Expert opinion on NSCLC small specimen biomarker testing - Part 2: Analysis, reporting, and quality assessment.

Best practice External quality assessment Liquid biopsy Molecular diagnostics Next-generation sequencing Non-small cell lung carcinoma

Journal

Virchows Archiv : an international journal of pathology
ISSN: 1432-2307
Titre abrégé: Virchows Arch
Pays: Germany
ID NLM: 9423843

Informations de publication

Date de publication:
Sep 2022
Historique:
received: 16 12 2021
accepted: 18 05 2022
revised: 16 05 2022
pubmed: 21 7 2022
medline: 23 9 2022
entrez: 20 7 2022
Statut: ppublish

Résumé

The diagnostic work-up for non-small cell lung cancer (NSCLC) requires biomarker testing to guide therapy choices. This article is the second of a two-part series. In Part 1, we summarised evidence-based recommendations for obtaining and processing small specimen samples (i.e. pre-analytical steps) from patients with advanced NSCLC. Here, in Part 2, we summarise evidence-based recommendations relating to analytical steps of biomarker testing (and associated reporting and quality assessment) of small specimen samples in NSCLC. As the number of biomarkers for actionable (genetic) targets and approved targeted therapies continues to increase, simultaneous testing of multiple actionable oncogenic drivers using next-generation sequencing (NGS) becomes imperative, as set forth in European Society for Medical Oncology guidelines. This is particularly relevant in advanced NSCLC, where tissue specimens are typically limited and NGS may help avoid tissue exhaustion compared with sequential biomarker testing. Despite guideline recommendations, significant discrepancies in access to NGS persist across Europe, primarily due to reimbursement constraints. The use of increasingly complex testing methods also has implications for the reporting of results. Molecular testing reports should include clinical interpretation with additional commentary on sample adequacy as appropriate. Molecular tumour boards are recommended to facilitate the interpretation of complex genetic information arising from NGS, and to collaboratively determine the optimal treatment for patients with NSCLC. Finally, whichever testing modality is employed, it is essential that adequate internal and external validation and quality control measures are implemented.

Identifiants

pubmed: 35857103
doi: 10.1007/s00428-022-03344-1
pii: 10.1007/s00428-022-03344-1
pmc: PMC9297263
doi:

Substances chimiques

Biomarkers 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

351-366

Informations de copyright

© 2022. The Author(s).

