Long-Term Outcomes in a Multicenter, Prospective Cohort Evaluating the Prognostic 31-Gene Expression Profile for...

Area of Science:

• Oncology
• Dermatology
• Molecular Diagnostics

Background:

• Current guidelines for stage I-IIA cutaneous melanoma (CM) lack methods to identify patients at high risk for metastasis.
• Improved risk stratification is needed to complement the American Joint Committee on Cancer (AJCC) staging system.

Purpose of the Study:

• To evaluate the prognostic value of a 31-gene expression profile (31-GEP) test in patients with stage I-III CM.
• To determine if stage I-IIA CM patients with a high-risk 31-GEP signature (class 2) have a metastatic risk comparable to higher-stage CM patients.

Main Methods:

• Prospective analysis of 323 patients with stage I-III CM from two multicenter registry studies (INTEGRATE and EXPAND).
• Assessment of 3-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS).
• Univariate and multivariable analyses of the 31-GEP's predictive performance.

Main Results:

• The 31-GEP was a significant independent predictor of RFS, DMFS, and OS across all stages.
• Stage I-IIA CM patients with a class 2 31-GEP result exhibited recurrence, metastasis, and death rates similar to stage IIB-III CM patients.
• Combining 31-GEP results with AJCC staging improved sensitivity for risk prediction compared to either method alone.

Conclusions:

• The 31-GEP test provides significant prognostic value for CM patients.
• Stage I-IIA CM patients with a class 2 31-GEP signature may benefit from more intensive surveillance strategies.
• Integrating 31-GEP with AJCC staging enhances the identification of high-risk patients.