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Real-world EGFR testing practices for non-small-cell lung cancer by thoracic pathology laboratories across Europe
P. Hofman, F. Calabrese, I. Kern, J. Adam, A. Alarcão, I. Alborelli, NT. Anton, A. Arndt, A. Avdalyan, M. Barberis, H. Bégueret, B. Bisig, H. Blons, P. Boström, L. Brcic, G. Bubanovic, A. Buisson, A. Caliò, M. Cannone, L. Carvalho, C. Caumont, A....
Language English Country England, Great Britain
Document type Journal Article, Research Support, Non-U.S. Gov't
NLK
Directory of Open Access Journals
from 2016
PubMed Central
from 2016
Europe PubMed Central
from 2016
Open Access Digital Library
from 2016-01-01
ROAD: Directory of Open Access Scholarly Resources
from 2016
- MeSH
- ErbB Receptors genetics MeSH
- Laboratories MeSH
- Humans MeSH
- Mutation MeSH
- Lung Neoplasms * diagnosis genetics pathology MeSH
- Carcinoma, Non-Small-Cell Lung * diagnosis genetics pathology MeSH
- Pandemics MeSH
- Retrospective Studies MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Geographicals
- Europe MeSH
BACKGROUND: Testing for epidermal growth factor receptor (EGFR) mutations is an essential recommendation in guidelines for metastatic non-squamous non-small-cell lung cancer, and is considered mandatory in European countries. However, in practice, challenges are often faced when carrying out routine biomarker testing, including access to testing, inadequate tissue samples and long turnaround times (TATs). MATERIALS AND METHODS: To evaluate the real-world EGFR testing practices of European pathology laboratories, an online survey was set up and validated by the Pulmonary Pathology Working Group of the European Society of Pathology and distributed to 64 expert testing laboratories. The retrospective survey focussed on laboratory organisation and daily EGFR testing practice of pathologists and molecular biologists between 2018 and 2021. RESULTS: TATs varied greatly both between and within countries. These discrepancies may be partly due to reflex testing practices, as 20.8% of laboratories carried out EGFR testing only at the request of the clinician. Many laboratories across Europe still favour single-test sequencing as a primary method of EGFR mutation identification; 32.7% indicated that they only used targeted techniques and 45.1% used single-gene testing followed by next-generation sequencing (NGS), depending on the case. Reported testing rates were consistent over time with no significant decrease in the number of EGFR tests carried out in 2020, despite the increased pressure faced by testing facilities during the COVID-19 pandemic. ISO 15189 accreditation was reported by 42.0% of molecular biology laboratories for single-test sequencing, and by 42.3% for NGS. 92.5% of laboratories indicated they regularly participate in an external quality assessment scheme. CONCLUSIONS: These results highlight the strong heterogeneity of EGFR testing that still occurs within thoracic pathology and molecular biology laboratories across Europe. Even among expert testing facilities there is variability in testing capabilities, TAT, reflex testing practice and laboratory accreditation, stressing the need to harmonise reimbursement technologies and decision-making algorithms in Europe.
