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)

AimThe aim of this study was to describe the testing rate and frequency of molecular alterations observed in the Lung Cancer Biomarker Testing Registry (LungPath).MethodsA 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.Results3226 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.ConclusionsDespite 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.

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EGFR testing and the CAP/IASLC/AMP lung cancer biomarker testing guidelines: knowledge gaps and future directions

Lung Cancer Management ◽

10.2217/lmt.15.4 ◽

2015 ◽

Vol 4 (2) ◽

pp. 87-95

Author(s):

Elena Vigliar ◽

Umberto Malapelle ◽

Claudio Bellevicine ◽

Giancarlo Troncone

Keyword(s):

Lung Cancer ◽

Cancer Biomarker ◽

Knowledge Gaps ◽

Future Directions ◽

Biomarker Testing ◽

Lung Cancer Biomarker

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Biomarker testing strategies in non-small cell lung cancer in the real-world setting: analysis of methods in the Prospective Central Lung Cancer Biomarker Registry (LungPath) from the Spanish Society of Pathology (SEAP)

Journal of Clinical Pathology ◽

10.1136/jclinpath-2021-208034 ◽

2021 ◽

pp. jclinpath-2021-208034

Author(s):

Javier Martín-López ◽

Federico Rojo ◽

Antonio Martínez-Pozo ◽

Teresa Hernández-Iglesias ◽

David Carcedo ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Real World ◽

Small Cell ◽

Small Cell Lung ◽

The Real ◽

Biomarker Testing ◽

Lung Cancer Biomarker

AimsThe aim of this study is to extend the analysis of the Lung Cancer Biomarker Testing Registry (LungPath), by analysing the techniques used in the determination of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1) and programmed death ligand-1 (PD-L1) for the diagnostic of patients with advanced non-small-cell lung cancer (NSCLC).MethodsInformation of the technique used for the determination of EGFR, ALK, ROS1 and PD-L1 was recorded from March 2018 to January 2019 from 44 centres, but only 34 centres matched with the 38 centres previously analysed, allowing to analyse the techniques used in 8970 matched determinations of EGFR, ALK, ROS1 and PD-L1. Therefore, a by-centre analysis studied the level of implementation of the techniques in the 44 centres, while a by-determination analysis made it possible to assess the overall frequency of the techniques used on the 9134 matched samples.ResultsBy-centre analysis showed that only 46.5% and 25.6% of the centres used reflex strategies for ALK and ROS1 determination, respectively. By-determination analysis showed that 94.4% of EGFR determinations were performed by PCR, 80.7% of ALK determinations were performed by IHC with clone D5F3, while 55.7% of ROS1 determinations were performed by IHC with clone D4D6. 22C3 were the PD-L1 clone more used (43.5%) followed by SP263 clone (31.1%).ConclusionsThe real-world evidence obtained from LungPath shows the effort of Spanish hospitals in performing biomarker determination in NSCLC with different methodologies despite that next-generation sequencing (NGS) utilisation in the year of the analysis was low. Biomarker determination results could be optimised with the incorporation of sequencing methods such as NGS in pathology departments.

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Comprehensive Genomic Profiling Facilitates Implementation of the National Comprehensive Cancer Network Guidelines for Lung Cancer Biomarker Testing and Identifies Patients Who May Benefit From Enrollment in Mechanism‐Driven Clinical Trials

The Oncologist ◽

10.1634/theoncologist.2016-0030 ◽

2016 ◽

Vol 21 (6) ◽

pp. 684-691 ◽

Cited By ~ 41

Author(s):

James H. Suh ◽

Adrienne Johnson ◽

Lee Albacker ◽

Kai Wang ◽

Juliann Chmielecki ◽

...

Keyword(s):

Lung Cancer ◽

Clinical Trials ◽

National Comprehensive Cancer Network ◽

Cancer Biomarker ◽

Genomic Profiling ◽

Comprehensive Genomic Profiling ◽

Biomarker Testing ◽

Lung Cancer Biomarker ◽

Cancer Network

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Lung cancer biomarker testing: perspective from Europe

Translational Lung Cancer Research ◽

10.21037/tlcr.2020.04.07 ◽

2020 ◽

Vol 9 (3) ◽

pp. 887-897

Author(s):

Erik Thunnissen ◽

Birgit Weynand ◽

Dalma Udovicic-Gagula ◽

Luka Brcic ◽

Malgorzata Szolkowska ◽

...

Keyword(s):

Lung Cancer ◽

Cancer Biomarker ◽

Biomarker Testing ◽

Lung Cancer Biomarker

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Biomarker tissue journey among patients (pts) with untreated metastatic non-small cell lung cancer (mNSCLC) in the U.S. Oncology Network community practices.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.9004 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 9004-9004

Author(s):

Nicholas J. Robert ◽

Esmond D. Nwokeji ◽

Janet L. Espirito ◽

Liwei Chen ◽

Mandar Karhade ◽

...

Keyword(s):

Lung Cancer ◽

Real World ◽

Performance Status ◽

The United States ◽

Molecular Testing ◽

Ecog Performance Status ◽

Biomarker Testing ◽

L1 Use ◽

The Individual ◽

Cancer Network

9004 Background: Given the importance of molecular testing and targeted therapy for mNSCLC, the MYLUNG (Molecularly Informed Lung Cancer Treatment in a Community Cancer Network) consortium pragmatic study assessed real-world biomarker testing rates and turnaround times (TAT) within The US Oncology Network of over 1,000 providers across the United States. Methods: This was a retrospective observational chart review study of pts with mNSCLC initiating first-line (1L) systemic therapy between 04/01/2018 and 03/31/2020. iKnowMed electronic health records were used to examine timing of biomarker testing: before 1L therapy (cohort 1), after 1L therapy (cohort 2) or no testing (cohort 3). We assessed testing rates for ALK, BRAF, EGFR, ROS1, and PD-L1; use of full next-generation sequencing panel (NGS); time from mNSCLC diagnosis (dx) to 1L therapy; TAT from biomarker orders to results; and time from mNSCLC dx to test results. Results: We identified 3474 adults. Median age was 69 years (range 23-90), 51% female, 74% with adenocarcinoma and 76% with a documented ECOG performance status of 0 or 1. Testing rates are shown in table: 90% of pts had at least one biomarker test and 46% received all 5 biomarker tests. Changes in testing rates from 2018 to 2020 were 51% to 59% for BRAF, 71% to 71% for EGFR, 71% to 70% for ALK, 69% to 67% for ROS1, 82% to 84% for PD-L1, and 42% to 49% for pts tested for all 5 biomarkers. NGS testing increased from 33% to 44% (p<0.0001). The median (interquartile range [IQR]) time from mNSCLC dx to 1L therapy for all pts was 35 (22, 55) days. Median (IQR) TAT from biomarker testing orders to results ranged from 10 (6, 17) to 15 (10, 22) days for the individual biomarkers; and time from mNSCLC dx to biomarker results ranged from 14 (7, 26) to 21 (12, 36) days by biomarker. Conclusions: This real-world study showed that most pts received at least one biomarker test prior to 1L, but <50% received all 5 tests. NGS testing occurred in <50% of pts but increased over the periods examined. Median time from dx to 1L therapy was about 5 weeks and TAT from orders to results about 2 weeks. Analyses by histology and other trends will be reported. These data will be compared to the next phase of the MYLUNG study, which will evaluate contemporary ordering practices and TATs prospectively[Table: see text]

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