BACKGROUND Adjuvant therapies have been approved for patients with AJCC (American Joint Committee on Cancer) stage III and stage IV cutaneous melanoma (CM) after complete resection. These therapies might also be indicated for patients with high-risk stage II CM. MATERIAL AND METHODS We included patients diagnosed with stage II melanoma between 2000 and 2016 and for which primary tumour tissue was available. The prognostic value of the 11-gene expression profiling score (GEPS) was evaluated as a dichotomized parameter (GEPS ≤0 vs. >0). Endpoints of the analysis were melanoma specific survival (MSS), distant metastasis-free survival (DMFS) and relapse-free survival (RFS). RESULTS GEPS was determined in 245 patients ranging between -0.7 and 3.53. A total of 111 females and 134 males were included; the median follow-up was 41 months. Kaplan Meier analyses showed statistically significant survival differences between patients with high GEPS (n = 154) and low GEPS (n = 91) for MSS (p = 0.018), DMFS (p = 0.005) and RFS (p = 0.009). The 5-year and 10-year MSS was 92% in the low-GEPS and 82% and 67% in the high-GEPS group, respectively. Multivariate Cox regression analysis showed independent significance for MSS of GEPS (HR = 1.55; p = 0.006), tumor thickness (HR = 1.21; p < 0.001) and age (HR1.05; p = 0.002). CONCLUSION GEPS was validated as independent prognostic factor for MSS in stage II CM and could be used for therapeutic decisions when systemic therapies become available in stage II CM.

中文翻译：

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在前瞻性收集的 AJCC v8 II 期皮肤黑色素瘤患者的 FFPE 组织中对预后 11 基因表达谱评分进行临床验证。


背景辅助治疗已被批准用于完全切除后的 AJCC（美国癌症联合委员会）III 期和 IV 期皮肤黑色素瘤 (CM) 患者。这些疗法也可能适用于高危 II 期 CM 患者。材料和方法 我们纳入了 2000 年至 2016 年间诊断为 II 期黑色素瘤且可获得原发肿瘤组织的患者。 11 基因表达谱评分 (GEPS) 的预后价值作为二分参数进行评估（GEPS ≤ 0 与 > 0）。分析的终点是黑色素瘤特异性生存期（MSS）、无远处转移生存期（DMFS）和无复发生存期（RFS）。结果 245 名患者的 GEPS 测定范围在 -0.7 至 3.53 之间。总共包括 111 名女性和 134 名男性；中位随访时间为 41 个月。 Kaplan Meier 分析显示，高 GEPS (n = 154) 和低 GEPS (n = 91) 患者之间 MSS (p = 0.018)、DMFS (p = 0.005) 和 RFS (p = 0.009) 的生存率存在显着差异。低 GEPS 组的 5 年和 10 年 MSS 分别为 92%，高 GEPS 组分别为 82% 和 67%。多变量 Cox 回归分析显示 GEPS 的 MSS（HR = 1.55；p = 0.006）、肿瘤厚度（HR = 1.21；p < 0.001）和年龄（HR1.05；p = 0.002）具有独立显着性。结论 GEPS 被验证为 II 期 CM 中 MSS 的独立预后因素，并且当 II 期 CM 中可以进行全身治疗时，可用于做出治疗决策。