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Updated: Apr 21, 2026
Author Spotlight: Advancements in Molecular Biomarker Testing for Non-Squamous Non-Small Cell Lung Cancer
Published on: September 8, 2023
Assessment of ALK status by FISH on 1000 Spanish non-small cell lung cancer patients
Joana Vidal1, Sergi Clavé, Silvia de Muga
1*Servei d'Oncologia Mèdica, Hospital del Mar, Barcelona, Spain; †Laboratori de Citogenètica Molecular, Department de Patologia, Hospital del Mar, Barcelona, Spain; ‡Cancer Research Program, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain; §Departament de Ciències Experimentals i de la Salut, Universitat Pompeu Fabra, Barcelona, Spain; ‖Department de Patologia, Hospital del Mar, Barcelona, Spain; ¶Medical Oncology Department, Hospital de Mataró, Barcelona, Spain; #Medical Oncology Service, iCMHO, Hospital Clinic Barcelona, Barcelona, Spain; **Pathology Department, Hospital Lluís Alcanyís, Xàtiva, Spain; ††Medical Oncology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; ‡‡Medical Oncology Department, Institut Català d'Oncologia (ICO), Hospital Universitari Dr. Josep Trueta, Girona, Spain; §§Department of Medical Sciences, University of Girona, Spain; ‖‖Pathology Department, Complejo Asistencial de Leon, Castilla y Leon, Spain; and ¶¶Medical Oncology Department, Institut Català d'Oncologia (ICO), Hospitalet de Llobregat, Barcelona, Spain.
Introduction:
Patients with non-small cell lung cancer (NSCLC) harboring anaplastic lymphoma kinase (ALK) rearrangement selectively respond to ALK inhibitors. Thus, identification of ALK rearrangements has become a standard diagnostic test in advanced NSCLC patients. Our institution has been a referral center in Spain for ALK determination by Fluorescent in situ hybridization (FISH). The aim of our study was to assess the feasibility and the FISH patterns of the ALK gene and to evaluate the clinical and pathological features of patients with ALK alterations.
Methods:
Between 2010 and 2014, 1092 samples were evaluated for ALK using FISH technique (927 histological samples, 165 cytological samples). Correlation with available clinical-pathological information was assessed.
Results:
ALK rearrangement was found in 35 patients (3.2%). Cytological samples (using either direct smears or cell blocks), were more frequently non-assessable than histological samples (69% versus 89%, respectively) (p < 0.001). Within the ALK-rearranged cases the majority were female, non-smokers, and stage IV.
Conclusions:
Although assessable in cytological samples, biopsies are preferred when available for ALK evaluation by FISH. The ALK translocation prevalence and the associated clinico-pathological features in Spanish NSCLC patients are similar to those previously reported.
Insights
Anaplastic lymphoma kinase (ALK) rearrangement testing is crucial for non-small cell lung cancer (NSCLC) treatment. Fluorescent in situ hybridization (FISH) is feasible, but histological samples are preferred over cytological ones for ALK evaluation.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Anaplastic lymphoma kinase (ALK) rearrangements are key biomarkers in non-small cell lung cancer (NSCLC), predicting response to targeted therapies.
- ALK testing is a standard diagnostic procedure for advanced NSCLC patients.
- Fluorescent in situ hybridization (FISH) is a primary method for ALK rearrangement detection.
Purpose of the Study:
- To evaluate the feasibility and FISH patterns of ALK gene analysis in NSCLC patients.
- To assess the clinical and pathological features associated with ALK alterations.
- To determine the prevalence of ALK rearrangements in a Spanish NSCLC cohort.
Main Methods:
- Analysis of 1092 NSCLC samples (927 histological, 165 cytological) for ALK rearrangement using FISH between 2010 and 2014.
- Correlation of ALK status with available clinical-pathological data.
- Assessment of sample assessability based on tissue type.
Main Results:
- ALK rearrangement was identified in 3.2% (35/1092) of NSCLC patients.
- Cytological samples showed higher non-assessability rates (69%) compared to histological samples (89%).
- ALK-rearranged NSCLC cases predominantly occurred in females, non-smokers, and patients with stage IV disease.
Conclusions:
- Histological biopsies are recommended over cytological samples for reliable ALK FISH evaluation.
- The prevalence of ALK translocations and associated features in Spanish NSCLC patients align with international findings.
- FISH remains a valuable tool for identifying ALK alterations in NSCLC for targeted therapy selection.
