Background: Patients with stage I cutaneous melanoma (CM) are considered at low risk for metastasis or melanoma specific death; however, because the majority of patients are diagnosed with stage I disease, they represent the largest number of melanoma deaths annually. The 31-gene expression profile (31-GEP) test has been prospectively validated to provide prognostic information independent of staging, classifying patients as low (Class 1A), intermediate (Class 1B/2A), or high (Class 2B) risk of poor outcomes. Methods: Patients enrolled in previous studies of the 31-GEP were combined and evaluated for recurrence-free (RFS) and melanoma-specific survival (MSS) (n = 1261, “combined”). A second large, unselected real-world cohort (n = 5651) comprising clinically tested patients diagnosed 2013–2018 who were linked to outcomes data from the NCI Surveillance, Epidemiology, and End Results (SEER) Program registries was evaluated for MSS. Results: Combined cohort Class 1A patients had significantly higher RFS than Class 1B/2A or Class 2B patients (97.3%, 88.6%, 77.3%,p< 0.001)—better risk stratification than AJCC8 stage IA (97.5%) versus IB (89.3%). The SEER cohort showed better MSS stratification by the 31-GEP (Class 1A = 98.0%, Class 1B/2A = 97.5%, Class 2B = 92.3%;p< 0.001) than by AJCC8 staging (stage IA = 97.6%, stage IB = 97.9%;p< 0.001). Conclusions: The 31-GEP test significantly improved patient risk stratification, independent of AJCC8 staging in patients with stage I CM. The 31-GEP provided greater separation between high- (Class 2B) and low-risk (Class 1A) groups than seen between AJCC stage IA and IB. These data support integrating the 31-GEP into clinical decision making for more risk-aligned management plans.
背景：I期皮肤黑色素瘤（CM）患者通常被认为转移或黑色素瘤特异性死亡风险较低；然而，由于大多数患者确诊时为I期，该群体每年在黑色素瘤死亡病例中占比最高。31基因表达谱（31-GEP）检测已通过前瞻性验证，可提供独立于分期的预后信息，将患者划分为低风险（1A类）、中风险（1B/2A类）或高风险（2B类）预后不良组。方法：整合既往31-GEP研究中的患者数据，评估无复发生存期（RFS）和黑色素瘤特异性生存期（MSS）（n=1261，“合并队列”）。另选取2013-2018年经临床检测、关联美国国家癌症研究所监测流行病学与最终结果（SEER）数据库结局数据的未筛选大型真实世界队列（n=5651）进行MSS评估。结果：合并队列中1A类患者的RFS显著高于1B/2A类或2B类患者（97.3% vs 88.6% vs 77.3%，p<0.001），其风险分层效果优于AJCC第八版分期中IA期（97.5%）与IB期（89.3%）的对比。SEER队列显示31-GEP的MSS分层能力（1A类=98.0%，1B/2A类=97.5%，2B类=92.3%；p<0.001）优于AJCC第八版分期（IA期=97.6%，IB期=97.9%；p<0.001）。结论：31-GEP检测能显著改善I期CM患者的风险分层，且独立于AJCC第八版分期标准。相较于AJCC分期中IA期与IB期的差异，31-GEP在高风险（2B类）与低风险（1A类）组间展现出更显著的分层区分度。这些数据支持将31-GEP整合至临床决策中，以制定更精准的风险适配管理方案。
肿瘤(癌症)患者之家