TY - CONF T1 - Precision cancer medicine: What has translated into clinical use in Belgium? T2 - Seminars in Cancer Biology Y1 - 2022 A1 - Marie Delnord A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Aline Antoniou A1 - Wannes Van Hoof A1 - Anouk Waeytens A1 - Marc Van den Bulcke JF - Seminars in Cancer Biology PB - Academic Press VL - 84 SN - 1044-579X ER - TY - JOUR T1 - PRECISION: the Belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment. JF - ESMO Open Y1 - 2022 A1 - J Thouvenin A1 - C Van Marcke A1 - L Decoster A1 - Gordana Raicevic A1 - K Punie A1 - Marc Van den Bulcke A1 - R Salgado A1 - Els Van Valckenborgh A1 - B Maes A1 - S Joris A1 - D Vander Steichel A1 - K Vranken A1 - S Jacobs A1 - F Dedeurwaerdere A1 - G Martens A1 - H Devos A1 - F P Duhoux A1 - M Rasschaert A1 - P Pauwels A1 - K Geboes A1 - J Collignon A1 - S Tejpar A1 - J-L Canon A1 - Michael Peeters A1 - A Rutten A1 - T Van de Mooter A1 - J Vermeij A1 - D Schrijvers A1 - W Demey A1 - W Lybaert A1 - J Van Huysse A1 - J Mebis A1 - A Awada A1 - K B M Claes A1 - Aline Hébrant A1 - J Van der Meulen A1 - B Delafontaine A1 - I Vanden Bempt A1 - J Maetens A1 - Maïté de Hemptinne A1 - S Rottey A1 - P Aftimos A1 - J De Grève KW - Belgium KW - Genomics KW - Humans KW - Medical Oncology KW - Neoplasms KW - Precision Medicine AB -

PRECISION is an initiative from the Belgian Society of Medical Oncology (BSMO) in collaboration with several stakeholders, encompassing four programs that aim to boost genomic and clinical knowledge with the ultimate goal to offer patients with metastatic solid tumors molecularly guided treatments. The PRECISION 1 study has led to the creation of a clinico-genomic database. The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) and GeNeo studies will increase the number of patients with advanced cancer that have comprehensive genotyping of their cancer. The PRECISION 2 project consists of investigator-initiated phase II studies aiming to provide access to a targeted drug for patients whose tumors harbor actionable mutations in case the matched drug is not available through reimbursement or clinical trials in Belgium.

VL - 7 CP - 4 M3 - 10.1016/j.esmoop.2022.100524 ER - TY - JOUR T1 - The Belgian practice and attitudes towards introducing genomics in clinical oncology JF - Belgian journal of medical oncology Y1 - 2021 A1 - Marc Van den Bulcke A1 - Wannes Van Hoof A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Gordana Rajcevic A1 - Kristof Van Assche VL - 15 CP - 4 ER - TY - RPRT T1 - Guidelines "Gepersonaliseerde geneeskunde": Bijzondere bepalingen voor de accreditatie van medische laboratoria die Next Generation Sequencing analysen voor hematologische en solide tumoren uitvoeren Y1 - 2021 A1 - Centre du cancer A1 - Aline Hébrant KW - Gepersonaliseerde geneeskunde KW - Guidelines KW - NGS AB -

Het voorliggende document heeft tot doel de medische laboratoria die geaccrediteerd zijn voor Next generation sequencing (NGS) analysen voor hematologische en solide tumoren te informeren i.v.m. bijkomende eisen. Deze werden opgesteld door de werkgroepen van de Personalised Medicine Commission (ComPerMed: https://www.compermed.be/activites/ngs-guidelines) en Molecular Diagnostics.be (https://moleculardiagnostics.be). ComPerMed is een committee van Belgische wetenschappelijke experten binnen dit domein. DNA/RNA sequenering m.b.v. de Next Generation Sequencing techniek maakt een gepersonaliseerde behandeling mogelijk en zorgt voor een optimalisatie van het beheer van kankerpatiënten. MolecularDiagnostics.be is een discussie forum en platform voor werknemers actief in de moleculaire diagnostiek in België.
De publicatie ‘Hébrant et al: BELG J MED ONCOL 2017;11(2):56-67d’ vormt de basis van deze bijkomende eisen. Werkgroepen van de ComPerMed en MD.be zorgen voor een actualisatie en verder detaillering hiervan. Gedurende accreditatie-audits, zal een specifieke beoordeling gebeuren om de naleving van de volgende specifieke vereisten na te gaan, waarbij alle relevante informatie opgenomen zal worden in het auditverslag.