Références

European Society for Medical Oncology (ESMO) (2020) Metastatic non-small-cell lung cancer: ESMO cinical practice guidelines for diagnosis, treatment and follow-up. Available from: https://www.esmo.org/content/download/347819/6934778/1/ESMO-CPG-mNSCLC-15SEPT2020.pdf . (cited 2021 25 November)
Lindeman NI, Cagle PT, Aisner DL, Arcila ME, Beasley MB, Bernicker EH, Colasacco C, Dacic S, Hirsch FR, Kerr K, Kwiatkowski DJ, Ladanyi M, Nowak JA, Sholl L, Temple-Smolkin R, Solomon B, Souter LH, Thunnissen E, Tsao MS, Ventura CB, Wynes MW, Yatabe Y (2018) Updated molecular testing guideline for the selection of lung cancer patients for treatment with targeted tyrosine kinase inhibitors: guideline from the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology. J Mol Diagn 20:129–159. https://doi.org/10.1016/j.jmoldx.2017.11.004
doi: 10.1016/j.jmoldx.2017.11.004 pubmed: 29398453
Penault-Llorca F, Kerr K, Garrido P, Thunnissen E, Dequeker E, Normanno N, Patton S, Fairley J, Kapp J, de Ridder D, Ryška A, Moch H (2022) Expert opinion on NSCLC small specimen biomarker testing — Part 1: Tissue collection and management. Virchows Archiv. https://doi.org/10.1007/s00428-022-03343-2
Hardtstock F, Myers D, Li T, Cizova D, Maywald U, Wilke T, Griesinger F (2020) Real-world treatment and survival of patients with advanced non-small cell lung cancer: a German retrospective data analysis. BMC Cancer 20:260. https://doi.org/10.1186/s12885-020-06738-z
doi: 10.1186/s12885-020-06738-z pubmed: 32228520 pmcid: 7106673
Lester J, Escriu C, Khan S, Hudson E, Mansy T, Conn A, Chan S, Powell C, Brock J, Conibear J, Nelless L, Nayar V, Zhuo X, Durand A, Amin A, Martin P, Zhang X, Pawar V (2021) Retrospective analysis of real-world treatment patterns and clinical outcomes in patients with advanced non-small cell lung cancer starting first-line systemic therapy in the United Kingdom. BMC Cancer 21:515. https://doi.org/10.1186/s12885-021-08096-w
doi: 10.1186/s12885-021-08096-w pubmed: 33962574 pmcid: 8106229
Tan L, Alexander M, Officer A, MacManus M, Mileshkin L, Jennens R, Herath D, de Boer R, Fox SB, Ball D, Solomon B (2018) Survival difference according to mutation status in a prospective cohort study of Australian patients with metastatic non-small-cell lung carcinoma. Intern Med J 48:37–44. https://doi.org/10.1111/imj.13491
doi: 10.1111/imj.13491 pubmed: 28544061
Della Corte CM, Morgillo F (2021) Rethinking treatment for RET-altered lung and thyroid cancers: selpercatinib approval by the EMA. ESMO Open 6:100041. https://doi.org/10.1016/j.esmoop.2020.100041
doi: 10.1016/j.esmoop.2020.100041 pubmed: 33477006 pmcid: 7820024
Kerr KM, Bibeau F, Thunnissen E, Botling J, Ryška A, Wolf J, Öhrling K, Burdon P, Malapelle U, Büttner R (2021) The evolving landscape of biomarker testing for non-small cell lung cancer in Europe. Lung Cancer 154:161–175. https://doi.org/10.1016/j.lungcan.2021.02.026
doi: 10.1016/j.lungcan.2021.02.026 pubmed: 33690091
Amgen (2022) European Commission approves Lumykras (sotorasib) for patients with KRAS G12C-mutated advanced non-small cell lung cancer [press release]. Available from: https://www.amgen.com/newsroom/press-releases/2022/01/european-commission-approves-lumykras-sotorasib-for-patients-with-kras-g12cmutated-advanced-nonsmall-cell-lung-cancer . (cited 2022 07 February)
Mosele F, Remon J, Mateo J, Westphalen CB, Barlesi F, Lolkema MP, Normanno N, Scarpa A, Robson M, Meric-Bernstam F, Wagle N, Stenzinger A, Bonastre J, Bayle A, Michiels S, Bieche I, Rouleau E, Jezdic S, Douillard JY, Reis-Filho JS, Dienstmann R, Andre F (2020) Recommendations for the use of next-generation sequencing (NGS) for patients with metastatic cancers: a report from the ESMO Precision Medicine Working Group. Ann Oncol 31:1491–1505. https://doi.org/10.1016/j.annonc.2020.07.014
