Hsueh EC, et al. – For the patients enrolled in two clinical registries, this reported study prospectively assessed the gene expression profile (GEP) performance. The ability of the 31–gene GEP’s to stratify early–stage cutaneous melanoma (CM) patients into two groups with significantly different metastatic risk, was supported by interim analysis of patient outcomes from a combined prospective cohort. In addition, GEP testing complemented current clinicopathologic features and increased identification of high–risk patients.

Methods

• The criteria of age ≥ 16 years, successful GEP result and ≥1 follow-up visit for inclusion in this interim analysis was satisfied by three-hundred twenty two CM patients enrolled in the EXPAND (NCT02355587) and INTEGRATE (NCT02355574) registries.
• Recurrence-free (RFS), distant metastasis-free (DMFS), and overall survival (OS) were primary endpoints.

Results

• For event-free patients, median follow-up was 1.5 years.
• In addition, median age for subjects was 58 years (range 18–87) and median Breslow thickness was 1.2 mm (range 0.2–12.0).
• This study observed stage I/II in eighty-eight percent (282/322) of cases and 74% (237/322) had a SLN biopsy.
• Class 1 molecular profiles were observed in seventy-seven percent (248/322).
• Moreover, 1.5-year RFS, DMFS, and OS rates were 97 vs. 77%, 99 vs. 89%, and 99 vs. 92% for class 1 vs. class 2, respectively (p < 0.0001 for each).
• Furthermore, multivariate Cox regression showed Breslow thickness, mitotic rate, and GEP class to significantly predict recurrence (p < 0.01).
• On the other hand, tumor thickness was the only significant predictor of distant metastasis and overall survival in this interim analysis.