PB - Sciensano CY - Brussels, Belgium ER - TY - RPRT T1 - Guidelines: "Médecine personnalisée": Exigences particulières pour l'accréditation des laboratoires médicaux qui réalisent des analyses de tumeurs hématologiques et solides selon la méthode Next Generation Sequencing Y1 - 2021 A1 - Centre du cancer A1 - Aline Hébrant KW - Guidelines KW - Médecine Personalisée KW - NGS AB -

Le présent document a pour objet d’informer les laboratoires médicaux des exigences particulières applicables pour l’exécution d’analyses de tumeurs hématologiques et solides selon la méthode Next Generation Sequencing (NGS). Ces exigences ont été définies par les groupes de travail de la « Commission de médecine personnalisée » (ComPerMed) et de Molecular Diagnostics.be. ComPerMed est un comité d'experts scientifiques belges dans ce domaine. Le séquençage de l'ADN/ARN avec la technique du « séquençage de prochaine génération » (NGS) permet un traitement personnalisé et optimise la prise en charge des patients cancéreux. MolecularDiagnostics.be est un forum de discussion et une plateforme pour ur les employés actifs dans le diagnostic moléculaire en Belgique. Ces exigences supplémentaires sont basées sur la publication « Hébrant et al: BELG J MED ONCOL 2017; 11 (2): 56-67d ». Les groupes de travail de ComPerMed et de MD.be veillent à ce qu'elles soient actualisées et détaillées. Au cours des audits d’accréditation, l’évaluation de la mise en œuvre des exigences particulières devra faire l’objet d’une attention particulière et les informations pertinentes seront intégrées au rapport d’audit.

PB - Sciensano ER - TY - JOUR T1 - Precision cancer medicine: What has translated into clinical use in Belgium? JF - Semin Cancer Biol Y1 - 2021 A1 - Marie Delnord A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Aline Antoniou A1 - Wannes Van Hoof A1 - Anouk Waeytens A1 - Marc Van den Bulcke KW - cancer KW - EVALUATION KW - implementation KW - Precision Medicine AB -

RATIONALE: In 2016, Belgium launched the Next Generation Sequencing (NGS) Roadbook, consisting in 10 Actions, across the health care system, to facilitate the uptake of NGS in routine clinical practice. We compiled feedback on deployment of the NGS Roadbook from governmental stakeholders and beneficiaries: health policy makers, insurance providers, pathologists, geneticists, and oncologists.

MAIN FINDINGS: The Roadbook ensured the establishment of a Commission on Personalized Medicine and NGS testing guidelines. A national benchmarking trial ensued, and 10 networks of hospitals and laboratories adopted a reimbursement convention with the Belgian Health Insurance Agency. The Healthdata.be platform centralizes the collection of NGS metrics, and citizens were consulted on their views about NGS and genomics.

CONCLUSION: The Roadbook facilitated the implementation of NGS in routine (hemato-)oncology care in Belgium. Some challenges remain linked to data sharing and access by a wider range of stakeholders. Next steps include continuous monitoring of health outcomes and the budgetary impact.