doi: 10.1016/j.annonc.2020.07.014 pubmed: 32853681
de Ruiter EJ, Mulder FJ, Koomen BM, Speel EJ, van den Hout M, de Roest RH, Bloemena E, Devriese LA, Willems SM (2021) Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC). Mod Pathol 34:1125–1132. https://doi.org/10.1038/s41379-020-0644-7
doi: 10.1038/s41379-020-0644-7 pubmed: 32759978
Salgado R, Bellizzi AM, Rimm D, Bartlett JMS, Nielsen T, Holger M, Laenkholm AV, Quinn C, Cserni G, Cunha IW, Alvarado-Cabrero I, Cree I (2020) How current assay approval policies are leading to unintended imprecision medicine. Lancet Oncol 21:1399–1401. https://doi.org/10.1016/s1470-2045(20)30592-1
doi: 10.1016/s1470-2045(20)30592-1 pubmed: 33098760
Kim H, Chung J-H (2019) PD-L1 testing in non-small cell lung cancer: past, present, and future. J Pathol Transl Med 53:199–206. https://doi.org/10.4132/jptm.2019.04.24
doi: 10.4132/jptm.2019.04.24 pubmed: 31042863 pmcid: 6639705
Thunnissen E (2018) How to validate predictive immunohistochemistry testing in pathology? A practical approach exploiting the heterogeneity of programmed death ligand-1 present in non–small cell lung cancer. Arch Pathol Lab Med 143:11–12. https://doi.org/10.5858/arpa.2018-0410-ED
doi: 10.5858/arpa.2018-0410-ED pubmed: 30307747
Thunnissen E, Weynand B, Udovicic-Gagula D, Brcic L, Szolkowska M, Hofman P, Smojver-Jezek S, Anttila S, Calabrese F, Kern I, Skov B, Perner S, Dale VG, Eri Z, Haragan A, Leonte D, Carvallo L, Prince SS, Nicholson S, Sansano I, Ryska A (2020) Lung cancer biomarker testing: perspective from Europe. Transl Lung Cancer Res 9:887–897. https://doi.org/10.21037/tlcr.2020.04.07
doi: 10.21037/tlcr.2020.04.07 pubmed: 32676354 pmcid: 7354119
Pisapia P, Pepe F, Baggi A, Barberis M, Galvano A, Gristina V, Mastrilli F, Novello S, Pagni F, Pasini S, Perrone G, Righi D, Russo A, Troncone G, Malapelle U (2022) Next generation diagnostic algorithm in non-small cell lung cancer predictive molecular pathology: the KWAY Italian multicenter cost evaluation study. Crit Rev Oncol Hematol 169:103525. https://doi.org/10.1016/j.critrevonc.2021.103525
doi: 10.1016/j.critrevonc.2021.103525 pubmed: 34813925
Tan AC, Lai GGY, Tan GS, Poon SY, Doble B, Lim TH, Aung ZW, Takano A, Tan WL, Ang MK, Tan BS, Devanand A, Too CW, Gogna A, Ong BH, Koh TPT, Kanesvaran R, Ng QS, Jain A, Rajasekaran T, Lim AST, Lim WT, Toh CK, Tan EH, Lim TKH, Tan DSW (2020) Utility of incorporating next-generation sequencing (NGS) in an Asian non-small cell lung cancer (NSCLC) population: incremental yield of actionable alterations and cost-effectiveness analysis. Lung Cancer 139:207–215. https://doi.org/10.1016/j.lungcan.2019.11.022
doi: 10.1016/j.lungcan.2019.11.022 pubmed: 31835042
Pennell NA, Zhou J, Hobbs B (2020) A model comparing the value of broad next-gen sequencing (NGS)-based testing to single gene testing (SGT) in patients with nonsquamous non-small cell lung cancer (NSCLC) in the United States. J Clin Oncol 38:9529. https://doi.org/10.1200/JCO.2020.38.15_suppl.9529
doi: 10.1200/JCO.2020.38.15_suppl.9529
Velizheva NP, Rechsteiner MP, Valtcheva N, Freiberger SN, Wong CE, Vrugt B, Zhong Q, Wagner U, Moch H, Hillinger S, Schmitt-Opitz I, Soltermann A, Wild PJ, Tischler V (2018) Targeted next-generation-sequencing for reliable detection of targetable rearrangements in lung adenocarcinoma—a single center retrospective study. Pathol Res Pract 214:572–578. https://doi.org/10.1016/j.prp.2018.02.001
doi: 10.1016/j.prp.2018.02.001 pubmed: 29580750 pmcid: 5899763
Bruno R, Fontanini G (2020) Next generation sequencing for gene fusion analysis in lung cancer: a literature review. Diagnostics (Basel) 10:521. https://doi.org/10.3390/diagnostics10080521
