Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
External Quality Asessment (GCP) of the Spanish Society of Pathology (SEAP), Madrid, Spain.
J Clin Pathol. 2022 Mar;75(3):193-200. doi: 10.1136/jclinpath-2020-207280. Epub 2021 Mar 15.
The aim of this study was to describe the testing rate and frequency of molecular alterations observed in the Lung Cancer Biomarker Testing Registry (LungPath).
A descriptive study of NSCLC biomarker determinations collected from March 2018 to January 2019, from 38 Spanish hospitals, was carried out. Only adenocarcinoma and not otherwise specified histologies were included for epidermal growth factor receptor (), anaplastic lymphoma kinase (), c-ros oncogene 1 () and programmed death ligand-1 (PD-L1) expression. The testing rate and the positivity rate were calculated. Multivariate logistic regression was used to explore the joint relationship between independent explanatory factors and both testing and positivity rates. Two models were adjusted: one with sample type and histology as independent factors, and the other adding the testing rate or the positivity rate of the other biomarkers.
3226 patient samples were analysed, where , , and PD-L1 information was collected (a total of 12 904 determinations). Overall, 9118 (71.4%) determinations were finally assessed. (91.4%) and (80.1%) were the mainly tested biomarkers. Positivity rates for , , and PD-L1 were 13.6%, 3.4%, 2.0% and 49.2%, respectively. Multivariate models showed a lower testing rate for ALK in surgical pieces, fine-needle aspiration or other types of samples versus biopsies.
Despite the high testing rate in EGFR and ALK in NSCLC, the real-world evidence obtained from the LungPath demonstrates that ROS1 and PD-L1 were not determined in a significant portion of patients. LungPath provides crucial information to improve the coverage in molecular testing in lung cancer, to monitor the positivity rate and the introduction of new biomarker testing in clinical practice.
本研究旨在描述肺癌生物标志物检测登记处（LungPath）中观察到的分子改变的检测率和频率。
对 2018 年 3 月至 2019 年 1 月来自 38 家西班牙医院的非小细胞肺癌生物标志物测定进行了描述性研究。仅纳入腺癌和其他未特指组织学的表皮生长因子受体（）、间变性淋巴瘤激酶（）、c-ros 癌基因 1（）和程序性死亡配体-1（PD-L1）表达。计算了检测率和阳性率。多变量逻辑回归用于探讨独立解释因素与检测率和阳性率之间的联合关系。建立了两个模型：一个以样本类型和组织学为独立因素，另一个加入其他生物标志物的检测率或阳性率。
分析了 3226 例患者样本，其中收集了关于、、和 PD-L1 的信息（共进行了 12904 次测定）。总体而言，最终评估了 9118 次测定（91.4%）。（91.4%）和（80.1%）是主要检测的生物标志物。、、和 PD-L1 的阳性率分别为 13.6%、3.4%、2.0%和 49.2%。多变量模型显示，手术标本、细针抽吸或其他类型标本中 ALK 的检测率较低，而活检标本中 ALK 的检测率较高。
尽管非小细胞肺癌中 EGFR 和 ALK 的检测率较高，但 LungPath 获得的真实世界证据表明，ROS1 和 PD-L1 在很大一部分患者中并未得到确定。LungPath 提供了重要信息，可改善肺癌分子检测的覆盖范围，监测阳性率，并在临床实践中引入新的生物标志物检测。