M3 - 10.1016/j.semcancer.2021.06.010 ER - TY - JOUR T1 - NGS for (Hemato-) Oncology in Belgium: Evaluation of Laboratory Performance and Feasibility of a National External Quality Assessment Program JF - Cancers Y1 - 2020 A1 - Thomas Delcourt A1 - Kevin Vanneste A1 - Mohamed Rida Soumali A1 - Wim Coucke A1 - V Ghislain A1 - Aline Hébrant A1 - Els Van Valckenborgh A1 - Sigrid C.J. De Keersmaecker A1 - Nancy Roosens A1 - P Van de Walle A1 - Marc Van den Bulcke A1 - Aline Antoniou KW - next-generation sequencing; hemato-oncology; oncology; external quality assessment; cancer AB -

Next-generation sequencing (NGS) is being integrated into routine clinical practice in the field of (hemato-) oncology to search for variants with diagnostic, prognostic, or therapeutic value at potentially low allelic frequencies. The complex sequencing workflows used require careful validation and continuous quality control. Participation in external quality assessments (EQA) helps laboratories evaluate their performance and guarantee the validity of tests results with the ultimate goal of ensuring high-quality patient care. Here, we describe three benchmarking trials performed during the period 2017–2018 aiming firstly at establishing the state-of-the-art and secondly setting up a NGS-specific EQA program at the national level in the field of clinical (hemato-) oncology in Belgium. DNAsamples derived from cell line mixes and artificially mutated cell lines, designed to carry variants of clinical relevance occurring in solid tumors, hematological malignancies, and BRCA1/BRCA2 genes, were sent to Belgian human genetics, anatomic pathology, and clinical biology laboratories, to be processed following routine practices, together with surveys covering technical aspects of the NGS workflows. Despite the wide variety of platforms and workflows currently applied in routine clinical practice, performance was satisfactory, since participating laboratories identified the targeted variants with success rates ranging between 93.06% and 97.63% depending on the benchmark, and few false negative or repeatability issues were identified. However, variant reporting and interpretation varied, underlining the need for further standardization. Our approach showcases the feasibility of developing and implementing EQA for routine clinical practice in the field of (hemato-) oncology, while highlighting the challenges faced.

VL - 12 CP - 11 M3 - 10.3390/cancers12113180 ER - TY - JOUR T1 - Algorithms for molecular testing in solid tumours JF - Belgian Journal of Medical Oncology (BJMO Y1 - 2019 A1 - Aline Hébrant A1 - M Lammens A1 - C Van den Broeck A1 - N. D’Haene A1 - J Van den Oord A1 - A. Vanderstichele A1 - A Dendooven A1 - P Neven A1 - K Punie A1 - G Floris A1 - J Van der Meulen A1 - H A Poirel A1 - C Dooms A1 - S Rottey A1 - T Boterberg A1 - L Brochez A1 - MC Burlacu A1 - G Costante A1 - D Creytens A1 - De Paepe, P A1 - R De Pauwn A1 - B Decallonne A1 - F Dedeurwaerdere A1 - H Denys A1 - L Ferdinande A1 - R Forsyth A1 - M Garmyn A1 - T Gevaert A1 - J De Grève A1 - E Govaerts A1 - E Hauben A1 - J Kerger A1 - O Kholmanskikh Van Criekingen A1 - V Kruse A1 - Y Lalami A1 - L Lapeire A1 - P Lefesvre A1 - JP Machiels A1 - B Maes A1 - G Martens A1 - M Remmelink A1 - I Salmon A1 - R Sciot A1 - S Tejpar A1 - K Van de Vijver A1 - L Van de Voorde A1 - I Van den Berghe A1 - A Van den Bruel A1 - K Vandecasteele A1 - L Vanwalleghem A1 - K Vermaelen A1 - R Salgado A1 - E Wauters A1 - B Weynand A1 - Els Van Valckenborgh A1 - G Raicevic A1 - Marc Van den Bulcke A1 - P Pauwels AB -

In order to advise the Federal Government on the reimbursement of molecular tests related to Personalised Medicine in Oncology, the Commission of Personalised Medicine (ComPerMed), represented by Belgian experts, has developed a methodology to classify molecular testing in oncology. The different molecular tests per cancer type are represented in algorithms and are annotated with a test level reflecting their relevance based on current guidelines, drug approvals and clinical data. The molecular tests are documented with recent literature, guidelines and a brief technical description. This methodology was applied on different solid tumours for which molecular testing is a clear clinical need.