doi: 10.3390/diagnostics10080521
Heydt C, Wölwer CB, Velazquez Camacho O, Wagener-Ryczek S, Pappesch R, Siemanowski J, Rehker J, Haller F, Agaimy A, Worm K, Herold T, Pfarr N, Weichert W, Kirchner T, Jung A, Kumbrink J, Goering W, Esposito I, Buettner R, Hillmer AM, Merkelbach-Bruse S (2021) Detection of gene fusions using targeted next-generation sequencing: a comparative evaluation. BMC Med Genomics 14:62. https://doi.org/10.1186/s12920-021-00909-y
doi: 10.1186/s12920-021-00909-y pubmed: 33639937 pmcid: 7912891
Di Capua D, Bracken-Clarke D, Ronan K, Baird AM, Finn S (2021) The liquid biopsy for lung cancer: state of the art, limitations and future developments. Cancers (Basel) 13:3923. https://doi.org/10.3390/cancers13163923
doi: 10.3390/cancers13163923
Radonic T, Geurts-Giele WRR, Samsom KG, Roemen G, von der Thusen JH, Thunnissen E, Meijssen IC, Sleddens H, Dinjens WNM, Boelens MC, Weijers K, Speel EJM, Finn SP, O’Brien C, van Wezel T, Cohen D, Monkhorst K, Roepman P, Dubbink HJ (2021) RET fluorescence in situ hybridization analysis is a sensitive but highly unspecific screening method for RET fusions in lung cancer. J Thorac Oncol 16:798–806. https://doi.org/10.1016/j.jtho.2021.01.1619
doi: 10.1016/j.jtho.2021.01.1619 pubmed: 33588111
Turashvili G, Yang W, McKinney S, Kalloger S, Gale N, Ng Y, Chow K, Bell L, Lorette J, Carrier M, Luk M, Aparicio S, Huntsman D, Yip S (2012) Nucleic acid quantity and quality from paraffin blocks: defining optimal fixation, processing and DNA/RNA extraction techniques. Exp Mol Pathol 92:33–43. https://doi.org/10.1016/j.yexmp.2011.09.013
doi: 10.1016/j.yexmp.2011.09.013 pubmed: 21963600
Roche (2021) Roche receives FDA approval for VENTANA ALK (D5F3) CDx Assay to identify lung cancer patients eligible for targeted treatment with LORBRENA (lorlatinib). Available from: https://diagnostics.roche.com/global/en/news-listing/2021/roche-receives-fda-approval-for-ventana-alk-d5f3-cdx-assay-to-identify-lung-cancer-patients-eligible-for-targeted-treatment-with-lorbrena-lorlatinib.html . (cited 2021 25 November)
Belli C, Penault-Llorca F, Ladanyi M, Normanno N, Scoazec JY, Lacroix L, Reis-Filho JS, Subbiah V, Gainor JF, Endris V, Repetto M, Drilon A, Scarpa A, André F, Douillard JY, Curigliano G (2021) ESMO recommendations on the standard methods to detect RET fusions and mutations in daily practice and clinical research. Ann Oncol 32:337–350. https://doi.org/10.1016/j.annonc.2020.11.021
doi: 10.1016/j.annonc.2020.11.021 pubmed: 33455880
van der Wekken AJ, Pelgrim R, Hart Nt, Werner N, Mastik MF, Hendriks L, van der Heijden E, Looijen-Salamon M, de Langen AJ, Staal-van den Brekel J, Riemersma S, van den Borne BE, Speel EJM, Dingemans AC, Hiltermann TJN, van den Berg A, Timens W, Schuuring E, Groen HJM (2017) Dichotomous ALK-IHC is a better predictor for ALK inhibition outcome than traditional ALK-FISH in advanced non-small cell lung cancer. Clin Cancer Res 23:4251–4258. https://doi.org/10.1158/1078-0432.Ccr-16-1631
doi: 10.1158/1078-0432.Ccr-16-1631 pubmed: 28183714
Mok T, Peters S, Camidge DR, Noé J, Gadgeel S, Ou S-HI, Kim D-W, Konopa K, Pozzi E, Liu T, Loftin IR, Williams C, Shaw AT (2021) Outcomes according to ALK status determined by central immunohistochemistry or fluorescence in situ hybridization in patients with ALK-positive NSCLC enrolled in the phase 3 ALEX study. J Thorac Oncol 16:259–268. https://doi.org/10.1016/j.jtho.2020.10.007
doi: 10.1016/j.jtho.2020.10.007 pubmed: 33334571
Malapelle U, Tiseo M, Vivancos A, Kapp J, Serrano MJ, Tiemann M (2021) Liquid biopsy for biomarker testing in non-small cell lung cancer: a European perspective. J Mol Pathol 2:255–273. https://doi.org/10.3390/jmp2030022
