title: ALK-Testing in non-small cell lung cancer (NSCLC): Immunohistochemistry (IHC) and/or fluorescence in-situ Hybridisation (FISH)?: Statement of the Germany Society for Pathology (DGP) and the Working Group Thoracic Oncology (AIO) of the German Cancer Society e.V. (Stellungnahme der Deutschen Gesellschaft für Pathologie und der AG Thorakale Onkologie der Arbeitsgemeinschaft Onkologie/Deutsche Krebsgesellschaft e.V.).
abstract: The EML4-ALK pathway plays an important role in a significant subset of non-small cell lung cancer patients. Treatment options such as ALK tyrosine kinase inhibitors lead to improved progression free survival and overall survival. These therapeutic options are chosen on the basis of the identification of the underlying genetic signature of the EML-ALK translocation. Efficient and easily accessible testing tools are required to identify eligible patients in a timely fashion. While FISH techniques are commonly used to detect this translocation, the broad implementation of this type of ALK testing into routine diagnostics is not optimal due to technical, structural and financial reasons. Immunohistochemical techniques to screen for EML4-ALK translocations may therefore play an important role in the near future. This consensus paper provides recommendations for the test algorithm and quality of the respective test approaches, which are discussed in the light of the current literature.
authors.affiliation: Institut für Pathologie, Charité Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany. Electronic address: maximilian.von-laffert@charite.de.
authors.forename: M
authors.initials: M
authors.lastname: von Laffert
authors.affiliation: Institut für Pathologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 224, 69120 Heidelberg, Germany.
authors.forename: P
authors.initials: P
authors.lastname: Schirmacher
authors.affiliation: Institut für Pathologie, Universitätsklinikum Heidelberg, Im Neuenheimer Feld 224, 69120 Heidelberg, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Warth
authors.affiliation: Institut für Allgemeine Pathologie und Pathologische Anatomie der Technischen Universität München, Trogerstrasse 18, 81675 München, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Weichert
authors.affiliation: Institut für Pathologie, Uniklinik Köln, Kerpener Str. 62, 50937 Köln, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Büttner
authors.affiliation: Sektion Pneumologie Innenstadt und Thorakale Onkologie, Klinikum der Universität München und Lungentumorzentrum München, Ziemssenstraße 1, 80336 München, Germany.
authors.forename: R M
authors.initials: RM
authors.lastname: Huber
authors.affiliation: Klinik I für Innere Medizin Uniklinik Köln, Kerpener Str. 62, 50937 Köln, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Wolf
authors.affiliation: Klinik für Hämatologie und Onkologie, Universitätsklinik Innere Medizin-Onkologie, Pius-Hospital Oldenburg, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Griesinger
authors.affiliation: Institut für Pathologie, Charité Universitätsmedizin, Charitéplatz 1, 10117 Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Dietel
authors.affiliation: Klinik für Pneumologie, Evangelische Lungenklinik Berlin, Lindenberger Weg 27, 13125 Berlin, Germany. Electronic address: Christian.Grohe@pgdiakonie.de.
authors.forename: Ch
authors.initials: C
authors.lastname: Grohé
mesh_terms: D000465:Algorithms; D000077548:Anaplastic Lymphoma Kinase; D002289:Carcinoma, Non-Small-Cell Lung / Q000235:genetics* / Q000473:pathology / Q000628:therapy; D000077547:Crizotinib; D018450:Disease Progression; D015321:Gene Rearrangement; D005858:Germany; D006801:Humans; D007150:Immunohistochemistry / Q000379:methods*; D017404:In Situ Hybridization, Fluorescence / Q000379:methods*; D008175:Lung Neoplasms / Q000235:genetics* / Q000473:pathology / Q000628:therapy; D015514:Oncogene Proteins, Fusion / Q000235:genetics; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011720:Pyrazoles / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D020794:Receptor Protein-Tyrosine Kinases / Q000235:genetics*; D013534:Survival; D014178:Translocation, Genetic
chemical_list: C522504:EML4-ALK fusion protein, human; D015514:Oncogene Proteins, Fusion; D047428:Protein Kinase Inhibitors; D011720:Pyrazoles; D011725:Pyridines; D000077547:Crizotinib; C000626173:ALK protein, human; D000077548:Anaplastic Lymphoma Kinase; D020794:Receptor Protein-Tyrosine Kinases
keywords: ALK-Testing; Fluorescence in-situ hybridisation (FISH); Immunohistochemistry (IHC); Non-small cell lung cancer (NSCLC)