Abstract

Simple SummaryMany 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.

Highlights

  • Cutaneous melanoma (CM) incidence has been increasing steadily since 1980, whilecutaneous melanoma (CM) mortality has decreased [1,2,3].One reason for this may be melanoma diagnoses at earlier tumor stages and due to the introduction of new systemic treatments during the last decade [4]

  • We previously reported results from a prospective study using a gene expression profile test (31-GEP) that uses the expression of discriminating and control genes from the primary tumor to stratify patients with stage IB–II CM by recurrence risk [8]

  • The objective of this study was to report updated disease-free survival (DFS) stratification according to 31-gene expression profile (31-GEP) classes (1A, 1B/2A, 2B) for longer-term outcomes to confirm the validity of the 31-GEP test in the study population

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Summary

Introduction

Cutaneous melanoma (CM) incidence has been increasing steadily since 1980, whileCM mortality has decreased [1,2,3].One reason for this may be melanoma diagnoses at earlier tumor stages and due to the introduction of new systemic treatments during the last decade [4]. Patients with stage I–II CM have localized disease, while stage III CM is characterized by the presence of microsatellites or regional metastasis, and stage IV by distant metastasis. Most newly diagnosed CM patients are diagnosed with localized, early stage I–II CM [4,5]. Despite overall good outcomes for many patients with localized disease (98% and 90% 5-year melanoma-specific survival for stage I and II, respectively) [6], 15% of stage I and 40% of stage II patients will still experience a recurrence or metastasis and may die from their disease [7]. We previously reported results from a prospective study using a gene expression profile test (31-GEP) that uses the expression of discriminating and control genes from the primary tumor to stratify patients with stage IB–II CM by recurrence risk [8]. Patient outcomes were compared using Kaplan-Meier and Cox regression analysis

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