Critical Assessment in Routine Clinical Practice of Liquid Biopsy for EGFR Status Testing in Non–Small-Cell Lung Cancer: A Single-Laboratory Experience (LPCE, Nice, France)

Heeke, Simon; Benzaquen, Jonathan; Hofman, Paul; Allègra, Maryline; Long‐Mira, Elodie; Lassalle, Sandra; Tanga, Virginie; Salacroup, Carole; Bonnetaud, Christelle; Fayada, Julien; Gazoppi, Loïc; Ribeyre, Lydia; Castelnau, Olivier; Garnier, G.; Cattet, Florian; Nanni, Isabelle; Fraipont, Florence de; Cohen, Charlotte; Berthet, Jean‐Philippe; Leroy, Sylvie; Poudenx, M.; Marquette, Charles Hugo; Denis, Marc G.; Barlési, Fabrice

doi:10.1016/j.cllc.2019.07.010

Cited by 25 publications

(29 citation statements)

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“…Indeed, in two of the patients where no tissue testing was possible, an EGFR exon 19 deletion has been detected and a targeted treatment was initiated, highlighting the usability of this approach. However, EGFR mutations can easily be detected using PCR-based assays, so the same results could have been obtained using such an approach [3]. However, with the development of novel targeted treatment options in lung cancer, the NGS approach might become more relevant in order to cover all the requested biomarkers.…”

Section: Discussionmentioning

confidence: 99%

“…2 Hospital-related Biobank (BB-00033-0025), Pasteur Hospital, Université Côte d' Azur, 30 Avenue de la Voie Romaine, 06000 Nice, France. 3 FHU OncoAge, Pasteur Hospital, Université Côte d' Azur, 30 Avenue de la Voie Romaine, 06000 Nice, France. 4 Pulmonary Department, Pasteur Hospital, Université Côte d' Azur, 30 Avenue de la Voie Romaine, 06000 Nice, France.…”

Section: Supplementary Informationmentioning

confidence: 99%

“…In patients with tissue material that is insufficient in size or quality to carry out all the planned analyses, liquid biopsies (LB) from plasma samples present an interesting alternative for the analysis of genomic alterations, even if a tissue re-biopsy should be mandatory if possible [2]. Initially, plasma-based testing has been mainly established for the analysis of EGFR mutations with good reproducibility but NGS has also recently been developed to allow the analysis of several genes in parallel, with resolution down to 0.1% allele frequency [3,4]. Today, plasma-based NGS can either be carried out in-house using targeted sequencing panels or blood can be sent out to certified testing centers who provide a final report outlining the detected genomic alterations.…”

Section: Introductionmentioning

confidence: 99%

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Prospective evaluation of NGS-based liquid biopsy in untreated late stage non-squamous lung carcinoma in a single institution

et al. 2020

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Background: NGS from plasma samples in non-squamous cell lung carcinoma (NSCC) can aid in the detection of actionable genomic alterations. However, the absolute clinical value of NGS in liquid biopsy (LB) made at baseline is currently uncertain. We assessed the impact of plasma-based NGS using an in-house test and an outsourced test in comparison to a routine molecular pathology workflow. Methods: Twenty-four advanced/metastatic treatment-naïve NSCC patients were prospectively included. NGS analyses were conducted both in-house using the Oncomine cfTNA Panel and in an external testing center using the Foundation Liquid assay. NGS analysis and/or specific molecular based assays were conducted in parallel on tissue or cytological samples. Results: Both LB tests were well correlated. Tissue NGS results were obtained in 67% of patients and demonstrated good correlation with LB assays. Activating EGFR mutations were detected using LB tests in three patients. PD-L1 expression assessed in tissue sections enabled the initiation of pembrolizumab treatment in five patients. Conclusion: NGS from LB is feasible in routine clinical practice using an in-house or an outsourced test at baseline. However, the impact on therapy selection was limited in this small series of patients and LB was not able to replace tissue-based testing in our hands.

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Section: Discussionmentioning

confidence: 99%

Section: Supplementary Informationmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Prospective evaluation of NGS-based liquid biopsy in untreated late stage non-squamous lung carcinoma in a single institution

et al. 2020

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“…Briefly, the Idylla method was carried out using the same tissue blocks as those used for the NGS method; a 10 µm thick FFPE tissue section was loaded directly into the cartridge using sterile forceps and was then placed in the Idylla system, allowing integrated DNA extraction and mutational hotspot analysis. In case of a discrepancy between the results using these two methods (i.e., an EGFR mutation detected with the NGS approach rather than the Idylla approach) an orthogonal method using dPCR (Stilla, Villejuif, France) was performed as described [28]. Briefly, the purity of the DNA was assessed by absorbance using a Nanodrop spectrophotometer (ThermoFischer, Waltham, MA, USA) prior to quantification by a fluorescent method using the Qubit Fluorimeter (ThermoFischer, Waltham, MA, USA).…”

