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ALK testing methods: is there a winner or loser?

Yuka Kozuma1,2, Gouji Toyokawa2, Takashi Seto1

  • 1a Department of Thoracic Oncology , National Kyushu Cancer Center , Fukuoka , Japan.

Expert Review of Anticancer Therapy
|December 22, 2018
PubMed
Abstract

Insights

Anaplastic lymphoma kinase (ALK) testing is crucial for non-small-cell lung cancer treatment. Immunohistochemistry (IHC) shows high accuracy for identifying patients who will benefit from ALK inhibitors.

Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Genetics

Background:

  • Anaplastic lymphoma kinase (ALK) is a key molecular target in non-small-cell lung cancer (NSCLC).
  • ALK inhibitors are standard care for patients with ALK gene rearrangements, necessitating accurate patient selection.
  • Effective patient stratification is vital for optimizing ALK inhibitor therapy outcomes.

Purpose of the Study:

  • To review current evidence on Anaplastic lymphoma kinase (ALK) testing methodologies for NSCLC.
  • To evaluate the diagnostic performance and clinical utility of different ALK detection methods.
  • To provide insights into patient selection for ALK inhibitor treatment.

Main Methods:

  • Review of evidence on ALK testing in NSCLC.
  • Comparison of Immunohistochemistry (IHC), Fluorescence In Situ Hybridization (FISH), and Reverse Transcription Polymerase Chain Reaction (RT-PCR).
  • Analysis of diagnostic accuracy, sensitivity, and specificity of IHC for ALK fusion detection.

Main Results:

  • Immunohistochemistry (IHC) demonstrates high sensitivity and specificity for detecting ALK fusions when properly performed.
  • Discrepancies between IHC and FISH exist, but IHC-positive/FISH-negative patients may still respond to alectinib.
  • ALK variants can influence prognosis and treatment efficacy, highlighting the potential role of RT-PCR.

Conclusions:

  • Immunohistochemistry (IHC) can serve as a standalone method for identifying patients eligible for ALK inhibitor therapy.
  • While FISH is a standard, IHC's performance supports its clinical use in ALK testing.
  • Reverse Transcription Polymerase Chain Reaction (RT-PCR) may become important for characterizing ALK variants and complementing other tests.
Keywords:
ALKFISHIHCRT-PCRnon-small-cell lung cancer

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