临床病理基因表达谱（CP-GEP）在识别不需要前哨淋巴结活检的皮肤黑色素瘤患者中的预测性能：系统回顾和荟萃分析。

IF 5.5 2区医学 Q1 HEMATOLOGY

Critical reviews in oncology/hematology Pub Date : 2025-06-20 DOI:10.1016/j.critrevonc.2025.104816

Terence Wong , Sydney Ch’ng , Peter Ferguson , Linda Martin , Alexander M. Menzies , Inês Pires da Silva , Georgina V. Long , Richard A. Scolyer , Alexander van Akkooi , Serigne N. Lo

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引用次数: 0

摘要

背景与目的：前哨淋巴结活检（SLNB）是一种检测显微淋巴结转移的侵入性手术，对准确分期和最佳治疗至关重要。在黑色素瘤中，大多数接受手术的患者没有检测到前哨淋巴结（SLN）转移。CP-GEP模型（Merlin Assay）的开发是为了根据原发肿瘤的临床病理和基因表达特征，确定没有SLN转移的患者，从而可以安全地放弃SLNB。虽然梅林试验已经通过相对中等样本量的独立队列进行了验证，但本荟萃分析旨在评估该模型的整体预测性能，并检查外部验证队列之间的潜在异质性。方法：在MEDLINE和Embase中检索2019年1月至2024年6月间发表的外部验证CP-GEP模型的研究。纳入了报道该模型敏感性和特异性的研究。质量评估由两名审稿人使用诊断准确性研究质量评估（QUADAS-2）工具进行。研究结果包括敏感性、特异性、阳性预测值（positive predictive value， PPV）、阴性预测值（negative predictive value， NPV）和SLNB减除率（SLNB减除率定义为基于Merlin试验结果可以放弃SLNB的患者比例）。采用随机效应荟萃分析模型对个体估计值进行汇总。采用T类进行亚组分析。结果（影响）：确定并纳入了四项外部验证研究（三项回顾性研究和一项前瞻性研究），涉及1099名参与者。合并中位年龄为60岁，中位布雷斯洛厚度为1.8mm。在所有原发性肿瘤分类组（pT1-pT4）中，合并敏感性为93% (95% CI: 88%-96%)，特异性为32% (95% CI: 23%-41%)， PPV为24% (95% CI: 18%-31%)， NPV为95% (95% CI: 92%-97%)， SLNB减少率为27% （95% CI: 20%-35）。亚组分析显示，pT2组模型表现最佳；合并敏感性为91% (95% CI: 82%-96%)，特异性为35% (95% CI: 30%-39%)， PPV为20% (95% CI: 14%-27%)， NPV为96% (95% CI: 91%-98%)， SLNB降低率为31% （95% CI: 27%-35%）。结论：本荟萃分析表明，CP-GEP模型可以减少不必要的slnb手术次数，特别是在pT2患者中。它可以改善临床决策和协助患者知情同意。更广泛的影响，如潜在的降低医疗费用和手术并发症的风险，应进一步探讨。普洛斯彼罗注册：CRD42024547893。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Predictive performance of the clinicopathologic gene expression profile (CP-GEP) in identifying cutaneous melanoma patients for whom sentinel lymph node biopsy is unnecessary: A systematic review and meta-analysis

Context & aim

Sentinel lymph node biopsy (SLNB) is an invasive procedure that detects microscopic nodal metastasis, crucial for accurate staging and optimal management. In melanoma, most patients who undergo the procedure have no sentinel lymph node (SLN) metastasis detected. The CP-GEP model (Merlin Assay) was developed to identify patients who do not have SLN metastases and who may therefore safely forgo SLNB, based upon clinicopathologic and gene expression features of the primary tumour. While the Merlin Assay has been validated by independent cohorts with relatively moderate sample sizes, this meta-analysis aims to assess the overall predictive performance of the model and examine potential heterogeneity between the external validation cohorts.

Method

We conducted a literature search in MEDLINE and Embase for studies that externally validated the CP-GEP model and were published between January 2019 and June 2024. Studies that reported the model’s sensitivity and specificity were included. Quality assessment was conducted by two reviewers using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. The outcomes investigated were sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and SLNB reduction rate, defined as the proportion of patients that can forgo SLNB based on the Merlin Assay outcome. Individual estimates were pooled using random effects meta-analysis model. Subgroup analysis was performed by T category.

Findings (Impact)

Four external validation studies (three retrospective and one prospective) were identified and included, involving 1099 participants. The pooled median age was 60 years and median Breslow thickness was 1.8 mm. Across all primary tumour classification groups (pT1-pT4), the pooled sensitivity was 93 % (95 % CI: 88 %-96 %), specificity was 32 % (95 % CI: 23 %-41 %), PPV was 24 % (95 % CI: 18 %-31 %), NPV was 95 %, (95 % CI: 92 %-97 %) and SLNB reduction rate was 27 % (95 % CI: 20 %-35). The subgroup analysis revealed that the model performed best in the pT2 group; pooled sensitivity was 91 % (95 % CI: 82 %-96 %), specificity was 35 % (95 % CI: 30 %-39 %), PPV was 20 % (95 % CI: 14 %-27 %), NPV was 96 %, (95 % CI: 91 %-98 %) and SLNB reduction rate was 31 % (95 % CI: 27 %-35 %).

Conclusion

This meta-analysis suggests that the CP-GEP model can reduce the number of unnecessary SLNBs performed, especially in pT2 patients. It can improve clinical decision making and assist in patients’ informed consent. Broader implications such as potential reductions in healthcare costs and risks of surgical complications should be explored further.

PROSPERO registration

CRD42024547893

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来源期刊

Critical reviews in oncology/hematology 医学-血液学

CiteScore

11.00

自引率

3.20%

发文量

213

审稿时长

55 days

期刊介绍： Critical Reviews in Oncology/Hematology publishes scholarly, critical reviews in all fields of oncology and hematology written by experts from around the world. Critical Reviews in Oncology/Hematology is the Official Journal of the European School of Oncology (ESO) and the International Society of Liquid Biopsy.