Enhanced Risk Stratification for Sentinel Lymph Node Biopsy in Head and Neck Melanoma Using the Merlin Assay (CP-GEP)

Area of Science:

• Oncology
• Dermatology
• Genomics

Background:

• Sentinel lymph node biopsy (SLNB) for head and neck melanomas presents significant challenges due to complex lymphatic anatomy.
• The Merlin Assay (CP-GEP) combines clinical data and gene expression profiling for non-invasive risk assessment of nodal metastasis.

Purpose of the Study:

• To evaluate the efficacy of the Merlin Assay (CP-GEP) in identifying low-risk head and neck melanoma patients.
• To assess the potential reduction in SLNB procedures using the CP-GEP model.
• To improve risk stratification and clinical decision-making for melanoma management.

Main Methods:

• The study included 250 clinically node-negative patients with stage I-III head and neck melanoma.
• The Merlin Assay (CP-GEP) integrated patient age, Breslow thickness, and eight-gene expression profiles.
• All patients underwent sentinel lymph node biopsy (SLNB) for comparison.

Main Results:

• The Merlin Assay predicted a 40.8% reduction in SLNB procedures with a 98% negative predictive value (NPV).
• For SLNB-negative patients, CP-GEP identified a low-risk subgroup with improved 5-year survival rates (RFS, DMFS, MSS).
• In T1-T2 patients, CP-GEP achieved a 56.3% SLNB reduction rate with a 98.9% NPV.

Conclusions:

• The Merlin Assay (CP-GEP) effectively categorizes head and neck melanoma patients by metastatic risk.
• This assay facilitates more accurate clinical decisions regarding SLNB and follow-up care.
• The findings are particularly relevant for early-stage melanoma management.