doi: 10.3390/jmp2030022
Russo A, Incorvaia L, Del Re M, Malapelle U, Capoluongo E, Gristina V, Castiglia M, Danesi R, Fassan M, Giuffre G, Gori S, Marchetti A, Normanno N, Pinto C, Rossi G, Santini D, Sartore-Bianchi A, Silvestris N, Tagliaferri P, Troncone G, Cinieri S, Beretta GD (2021) The molecular profiling of solid tumors by liquid biopsy: a position paper of the AIOM-SIAPEC-IAP-SIBioC-SIC-SIF Italian Scientific Societies. ESMO Open 6:100164. https://doi.org/10.1016/j.esmoop.2021.100164
doi: 10.1016/j.esmoop.2021.100164 pubmed: 34091263 pmcid: 8182269
Li YS, Jiang BY, Yang JJ, Zhang XC, Zhang Z, Ye JY, Zhong WZ, Tu HY, Chen HJ, Wang Z, Xu CR, Wang BC, Du HJ, Chuai S, Han-Zhang H, Su J, Zhou Q, Yang XN, Guo WB, Yan HH, Liu YH, Yan LX, Huang B, Zheng MM, Wu YL (2018) Unique genetic profiles from cerebrospinal fluid cell-free DNA in leptomeningeal metastases of EGFR-mutant non-small-cell lung cancer: a new medium of liquid biopsy. Ann Oncol 29:945–952. https://doi.org/10.1093/annonc/mdy009
doi: 10.1093/annonc/mdy009 pubmed: 29346604
Liu Y, Yang S, Zhao J, He Z, Ma J, Guo Y, Wang W, Yoshizawa A, Prelaj A, Tiseo M, Normanno N, Van Schil PE, Wang Q, Yang X (2021) Cell-free DNA from cerebrospinal fluid can be used to detect the EGFR mutation status of lung adenocarcinoma patients with central nervous system metastasis. Transl Lung Cancer Res 10:914–925. https://doi.org/10.21037/tlcr-21-62
doi: 10.21037/tlcr-21-62 pubmed: 33718032 pmcid: 7947414
Reckamp KL, Melnikova VO, Karlovich C, Sequist LV, Camidge DR, Wakelee H, Perol M, Oxnard GR, Kosco K, Croucher P, Samuelsz E, Vibat CR, Guerrero S, Geis J, Berz D, Mann E, Matheny S, Rolfe L, Raponi M, Erlander MG, Gadgeel S (2016) A highly sensitive and quantitative test platform for detection of NSCLC EGFR mutations in urine and plasma. J Thorac Oncol 11:1690–1700. https://doi.org/10.1016/j.jtho.2016.05.035
doi: 10.1016/j.jtho.2016.05.035 pubmed: 27468937
Rolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D (2021) Liquid biopsy for advanced NSCLC: a consensus statement from the International Association for the Study of Lung Cancer. J Thorac Oncol 16:1647–1662. https://doi.org/10.1016/j.jtho.2021.06.017
doi: 10.1016/j.jtho.2021.06.017 pubmed: 34246791
Larson MH, Pan W, Kim HJ, Mauntz RE, Stuart SM, Pimentel M, Zhou Y, Knudsgaard P, Demas V, Aravanis AM, Jamshidi A (2021) A comprehensive characterization of the cell-free transcriptome reveals tissue- and subtype-specific biomarkers for cancer detection. Nat Commun 12:2357. https://doi.org/10.1038/s41467-021-22444-1
doi: 10.1038/s41467-021-22444-1 pubmed: 33883548 pmcid: 8060291
International Association for the Study of Lung Cancer (IASLC) (2020) IASLC atlas of diagnostic immunohistochemistry. Available from: https://s3.us-east-1.amazonaws.com/fonteva-customer-media/00D3i000000D3mbEAC/TRGNDBDv_IASLC_Atlas_2020_Interactive_pdf . (cited 2021 24 November)
Pisapia P, Pepe F, Sgariglia R, Nacchio M, Russo G, Conticelli F, Girolami I, Eccher A, Bellevicine C, Vigliar E, Malapelle U, Troncone G (2021) Next generation sequencing in cytology. Cytopathology 32:588–595. https://doi.org/10.1111/cyt.12974
doi: 10.1111/cyt.12974 pubmed: 33792981 pmcid: 8451925
Scarpa A, Sikora K, Fassan M, Rachiglio AM, Cappellesso R, Antonello D, Amato E, Mafficini A, Lambiase M, Esposito C, Bria E, Simonato F, Scardoni M, Turri G, Chilosi M, Tortora G, Fassina A, Normanno N (2013) Molecular typing of lung adenocarcinoma on cytological samples using a multigene next generation sequencing panel. PLoS ONE 8:e80478. https://doi.org/10.1371/journal.pone.0080478
doi: 10.1371/journal.pone.0080478 pubmed: 24236184 pmcid: 3827450
