Background

Multiple studies have reported on the accuracy of the prognostic 31-gene expression profile test for cutaneous melanoma. Consistency of the test results across studies has not been systematically evaluated.

Objective

To assess the robustness of the prognostic value of the 31-gene expression profile.

Methods

Raw data were obtained from studies identified from systematic review. A meta-analysis was performed to determine overall effect of the 31-gene expression profile. Clinical outcome metrics for the 31-gene expression profile were compared with American Joint Committee on Cancer staging.

Results

Three studies met inclusion criteria; data from a novel cohort of 211 patients were included (n = 1,479). Five-year recurrence-free and distant metastasis-free survival rates were 91.4% and 94.1% for Class 1A patients and 43.6% and 55.5% for Class 2B patients (P < .0001). Meta-analysis results showed that Class 2 was significantly associated with recurrence (hazard ratio 2.90; P < .0001) and distant metastasis (hazard ratio 2.75; P < .0001). The 31-gene expression profile identified American Joint Committee on Cancer stage I to III patient subsets with high likelihood for recurrence and distant metastasis. Sensitivity was 76% (95% confidence interval 71%-80%) and 76% (95% confidence interval 70%-82%) for each end point, respectively. When 31-gene expression profile and sentinel lymph node biopsy results were considered together, sensitivity and negative predictive value for distant metastasis-free survival were both improved.

Conclusion

The 31-gene expression profile test consistently and accurately identifies melanoma patients at increased risk of metastasis, is independent of other clinicopathologic covariates, and augments current risk stratification by reclassifying patients for heightened surveillance who were previously designated as being at low risk.

中文翻译：

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皮肤黑素瘤的分子风险预测：对1,479例患者中31基因表达谱预后测试的荟萃分析。

背景

多项研究报告了皮肤黑色素瘤的预后31基因表达谱测试的准确性。整个研究中测试结果的一致性尚未得到系统的评估。

目的

评估31基因表达谱的预后价值的鲁棒性。

方法

原始数据来自系统回顾确定的研究。进行荟萃分析以确定31基因表达谱的总体效果。将31种基因表达谱的临床结果指标与美国癌症分期联合委员会进行了比较。

结果

三项研究符合纳入标准；包括来自211名患者的一组新患者的数据（n = 1,479）。1A类患者的五年无复发和远处无转移生存率分别为91.4％和94.1％，2B类患者为43.6％和55.5％（P  <.0001）。荟萃分析结果显示，第2类与复发（危险比2.90；P  <.0001）和远处转移（危险比2.75；P）显着相关。 <.0001）。31个基因的表达谱确定了美国癌症联合委员会I至III期患者亚组的复发和远处转移的可能性很高。每个端点的灵敏度分别为76％（95％置信区间71％-80％）和76％（95％置信区间70％-82％）。当同时考虑31基因表达谱和前哨淋巴结活检结果时，远处无转移生存的敏感性和阴性预测值均得到改善。

结论

31基因表达谱测试能够一致，准确地识别出转移风险增加的黑色素瘤患者，并且独立于其他临床病理协变量，并且通过将先前指定为低风险的加强监测患者重新分类来增加当前的风险分层。