Clinicopathologic models predicting non‐sentinel lymph node metastasis in cutaneous melanoma patients: Are they useful for patients with a single positive sentinel node?
AbstractBackground and ObjectivesOf clinically node‐negative (cN0) cutaneous melanoma patients with sentinel lymph node (SLN) metastasis, between 10% and 30% harbor additional metastases in non‐sentinel lymph nodes (NSLNs). Approximately 80% of SLN‐positive patients have a single positive SLN.MethodsTo assess whether state‐of‐the‐art clinicopathologic models predicting NSLN metastasis had adequate performance, we studied a single‐institution cohort of 143 patients with cN0 SLN‐positive primary melanoma who underwent subsequent completion lymph node dissection. We used sensitivity (SE) and positive predictive value (PPV) to characterize the ability of the models to identify patients at high risk for NSLN disease.ResultsAcross Stage III patients, all clinicopathologic models tested had comparable performances. The best performing model identified 52% of NSLN‐positive patients (SE = 52%, PPV = 37%). However, for the single SLN‐positive subgroup (78% of cohort), none of the models identified high‐risk patients (SE > 20%, PPV > 20%) irrespective of the chosen probability threshold used to define the binary risk labels. Thus, we designed a new model to identify high‐risk patients with a single positive SLN, which achieved a sensitivity of 49% (PPV = 26%).ConclusionFor the largest SLN‐positive subgroup, those with a single positive SLN, current model performance is inadequate. New approaches are needed to better estimate nodal disease burden of these patients.
Validation of CP‐GEP (Merlin Assay) for predicting sentinel lymph node metastasis in primary cutaneous melanoma patients: A U.S. cohort study
AbstractBackgroundApproximately 85% of melanoma patients who undergo a sentinel lymph node biopsy (SLNB) are node‐negative. Melanoma incidence is highest in patients ≥65 years, but their SLNB positivity rate is lower than in younger patients. CP‐GEP, a model combining clinicopathologic and gene expression variables, identifies primary cutaneous melanoma (CM) patients who may safely forgo SLNB due to their low risk for nodal metastasis. Here, we validate CP‐GEP in a U.S. melanoma patient cohort.MethodsA cohort of 208 adult patients with primary CM from the Mayo Clinic and West Virginia University was used. Patients were stratified according to their risk for nodal metastasis: CP‐GEP High Risk and CP‐GEP Low Risk. The main performance measures were SLNB reduction rate (RR) and negative predictive value (NPV).ResultsSLNB positivity rate for the entire cohort was 21%. Most patients had a T1b (34%) or T2a (31%) melanoma. In the T1‐T2 group (153 patients), CP‐GEP achieved an SLNB RR of 41.8% (95% CI: 33.9‐50.1) at an NPV of 93.8% (95% CI: 84.8‐98.3). Subgroup analysis showed similar performance in T1‐T2 patients ≥65 years of age (51 patients; SLNB positivity rate, 9.8%): SLNB RR of 43.1% (95% CI: 29.3‐57.8) at an NPV of 95.5% (95% CI: 77.2‐99.9).ConclusionWe confirmed the potential of CP‐GEP to reduce negative SLNB in all relevant age groups. Our findings are especially relevant to patients ≥65 years, where surgery is often elective. CP‐GEP may guide SLNB decision‐making in clinical practice.