Articles

Genetic and molecular biology in pancreatobiliary cancers: Testing for pancreatobiliary cancer in the context of the Belgian NGS convention

BJMO - volume 15, issue 4, june 2021

Ir A. Hébrant PhD, H. Antoine-Poirel MD, PhD, K.B.M. Claes PhD, F. Dedeurwaerdere MD, J. Van der Meulen MD, F. Lambert MD, J. Van Huysse MD, G. Martens MD, PhD, N. D’Haene MD, PhD, K. Geboes MD, PhD, P. Pauwels MD, PhD, A. Jouret-Mourin MD, PhD, P. Peeters MD, M. van den Eynde MD, PhD, R. Salgado MD, PhD, P-J. Van Dam MD, P. Lefesvre MD, PhD, X. Sagaert MD, S. Metsu PhD, A. Demols MD, PhD, J-L. van Laethem MD, PhD

SUMMARY

Pancreatobiliary cancers (PBC) group pancreatic and biliary tract cancers and are among the cancers with the lowest survival rate. Emerging data suggest that novel biomarker-specific targeted therapies can be proposed for selected populations with survival benefit. This review summarises the scientific evidence to test for these biomarkers in order to optimise the management of pancreatobiliary cancers, within the context of the Belgian NGS convention.

(BELG J MED ONCOL 2021;15(4):170-6)

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Algorithms for molecular testing in solid tumours

BJMO - volume 13, issue 7, november 2019

Ir A. Hébrant PhD, M. Lammens MD, PhD, C. Van den Broecke MD, N. D’Haene MD, PhD, J. Van den Oord MD, PhD, A. Vanderstichele MD, PhD, A. Dendooven MD, PhD, P. Neven MD, PhD, K. Punie MD, G. Floris MD, PhD, J. Van der Meulen MD, HA. Poirel MD, PhD, C. Dooms MD, PhD, S. Rottey MD, PhD, T. Boterberg MD, PhD, L. Brochez MD, PhD, M.C. Burlacu MD, G. Costante MD, D. Creytens MD, PhD, P. De Paepe MD, PhD, R. De Pauwn MD, B. Decallonne MD, PhD, F. Dedeurwaerdere MD, H. Denys MD, PhD, L. Ferdinande MD, PhD, R. Forsyth MD, PhD, M. Garmyn MD, PhD, T. Gevaert MD, PhD, J. De Grève MD, PhD, E. Govaerts MD, E. Hauben MD, PhD, J. Kerger MD, O. Kholmanskikh Van Criekingen MD, PhD, V. Kruse MD, PhD, Y. Lalami MD, L. Lapeire MD, PhD, P. Lefesvre MD, PhD, J.P. Machiels MD, PhD, B. Maes MD, PhD, G. Martens MD, PhD, M. Remmelink MD, PhD, I. Salmon MD, PhD, R. Sciot MD, PhD, S. Tejpar MD, PhD, K. Van de Vijver MD, PhD, L. Van de Voorde MD, I. Van den Berghe MD, A. Van den Bruel MD, K. Vandecasteele MD, PhD, L. Vanwalleghem MD, K. Vermaelen MD, PhD, R. Salgado MD, PhD, E. Wauters MD, PhD, B. Weynand MD, PhD, E. Van Valckenborgh PhD, G. Raicevic PhD, M. Van den Bulcke PhD, P. Pauwels MD, PhD

SUMMARY

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.

(BELG J MED ONCOL 2019;13(7):286–95)

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Molecular test algorithms for breast tumours

BJMO - volume 13, issue 2, march 2019

Ir A. Hébrant PhD, K. Punie MD, F.P. Duhoux MD, PhD, C. Colpaert MD, PhD, G. Floris MD, PhD, K. Lambein MD, PhD, P. Neven MD, PhD, M. Berlière MD, PhD, R. Salgado MD, PhD, M. Chintinne MD, PhD, K. Dahan MD, PhD, S. Dedeurwaerdere MD, J. De Grève MD, PhD, A. de Leener MD, PhD, H. Denys MD, PhD, R. de Putter MD, L. Desmyter PhD, M. Baldewijns MD, PhD, D. Feret MD, C. Fontaine MD, C. Galant MD, P. Hilbert PhD, J. Janssens MD, PhD, D. Larsimont MD, PhD, P. Lefesvre MD, PhD, T. Sticca PhD, M-D. Tkint de Roodenbeke MD, G. Van Den Eynden MD, PhD, I. Vanden Bempt PhD, C. Van den Broecke MD, I. Vandernoot MD, C. Sotiriou MD, PhD, J. van Dorpe MD, PhD, H.A. Poirel MD, PhD, E. Van Valckenborgh PhD, G. Raicevic PhD, M. Van den Bulcke PhD, P. Aftimos MD

SUMMARY

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.

