Abstract

Background: Sentinel node biopsy is a prognostic indicator of melanoma recurrence. We hypothesized that the addition of the primary melanoma molecular signature from the 31-gene expression profile (31-GEP) test could refine the risk of recurrence for patients with a negative, positive, or no sentinel node biopsy, respectively. Materials and methods: Kaplan-Meier, Cox regression, and accuracy metrics were retrospectively analyzed for 438 patients with stage I-III melanoma from 2 surgical oncology centers and 1 dermatology center, consecutively tested with the 31-GEP test. Patients were stratified by the 31-GEP as low-risk (Class 1A), intermediate-risk (Class 1B/2A), and high-risk (Class 2B) of recurrence or metastasis. Results: The 31-GEP significantly stratified patient risk for RFS (P < .001), DMFS (P < .001), and MSS (P < .001), and was a significant, independent predictor of metastatic recurrence (HR 5.38, P = .014). Combining the 31-GEP with sentinel lymph node status identified patients with higher (26.7%; Class 2B/node-positive) or lower (2.0%; Class 1A/node-negative) recurrence risk than if using SLN status alone. Conclusions: The 31-GEP improves prognostic accuracy in stage I-III melanoma.

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