Department of Surgical Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, the Netherlands.
Department of Surgical Oncology, Erasmus Medical Center - Cancer Institute, Rotterdam, the Netherlands; Departments of Medical Oncology and Radiology & Nuclear Medicine, Erasmus Medical Center - Cancer Institute, Rotterdam, the Netherlands.
Eur J Surg Oncol. 2023 Dec;49(12):107249. doi: 10.1016/j.ejso.2023.107249. Epub 2023 Oct 26.
Sentinel lymph node biopsy (SLNB) is recommended for patients with >pT1b cutaneous melanoma, and should be considered and discussed with patients diagnosed with pT1b cutaneous melanoma for the purpose of staging, prognostication and determining eligibility for adjuvant therapy. Previously, the clinicopathologic and gene expression profile (CP-GEP, Merlin Assay®) model was developed to identify patients who can forgo SLNB because of a low risk for sentinel node metastasis. The aim of this study was to evaluate the clinical use and implementation of the CP-GEP model in a prospective multicenter study in the Netherlands. Both test performance and feasibility for clinical implementation were assessed in 260 patients with T1-T4 melanoma. The CP-GEP model demonstrated an overall negative predictive value of 96.7% and positive predictive value of 23.7%, with a potential SLNB reduction rate of 42.2% in patients with T1-T3 melanoma. With a median time of 16 days from initiation to return of test results, there was sufficient time left before the SLNB was performed. Based on these outcomes, the model may support clinical decision-making to identify patients who can forgo SLNB in clinical practice.
前哨淋巴结活检（SLNB）推荐用于>pT1b 皮肤黑色素瘤患者，对于诊断为 pT1b 皮肤黑色素瘤的患者，应考虑并讨论 SLNB 的目的是分期、预后和确定辅助治疗的资格。此前，开发了临床病理和基因表达谱（CP-GEP，Merlin 检测）模型，以确定由于前哨淋巴结转移风险低而可以避免 SLNB 的患者。本研究旨在评估 CP-GEP 模型在荷兰一项前瞻性多中心研究中的临床应用和实施情况。在 260 例 T1-T4 黑色素瘤患者中评估了该模型的检测性能和临床实施的可行性。CP-GEP 模型显示总体阴性预测值为 96.7%，阳性预测值为 23.7%，T1-T3 黑色素瘤患者 SLNB 潜在减少率为 42.2%。从开始到获得检测结果的中位时间为 16 天，在进行 SLNB 之前有足够的时间。基于这些结果，该模型可能支持临床决策，以确定在临床实践中可以避免 SLNB 的患者。