(BELG J MED ONCOL 2019;13(2):40–45)

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Molecular test algorithms for digestive tumours

BJMO - volume 13, issue 1, february 2019

Ir A. Hébrant PhD, Ir , A. Jouret-Mourin MD, PhD, G. Froyen PhD, J. Van der Meulen MD, M. De Man MD, R. Salgado MD, PhD, M. van den Eynde MD, PhD, N. D’Haene MD, PhD, G. Martens MD, PhD, E. van Cutsem MD, PhD, H.A. Poirel MD, PhD, S. Tejpar MD, PhD, J-L. van Laethem MD, PhD, K. Geboes MD, PhD, P. Pauwels MD, PhD, F. Dedeurwaerdere MD, B. Maes MD, PhD, J. De Grève MD, PhD, J. Vanhuysse , P. Peeters MD, L. Vanacker MD, M. Gomez-Galdon , M. Chintinne MD, PhD, A. Hendlisz MD, PhD, G. de Hertogh MD, X. Sagaert MD, M. Peeters MD, PhD, P. Vannuffel , P. Lefesvre MD, PhD, J. Vermeij , M. Simoens , T. Van den Mooter MD, N. van Damme , M. Van den Bulcke PhD

The Belgian Commission of Personalized Medicine 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 in the digestive tumours within a scientific-based framework. 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. For each digestive tumour type, the different molecular tests are represented as decision trees with its test utility, test level and a brief technical test description.

(BELG J MED ONCOL 2019;13(1):4–10)

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Opportunities and challenges in oncology and molecular testing: the Belgian strategy

BJMO - volume 12, issue 2, march 2018

Ir A. Hébrant PhD, E. Van Valckenborgh PhD, R. Salgado MD, PhD, G. Froyen PhD, F. Hulstaert MD, D. Roberfroid MD, PhD, S. Tejpar MD, PhD, A. Jouret-Mourin MD, PhD, M. Van den Bulcke PhD, A. Waeytens PhD

Summary

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.

(BELG J MED ONCOL 2018;12(2):46–50)

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The Belgian next generation sequencing guidelines for haematological and solid tumours

BJMO - volume 11, issue 2, march 2017

Ir A. Hébrant PhD, G. Froyen PhD, B. Maes MD, PhD, R. Salgado MD, PhD, M. Le Mercier PhD, N. D’Haene MD, PhD, S. De Keersmaecker PhD, K. Claes PhD, J. Van der Meulen MD, P. Aftimos MD, J. Van Houdt PhD, K. Cuppens MD, K. Vanneste PhD, E. Dequeker PhD, S. Van Dooren PhD, J. Van Huysse MD, F. Nollet PhD, S. Van Laere PhD, B. Denys MD, V. Ghislain , C. Van Campenhout PhD, M. Van den Bulcke PhD

SUMMARY

Targeted next generation sequencing is a complex procedure including the ‘wet bench’ and ‘dry bench’ parts. Both parts are composed of many steps for which optimal assay conditions and settings must be determined.

The aim of these guidelines is to provide generic, platform independent, recommendations for targeted next generation sequencing tests to detect acquired somatic mutations in DNA, in (haemato)-oncology that are complementary to the ISO 15189 norm (medical laboratories) in order to:

  1. facilitate the implementation of the required quality metrics for the detection of somatic variants by next generation sequencing in oncology and haemato-oncology in the Belgian laboratories,
  2. harmonise test validation and verification,
  3. harmonise clinical interpretation and reporting of variants and,
  4. assure and maintain optimal test performance by establishing procedures and modalities for internal quality control and external quality assessments.

(BELG J MED ONCOL 2017;11(2):56–67)

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State of the art: gene expression profiles in early breast cancer

BJMO - volume 10, issue 4, july 2016

K. Van Asten MSc, P. Neven MD, PhD, G. Floris MD, PhD, R. Salgado MD, PhD, C. Sotiriou MD, PhD, H. Wildiers MD, PhD

Summary

Gene expression profiles provide strong prognostic information and can predict breast cancer outcome mainly in women with lymph node-negative, oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. They are primarily designed to enable a more precise assessment on whether or not a patient needs adjuvant chemotherapy. However, the optimal use in clinical practice is still not established. The first set of data published from the TAILORx study and the results from the MINDACT study provide strong evidence for the clinical utility of gene expression profiles. Full disclosure of the results of prospective studies such as MINDACT and TAILORx on this topic is awaited in order to define their exact place in clinical decision-making. However, in several countries, these tests are already used in daily clinical practice, and are reimbursed. In addition, the use of gene expression profiles as a potential ancillary tool for treatment decisions is supported in several international treatment guidelines. Multiple studies have shown that there is a change in treatment decision based on gene expression profiles. In addition, different assays may provide different risk stratification at short-, middle- and long-term, so thoughtful use of these tests is recommended. Patients should be well informed about the benefits, risks, costs and uncertainties associated with these tests. Clinicians should also be educated on these matters. Furthermore, as gene expression profiles are expensive and not reimbursed in many countries, these tests are not accessible to all breast cancer patients. Patients’ preferences are important when making risk assessments and treatment decisions in those cases where there is doubt on the benefit of giving adjuvant chemotherapy. Taken together, gene expression profiles provide information that may be complementary to that provided by standard clinicopathological assessment in guiding decision of therapy in the adjuvant setting. These assays represent a step forward towards personalised medicine. We strongly propose to allow reimbursement of gene expression profiles in Belgium, but pragmatic and clear criteria for reimbursement should be developed with all stakeholders to avoid overconsumption.

(BELG J MED ONCOL 2016;10(4):114–122)

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