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
To establish evidence-based recommendations for the molecular analysis of lung cancers that are 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. Three cochairs without conflicts of inter...
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| Published in | Journal of thoracic oncology Vol. 8; no. 7; pp. 823 - 859 |
|---|---|
| Main Authors | , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Elsevier Inc
01.07.2013
International Association for the Study of Lung Cancer |
| Subjects | |
| Online Access | Get full text |
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| Abstract | To establish evidence-based recommendations for the molecular analysis of lung cancers that are 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.
Three cochairs without conflicts of interest were selected, one from each 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.
Three unbiased literature searches of electronic databases were performed to capture articles published 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.
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).
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. |
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| AbstractList | OBJECTIVE:To establish evidence-based recommendations for the molecular analysis of lung cancers that are 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 from each of the 3 sponsoring professional societiesCollege 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 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. To establish evidence-based recommendations for the molecular analysis of lung cancers that are 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.OBJECTIVETo establish evidence-based recommendations for the molecular analysis of lung cancers that are 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.Three cochairs without conflicts of interest were selected, one from each 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.PARTICIPANTSThree cochairs without conflicts of interest were selected, one from each 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.Three unbiased literature searches of electronic databases were performed to capture articles published 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.EVIDENCEThree unbiased literature searches of electronic databases were performed to capture articles published 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.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).CONSENSUS PROCESSInitial 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).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.CONCLUSIONSThe 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. To establish evidence-based recommendations for the molecular analysis of lung cancers that are 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. Three cochairs without conflicts of interest were selected, one from each 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. Three unbiased literature searches of electronic databases were performed to capture articles published 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. 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). 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 | Jenkins, Robert Brian Kwiatkowski, David J. Thunnissen, Erik Dacic, Sanja Giaccone, Giuseppe Cagle, Philip T. Squire, Jeremy Ladanyi, Marc Saldivar, Juan-Sebastian Beasley, Mary Beth Chitale, Dhananjay Arun Lindeman, Neal I. |
| AuthorAffiliation | From the Departments of Pathology (Dr Lindeman) and Medicine (Dr Kwiatkowski), Brigham & Women’s Hospital, Boston, Massachusetts; the Department of Pathology and Genomic Medicine, The Methodist Hospital, Houston, Texas (Dr Cagle); the Department of Pathology, Mt Sinai Medical Center, New York, New York (Dr Beasley); the Department of Pathology, Henry Ford Hospital, Detroit, Michigan (Dr Chitale); the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Dacic); the Medical Oncology Branch, National Institutes of Health, Bethesda, Maryland (Dr Giaccone); the Department of Laboratory Medicine and Pathology, Department of Laboratory Genetics, Mayo Clinic, Rochester, Minnesota (Dr Jenkins); the Department of Pathology, City of Hope National Medical Center, Duarte, California (Dr Saldivar); the Department of Pathology and Molecular Medicine, Kingston General Hospital, Queen’s University, Kingston, Ontario, Canada (Dr Squire); the Department of Pathol |
| AuthorAffiliation_xml | – name: From the Departments of Pathology (Dr Lindeman) and Medicine (Dr Kwiatkowski), Brigham & Women’s Hospital, Boston, Massachusetts; the Department of Pathology and Genomic Medicine, The Methodist Hospital, Houston, Texas (Dr Cagle); the Department of Pathology, Mt Sinai Medical Center, New York, New York (Dr Beasley); the Department of Pathology, Henry Ford Hospital, Detroit, Michigan (Dr Chitale); the Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (Dr Dacic); the Medical Oncology Branch, National Institutes of Health, Bethesda, Maryland (Dr Giaccone); the Department of Laboratory Medicine and Pathology, Department of Laboratory Genetics, Mayo Clinic, Rochester, Minnesota (Dr Jenkins); the Department of Pathology, City of Hope National Medical Center, Duarte, California (Dr Saldivar); the Department of Pathology and Molecular Medicine, Kingston General Hospital, Queen’s University, Kingston, Ontario, Canada (Dr Squire); the Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands (Dr Thunnissen); and the Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York (Dr Ladanyi) |
| Author_xml | – sequence: 1 givenname: Neal I. surname: Lindeman fullname: Lindeman, Neal I. email: nlindeman@partners.org organization: Departments of Pathology, Brigham & Women's Hospital, Boston, Massachusetts – sequence: 2 givenname: Philip T. surname: Cagle fullname: Cagle, Philip T. organization: Department of Pathology and Genomic Medicine, The Methodist Hospital, Houston, Texas – sequence: 3 givenname: Mary Beth surname: Beasley fullname: Beasley, Mary Beth organization: Department of Pathology, Mt Sinai Medical Center, New York, New York – sequence: 4 givenname: Dhananjay Arun surname: Chitale fullname: Chitale, Dhananjay Arun organization: Department of Pathology, Henry Ford Hospital, Detroit, Michigan – sequence: 5 givenname: Sanja surname: Dacic fullname: Dacic, Sanja organization: Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania – sequence: 6 givenname: Giuseppe surname: Giaccone fullname: Giaccone, Giuseppe organization: Medical Oncology Branch, National Institutes of Health, Bethesda, Maryland – sequence: 7 givenname: Robert Brian surname: Jenkins fullname: Jenkins, Robert Brian organization: Department of Laboratory Medicine and Pathology, Department of Laboratory Genetics, Mayo Clinic, Rochester, Minnesota – sequence: 8 givenname: David J. surname: Kwiatkowski fullname: Kwiatkowski, David J. organization: Departments of Medicine, Brigham & Women's Hospital, Boston, Massachusetts – sequence: 9 givenname: Juan-Sebastian surname: Saldivar fullname: Saldivar, Juan-Sebastian organization: Department of Pathology, City of Hope National Medical Center, Duarte, California – sequence: 10 givenname: Jeremy surname: Squire fullname: Squire, Jeremy organization: Department of Pathology and Molecular Medicine, Kingston General Hospital, Queen's University, Kingston, Ontario, Canada – sequence: 11 givenname: Erik surname: Thunnissen fullname: Thunnissen, Erik organization: Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands – sequence: 12 givenname: Marc surname: Ladanyi fullname: Ladanyi, Marc organization: Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23552377$$D View this record in MEDLINE/PubMed |
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| Snippet | To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed therapies,... OBJECTIVE:To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed... |
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| SubjectTerms | Anaplastic Lymphoma Kinase Biomarkers, Tumor - genetics ErbB Receptors - antagonists & inhibitors ErbB Receptors - genetics Evidence-Based Medicine Expert Testimony Gene Rearrangement Genetic Testing Humans International Agencies Lung Neoplasms - drug therapy Lung Neoplasms - genetics Lung Neoplasms - metabolism Mutation - genetics Patient Selection Protein Kinase Inhibitors - therapeutic use Receptor Protein-Tyrosine Kinases - antagonists & inhibitors Receptor Protein-Tyrosine Kinases - genetics Societies, Medical Systematic Reviews as Topic |
| 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 |
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