TY - JOUR
T1 - Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors
T2 - Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology
AU - Lindeman, Neal I.
AU - Cagle, Philip T.
AU - Aisner, Dara L.
AU - Arcila, Maria E.
AU - Beasley, Mary Beth
AU - Bernicker, Eric
AU - Colasacco, Carol
AU - Dacic, Sanja
AU - Hirsch, Fred R.
AU - Kerr, Keith
AU - Kwiatkowski, David J.
AU - Ladanyi, Marc
AU - Nowak, Jan A.
AU - Sholl, Lynette
AU - Temple-Smolkin, Robyn
AU - Solomon, Benjamin
AU - Souter, Lesley H.
AU - Thunnissen, Erik
AU - Tsao, Ming S.
AU - Ventura, Christina B.
AU - Wynes, Murry W.
AU - Yatabe, Yasushi
N1 - Funding Information:
∗ Name Interest/Activity Type Entity Dara L. Aisner, MD, PhD Consulting/advisory fees Oxford Oncology Fred R. Hirsch, MD, PhD Advisory board Pfizer AstraZeneca Consulting/advisory fees Novartis Research grants Lilly/Imclone Celgene Research grants, advisory board Bristol-Myers Squibb Research grants, consulting/advisory fees Amgen Roche/Genentech Keith Kerr, MB, ChB Advisory board, consulting/advisory fees Roche/Genentech Speaker fees/honoraria Eli Lilly David J. Kwiatkowski, MD, PhD Consulting/advisory fees Astra-Zeneca Marc Ladanyi, MD Consulting/advisory fees NCCN/Boehringer-Ingelheim Afatinib Targeted Therapy Advisory Committee Stock options/bonds Foundation Medicine Research grants LOXO Pharmaceuticals Lynette Sholl, MD Research grants, consulting/advisory fees Roche/Genentech Benjamin Solomon, MBBS, PhD Advisory board Bristol-Myers Squibb Roche/Genentech Ming S. Tsao, MD Research grants, consulting/advisory fees Pfizer Canada AstraZeneca Merck Canada Consulting/advisory fees Ventana/Hoffmann La Roche Erik Thunnissen, MD, PhD Research grants Pfizer The following disclosures are provided but were determined to represent no financial conflict of interest: Dara L. Aisner, MD, PhD Speaker fees/honoraria Clovis Oncology AstraZeneca Consulting/advisory fees Casdin Capital Maria E. Arcila, MD Speaker fees/honoraria Raindance Technologies Mary Beth Beasley, MD Consulting/advisory fees Roche/Genentech Eric Bernicker, MD Speaker fees/honoraria Myriad Genetics Consulting/advisory fees Foundation Medicine Philip T. Cagle, MD Position of influence Editor in chief, Archives of Pathology & Laboratory Medicine Research funding Roche Fred R. Hirsch, MD, PhD Consulting/advisory fees Bristol-Myers Squibb Merck Sharp Dohme HTG Molecular Pfizer Eli Lilly Roche AstraZeneca Boehringer Ingelheim Position of influence Chief executive officer, IASLC, 2013–current Keith Kerr, MB, ChB Speaker fees/honoraria Boehringer Ingelheim Pfizer Eli Lilly Consulting/advisory fees Pfizer Boehringer Ingelheim Consulting/advisory fees, speaker fees/honoraria Roche AstraZeneca Novartis Position of influence Board member, IASLC Member, Scottish NHS Molecular Pathology Evaluation Panel David J. Kwiatkowski, MD, PhD Consulting/advisory fees Novartis Jan A. Nowak, MD, PhD Employment Chief medical officer, OmniSeq, LLC Position of influence CAP Center Committee, Pathology and Laboratory Quality Center, 2009–2015 Council on Governmental and Professional Affairs—PHC Working Group, 2012–2016 PHC Archives of Pathology & Laboratory Medicine , associate editor for clinical pathology, 2012–current CAP Guideline Metrics Expert Panel, member, 2014–current AMA CPT Editorial Panel member (American Hospital Association) 2015–current AMA CPT MPAG 2015–current AMP Economic Affairs Committee 2009–current (cochair 2013–2014) Pathology Coding Caucus–AMP representative 2005–2008; 2013–2015 Lynette Sholl, MD Consulting/advisory fees Eli Lilly Benjamin Solomon, MBBS, PhD Royalties University of Colorado for (Veristrat) Biodesix Consulting/advisory fees Merck Sharp Dohme Roche Consulting/advisory fees, speaker fees/honoraria Bristol-Myers Squibb AstraZeneca Speaker fees/honoraria Pfizer Erik Thunnissen, MD, PhD Speaker fees/honoraria Pfizer Consulting/advisory fees Merck Sharp Dohme Clovis Oncology Bristol-Myers Squibb Research grants Pfizer Ming S. Tsao, MD Consulting/advisory fees Boehringer Ingelheim Canada Bristol-Myers Squibb Position of Influence Member, Advisory Committee on Research, Canadian Cancer Society Research Institute Cochair, Correlative Science and Tumor Biology Committee, Canadian Cancer Trials Group Yasushi Yatabe, MD, PhD Speaker fees/honoraria AstraZeneca Pfizer Chugai-pharm Yakuruto-pharm Novartis Roche Merck Sharp Dohme AMA, American Medical Association; AMP, Association for Molecular Pathology; CAP, College of American Pathologists; CPT, Current Procedural Terminology; IASLC, International Association for the Study of Lung Cancer; MPAG, Molecular Pathology Advisory Group; PHC, Personalized Healthcare Committee. ∗ Carol Colasacco, MLIS, SCT(ASCP), Sanja Dacic, MD, PhD, Neal I. Lindeman, MD, PhD, Lesley H. Souter, PhD, Robyn Temple-Smolkin, PhD, Christina B. Ventura, MPH, MT(ASCP), and Murry W. Wynes, PhD have no reported conflicts of interest to disclose.
Publisher Copyright:
© 2018 College of American Pathologists, International Association for the Study of Lung Cancer, Association for Molecular Pathology, and American Society for Investigative Pathology
PY - 2018/3
Y1 - 2018/3
N2 - 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.
AB - 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.
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U2 - 10.1016/j.jmoldx.2017.11.004
DO - 10.1016/j.jmoldx.2017.11.004
M3 - Article
C2 - 29398453
AN - SCOPUS:85041563833
SN - 1525-1578
VL - 20
SP - 129
EP - 159
JO - Journal of Molecular Diagnostics
JF - Journal of Molecular Diagnostics
IS - 2
ER -