5 april 2025: Bron: European Journal of cancer, Available online 4 April 2025
Wanneer bij melanoompatiënten stadium I/II geen schildwachtklierbiopsie is uitgevoerd zou een aanvuillende Merlin CP-GEP test alsnog patiënten in kunnen delen in laag of hoog risico op een recidief. En daardoor belangrijk voor chirurgen bij operaties en gepersonaliseerde behandelingen. Dat blijkt uit een 10-jarige studie bij totaal 930 melanoompatiënten met stadium I/II die na de diagnose geen schildwachtklierbiopsie hadden gehad.
De belangrijkste resultaten uit de studie vertaald uit het abstract van het studierapport:
- Merlin CP-GEP testte succesvol 930 stadium I/II melanoom patienten: 879 (94.5%) bleken Merlin Laag-Risico en 51 (5.5%) bleken achteraf Merlin Hoog-Risico te zijn geweest.
- Patienten geïdentificeerd als Laag-Risico toonden een uitstekende 5-jaars en 10-jaars recidiefvrije overlevingspercentage (RFS) van 96% en 94.5% respectievelijk.
- Patienten in de Merlin (CP-GEP) Hoog-Risico groep werden ongeveer 20 keer vaker gezien met een recidief vergeleken met de Merlin Laag-Risico groep. In die groep was de 5-jaars en 10-jaars recidiefvrije overleving 37.5% voor beide einddoelen .
- Aanvullend: Hoog-Risico patienten toonden significante verhoogde percentages van uitzaaiingen op afstand en aan het melanoom gerelateerd overlijden, daarmee de klinische waarde aantonend van de Merlin CP-GEP test in het identificeren van patienten op hoog risico voor een recidief.
Hier een grafiek uit het studierapport gekopieerd:

CP-GEP is een niet-invasief voorspellingsmodel voor patiënten met cutaan melanoom en is de enige commercieel beschikbare GEP-test die klinisch-pathologische (CP) variabelen combineert met genexpressieprofilering (GEP) in één geïntegreerd algoritme. Dit CP-GEP-model is ook de enige GEP-test die een binaire stratificatie van alle patiënten biedt op basis van een hoog of laag risico op metastasen en hen daardoor toewijst aan de juiste chirurgische actiecategorieën zoals vermeld in op bewijs gebaseerde richtlijnen voor kankerbehandeling, preventie en screening.
Het volledige studierapport is al online gepubliceerd in European Journal of Cancer en wordt ook uitgebreid toegelicht in een persbericht op de website van SkylineDx, gevestigd in Rotterdam o.a.
Original Research
Risk stratification using the Merlin Assay (CP-GEP) in an independent cohort of 930 patients with clinical stage I/II melanoma who did not undergo sentinel lymph node biopsy
Under a Creative Commons license
Open access
Funding
This study was partially funded by SkylineDx - all funds paid to the Institution - Dermato-oncology Department of the University Hospital Tuebingen. We acknowledge support from the Open Access Publication Fund of the University of Tübingen.
CRediT authorship contribution statement
Teresa Amaral: Study concept, Data Collection, Data analysis, Data interpretation, Writing, Final approval. Eftychia Chatziioannou: Study concept, Data Collection, Data analysis, Data interpretation, Writing, Final approval. Alica Nuebling: Data Collection, Data interpretation, Writing, Final approval. Lena Nanz: Data Collection, Data analysis, Data interpretation, Writing, Final approval. Tobias Sinnberg: Study concept, Data Collection, Data interpretation, Writing, Final approval. Heike Niessner: Study concept, Data Collection, Data interpretation, Writing, Final approval. Tim Arentsen: Study concept, Data Collection, Data analysis, Data interpretation, Writing, Final approval. Romy Ruiter: Data Collection, Data analysis, Data interpretation, Writing, Final approval. Jvalini Dwarkasing: Study concept, Data analysis, Data interpretation, Writing, Final approval. Alexander M. Eggermont: Study concept, Data analysis, Data interpretation, Writing, Final approval. Ulrike Leiter: Data Collection, Data analysis, Data interpretation, Writing, Final approval. Lukas Flatz: Data interpretation, Writing, Final approval. Stephan Forchhammer: Study concept, Data Collection, Data analysis, Data interpretation, Writing, Final approval.
Declaration of Competing Interest
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: TA reports personal fees for advisory board membership from Delcath and Philogen; personal fees as an invited speaker from Bristol Myers Squibb (BMS), Medscape, Neracare, Novartis and Pierre Fabre; personal fees for a writing engagement from CeCaVa and Medtrix; institutional fees as local principal investigator (PI) from Agenus Inc., AstraZeneca, BioNTech, BMS, HUYA Bioscience, Immunocore, IO Biotech, MSD, Pfizer, Philogen, Regeneron, Roche and University Hospital Essen; institutional fees as coordinating PI from Unicancer; institutional research grants from iFIT and Novartis; institutional funding from MNI - Naturwissenschaftliches und Medizinisches Institut, Neracare, Novartis, Pascoe, Sanofi and Skyline-Dx; non-remunerated membership of the American Society of Clinical Oncology (ASCO) and the Portuguese Society for Medical Oncology; a role as clinical expert in the area of medical oncology for Infarmed, and a role as an expert for SGA-Oncology at EMA. EC: No relationships to disclose. AL: No relationships to disclose. LN: No relationships to disclose. TS: reports institutional funding from Novartis and Pierre-Fabre outside the submitted work. HN: reports institutional funding from Novartis and Pierre-Fabre outside the submitted work. TA: reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V. RR: reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V. JD: reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V.; Leadership – SkylineDx B.V. and Honoraria – SciBase A.B. AE: reports stock and other ownership interests - IO Biotech, Sairopa B.V., SkylineDx B.V.; Honoraria Consulting or Scientific Advisory Role - Agenus, Boehringer Ingelheim GmbH, BioInvent, BioNTech, Brenus, CatalYm GmbH, Egle, Eurobio, ImmTech, IO Biotech, IQVIA, Merck KgA, Merck&Co, MSD, Oncolytics, Pierre Fabre, Sairopa BV, Secarna GmbH, SkylineDx B.V., Thermosome GmbH, Trained Immunity Therapeutics Discovery; Data safety monitoring board: BioNTech, IQVIA, Pfizer. UL: reports research support from MSD, consulting fees and honoraria from Sun Pharma, Sanofi (personal and institutional), MSD (personal and institutional), Novartis, Roche, Almirall Hermal, support for attending meeting from Sun Pharma and participation on a Data Safety Monitoring Board or Advisory Board from Sun Pharma, Sanofi, MSD, Novartis, Roche, Almirall Hermal, outside the submitted work. LF: reports Grants or contracts from Hookipa Pharma, SAKK / Immunophotonics, DFG Grant (Deutsche Forschungsgemeinschaft), Philogen and Mundipharma; consulting fees from Philogen, Sanofi, Novartis, BMS; participation on Data Safety Board University of Basel and stocks or stock options from Hookipa Pharma, outside the submitted work. SF: reports institutional funding from SkylineDx B.V. in relation with the submitted work; institutional grants from BioNTech and Neracare as well as personal honoraria for lectures from Recordati, Kyowa Kirin and Stemline Pharmaceutical, outside the submitted work.
Appendix A. Supplementary material
Supplementary Figure 1 - 5- and 10 years relapse free survival, distant metastasis free survival, melanoma specific survival and overall survival for the whole cohort
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