Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors

By N. Lindeman, P. Cagle, M. Beasley, D. Chitale, S. Dacic, G. Giaccone, R. Jenkins, D. Kwiatkowski, J. Saldivar, J. Squire and 2 more. Archives of Pathology & Laboratory Medicine, 2013

1,308 citations recorded by the source corpus.

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 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.

Subfields: Oncology, Pulmonary and Respiratory Medicine

View Paper: https://www.semanticscholar.org/paper/5e5418542bb7426e50dd1f6ca0620f6a281ec400

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Citations in the corpus

Translating RNA sequencing into clinical diagnostics: opportunities and challenges (2016, neutral): “Recent clinical guidelines recommend against using qRT-PCR-based ALK fusion detection for treatment selection in lung cancer owing to the challenges of RNA sample quality in routine formalin-fixed paraffin-embedded (FFPE) pathology samples, as well as the risk of false negatives resulting from limit”
A Prospective, Molecular Epidemiology Study of EGFR Mutations in Asian Patients with Advanced Non–Small-Cell Lung Cancer of Adenocarcinoma Histology (PIONEER) (2014, background): “Indeed, recent molecular testing guidelines copublished by three societies recommended the use of EGFR mutation testing to guide patient selection for therapy with an EGFR inhibitor, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk ”
Management of acquired resistance to EGFR TKI–targeted therapy in advanced non-small cell lung cancer (2018, neutral): “5% mutant allele fraction) in clinical practice [50].”