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Independent Dutch Validation Study of CP-GEP (Merlin Assay) for the Prediction of Nodal Metastasis and Long-Term

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Clinicopathological gene expression profile (CP-GEP) shows promise in predicting melanoma recurrence risk. This noninvasive test could potentially reduce the need for sentinel lymph node biopsy (SLNB) in certain melanoma patients.

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Area of Science:

  • Oncology
  • Genomics
  • Dermatology

Background:

  • Sentinel lymph node biopsy (SLNB) is standard for stage IB-II melanoma.
  • Advances in systemic therapy prompt re-evaluation of SLNB's role.
  • Clinicopathological gene expression profile (CP-GEP) is being investigated as an alternative staging tool.

Purpose of the Study:

  • To validate the diagnostic accuracy of CP-GEP.
  • To assess CP-GEP's ability to predict sentinel node metastases and melanoma recurrence.
  • To evaluate CP-GEP as a potential noninvasive alternative to SLNB.

Main Methods:

  • Analyzed data from 252 patients with clinical stage I/II melanoma (2007-2015).
  • Utilized CP-GEP including eight tumor-associated genes and two housekeeping genes.
  • Combined gene expression data with clinicopathological variables, age, and Breslow thickness.

Main Results:

  • CP-GEP identified 28% of patients as low risk and 72% as high risk.
  • Overall sensitivity was 92.5% and negative predictive value (NPV) was 94.1%.
  • CP-GEP showed high NPV (95.2%) and high SLNB reduction rate (80.8%) in T1 melanomas; 5-year recurrence-free survival was 89.6% for low-risk vs. 76.8% for high-risk patients.

Conclusions:

  • CP-GEP demonstrates strong prognostic performance for melanoma.
  • It is particularly effective in pT1b-pT2a melanoma patients.
  • CP-GEP may serve as a noninvasive alternative to SLNB for staging and risk assessment.