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

311 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 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. Evidence: Three unbiased literature searches of electronic databases were performed to capture published articles 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)415-453
Number of pages39
JournalJournal of Molecular Diagnostics
Volume15
Issue number4
DOIs
StatePublished - Jul 2013

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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

  • Molecular Medicine
  • Pathology and Forensic Medicine

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: Journal of Molecular Diagnostics, Vol. 15, No. 4, 07.2013, p. 415-453.

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: Journal of Molecular Diagnostics. 2013 ; Vol. 15, No. 4. pp. 415-453.
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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

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