Dietel M, Bubendorf L, Dingemans AM, Dooms C, Elmberger G, Garcia RC, Kerr KM, Lim E, Lopez-Rios F, Thunnissen E, Van Schil PE, von Laffert M (2016) Diagnostic procedures for non-small-cell lung cancer (NSCLC): recommendations of the European Expert Group. Thorax 71:177–184. https://doi.org/10.1136/thoraxjnl-2014-206677
doi: 10.1136/thoraxjnl-2014-206677 pubmed: 26530085
Li MM, Datto M, Duncavage EJ, Kulkarni S, Lindeman NI, Roy S, Tsimberidou AM, Vnencak-Jones CL, Wolff DJ, Younes A, Nikiforova MN (2017) Standards and guidelines for the interpretation and reporting of sequence variants in cancer: a joint consensus recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists. J Mol Diagn 19:4–23. https://doi.org/10.1016/j.jmoldx.2016.10.002
doi: 10.1016/j.jmoldx.2016.10.002 pubmed: 27993330 pmcid: 5707196
Mateo J, Chakravarty D, Dienstmann R, Jezdic S, Gonzalez-Perez A, Lopez-Bigas N, Ng CKY, Bedard PL, Tortora G, Douillard JY, Van Allen EM, Schultz N, Swanton C, André F, Pusztai L (2018) A framework to rank genomic alterations as targets for cancer precision medicine: the ESMO Scale for Clinical Actionability of molecular Targets (ESCAT). Ann Oncol 29:1895–1902. https://doi.org/10.1093/annonc/mdy263
doi: 10.1093/annonc/mdy263 pubmed: 30137196 pmcid: 6158764
Tack V, Dufraing K, Deans ZC, van Krieken HJ, Dequeker EMC (2017) The ins and outs of molecular pathology reporting. Virchows Arch 471:199–207. https://doi.org/10.1007/s00428-017-2108-0
doi: 10.1007/s00428-017-2108-0 pubmed: 28343306
Irmisch A, Bonilla X, Chevrier S, Lehmann KV, Singer F, Toussaint NC, Esposito C, Mena J, Milani ES, Casanova R, Stekhoven DJ, Wegmann R, Jacob F, Sobottka B, Goetze S, Kuipers J, Sarabia Del Castillo J, Prummer M, Tuncel MA, Menzel U, Jacobs A, Engler S, Sivapatham S, Frei AL, Gut G, Ficek J, Miglino N, Aebersold R, Bacac M, Beerenwinkel N, Beisel C, Bodenmiller B, Dummer R, Heinzelmann-Schwarz V, Koelzer VH, Manz MG, Moch H, Pelkmans L, Snijder B, Theocharides APA, Tolnay M, Wicki A, Wollscheid B, Rätsch G, Levesque MP (2021) The Tumor Profiler Study: integrated, multi-omic, functional tumor profiling for clinical decision support. Cancer Cell 39:288–293. https://doi.org/10.1016/j.ccell.2021.01.004
doi: 10.1016/j.ccell.2021.01.004 pubmed: 33482122
Dufraing K, Casteren K, Breyne J, D'Haene N, Campenhout CV, Borght SV, Zwaenepoel K, Rouleau E, Schuuring E, Thüsen J, Dequeker E (2021) Molecular pathology testing for non-small cell lung cancer: an observational study of elements currently present in request forms and result reports and the opinion of different stakeholders. Res Square [Preprint]. https://doi.org/10.21203/rs.3.rs-149142/v1
de Moor JS, Gray SW, Mitchell SA, Klabunde CN, Freedman AN (2020) Oncologist confidence in genomic testing and implications for using multimarker tumor panel tests in practice. JCO Precis Oncol 4:PO.19.00338. https://doi.org/10.1200/PO.19.00338
International Organization for Standardization (ISO) (2012) Medical laboratories — Requirements for quality and competence [ISO 15189:2012(en)]. Available from: https://www.iso.org/obp/ui/#iso:std:iso:15189:ed-3:v2:en . (cited 2021 25 November)
Specchia ML, Frisicale EM, Carini E, Di Pilla A, Cappa D, Barbara A, Ricciardi W, Damiani G (2020) The impact of tumor board on cancer care: evidence from an umbrella review. BMC Health Serv Res 20:73. https://doi.org/10.1186/s12913-020-4930-3
doi: 10.1186/s12913-020-4930-3 pubmed: 32005232 pmcid: 6995197
Fumagalli C, Guerini-Rocco E, Barberis M (2021) Making the most of complexity to create opportunities: comprehensive genomic profiling and molecular tumor board for patients with non-small cell lung cancer (NSCLC). Cancers (Basel) 13:609. https://doi.org/10.3390/cancers13040609
doi: 10.3390/cancers13040609
