Multicenter ALK Testing in Non–Small-Cell Lung Cancer: Results of a Round Robin Test

Laffert, Maximilian von; Penzel, Roland; Schirmacher, Peter; Warth, Arne; Lenze, Dido; Hummel, Michael; Dietel, Manfred

doi:10.1097/jto.0000000000000307

Cited by 17 publications

(15 citation statements)

References 34 publications

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“…For predictive testing in NSCLC, reports have been published for EGFR 40–42 and KRAS 42 mutational analysis, and ALK 4344 Guidelines for standardisation of EQA schemes have recently been introduced 45…”

Section: Resultsmentioning

confidence: 99%

“…To identify institutions capable of providing high-quality molecular testing, QuIP organises EQAs procedures for different diagnostic applications. Until now, two ALK-QCs (based on ISH) had been enrolled in Germany, Switzerland and Austria: The first was performed at the end of 2012; 60.3% (32/53) of the participating institutes passed the EQA and were certified for ALK testing 43. The second ALK-QC took place at the beginning of 2014; in this programme, a total of 92.5% (37/40) of participating institutes passed the EQA, demonstrating a successful learning curve.…”

Section: Resultsmentioning

confidence: 99%

“…Until now, two ALK-QCs (based on ISH) had been enrolled in Germany, Switzerland and Austria: The first was performed at the end of 2012; 60.3% (32/53) of the participating institutes passed the EQA and were certified for ALK testing. 43 The second ALK-QC took place at the beginning of 2014; in this programme, a total of 92.5% (37/40) of participating institutes passed the EQA, demonstrating a successful learning curve. EQAs might also help to gain experience in potential additional testing methods: ALK IHC was highlighted as an effective method for multicentre application, if carefully validated.…”

Section: Eqa/qc At the National Levelmentioning

confidence: 99%

See 2 more Smart Citations

Diagnostic procedures for non-small-cell lung cancer (NSCLC): recommendations of the European Expert Group

Dietel

Bubendorf

Dingemans

et al. 2015

Thorax

Self Cite

160

159

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BackgroundThere is currently no Europe-wide consensus on the appropriate preanalytical measures and workflow to optimise procedures for tissue-based molecular testing of non-small-cell lung cancer (NSCLC). To address this, a group of lung cancer experts (see list of authors) convened to discuss and propose standard operating procedures (SOPs) for NSCLC.MethodsBased on earlier meetings and scientific expertise on lung cancer, a multidisciplinary group meeting was aligned. The aim was to include all relevant aspects concerning NSCLC diagnosis. After careful consideration, the following topics were selected and each was reviewed by the experts: surgical resection and sampling; biopsy procedures for analysis; preanalytical and other variables affecting quality of tissue; tissue conservation; testing procedures for epidermal growth factor receptor, anaplastic lymphoma kinase and ROS proto-oncogene 1, receptor tyrosine kinase (ROS1) in lung tissue and cytological specimens; as well as standardised reporting and quality control (QC). Finally, an optimal workflow was described.ResultsSuggested optimal procedures and workflows are discussed in detail. The broad consensus was that the complex workflow presented can only be executed effectively by an interdisciplinary approach using a well-trained team.ConclusionsTo optimise diagnosis and treatment of patients with NSCLC, it is essential to establish SOPs that are adaptable to the local situation. In addition, a continuous QC system and a local multidisciplinary tumour-type-oriented board are essential.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Eqa/qc At the National Levelmentioning

confidence: 99%

See 1 more Smart Citation

Diagnostic procedures for non-small-cell lung cancer (NSCLC): recommendations of the European Expert Group

Dietel

Bubendorf

Dingemans

et al. 2015

Thorax

Self Cite

160

159

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“…Die enorme Geschwindigkeit in der Entdeckung und Translation prädik-tiver gewebsständiger Biomarker hat Pathologen in den letzten Jahren insbesondere vor die Herausforderung gestellt, entsprechende Analysen zeitnah und mit hoher Qualität anbieten zu können. Das Konzept von nationalen Ringersuchen mit daraus abgeleiteten Handlungsempfehlungen hat sich hierbei als ein Erfolgsfaktor in der Molekularpathologie erwiesen [12,15,16].…”

