Clinical and Scientific Affairs Division, Association for Molecular Pathology, Bethesda, Maryland. 16. Molecular Therapeutics and Biomarkers Laboratory, Peter Maccallum Cancer Center, Melbourne, Australia. 17. Private Practice, Wellanport, Ontario, Canada. 18. Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands. 19. Department of Laboratory Medicine and Pathobiology, Princess Margaret Cancer Center, Toronto, Ontario, Canada. 20. Scientific Affairs, International Association for the Study of Lung Cancer, Aurora, Colorado. 21. Department of Pathology and Molecular Diagnostics, Aichi Cancer Center, Nagoya, Japan.
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.
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 adenocarcinomapatients; 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 EGFRT790M 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.
Authors: Charu Aggarwal; Christian D Rolfo; Geoffrey R Oxnard; Jhanelle E Gray; Lynette M Sholl; David R Gandara Journal: Nat Rev Clin Oncol Date: 2020-09-11 Impact factor: 66.675