欧洲胸科病理实验室对非小细胞肺癌进行的EGFR测试实践情况
Real-world EGFR testing practices for non-small-cell lung cancer by thoracic pathology laboratories across Europe.
发表日期:2023 Sep 13
作者:
P Hofman, F Calabrese, I Kern, J Adam, A Alarcão, I Alborelli, N T 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 Cayre, L Chalabreysse, M P Chenard, E Conde, M C Copin, J F Côté, N D'Haene, H Y Dai, L de Leval, P Delongova, M Denčić-Fekete, A Fabre, F Ferenc, F Forest, F de Fraipont, M Garcia-Martos, G Gauchotte, R Geraghty, E Guerin, D Guerrero, S Hernandez, P Hurník, B Jean-Jacques, K Kashofer, D Kazdal, S Lantuejoul, C Leonce, A Lupo, U Malapelle, R Matej, J L Merlin, K D Mertz, A Morel, A Mutka, N Normanno, P Ovidiu, A Panizo, M G Papotti, E Parobkova, G Pasello, P Pauwels, G Pelosi, F Penault-Llorca, T Picot, N Piton, A Pittaro, G Planchard, N Poté, T Radonic, I Rapa, A Rappa, C Roma, M Rot, J C Sabourin, I Salmon, S Savic Prince, A Scarpa, E Schuuring, I Serre, V Siozopoulou, D Sizaret, S Smojver-Ježek, J Solassol, K Steinestel, J Stojšić, C Syrykh, S Timofeev, G Troncone, A Uguen, S Valmary-Degano, A Vigier, M Volante, S G F Wahl, A Stenzinger, M Ilié
来源:
ESMO Open
摘要:
在转移性非鳞状非小细胞肺癌指南中,检测表皮生长因子受体(EGFR)突变是一个基本的建议,在欧洲国家被视为强制性要求。然而,在实践中,常常面临着进行常规生物标志物测试的挑战,包括获取测试的机会、样本不足和长时间的周转周期(TATs)。为了评估欧洲病理学实验室在现实世界中的EGFR测试实践,由欧洲病理学学会肺部病理学工作组设置了一个在线调查,并向64个专业测试实验室分发,并进行了验证。这项回顾性调查关注了2018年至2021年间病理学家和分子生物学家在实验室组织和日常EGFR测试实践方面的情况。TAT在和在国家内部都存在很大的差异。这些差异可能部分归因于反射性测试实践,因为20.8%的实验室仅在临床医生要求时进行EGFR测试。整个欧洲的许多实验室仍然倾向于将单一测试测序作为EGFR突变鉴定的首选方法;32.7%的实验室表示他们仅使用定向技术,45.1%的实验室使用单基因测试后跟下一代测序(NGS),具体取决于情况。报道的测试率随时间变化保持一致,在2020年并没有明显减少EGFR测试的数量,尽管在COVID-19大流行期间测试机构面临了增加的压力。 ISO 15189认可机构有42.0%的分子生物学实验室进行单一测试测序,42.3%进行NGS认证。92.5%的实验室表示他们定期参与外部质量评估方案。这些结果突显了欧洲胸部病理学和分子生物学实验室在EGFR测试中仍然存在着很强的异质性。即使在专业测试机构中,测试能力、TAT、反射测试实践和实验室认证也存在差异,强调了在欧洲需要协调报销技术和决策算法的必要性。2023年版权所有。由Elsevier Ltd.发表。版权所有。
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.Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.