Prognostic significance of an 11-gene RNA assay in archival tissue of cutaneous melanoma stage I-III patients.

The purpose of this study was to validate the results of an 11-gene expression profiling (GEP) assay which aims to improve the precision of individual prognosis beyond conventional American Joint Committee on Cancer staging for patients with cutaneous melanoma. The reverse transcriptase polymerase chain reaction test of 11 prospectively selected genes was performed on 291 formalin-fixed, paraffin-embedded primary tumours of patients with stage I-III cutaneous melanoma. The expression levels of eight prognostic and three reference genes were used in a predefined algorithm to calculate a numerical score (-0.84 to 3.53) and then assign each patient to a preselected risk group (low versus high score) for melanoma-specific survival (MSS). One hundred twenty-seven patients were allocated to the low-score group, with a corresponding five-year disease-free survival (DFS) and MSS of 95% and 99%, respectively. 164 patients were allocated to the high-score group, with a corresponding five-year DFS and MSS of 78% and 88%. Continuous regression analysis demonstrated decreasing MSS probabilities with increasing scores. In a multivariate cox regression, only the 11-GEP, tumour thickness and age were statistically associated with MSS (p = 0.0068, 0.002 and 0.0159). The 11-GEP has been validated as an independent predictor of outcome for melanoma patients. More specifically, using an 11-GEP score cut-off of ≤0, the assay can identify patient cohorts with 10-year survival probabilities well above 90%. This information may be used in the decision-making for a potential adjuvant therapy.

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Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement T. Gambichler reports receiving speakers and/or advisory board honoraria from BMS, Sanofi-Genzyme, MSD, Novartis Pharma, Roche, Abbvie, Almirall, Janssen, Lilly, Pfizer, Neracare, Pierre Fabre, outside the submitted work; U.Reinhold reports receiving speakers and/or advisory board honorarira from Novartis, Janssen, Pierre Fabre, Almirall, outside the submitted work; A. Hauschild reports receiving grants and personal fees from Amgen, grants and personal fees from BMS, grants and personal fees from MerckSerono, grants and personal fees from MSD/Merck, grants and personal fees from Philogen, grants and personal fees from Pierre Fabre, grants and personal fees from Provectus, grants and personal fees from Regeneron, grants and personal fees from Roche, personal fees from OncoSec, grants and personal fees from Sanofi-Genzyme, personal fees from Sun Pharma, grants and personal fees from Novartis Pharma outside the submitted work; T. Amaral reports receiving grants from Neracare; travel support from Novartis, personal fees and travel support from BMS, personal fees from the Klinik für Dermatologie und Allergologie Universitätsklinikum Gieβen und Marburg GmbH, outside the submitted work; C. Garbe reports receiving grants and personal fees from Neracare during the conduction of the study; personal fees from Amgen, personal fees from MSD, grants and personal fees from Novartis, grants and personal fees from BMS, personal fees from Philogen, grants and personal fees from Roche, grants and personal fees from Sanofi, outside the submitted work. No potential conflicts of interest were disclosed by all other authors.