Biomedical Research Centre Navarra Health Service Pamplona Navarra Spain
Cell Biology and Biotherapy Unit INT Fondazione Pascale Via M Semmola Naples Italy
Department of Biopathology Centre Léon Bérard Lyon France
Department of Biopathology CHRU ICL CHRU Nancy Vandoeuvre lès Nancy France
Department of Biopathology Jean Perrin Centre Clermont Ferrand France
Department of Cardiac Thoracic Vascular Sciences and Public Health University of Padova Padova Italy
Department of Genetics University Hospital Bichat Claude Bernard Paris University Paris France
Department of Oncology and Hemato Oncology University of Milan Milan Italy
Department of Oncology University of Turin San Luigi Hospital Orbassano Turin Italy
Department of Pathological Anatomy and Cytology CHRU de Brest Brest France
Department of Pathology and Molecular Medicine Thomayer University Hospital Prague Czech Republic
Department of Pathology CHRU Tours Hôpital Trousseau Chambray lès Tours France
Department of Pathology CHU de Caen Côte de Nacre Caen France
Department of Pathology Complejo Hospitalario de Navarra Pamplona Navarra Spain
Department of Pathology Erasme Hospital HUB ULB Brussels Belgium
Department of Pathology Gregorio Marañón General University Hospital Madrid Spain
Department of Pathology Groupe Hospitalier Paris Saint Joseph Paris France
Department of Pathology Groupement Hospitalier Est Bron France
Department of Pathology Hospital Bichat Bichat Assistance Publique Hôpitaux de Paris
Department of Pathology Institut Mutualiste Montsouris Paris France
Department of Pathology IUC T Oncopole Toulouse France
Department of Pathology St Olav's Hospital Trondheim University Hospital Trondheim Norway
Department of Pathology Turku University Hospital Turku Finland
Department of Pathology Université d'Angers Centre Hospitalier Universitaire d'Angers Angers France
Department of Pathology University Clinic Golnik Golnik Slovenia
Department of Pathology University Hospital Antwerp and University of Antwerp Antwerp Belgium
Department of Pathology University Hospital of Bordeaux Hôpital Haut Lévêque Pessac France
Department of Pathology University Hospital of Saint Etienne Saint Etienne France
Department of Pathology University Hospital of Strasbourg 67098 Strasbourg France
Department of Pathology University of Oradea Oradea Romania
Department of Public Health University of Naples Federico 2 Naples Italy
Department of Tumor Biology University Hospital of Bordeaux Hospital Haut Lévêque Pessac France
Diagnostic and Research Institute of Pathology Medical University of Graz Graz Austria
Division of Medical Oncology 2 Veneto Institute of Oncology IOV IRCCS Padova Italy
Division of Pathology University Hospital Città Della Salute Turin Italy
HUSLAB Department of Pathology Helsinki University Hospital Helsinki Finland
Institute for Pathology Medical Faculty Belgrade Serbia
Institute of Pathology Cantonal Hospital Baselland Liestal Switzerland
Institute of Pathology Heidelberg University Hospital Heidelberg Germany
LBAI UMR1227 INSERM University of Brest CHU de Brest Brest France
Medical Unit of Molecular Genetic Grenoble University Hospital Grenoble France
Multidisciplinary Clinical Center Kommunarka of the Moscow Health Department Moscow Russia
Oncogenomics Unit European Institute of Oncology Milan Italy
Pathology Unit San Luigi Hospital Orbassano Turin Italy
Translational Lung Research Center Heidelberg Heidelberg Germany
References provided by Crossref.org
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- $a BACKGROUND: Testing for epidermal growth factor receptor (EGFR) mutations is an essential recommendation in guidelines for metastatic non-squamous non-small-cell lung cancer, and is considered mandatory in European countries. However, in practice, challenges are often faced when carrying out routine biomarker testing, including access to testing, inadequate tissue samples and long turnaround times (TATs). MATERIALS AND METHODS: To evaluate the real-world EGFR testing practices of European pathology laboratories, an online survey was set up and validated by the Pulmonary Pathology Working Group of the European Society of Pathology and distributed to 64 expert testing laboratories. The retrospective survey focussed on laboratory organisation and daily EGFR testing practice of pathologists and molecular biologists between 2018 and 2021. RESULTS: TATs varied greatly both between and within countries. These discrepancies may be partly due to reflex testing practices, as 20.8% of laboratories carried out EGFR testing only at the request of the clinician. Many laboratories across Europe still favour single-test sequencing as a primary method of EGFR mutation identification; 32.7% indicated that they only used targeted techniques and 45.1% used single-gene testing followed by next-generation sequencing (NGS), depending on the case. Reported testing rates were consistent over time with no significant decrease in the number of EGFR tests carried out in 2020, despite the increased pressure faced by testing facilities during the COVID-19 pandemic. ISO 15189 accreditation was reported by 42.0% of molecular biology laboratories for single-test sequencing, and by 42.3% for NGS. 92.5% of laboratories indicated they regularly participate in an external quality assessment scheme. CONCLUSIONS: These results highlight the strong heterogeneity of EGFR testing that still occurs within thoracic pathology and molecular biology laboratories across Europe. Even among expert testing facilities there is variability in testing capabilities, TAT, reflex testing practice and laboratory accreditation, stressing the need to harmonise reimbursement technologies and decision-making algorithms in Europe.
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