Real-world biomarker testing rate and positivity rate in NSCLC in Spain: Prospective Central Lung Cancer Biomarker Testing Registry (LungPath) from the Spanish Society of Pathology (SEAP)

March 22, 2021

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Publicated to:Journal Of Clinical Pathology. 75 (3): 193-200 - 2022-03-01 75(3), DOI: 10.1136/jclinpath-2020-207280

Authors: Salas, C; Martin-Lopez, J; Martinez-Pozo, A; Rojo, F; Hernandez-Iglesias, T; Carcedo, D; de Alda, LR; Garcia, JF

Affiliations

Hosp Univ Puerta Hierro, Madrid, Spain - Author

Hospital Universitario Fundacion Jimenez Diaz - Author

Hospital Universitario Puerta de Hierro - Author

Hygeia Consulting S.A - Author

Hygeia Consulting SA, Barcelona, Spain - Author

IIS Fdn Jimenez Diaz Univ Hosp CIBERONC, Madrid, Spain - Author

Roche Farma S.A. - Author

Roche Farma SA, Madrid, Spain - Author

Spanish Soc Pathol SEAP, External Qual Asessment GCP, Madrid, Spain - Author

Spanish Soc Pathol SEAP, Qual Control Program, Madrid, Spain - Author

Spanish Society of Pathological Anatomy - Author

Univ Barcelona, Hosp Clin, Pathol Dept, IDIBAPS, Barcelona, Spain - Author

Universitat de Barcelona - Author

Abstract

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. Aim: 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). Methods: 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 (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1) 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. Results: 3226 patient samples were analysed, where EGFR, ALK, ROS1 and PD-L1 information was collected (a total of 12 904 determinations). Overall, 9118 (71.4%) determinations were finally assessed. EGFR (91.4%) and ALK (80.1%) were the mainly tested biomarkers. Positivity rates for EGFR, ALK, ROS1 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. Conclusions: 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.

Keywords

biomarkerscrizotinibegfrguidelineslung neoplasmsmedicinerearrangementstatisticstherapytumourBiomarkersLung neoplasmsMolecular biomarkersStatisticsTumour

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Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Journal Of Clinical Pathology due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position , thus managing to position itself as a Q1 (Primer Cuartil), in the category Pathology and Forensic Medicine.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 2.5. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

Weighted Average of Normalized Impact by the Scopus agency: 1.56 (source consulted: FECYT Feb 2024)
Field Citation Ratio (FCR) from Dimensions: 4.93 (source consulted: Dimensions Oct 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-10-16, the following number of citations:

WoS: 15
Scopus: 14
Europe PMC: 6

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