皮肤黑素瘤基因表达谱检测的证据水平评价。
Level of Evidence Review for a Gene Expression Profile Test for Cutaneous Melanoma.
机构信息
Department of Dermatology, Icahn School of Medicine at Mount Sinai, 234 East 85th Street, 5th Floor, New York, NY, 10028, USA.
Arkansas Dermatology Skin Cancer Center, Little Rock, AR, USA.
出版信息
Am J Clin Dermatol. 2019 Dec;20(6):763-770. doi: 10.1007/s40257-019-00464-4.
BACKGROUND
The advent of molecular medicine may allow for individualized cancer prognostication, which should enable better clinical management and, hopefully, improve patient outcomes. A 31-gene expression profile (31-GEP) test is currently available for patients diagnosed with cutaneous melanoma; this test helps inform patients' individual treatment plans, especially when combined with traditional biomarkers.
OBJECTIVE
The objective of this study was to review the current literature and establish the level of evidence for a cutaneous melanoma 31-GEP test.
METHODS
A review of seven development and validation studies for the 31-GEP test was conducted. The respective strengths and weaknesses of each study were applied to the level of evidence criteria from major organizations that publish guidelines for melanoma management: American Joint Committee on Cancer, National Comprehensive Cancer Network, and American Academy of Dermatology.
RESULTS
Evaluating each study led to classifying the 31-GEP test as level I/II, I-IIIB, and IIA according to American Joint Committee on Cancer, National Comprehensive Cancer Network, and American Academy of Dermatology criteria, respectively. This stands in contrast to the official unrated status conferred by the American Joint Committee on Cancer and National Comprehensive Cancer Network and the II/IIIC rating designated by the American Academy of Dermatology.
CONCLUSIONS
Differences between the authors' findings and official published ratings may be attributed to chronological issues, as many of the studies were not yet published when the aforementioned organizations conducted their reviews. There was also difficulty in applying the National Comprehensive Cancer Network criteria to this prognostic test, as their guidelines were intended for evaluation of predictive markers. Nevertheless, based upon the most current data available, integration of the 31-GEP test into clinical practice may be warranted in certain clinical situations.
背景
分子医学的出现可能使癌症预后个体化成为可能，这将有助于更好的临床管理，并有望改善患者的预后。目前可对诊断为皮肤黑色素瘤的患者进行 31 基因表达谱（31-GEP）检测；该检测有助于为患者制定个体化治疗计划，尤其是与传统生物标志物联合使用时。
目的
本研究旨在回顾当前文献，确定皮肤黑色素瘤 31-GEP 检测的证据水平。
方法
对 31-GEP 检测的 7 项开发和验证研究进行了综述。根据发布黑色素瘤管理指南的主要组织（美国癌症联合委员会、国家综合癌症网络和美国皮肤病学会）的证据标准，分别对每项研究的优缺点进行了评估。
结果
对每项研究进行评估后，根据美国癌症联合委员会、国家综合癌症网络和美国皮肤病学会的标准，将 31-GEP 检测分别归类为 I/II 级、I-IIIB 级和 IIA 级。这与美国癌症联合委员会和国家综合癌症网络授予的官方未评级状态以及美国皮肤病学会指定的 II/IIIC 评级形成对比。
结论
作者的发现与官方公布的评级之间的差异可能归因于时间上的差异，因为在上述组织进行审查时，许多研究尚未发表。将国家综合癌症网络标准应用于该预后检测也存在困难，因为他们的指南旨在评估预测标志物。尽管如此，根据目前可获得的最新数据，在某些临床情况下，将 31-GEP 检测纳入临床实践可能是合理的。
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