Section: Methodsmentioning

confidence: 99%

Targeted Assessment of the EGFR Status as Reflex Testing in Treatment-Naive Non-Squamous Cell Lung Carcinoma Patients: A Single Laboratory Experience (LPCE, Nice, France)

Lassalle

Hofman

Heeke

et al. 2020

Cancers

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Background: Assessment of actionable EGFR mutations is mandatory for treatment-naïve advanced or metastatic non-squamous lung carcinoma (NSLC), but the results need to be obtained in less than 10 working days. For rapid EGFR testing, an EGFR-specific polymerase chain reaction (PCR) assay is an alternative and simple approach compared to next generation sequencing (NGS). Here, we describe how a rapid EGFR-specific PCR assay can be implemented in a single laboratory center (LPCE, Nice, France) as reflex testing in treatment-naïve NSLC. Methods: A total of 901 biopsies from NSLC with more than 10% of tumor cells were prospectively and consecutively evaluated for EGFR mutation status between November 2017 and December 2019 using the Idylla system (Biocartis NV, Mechelen, Belgium). NGS was performed for nonsmokers with NSLC wild type for EGFR, ALK, ROS1, and BRAF and with less than 50% PD-L1 positive cells using the Hotspot panel (Thermo Fisher Scientific, Waltham, MA, USA). Results: Results were obtained from 889/901 (97%) biopsies with detection of EGFR mutations in 114/889 (13%) cases using the Idylla system. Among the 562 EGFR wild type tumors identified with Idylla, NGS detected one actionable and one nonactionable EGFR mutation. Conclusions: Rapid and targeted assessment of EGFR mutations in treatment-naïve NSLC can be implemented in routine clinical practice. However, it is mandatory to integrate this approach into a molecular algorithm that allows evaluation of potentially actionable genomic alterations other than EGFR mutations.

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“…The different algorithms associated with liquid biopsy practice in NSCLC follow certain international guidelines. [42][43][44] Because the use of liquid biopsy-mainly to monitor NSCLC patients receiving first-or second-generation EGFR TKIs-has Lung Cancer Molecular Pathology in France/Hofman et al increased considerably in recent years, the impact on the budget of the different blood-based molecular tests is difficult to evaluate. As indicated above for tumors, external quality assessment schemes have also been established for circulating DNA by Gen&tiss.…”

Section: Current Functioning: a New Funding Systemmentioning

confidence: 99%

Predictive molecular pathology in non–small cell lung cancer in France: The past, the present and the perspectives

Hofman

Rouleau

Sabourin

et al. 2020

Cancer Cytopathology

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The advent of molecular targets for novel therapeutics in oncology, notably for non–small cell lung carcinoma (NSCLC), led the French National Cancer Institute (INCa) to establish a national network of 28 hospital Molecular Genetics Centers for Cancer (MGCC) in 2007. In each University in France, laboratories were established to develop molecular biology testing to evaluate a few genomic alterations, initially a selection of genes, by using specific targeted polymerase chain reaction (PCR) assays. In a second phase, the number of studied genes was increased. In 2015, the MGCC benefited from an additional dedicated budget from the INCa to develop next‐generation sequencing (NGS) technology. In the meantime, a new financial regulation for innovative testing has been established for the acts out of nomenclature. Consequently, all private and public laboratories in France have access to funding for molecular biology testing in oncology. The gene‐based PCR assays or NGS tests have benefitted from reimbursement of cost testing by the INCa. Today, the laboratories consider this reimbursement to be only partial, and its use to be complex. In 2018, a strategic plan for medical genomic analyses (France Médecine Génomique 2025) was implemented to introduce more systematic sequencing into the health care pathway and oncology practice. The large panel of molecular tests should be centralized to a limited number of molecular genetic centers. This review describes the evolution of the different stages of implementation of molecular pathology testing for NSCLC patients over the last few years in France.

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Critical Assessment in Routine Clinical Practice of Liquid Biopsy for EGFR Status Testing in Non–Small-Cell Lung Cancer: A Single-Laboratory Experience (LPCE, Nice, France)

Cited by 25 publications

References 28 publications

Prospective evaluation of NGS-based liquid biopsy in untreated late stage non-squamous lung carcinoma in a single institution

Prospective evaluation of NGS-based liquid biopsy in untreated late stage non-squamous lung carcinoma in a single institution

Targeted Assessment of the EGFR Status as Reflex Testing in Treatment-Naive Non-Squamous Cell Lung Carcinoma Patients: A Single Laboratory Experience (LPCE, Nice, France)

Predictive molecular pathology in non–small cell lung cancer in France: The past, the present and the perspectives

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