Real-world EGFR testing practices for non-small-cell lung cancer by thoracic pathology laboratories across Europe
Paul Hofman, Fiorella Calabrese, Izidor Kern, Julien Adam, Ana Alarcão, Ilaria Alborelli, N.T. Anton, Annette Arndt, A. M Avdalyan, Massimo Barberis, Hugues Bégueret, Bettina Bisig, Hélène Blons, Pontus Boström, L. Brcic, Gordana Bubanović, A. Buisson, Anna Caliò, Maria Cannone, Lucas Resende de Carvalho, C. Caumont, Anne Cayre, L. Chalabreysse, Marie Pierre Chenard, Esther Conde, Marie‐Christine Copin, Jean‐François Côté, Nicky D’Haene, Hong Dai, Laurence de Leval, P. Delongova, Marija Denčić‐Fekete, Aurélie Fabre, F. Ferenc, Fabien Forest, Florence de Fraipont, M. Garcia-Martos, Guillaume Gauchotte, Robert Geraghty, Éric Guérin, D. Guerrero, Susana Hernández, Pavel Hurník, B. Jean-Jacques, Karl Kashofer, Daniel Kazdal, Sylvie Lantuéjoul, Camille Léonce, Antonio Lupo, Umberto Malapelle, Radoslav Matěj, Jean‐Louis Merlin, Kirsten D. Mertz, Alain Morel, Aino Mutka, Nicola Normanno, P. Ovidiu, Ángel Panizo, Mauro Papotti, Eva Parobková, Giulia Pasello, Patrick Pauwels, Giuseppe Pelosi, Frédérique Penault‐Llorca, Tiphanie Picot, Nicolas Piton, Alessandra Pittaro, G. Planchard, Nicolas Poté, Teodora Radonic, Ida Rapa, Alessandra Rappa, Cristin Roma, Mitja Rot, Jean‐Christophe Sabourin, Indra Pratama Putra Salmon, S. Savic Prince, Aldo Scarpa, Ed Schuuring, I. Serre, Vasiliki Siozopoulou, D. Sizaret, Silvana Smojver‐Ježek, Jérôme Solassol, Konrad Steinestel, Jelena Stojšić, C. Syrykh, Sergei Timofeev, Giancarlo Troncone, Arnaud Uguen, Séverine Valmary‐Degano, A. Vigier, Marco Volante, Sissel Gyrid Freim Wahl, Albrecht Stenzinger, Marius Ilié
Abstract
•Substantial heterogeneity exists in several aspects of EGFR mutation testing, including among expert testing facilities.•Targeted sequencing is commonly used in conjunction with or in place of NGS.•While the average TAT reported for EGFR mutation testing was 7-10 days, few laboratories reported TATs of up to 30 days. BackgroundTesting 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 methodsTo 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.ResultsTATs 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.ConclusionsThese 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. 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). 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. 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. 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.