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Journal of Thoracic Oncology:
doi: 10.1097/JTO.0b013e318290868f
Special Article

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

Supplemental Author Material
Erratum

Erratum

A recently published article [Lindeman NI, Cagle PT, Beasley MB, et al. 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. J Thorac Oncol. 2013;8:823–859] contains an error in Table 4, EGFR Mutation Prevalence in Different Lung Adenocarcinoma Patient Populations, and in Supplemental Table 5, EGFR Mutation Prevalence in Different Lung Adenocarcinoma Patient Populations. These analyses failed to distinguish between European Spanish and Latin American (Hispanic) populations. Re-analysis of the 4 studies originally cited as providing data for Latin American (Hispanic) populations led to the re-categorization of 369 patients, with only 3 remaining Latin American (Hispanic) patients, which was too limited for meaningful analysis of this population. The re-categorization of the remaining 369 patients did not make a significant change in the data for the other patient populations as originally presented in Table 4 and in Supplemental Table 5.

Journal of Thoracic Oncology. 8(10):1343, October 2013.

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Abstract

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 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 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.

Copyright © 2013 by the International Association for the Study of Lung Cancer

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