一项针对皮肤黑色素瘤的31基因表达谱检测对皮肤科医生临床管理决策的影响。

Impact of a 31-gene Expression Profiling Test for Cutaneous Melanoma on Dermatologists' Clinical Management Decisions.

作者信息

Farberg Aaron S, Glazer Alex M, White Richard, Rigel Darrell S

出版信息

J Drugs Dermatol. 2017 May 1;16(5):428-431.

Abstract

Importance: Current guidelines for cutaneous malignant melanoma (CMM) provide general recommendations regarding surveillance while indicating that management should be tailored to patients' individual probability of recurrence. A 31-gene expression profile (31-GEP) test to predict metastatic risk has been previously validated, and classifies patients as either Class 1 (low risk) or Class 2 (high risk).

Objective: To determine the impact of the 31-GEP test's result on clinical decision-making.

Design, Setting, and Participants: Dermatology residents who attended a national educational conference were presented with clinical validity evidence for the 31-GEP. Respondents were given six CMM patient vignettes with descriptions of clinical features and answered questions about their willingness to recommend sentinel lymph node biopsy (SLNBx) or imaging based on each scenario. Additionally, respondents were asked to provide the Breslow thickness (BT), ranging from 0.7-1.5mm in 0.1mm increments, at which they would recommend SLNBx, imaging, or oncology referral.

Main Outcomes and Measures: The number of respondents who would recommend each management modality based upon three outcomes (no result, Class 1, or Class 2) was quantified. Differences between response groups were assessed using Fisher's exact test.

Results: The majority of respondents (62%, 57%, and 55%, respectively) indicated a 1.0mm BT as the guiding modality, reflecting adherence to current guidelines. After inclusion of a Class 2 result, the BT used to guide SLNBx, oncology referral, and imaging was changed in 47%, 50% and 47% of the responses, respectively, with 95%, 84% and 97% of the cases, respectively, changed in a risk-appropriate direction (decreased BT). Based on a 31-GEP Class 1 or Class 2 result, risk appropriate recommendations were more likely to be made for each management modality tested in five of the six patient vignettes (P less than 0.05).

Conclusions and Relevance: The 31-GEP test had a significant and appropriate impact on management while remaining within the context of established guidelines.

J Drugs Dermatol. 2017;16(5):428-431.

摘要

重要性

当前皮肤恶性黑色素瘤（CMM）指南提供了关于监测的一般建议，同时指出管理应根据患者个体复发概率进行调整。一种用于预测转移风险的31基因表达谱（31-GEP）检测先前已得到验证，并将患者分为1类（低风险）或2类（高风险）。

目的

确定31-GEP检测结果对临床决策的影响。

设计、设置和参与者：参加全国教育会议的皮肤科住院医师了解了31-GEP的临床有效性证据。受访者收到六个CMM患者案例，其中描述了临床特征，并回答了关于他们在每种情况下推荐前哨淋巴结活检（SLNBx）或影像学检查意愿的问题。此外，要求受访者提供Breslow厚度（BT），范围为0.7-1.5mm，以0.1mm为增量，说明他们会在何种BT值时推荐SLNBx、影像学检查或转诊至肿瘤科。

主要结局和测量指标

量化根据三种结果（无结果、1类或2类）推荐每种管理方式的受访者数量。使用Fisher精确检验评估反应组之间的差异。

结果

大多数受访者（分别为62%、57%和55%）表示以1.0mm的BT作为指导方式，这反映了对当前指南的遵循。纳入2类结果后，分别有47%、50%和47%的回答中，用于指导SLNBx、转诊至肿瘤科和影像学检查的BT值发生了变化，分别有95%、84%和97%的病例朝着风险适当的方向变化（BT值降低）。基于31-GEP的1类或2类结果，在六个患者案例中的五个案例中，对于所测试的每种管理方式，更有可能做出风险适当的推荐（P小于0.05）。