VL - 13 CP - 7 ER - TY - JOUR T1 - Diagnostic testing in myeloid malignancies by next-generation sequencing: recommendations from the commission personalised medicine JF - Belgian Journal of Hematology Y1 - 2019 A1 - Els Van Valckenborgh A1 - E Boone A1 - A Camboni A1 - JP Defour A1 - B Denys A1 - H Devos A1 - L Dewispelaere A1 - Guy Froyen A1 - Aline Hébrant A1 - P Heimann A1 - P Hermans A1 - E Heylen A1 - K Jacobs A1 - F Lambert A1 - Marie Le Mercier A1 - Els Lierman A1 - H Louagie A1 - B Maes A1 - MB Maes A1 - G Martens A1 - L Michaux A1 - Friedel Nollet A1 - H A Poirel A1 - G Raicevic A1 - P Saussoy A1 - T Tousseyn A1 - Marc Van den Bulcke A1 - P Vandenberghe A1 - Karl Vandepoele A1 - P Vannuffel A1 - T Venken A1 - K Vermeulen AB -

Molecular diagnostics have an increasing impact on diagnosis, risk stratification and targeted treatment in haemato-oncology. In the framework of a pilot study for the implementation of next-generation sequencing in the Belgian healthcare system, the Commission of Personalised Medicine was founded to give professional and evidence-based advice on the molecular analysis in haemato-oncology. This paper describes its recommendations for NGS analysis in myeloid malignancies. In addition, the minimally required set of genes that must be analysed is defined and algorithms for molecular workflow in myeloid malignancies are proposed.

VL - 10 CP - 6 ER - TY - JOUR T1 - Molecular test algorithms for breast tumours JF - Belgian Journal of Medical Oncology Y1 - 2019 A1 - Aline Hébrant A1 - K Punie A1 - FP Duhoux A1 - C Colpaert A1 - G Floris A1 - K Lambein A1 - P Neven A1 - M Berlière A1 - R Salgado A1 - M Chintinne A1 - K Dahan A1 - S Dedeurwaerdere A1 - J De Grève A1 - A de Leener A1 - H Denys A1 - R de Putter A1 - L Desmyter A1 - M Baldewijns A1 - D Feret A1 - C Fontaine A1 - C Galant A1 - P Hilbert A1 - J Janssens A1 - D Larsimont A1 - P Lefesvre A1 - T Sticca A1 - MD Tkint de Roodenbeke A1 - I Vanden Bempt A1 - C Van den Broeck A1 - I Vandernoot A1 - C Sotiriou A1 - J Van Dorpe A1 - H Antoine-Poirel A1 - Els Van Valckenborgh A1 - Gordana Raicevic A1 - Marc Van den Bulcke A1 - P Aftimos AB -

In order to advise the Federal Government on all matters related to personalised medicine in oncology, including the reimbursement of molecular tests, the Commission of Personalized Medicine (ComPerMed) has applied, for the breast tumours, the same methodology as previously applied for the digestive tumours. Meaning, the different molecular tests, represented in the shape of algorithms, are annotated with test levels — which aim to reflect their relevance based on current available data and to define the reimbursement — and are documented with recent literature, guidelines and a brief technical description.

