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

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

Research output: Contribution to journalArticle

285 Citations (Scopus)

Abstract

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 fromeach 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 articles published 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.

Original languageEnglish (US)
Pages (from-to)828-860
Number of pages33
JournalArchives of Pathology and Laboratory Medicine
Volume137
Issue number6
DOIs
StatePublished - Jun 2013

Fingerprint

Molecular Pathology
Epidermal Growth Factor Receptor
Protein-Tyrosine Kinases
Lung Neoplasms
Guidelines
Conflict of Interest
Oncogenes
Patient Selection
Consensus
Adenocarcinoma
Therapeutics
Randomized Controlled Trials
Smoking
History
Databases
Mutation
anaplastic lymphoma kinase
Pathologists

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

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. / Lindeman, Neal I.; Cagle, Philip T.; Beasley, Mary Beth; Chitale, Dhananjay Arun; Dacic, Sanja; Giaccone, Giuseppe; Jenkins, Robert Brian; Kwiatkowski, David J.; Saldivar, Juan Sebastian; Squire, Jeremy; Thunnissen, Erik; Ladanyi, Marc.

In: Archives of Pathology and Laboratory Medicine, Vol. 137, No. 6, 06.2013, p. 828-860.

Research output: Contribution to journalArticle

Lindeman, Neal I. ; Cagle, Philip T. ; Beasley, Mary Beth ; Chitale, Dhananjay Arun ; Dacic, Sanja ; Giaccone, Giuseppe ; Jenkins, Robert Brian ; Kwiatkowski, David J. ; Saldivar, Juan Sebastian ; Squire, Jeremy ; Thunnissen, Erik ; Ladanyi, Marc. / 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. In: Archives of Pathology and Laboratory Medicine. 2013 ; Vol. 137, No. 6. pp. 828-860.
@article{7647dd601c93463ba13f3f7d06108fc7,
title = "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",
abstract = "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 fromeach 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 articles published 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.",
author = "Lindeman, {Neal I.} and Cagle, {Philip T.} and Beasley, {Mary Beth} and Chitale, {Dhananjay Arun} and Sanja Dacic and Giuseppe Giaccone and Jenkins, {Robert Brian} and Kwiatkowski, {David J.} and Saldivar, {Juan Sebastian} and Jeremy Squire and Erik Thunnissen and Marc Ladanyi",
year = "2013",
month = "6",
doi = "10.5858/arpa.2012-0720-OA",
language = "English (US)",
volume = "137",
pages = "828--860",
journal = "Archives of Pathology and Laboratory Medicine",
issn = "0003-9985",
publisher = "College of American Pathologists",
number = "6",

}

TY - JOUR

T1 - Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors

T2 - Guideline from the College of American Pathologists, International Association for the study of lung cancer, and Association for Molecular Pathology

AU - Lindeman, Neal I.

AU - Cagle, Philip T.

AU - Beasley, Mary Beth

AU - Chitale, Dhananjay Arun

AU - Dacic, Sanja

AU - Giaccone, Giuseppe

AU - Jenkins, Robert Brian

AU - Kwiatkowski, David J.

AU - Saldivar, Juan Sebastian

AU - Squire, Jeremy

AU - Thunnissen, Erik

AU - Ladanyi, Marc

PY - 2013/6

Y1 - 2013/6

N2 - 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 fromeach 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 articles published 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.

AB - 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 fromeach 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 articles published 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.

UR - http://www.scopus.com/inward/record.url?scp=84879635389&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84879635389&partnerID=8YFLogxK

U2 - 10.5858/arpa.2012-0720-OA

DO - 10.5858/arpa.2012-0720-OA

M3 - Article

C2 - 23551194

AN - SCOPUS:84879635389

VL - 137

SP - 828

EP - 860

JO - Archives of Pathology and Laboratory Medicine

JF - Archives of Pathology and Laboratory Medicine

SN - 0003-9985

IS - 6

ER -