Using a 31-Gene Expression Profile Test to Stratify Patients with Stage I–II Cutaneous Melanoma According to Recurrence Risk: Update to a Prospective, Multicenter Study.

Simple Summary: Many people with skin cancer will have their cancer come back. The 31-gene expression profile (31-GEP) test can help predict if a cancer has a low (Class 1) or high (Class 2) chance of returning. This study looked at 86 patients with early skin cancer to see how well the 31-GEP test predicted if their cancer would return. None of the patients with a Class 1 GEP result had their cancer return within 3 years, but one-fourth of patients with a Class 2 result did. This study showed that the 31-GEP test can help predict if a patient's skin cancer will return. Accurate risk prediction can help doctors make better treatment plans for patients with skin cancer. Background: Fifteen to forty percent of patients with localized cutaneous melanoma (CM) (stages I–II) will experience disease relapse. The 31-gene expression profile (31-GEP) uses gene expression data from the primary tumor in conjunction with clinicopathologic features to refine patient prognosis. The study's objective was to evaluate 31-GEP risk stratification for disease-free survival (DFS) in a previously published cohort with longer follow-up. Methods: Patients with stage IB–II CM (n = 86) were prospectively tested with the 31-GEP. Follow-up time increased from 2.2 to 3.9 years. Patient outcomes were compared using Kaplan-Meier and Cox regression analysis. Results: A Class 2B result was a significant predictor of 3-year DFS (hazard ratio (HR) 8.4, p = 0.008) in univariate analysis. The 31-GEP significantly stratified patients by risk of relapse (p = 0.005). A Class 2B result was associated with a lower 3-year DFS (75.0%) than a Class 1A result (100%). The 31-GEP had a high sensitivity (77.8%) and negative predictive value (95.0%). Conclusions: The 31-GEP is a significant predictor of disease relapse in patients with stage IB–II melanoma and accurately stratified patients by risk of relapse. [ABSTRACT FROM AUTHOR]