Hendriks LEL, Dingemans AC, De Ruysscher DKM, Aarts MJ, Barberio L, Cornelissen R, Hartemink KJ, van den Heuvel M, Schuuring E, Smit HJM, van der Wekken AJ, Smit EF (2021) Lung cancer in the Netherlands. J Thorac Oncol 16:355–365. https://doi.org/10.1016/j.jtho.2020.10.012
doi: 10.1016/j.jtho.2020.10.012 pubmed: 33641718
Willemsen A, Krausz S, Ligtenberg MJL, Grunberg K, Groen HJM, Voest EE, Cuppen E, van Laarhoven HWM, van Herpen CML (2019) Molecular tumour boards and molecular diagnostics for patients with cancer in the Netherlands: experiences, challenges, and aspirations. Br J Cancer 121:34–36. https://doi.org/10.1038/s41416-019-0489-3
doi: 10.1038/s41416-019-0489-3 pubmed: 31130724 pmcid: 6738039
Tamborero D, Dienstmann R, Rachid MH, Boekel J, Baird R, Brana I, De Petris L, Yachnin J, Massard C, Opdam FL, Schlenk R, Vernieri C, Garralda E, Masucci M, Villalobos X, Chavarria E, Cancer Core Europe consortium, Calvos F, Frohling S, Eggermont A, Apolone G, Voest EE, Caldas C, Tabernero J, Ernberg I, Rodon R, Lehtio J (2020) Support systems to guide clinical decision-making in precision oncology: the Cancer Core Europe Molecular Tumor Board Portal. Nat Med 26:992–994. https://doi.org/10.1038/s41591-020-0969-2
doi: 10.1038/s41591-020-0969-2 pubmed: 32632195
Stevenson MM, Irwin T, Lowry T, Ahmed MZ, Walden TL, Watson M, Sutton L (2013) Development of a virtual multidisciplinary lung cancer tumor board in a community setting. J Oncol Pract 9:e77–e80. https://doi.org/10.1200/jop.2013.000882
doi: 10.1200/jop.2013.000882 pubmed: 23942505 pmcid: 3651575
Jackman DM, Zhang Y, Dalby C, Nguyen T, Nagle J, Lydon CA, Rabin MS, McNiff KK, Fraile B, Jacobson JO (2017) Cost and survival analysis before and after implementation of Dana-Farber clinical pathways for patients with stage IV non-small-cell lung cancer. J Oncol Pract 13:e346–e352. https://doi.org/10.1200/jop.2017.021741
doi: 10.1200/jop.2017.021741 pubmed: 28260402
Dufraing K, Fenizia F, Torlakovic E, Wolstenholme N, Deans ZC, Rouleau E, Vyberg M, Parry S, Schuuring E, Dequeker EMC, ABSL IQ (2021) Biomarker testing in oncology - requirements for organizing external quality assessment programs to improve the performance of laboratory testing: revision of an expert opinion paper on behalf of IQNPath ABSL. Virchows Arch 478:553–565. https://doi.org/10.1007/s00428-020-02928-z
doi: 10.1007/s00428-020-02928-z pubmed: 33047156
Van Casteren K, Keppens C, Schuuring E, Deans ZC, Normanno N, Patton SJ, Dequeker EMC, International Quality Network for Pathology ct DNAWG, the European Society of Pathology Foundation A (2020) External quality assessment schemes for biomarker testing in oncology: comparison of performance between formalin-fixed, paraffin-embedded-tissue and cell-free tumor DNA in plasma. J Mol Diagn 22:736-747.  https://doi.org/10.1016/j.jmoldx.2020.02.011
Keppens C, Dequeker EMC, Patton SJ, Normanno N, Fenizia F, Butler R, Cheetham M, Fairley JA, Williams H, Hall JA, Schuuring E, Deans ZC, On behalf of IQNPA, (2018) International pilot external quality assessment scheme for analysis and reporting of circulating tumour DNA. BMC Cancer 18:804. https://doi.org/10.1186/s12885-018-4694-x
doi: 10.1186/s12885-018-4694-x pubmed: 30092778 pmcid: 6085634
Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed January 25, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way
Keppens C, Tack V, Hart N, Tembuyser L, Ryska A, Pauwels P, Zwaenepoel K, Schuuring E, Cabillic F, Tornillo L, Warth A, Weichert W, Dequeker E (2018) A stitch in time saves nine: external quality assessment rounds demonstrate improved quality of biomarker analysis in lung cancer. Oncotarget 9:20524–20538. https://doi.org/10.18632/oncotarget.24980

