Background

A substantial number of patients who relapse and die from cutaneous melanoma (CM) are categorized as being at low risk by traditional staging factors. The 31-gene expression profile (31-GEP) test independently stratifies metastatic risk of patients with CM as low (Class 1, with 1A indicating lowest risk) or high (Class 2,with 2B indicating highest risk).

Objective

To assess risk prediction by the 31-GEP test within 3 low-risk (according to the American Joint Committee on Cancer) populations of patients with CM: those who are sentinel lymph node (SLN) negative, those with stage I to IIA tumors, and those with thin (≤1 mm [T1]) tumors.

Methods

A total of 3 previous validation studies provided a nonoverlapping cohort of 690 patients with 31-GEP results, staging information, and survival outcomes. Kaplan-Meier and Cox regression analysis were performed.

Results

The results included the identification of 70% of SLN-negative patients who experienced metastasis as Class 2, the discovery of reduced recurrence-free survival for patients with thin tumors and Class 2B biology compared with that of those with Class 1A biology (P < .0001); and determination of the 31-GEP test as an independent predictor of risk compared with traditional staging factors in patients with stage I to IIA tumors.

Limitations

Diagnoses spanned multiple versions of pathologic staging criteria.

Conclusions

The 31-GEP test identifies high-risk patients who are likely to experience recurrence or die of melanoma within low-risk groups of subpopulations of patients with CM who have SLN-negative disease, stage I to IIA tumors, and thin tumors.

中文翻译：

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使用预后的31基因表达谱鉴定具有预后良好的黑色素瘤患者亚群中有转移风险的患者

背景

传统的分期因素将许多复发性和死于皮肤黑色素瘤（CM）的患者归为低风险。31基因表达谱（31-GEP）测试独立地将CM患者的转移风险分层为低（1级，最低风险为1A）或高（2B级，最高风险为2B）。

客观的

为了通过31种GEP测试评估CM患者的3种低危人群（根据美国癌症联合委员会）的风险预测：前哨淋巴结（SLN）阴性的人群，I至IIA期肿瘤的人群，以及那些薄（≤1mm [T1]）肿瘤的患者。

方法

共有3项先前的验证研究提供了690名患者的非重叠队列，其结果为31-GEP，分期信息和生存结果。进行了Kaplan-Meier和Cox回归分析。

结果

结果包括确定70％发生转移的SLN阴性患者为2类，发现与1A类生物学患者相比，薄肿瘤和2B类生物学患者的无复发生存率降低（P  <。 0001）; I-IIA期患者与传统分期因素相比，确定31-GEP测试作为风险的独立预测因子。

局限性

诊断涵盖病理分期标准的多个版本。

结论

31 GEP检验可确定患有SLN阴性疾病，I至IIA期肿瘤和薄肿瘤的CM患者低风险人群中可能复发或死亡的黑色素瘤高危患者。