Section: Bedeutung Der Molekularpathologieunclassified

“…zytologischem Material Aussagen zu einem kompletten Tumor getroffen werden sollen. Die Anstrengungen die hierbei bei der Etablierung einer verlässlichen ALK-Immunhistochemie unternommen wurden belegen exemplarisch, dass reproduzierbare immunhistochemische Analysen flä-chendeckend prinzipiell möglich sind [15,16]. Auch ROS1 ist ein potentieller Kandidat, bei welchem zumindest ein Screening mittels Immunhistochemie möglich erscheint [26].…”

Section: Bedeutung Der Molekularpathologieunclassified

Diagnose, Prognose und Prädiktion nicht-kleinzelliger Lungenkarzinome

Warth

2015

Pathologe

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Tumor diagnostics are based on histomorphology, immunohistochemistry and molecular pathological analysis of mutations, translocations and amplifications which are of diagnostic, prognostic and/or predictive value. In recent decades only histomorphology was used to classify lung cancer as either small (SCLC) or non-small cell lung cancer (NSCLC), although NSCLC was further subdivided in different entities; however, as no specific therapy options were available classification of specific subtypes was not clinically meaningful. This fundamentally changed with the discovery of specific molecular alterations in adenocarcinoma (ADC), e.g. mutations in KRAS, EGFR and BRAF or translocations of the ALK and ROS1 gene loci, which now form the basis of targeted therapies and have led to a significantly improved patient outcome. The diagnostic, prognostic and predictive value of imaging, morphological, immunohistochemical and molecular characteristics as well as their interaction were systematically assessed in a large cohort with available clinical data including patient survival. Specific and sensitive diagnostic markers and marker panels were defined and diagnostic test algorithms for predictive biomarker assessment were optimized. It was demonstrated that the semi-quantitative assessment of ADC growth patterns is a stage-independent predictor of survival and is reproducibly applicable in the routine setting. Specific histomorphological characteristics correlated with computed tomography (CT) imaging features and thus allowed an improved interdisciplinary classification, especially in the preoperative or palliative setting. Moreover, specific molecular characteristics, for example BRAF mutations and the proliferation index (Ki-67) were identified as clinically relevant prognosticators. Comprehensive clinical, morphological, immunohistochemical and molecular assessment of NSCLCs allow an optimized patient stratification. Respective algorithms now form the backbone of the 2015 lung cancer World Health Organization (WHO) classification.

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Predictive molecular pathology of lung cancer in Germany with focus on gene fusion testing: Methods and quality assurance

Siemanowski

Heydt

Merkelbach‐Bruse

2020

Cancer Cytopathology

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Predictive molecular testing has become an important part of the diagnosis of any patient with lung cancer. Using reliable methods to ensure timely and accurate results is inevitable for guiding treatment decisions. In the past few years, parallel sequencing has been established for mutation testing, and its use is currently broadened for the detection of other genetic alterations, such as gene fusion and copy number variations. In addition, conventional methods such as immunohistochemistry and in situ hybridization are still being used, either for formalin‐fixed, paraffin‐embedded tissue or for cytological specimens. For the development and broad implementation of such complex technologies, interdisciplinary and regional networks are needed. The Network Genomic Medicine (NGM) has served as a model of centralized testing and decentralized treatment of patients and incorporates all German comprehensive cancer centers. Internal quality control, laboratory accreditation, and participation in external quality assessment is mandatory for the delivery of reliable results. Here, we provide a summary of current technologies used to identify patients who have lung cancer with gene fusions, briefly describe the structures of NGM and the national NGM (nNGM), and provide recommendations for quality assurance.

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Multicenter ALK Testing in Non–Small-Cell Lung Cancer: Results of a Round Robin Test

Cited by 17 publications

References 34 publications

Diagnostic procedures for non-small-cell lung cancer (NSCLC): recommendations of the European Expert Group

Diagnostic procedures for non-small-cell lung cancer (NSCLC): recommendations of the European Expert Group

Diagnose, Prognose und Prädiktion nicht-kleinzelliger Lungenkarzinome

Predictive molecular pathology of lung cancer in Germany with focus on gene fusion testing: Methods and quality assurance

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