Abstract：
BACKGROUND: The survival of patients with lung cancer has substantially increased in the last decade by about 15%. This increase is, basically, due to targeted therapies available for advanced stages and the emergence of immunotherapy itself. This work aims to study the situation of biomarker testing in Spain.
METHODS: The Thoracic Tumours Registry (TTR) is an observational, prospective, registry-based study that included patients diagnosed with lung cancer and other thoracic tumours, from September 2016 to 2020. This TTR study was sponsored by the Spanish Lung Cancer Group (GECP) Foundation, an independent, scientific, multidisciplinary oncology society that coordinates more than 550 experts and 182 hospitals across the Spanish territory.
RESULTS: Nine thousand two hundred thirty-nine patients diagnosed with stage IV non-small cell lung cancer (NSCLC) between 2106 and 2020 were analysed. 7,467 (80.8%) were non-squamous and 1,772 (19.2%) were squamous. Tumour marker testing was performed in 85.0% of patients with non-squamous tumours vs 56.3% in those with squamous tumours (p-value < 0.001). The global testing of EGFR, ALK, and ROS1 was 78.9, 64.7, 35.6% respectively, in non-squamous histology. PDL1 was determined globally in the same period (46.9%), although if we focus on the last 3 years it exceeds 85%. There has been a significant increase in the last few years of all determinations and there are even close to 10% of molecular determinations that do not yet have targeted drug approval but will have it in the near future. 4,115 cases had a positive result (44.5%) for either EGFR, ALK, KRAS, BRAF, ROS1, or high PDL1.
CONCLUSIONS: Despite the lack of a national project and standard protocol in Spain that regulates the determination of biomarkers, the situation is similar to other European countries. Given the growing number of different determinations and their high positivity, national strategies are urgently needed to implement next-generation sequencing (NGS) in an integrated and cost-effective way in lung cancer.
METHODS: The Thoracic Tumours Registry (TTR) is an observational, prospective, registry-based study that included patients diagnosed with lung cancer and other thoracic tumours, from September 2016 to 2020. This TTR study was sponsored by the Spanish Lung Cancer Group (GECP) Foundation, an independent, scientific, multidisciplinary oncology society that coordinates more than 550 experts and 182 hospitals across the Spanish territory.
RESULTS: Nine thousand two hundred thirty-nine patients diagnosed with stage IV non-small cell lung cancer (NSCLC) between 2106 and 2020 were analysed. 7,467 (80.8%) were non-squamous and 1,772 (19.2%) were squamous. Tumour marker testing was performed in 85.0% of patients with non-squamous tumours vs 56.3% in those with squamous tumours (p-value < 0.001). The global testing of EGFR, ALK, and ROS1 was 78.9, 64.7, 35.6% respectively, in non-squamous histology. PDL1 was determined globally in the same period (46.9%), although if we focus on the last 3 years it exceeds 85%. There has been a significant increase in the last few years of all determinations and there are even close to 10% of molecular determinations that do not yet have targeted drug approval but will have it in the near future. 4,115 cases had a positive result (44.5%) for either EGFR, ALK, KRAS, BRAF, ROS1, or high PDL1.
CONCLUSIONS: Despite the lack of a national project and standard protocol in Spain that regulates the determination of biomarkers, the situation is similar to other European countries. Given the growing number of different determinations and their high positivity, national strategies are urgently needed to implement next-generation sequencing (NGS) in an integrated and cost-effective way in lung cancer.
摘要：
背景：肺癌患者的生存率在过去十年中大幅增加了约15％。这种增加是，基本上，由于晚期可用的靶向疗法和免疫疗法本身的出现。本文旨在研究西班牙生物标志物检测情况。
方法：胸部肿瘤登记（TTR）是一个观察性的，prospective,基于注册的研究，包括诊断为肺癌和其他胸部肿瘤的患者，从2016年9月到2020年。这项TTR研究由西班牙肺癌组织（GECP）基金会赞助，一个独立的,科学,多学科肿瘤学会，协调西班牙境内的550多名专家和182家医院。
结果：分析了在2106至2020年间诊断为IV期非小细胞肺癌（NSCLC）的9,000名患者。7,467（80.8％）是非鳞状细胞，1,772（19.2％）是鳞状细胞。85.0%的非鳞状肿瘤患者与56.3%的鳞状肿瘤患者进行肿瘤标志物检测(p值<0.001)。EGFR的全球检测，ALK,ROS1分别为78.9,64.7,35.6%,在非鳞状组织学。PDL1是在同一时期全球确定的(46.9%)，尽管如果我们专注于过去3年，它超过了85%。在过去的几年中，所有测定都有显着增加，甚至有接近10％的分子测定尚未获得靶向药物批准，但将在不久的将来获得批准。4,115例EGFR阳性结果（44.5%），ALK,KRAS,BRAF,ROS1或高PDL1。
结论：尽管西班牙缺乏规范生物标志物测定的国家项目和标准方案，情况与其他欧洲国家相似。考虑到越来越多的不同决定及其高度积极，迫切需要国家战略,以综合和经济有效的方式在肺癌中实施下一代测序(NGS).
方法：胸部肿瘤登记（TTR）是一个观察性的，prospective,基于注册的研究，包括诊断为肺癌和其他胸部肿瘤的患者，从2016年9月到2020年。这项TTR研究由西班牙肺癌组织（GECP）基金会赞助，一个独立的,科学,多学科肿瘤学会，协调西班牙境内的550多名专家和182家医院。
结果：分析了在2106至2020年间诊断为IV期非小细胞肺癌（NSCLC）的9,000名患者。7,467（80.8％）是非鳞状细胞，1,772（19.2％）是鳞状细胞。85.0%的非鳞状肿瘤患者与56.3%的鳞状肿瘤患者进行肿瘤标志物检测(p值<0.001)。EGFR的全球检测，ALK,ROS1分别为78.9,64.7,35.6%,在非鳞状组织学。PDL1是在同一时期全球确定的(46.9%)，尽管如果我们专注于过去3年，它超过了85%。在过去的几年中，所有测定都有显着增加，甚至有接近10％的分子测定尚未获得靶向药物批准，但将在不久的将来获得批准。4,115例EGFR阳性结果（44.5%），ALK,KRAS,BRAF,ROS1或高PDL1。
结论：尽管西班牙缺乏规范生物标志物测定的国家项目和标准方案，情况与其他欧洲国家相似。考虑到越来越多的不同决定及其高度积极，迫切需要国家战略,以综合和经济有效的方式在肺癌中实施下一代测序(NGS).
