Identification of stage I/II melanoma patients at high risk for recurrence using a model combining clinicopathologic factors with gene expression profiling (CP-GEP).

Patients with cutaneous melanoma stage I/IIA disease are currently not eligible for adjuvant therapy, despite their risk for relapses and death. This study validates the ability of a model combining clinicopathologic factors with gene expression profiling (CP-GEP) to identify patients at high risk for disease recurrence in stage I/II and subgroup stage I/IIA. 543 patients with stage I/II primary cutaneous melanoma from the University of Tuebingen diagnosed between 2000 and 2017 were analysed. All patients received sentinel lymph node biopsy (SLNB). Analysis was conducted for a separate group of 80 patients who did not undergo SLNB. CP-GEP stratified 424 stage I/IIA patients (78% of the cohort) according to their risk for recurrence, with five-year relapse-free survival (RFS) rates of 77.8% and 93% for CP-GEP high risk (195 patients) and low risk (229 patients), respectively, and hazard ratio of 3.53 (p-value <0.001). In patients who did not receive SLNB biopsy, CP-GEP captured 6 out of 7 relapses. CP-GEP can be used to identify primary cutaneous melanoma patients with a high risk for disease recurrence - especially for stage I/IIA, who are considered low risk by AJCC 8th. These patients may benefit from adjuvant therapy. Also, in the future, when SLNB may become irrelevant, CP-GEP may serve as a risk stratification tool.

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Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: TA reports institutional funding from SkylineDx B.V. in relation to the submitted work. Dr. TA reports personal honoraria from BMS, CeCaVa, Novartis and Pierre-Fabre; Institutional financial support from iFIT, Neracare, Novartis and Sanofi and institutional research Grant from Novartis, outside the submitted work. TS reports institutional funding from Novartis and Pierre-Fabre outside the submitted work. EC reports no relationships to disclose. HN reports institutional funding from Novartis and Pierre-Fabre outside the submitted work. 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. UK reports no relationships to disclose. AF reports honoraria for presentations for BMS, MSD, Novartis, Pierre-Fabre; Travel support and congress participation support from BMS, Pierre-Fabre, Novartis; Advisory Boards from MSD, BMS, Novartis, Pierre-Fabre, Immunocore and institutional funding from BMS Stiftung Immunonkologie, outside the submitted work. JD reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V.; Leadership – SkylineDx B.V. and Honoraria – SciBase A.B. FTF reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V. RW reports stock and other ownership interests – SkylineDx B.V., Employment – SkylineDx B.V. 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. AE reports stock and other ownership interests - IO Biotech, Sairopa, SkylineDx B.V.; Honoraria – BMS; Merck/MSD Consulting or Advisory Role - Agenus, BioInvent, Brenus, CatalYm, Clover Pharmaceuticals, Ellipses, Galecto, GSK, IO Biotech, Immunicum, ISA Pharmaceuticals, Merck, MSD, Sairopa, Sellas, SkylineDx B.V., TigaTx, Trained Therapeutics; Data safety monitoring board: Biocad, BioNTech, GSK, Pfizer; Advisory board: BioInvent, CatalYm, GSK, IO Biotech, Merck. SF reports institutional funding from SkylineDx B.V. in relation to the submitted work. Dr. SFalso reports institutional Grants/Contracts from Biontech and Neracare and personal honoraria for lectures from Recordati and KyowaKirin, outside the submitted work.