VL - 13 CP - 2 ER - TY - JOUR T1 - Standardization of Somatic Variant Classifications in Solid and Haematological Tumours by a Two-Level Approach of Biological and Clinical Classes: An Initiative of the Belgian ComPerMed Expert Panel. JF - Cancers (Basel) Y1 - 2019 A1 - Guy Froyen A1 - Marie Le Mercier A1 - Els Lierman A1 - Karl Vandepoele A1 - Friedel Nollet A1 - Elke Boone A1 - Joni Van der Meulen A1 - Koen Jacobs A1 - Suzan Lambin A1 - Sara Vander Borght A1 - Els Van Valckenborgh A1 - Aline Antoniou A1 - Aline Hébrant AB -

In most diagnostic laboratories, targeted next-generation sequencing (NGS) is currently the default assay for the detection of somatic variants in solid as well as haematological tumours. Independent of the method, the final outcome is a list of variants that differ from the human genome reference sequence of which some may relate to the establishment of the tumour in the patient. A critical point towards a uniform patient management is the assignment of the biological contribution of each variant to the malignancy and its subsequent clinical impact in a specific malignancy. These so-called biological and clinical classifications of somatic variants are currently not standardized and are vastly dependent on the subjective analysis of each laboratory. This subjectivity can thus result in a different classification and subsequent clinical interpretation of the same variant. Therefore, the ComPerMed panel of Belgian experts in cancer diagnostics set up a working group with the goal to harmonize the biological classification and clinical interpretation of somatic variants detected by NGS. This effort resulted in the establishment of a uniform, two-level classification workflow system that should enable high consistency in diagnosis, prognosis, treatment and follow-up of cancer patients. Variants are first classified into a tumour-independent biological five class system and subsequently in a four tier ACMG clinical classification. Here, we describe the ComPerMed workflow in detail including examples for each step of the pipeline. Moreover, this workflow can be implemented in variant classification software tools enabling automatic reporting of NGS data, independent of panel, method or analysis software.

VL - 11 CP - 12 M3 - 10.3390/cancers11122030 ER - TY - JOUR T1 - Opportunities and challenges in oncology and molecular testing: the Belgian strategy JF - Belg J Med Oncol Y1 - 2018 A1 - Aline Hébrant A1 - Els Van Valckenborgh A1 - Roberto Salgado A1 - Guy Froyen A1 - Frank Hulstaert A1 - Dominique Roberfroid A1 - Sabine Tejpar A1 - Anne Jouret-Mourin A1 - Marc Van den Bulcke A1 - Anouk Waeytens AB - Molecular diagnostics in cancer aiming at improving diagnosis, prognosis and treatment are constantly exposed to new opportunities and challenges. The Belgian Commission of Personalised Medicine (ComPer-Med) has been created to advise the Federal Government on all matters related to personalised medicine in oncology, including the reimbursement of molecular tests. Here, we propose the Belgian strategy for molecular testing within a scientific based framework and its implementation in the Belgian healthcare system. For each tested biomarker a clinical test level is attached, which is key to establish the relevance of the test and to define the reimbursement. VL - 12 CP - 2 ER - TY - JOUR T1 - Roadbook for the implementation of next-generation sequencing in clinical practice in oncology and hemato-oncology in Belgium. JF - Arch Public Health Y1 - 2018 A1 - Els Van Valckenborgh A1 - Aline Hébrant A1 - Aline Antoniou A1 - Wannes Van Hoof A1 - Johan Van Bussel A1 - Patrick Pauwels A1 - Roberto Salgado A1 - Waltruda van Doren A1 - Anouk Waeytens A1 - Marc Van den Bulcke AB -

In the field of oncology research, next-generation sequencing has contributed significantly to the discovery of DNA mutations associated with diagnosis and prognosis. It also aids in the development of targeted therapies to specific mutations and the rise of personalized medicine. As part of molecular diagnostics in cancer patients, analysis by next-generation sequencing is becoming part of routine clinical practice. The introduction of this complex technology in a healthcare system comes with multiple challenges and requires a clear action plan. Such an action plan, as outlined in this paper, was developed in Belgium and includes steps in ensuring the quality and indications of NGS testing, installing data registration and tackling ethical issues. A final step is to perform a pilot study to control the access, quality, harmonization and expertise in DNA testing. This action plan can serve as a guide for similar initiatives by other countries to facilitate NGS implementation in clinical practice.

