使用31基因表达谱对I期皮肤黑色素瘤患者进行风险分层

Risk Stratification of Patients with Stage I Cutaneous Melanoma Using 31-Gene Expression Profiling.

作者信息

Martin Brian J, Covington Kyle R, Quick Ann P, Cook Robert W

机构信息

All authors are employees with Castle Biosciences, Inc. in Friendswood, Texas.

出版信息

J Clin Aesthet Dermatol. 2021 Sep;14(9):E61-E63.

PMID:34980974

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8675338/

Abstract

BACKGROUND

While patients with localized cutaneous melanoma (CM) generally have good five-year melanoma-specific survival rates, identifying patients with localized disease at a high risk of recurrence could allow them access to additional follow-up or surveillance.

OBJECTIVE

We sought to examine the prognostic value of the 31-gene expression profile (31-GEP) test for the risk of recurrence in stage I CM patients according to 31-GEP main class (low risk: Class 1 vs. high-risk: Class 2) and the lowest and highest risk 31-GEP subclasses (Class 1A vs. Class 2B).

METHODS

Data from a previously described meta-analysis detailing the 31-GEP results for patients with stage I CM (N = 623) were re-analyzed to determine 31-GEP accuracy.

RESULTS

Patients with stage I CM and a Class 1 31-GEP result were less likely to have a recurrence (15/556; 2.7% vs. 6/67; 9.0%; =0.018) than patients with a Class 2 result and had a higher five-year recurrence-free survival (RFS) (96% vs. 85%). Patients with a Class 2 result were 2.8 times as likely to experience a recurrence (positive likelihood ratio: 2.82; 95% confidence interval: 1.38-5.77). In a subset of patients with stage I CM stratified further into 31-GEP subclasses (n = 206), patients with a Class 1A result had a higher five-year RFS than those with a Class 2B result (98% vs. 73%). Patients with a Class 2B result were also 6.5 times as likely to experience a recurrence (positive likelihood ratio: 6.45; 95% confidence interval: 2.44-17.00) than those with a Class 1A result, and the 31-GEP had a negative predictive value of 96.3% (95% confidence interval: 92.3%-98.4%).

CONCLUSION

The 31-GEP test significantly differentiates between low and high recurrence risk in patients with stage I CM.

摘要

背景

虽然局限性皮肤黑色素瘤（CM）患者的五年黑色素瘤特异性生存率通常较好，但识别出局部疾病复发风险高的患者可以让他们获得额外的随访或监测。

目的

我们试图根据31基因表达谱（31-GEP）主要类别（低风险：1类与高风险：2类）以及最低和最高风险的31-GEP亚类（1A类与2B类），研究31-GEP检测对I期CM患者复发风险的预后价值。

方法

对先前描述的一项荟萃分析的数据进行重新分析，该分析详细列出了I期CM患者（N = 623）的31-GEP结果，以确定31-GEP的准确性。

结果

与31-GEP结果为2类的患者相比，31-GEP结果为1类的I期CM患者复发的可能性较小（15/556；2.7%对6/67；9.0%；P = 0.018），且五年无复发生存率（RFS）更高（96%对85%）。31-GEP结果为2类的患者复发的可能性是结果为1类患者的2.8倍（阳性似然比：2.82；95%置信区间：1.38 - 5.77）。在进一步分层为31-GEP亚类的I期CM患者亚组（n = 206）中，31-GEP结果为1A类的患者五年RFS高于结果为2B类的患者（98%对73%）。31-GEP结果为2B类的患者复发的可能性也是结果为1A类患者的6.5倍（阳性似然比：6.45；95%置信区间：2.44 - 17.00），且31-GEP的阴性预测值为96.3%（95%置信区间：92.3% - 98.4%）。