Auteurs

Frédérique Penault-Llorca (F)

University Clermont Auvergne, INSERM U1240, Centre Jean Perrin, Clermont-Ferrand, France.

Keith M Kerr (KM)

Department of Pathology, Aberdeen University Medical School and Aberdeen Royal Infirmary, Aberdeen, UK.

Pilar Garrido (P)

Medical Oncology Department, Hospital Universitario Ramón Y Cajal, University of Alcalá, Madrid, Spain.

Erik Thunnissen (E)

Amsterdam University Medical Center, VU Medical Center, Amsterdam, the Netherlands.

Elisabeth Dequeker (E)

Department of Public Health, Biomedical Quality Assurance Research Unit, Campus Gasthuisberg, University Leuven, Leuven, Belgium.

Nicola Normanno (N)

Cell Biology and Biotherapy Unit, Istituto Nazionale Tumori "Fondazione Giovanni Pascale" IRCCS, Naples, Italy.

Simon J Patton (SJ)

EMQN CIC, Manchester, UK.

Jenni Fairley (J)

GenQA, Edinburgh, UK.

Joshua Kapp (J)

Amgen (Europe) GmbH, Rotkreuz, Switzerland.

Daniëlle de Ridder (D)

Amgen BV, Breda, the Netherlands.

Aleš Ryška (A)

Department of Pathology, Charles University Medical Faculty Hospital, Hradec Králové, Czech Republic.

Holger Moch (H)

Department of Pathology and Molecular Pathology, University Hospital Zurich and University of Zurich, Zurich, Switzerland. holger.moch@usz.ch.

Articles similaires

Genome, Chloroplast Phylogeny Genetic Markers Base Composition High-Throughput Nucleotide Sequencing

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C

Classifications MeSH