VL - 76 M3 - 10.1186/s13690-018-0295-z ER - TY - JOUR T1 - The Belgian NGS guidelines for (haemato)-oncology: 2016- version 01 JF - BSMO J Y1 - 2016 A1 - Aline Hébrant A1 - Froyen,G. A1 - Maes,B. A1 - Salgado,R. A1 - Le Mercier,M. A1 - D'Haene,N. A1 - Sigrid C.J. De Keersmaecker A1 - Claes,K. A1 - Van der Meulen,J. A1 - Aftimos,P. A1 - Van Houdt,J. A1 - Cuppens,K. A1 - Kevin Vanneste A1 - Dequeker,E. A1 - Van Dooren,S. A1 - Van Huysse,J. A1 - Nollet,F. A1 - van Laere,S. A1 - Denys,B. A1 - V Ghislain A1 - C . Van Campenhout A1 - Marc Van den Bulcke KW - / KW - Belgian KW - Guidelines KW - NGS KW - Version AB - / VL - / U1 - 5785 ER - TY - Generic T1 - Symposium NGS 2016 - ​Guidelines ‘NGS in (hemato-)oncology' NGS genepanel testing (EN) Y1 - 2016 A1 - Aline Hébrant KW - Next-generation sequencing (NGS) KW - NGS KW - oncology KW - personalized medicine AB -

The NGS in (haemato)-oncology
1. The Belgian NGS guidelines for (haemato)- oncology
2. NGS gene panels for oncological use – solid tumors

JF - Symposium NGS 2016 PB - Sciensano CY - Brussels, Belgium ER - TY - JOUR T1 - PRECISION: the Belgian molecular profiling program of metastatic cancer for clinical decision and treatment assignment Y1 - 0 A1 - J. Thouvenin1,2 A1 - C. Van Marcke3 A1 - L. Decoster4 A1 - G. Raicevic A1 - K. Punie A1 - M. Vandenbulcke5 A1 - R. Salgado A1 - Els Van Valckenborgh A1 - B. Maes A1 - S. Joris A1 - D. Vander Steichel A1 - K. Vranken A1 - S. Jacobs A1 - F. Dedeurwaerdere12 A1 - G. Martens A1 - F. H. Devos A1 - F. P. Duhoux A1 - M. Rasschaert A1 - P. Pauwels17 A1 - K. Geboes A1 - J. Collignon20 A1 - S. Tejpar A1 - J.-L. Canon21 A1 - M. Peeters A1 - A. Rutten A1 - T. Van de Mooter23 A1 - J. Vermeij A1 - D. Schrijvers A1 - W. Demey A1 - W. Lybaert A1 - J. Van Huysse27 A1 - J. Mebis A1 - A. Awada A1 - K. B. M. Claes A1 - Aline Hébrant A1 - J. Van der Meulen A1 - B. Delafontaine30 A1 - I. Vanden Bempt A1 - J Maetens A1 - Maïté de Hemptinne A1 - S. Rottey A1 - P. Aftimos28 A1 - J. De Grève4 KW - genomic alterations KW - genomic-driven therapy KW - metastatic tumors KW - molecular tumor board KW - Next-generation sequencing (NGS) AB -

PRECISION is an initiative from the Belgian Society of Medical Oncology (BSMO) in collaboration with several stakeholders, encompassing four programs that aim to boost genomic and clinical knowledge with the ultimate goal to offer patients with metastatic solid tumors molecularly guided treatments. The PRECISION 1 study has led to the creation of a clinicogenomic database. The Belgian Approach for Local Laboratory Extensive Tumor Testing (BALLETT) and GeNeo studies will increase the number of patients with advanced cancer that have comprehensive genotyping of their cancer. The PRECISION 2 project consists of investigator-initiated phase II studies aiming to provide access to a targeted drug for patients whose tumors harbor actionable mutations in case the matched drug is not available through reimbursement or clinical trials in Belgium.

ER -