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Review
EGFR fluorescence in situ hybridisation assay: guidelines for application to non-small-cell lung cancer
  1. M Varella-Garcia1,
  2. J Diebold2,
  3. D A Eberhard3,
  4. K Geenen4,
  5. A Hirschmann2,
  6. M Kockx4,
  7. I Nagelmeier5,
  8. J Rüschoff5,
  9. M Schmitt5,
  10. S Arbogast6,
  11. F Cappuzzo7
  1. 1
    University of Colorado Cancer Center, Aurora, Colorado, USA
  2. 2
    Luzerner Kantonsspital, Luzern, Switzerland
  3. 3
    Independent Consultant, San Francisco, USA
  4. 4
    Histogenex, Antwerp, Belgium
  5. 5
    Targos GmbH, Kassel, Germany
  6. 6
    Roche, Penzberg, Germany
  7. 7
    Istituto Clinico Humanitas, Milano, Italy
  1. Correspondence to M Varella-Garcia, University of Colorado Cancer Center, Aurora, CO 80045, USA; marileila.garcia{at}ucdenver.edu

Abstract

There is a need for predictive biomarkers that identify non-small-cell lung cancer (NSCLC) patients most likely to respond to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) treatment. There are numerous potential candidates, although none has been proven in prospective clinical trials. The EGFR gene copy number evaluated by fluorescence in situ hybridisation (FISH) has been highlighted as one of the most effective markers for sensitivity to EGFR TKIs in large phase III, randomised placebo-controlled trials and has been used in clinical settings to assist physicians in defining the therapeutic regimen. The EGFR FISH assay has technical challenges and it is critical that detailed guidelines are provided to help clinical laboratories in performing and interpreting the test. Excellent assay reproducibility and portability rates among laboratories are crucial to guarantee that accurate clinical decisions can be made for patients with NSCLC. This article discusses the consensus outcomes of a global workshop convened to discuss key technical issues and standardise reading strategies for the EGFR FISH assay of NSCLC tumour tissue.

https://doi.org/10.1136/jcp.2009.066548

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    Footnotes

    • Funding The global EGFR FISH workshop was sponsored by F Hoffmann-La Roche Ltd, Genentech, Inc, and OSI Pharmaceuticals, Inc, who also provided third-party medical writing support (Huzefa Photowala, PhD, of Gardiner-Caldwell Communications).

    • Competing interests Conflicts of interest for Dr Varella-Garcia: (1) co-inventor in the US 2008/0090233 A1 patent for “Methods for prediction of clinical outcome to epidermal growth factor receptor inhibitors by cancer”; (2) Honorarium <US$10 000, Abbott Molecular. All other authors: no competing interests to declare.

    • Provenance and peer review Not commissioned; externally peer reviewed.