Pazhava Ani, Yu Wesley Y, Jing Frank Z, Hill Sheena, Rohr Bethany R, Honda Kord S, Tjien-Fooh Félicia, Wever Renske, Dwarkasing Jvalini, Hieken Tina J, Meves Alexander
Department of Dermatology, Mayo Clinic, Rochester, MN, USA.
Department of Dermatology, Oregon Health and Science University, Portland, OR, USA.
Ann Surg Oncol. 2025 Apr;32(4):2748-2755. doi: 10.1245/s10434-024-16551-8. Epub 2024 Nov 23.
Sentinel lymph node biopsy (SLNB) for head and neck melanomas involves complex challenges due to intricate lymphatic networks and delicate anatomic structures. The Merlin Assay (CP-GEP), merging clinicopathologic data with gene expression profiling, offers a non-invasive method to identify patients who have a low risk for nodal metastasis, potentially sparing these low-risk patients from surgical procedures.
This study evaluated 250 clinically node-negative patients with stage I, II, or III melanoma from the Mayo Clinic and University Hospitals Cleveland Medical Center who had tumors in the head and neck region diagnosed between 2004 and 2021. All the patients underwent SLNB. The Merlin Assay, using the CP-GEP model, combines patient age at diagnosis, Breslow thickness, and gene expression of eight specific genes from the primary tumor to predict the risk of nodal metastasis.
The SLNB positivity rate was 14% overall, and CP-GEP predicted a possible 40.8% reduction in SLNB procedures with a negative predictive value (NPV) of 98%. For 215 SLNB-negative patients (5-year recurrence-free survival [RFS] of 76.9%, distant metastasis-free survival [DMFS] of 84.3%, and melanoma-specific survival [MSS] of 90.6%), CP-GEP improved risk stratification by identifying 100 patients as low risk with 5-year RFS of 86.1%, DMFS of 92.7%, and MSS of 95.3%. Among 167 T1-T2 patients, the SLNB positivity rate was 8.4%, and CP-GEP achieved an SLNB reduction rate of 56.3% with an NPV of 98.9%.
The Merlin Assay effectively categorizes head and neck melanoma patients by risk, enabling more accurate clinical decision-making regarding SLNB and follow-up evaluation, especially for early-stage melanoma patients.
由于头颈部黑色素瘤的淋巴网络错综复杂且解剖结构精细，前哨淋巴结活检（SLNB）面临诸多复杂挑战。Merlin检测（CP-GEP）将临床病理数据与基因表达谱相结合，提供了一种非侵入性方法来识别淋巴结转移风险低的患者，有可能使这些低风险患者免于手术。
本研究评估了来自梅奥诊所和克利夫兰大学医院医疗中心的250例临床淋巴结阴性的I、II或III期黑色素瘤患者，这些患者于2004年至2021年期间被诊断为头颈部肿瘤。所有患者均接受了SLNB。Merlin检测使用CP-GEP模型，结合诊断时的患者年龄、Breslow厚度以及原发肿瘤中八个特定基因的基因表达来预测淋巴结转移风险。
总体SLNB阳性率为14%，CP-GEP预测SLNB手术可能减少40.8%，阴性预测值（NPV）为98%。对于215例SLNB阴性患者（5年无复发生存率[RFS]为76.9%，无远处转移生存率[DMFS]为84.3%，黑色素瘤特异性生存率[MSS]为90.6%），CP-GEP通过将100例患者识别为低风险，改善了风险分层，这些患者的5年RFS为86.1%，DMFS为92.7%，MSS为95.3%。在167例T1-T2患者中，SLNB阳性率为8.4%，CP-GEP实现了56.3%的SLNB减少率，NPV为98.9%。
Merlin检测能有效地根据风险对头颈部黑色素瘤患者进行分类，有助于就SLNB和后续评估做出更准确的临床决策，特别是对于早期黑色素瘤患者。
