Importance Accuracy of the predicted metastasis-free survival (MFS) by a commercially available gene expression profiling (GEP) test is not known. Objective To compare the predicted MFS with the observed MFS in patients in this cohort and with those in published studies (published MFS, meta-analysis). Design, Setting, and Participants This cohort study included consecutive patients from the University of Iowa and Cleveland Clinic who were diagnosed with uveal melanoma who underwent prognostic fine-needle aspiration biopsy at the time of primary treatment. Patients were recruited from December 2012 to December 2020. The predicted MFS for patients was extracted from the GEP report. The observed MFS was defined as time to metastasis. Cox proportional hazards models were fit to identify tumor variables impacting MFS in patients with class 2 tumors. The overall estimate of the published MFS was obtained by performing meta-analysis of data from published series. Analysis took place in August 2021. Main Outcomes and Measures MFS. Results There were 92 patients from the University of Iowa and 255 patients from the Cleveland Clinic. The mean (SD) age at diagnosis was 59.4 (13.0) years. The median (IQR) follow-up interval was 38.0 (19.0-57.0) months. The observed MFS for patients with class 2 tumor in this cohort (3 years: 67% [95% CI, 59%-77%]; 5 years: 47% [95% CI, 37%-61%]) and in published studies (3 years: 62% [95% CI, 57%-66%]; 5 years: 40% [95% CI, 34%-46%]) were better than those predicted (50% and 28% for 3 and 5 years, respectively). Within patients with class 2 tumor, those with metastasis had larger tumors compared with nonmetastatic tumors (mean largest basal diameter difference, 1.7 [95% CI, 0.5-3.0] mm; P = .01; mean thickness ratio, 1.3 [95% CI, 1.04-1.5]; P = .01, respectively). An increasing tumor size was significantly associated with increased hazard ratio (1.16 [95% CI, 1.06-1.27]; P < .001) of metastasis. Conclusions and Relevance These findings suggest the predicted MFS for metastatic tumors (class 2) appears to be worse than that observed here and reported by others. Incorporation of tumor size in the prediction model may enhance its accuracy. Adjuvant therapy trials may not be able to rely on predicted MFS to calculate efficacy with a high degree of confidence.

中文翻译：

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葡萄膜黑色素瘤患者的预测无转移生存期与观察到的无转移生存期。

市售基因表达谱 (GEP) 测试预测的无转移生存 (MFS) 的准确性尚不清楚。目的 将该队列中的患者以及已发表的研究（已发表的 MFS，荟萃分析）中的患者的预测 MFS 与观察到的 MFS 进行比较。设计、背景和参与者 这项队列研究包括来自爱荷华大学和克利夫兰诊所的连续患者，这些患者被诊断为葡萄膜黑色素瘤，并在主要治疗时接受了预后细针抽吸活检。患者招募时间为 2012 年 12 月至 2020 年 12 月。患者的预测 MFS 是从 GEP 报告中提取的。观察到的 MFS 定义为转移时间。Cox 比例风险模型适合识别影响 2 类肿瘤患者 MFS 的肿瘤变量。已发表的 MFS 的总体估计是通过对已发表的系列数据进行荟萃分析获得的。分析于 2021 年 8 月进行。主要成果和措施 MFS。结果 爱荷华大学有 92 名患者，克利夫兰诊所有 255 名患者。诊断时的平均 (SD) 年龄为 59.4 (13.0) 岁。中位随访时间 (IQR) 为 38.0 (19.0-57.0) 个月。在该队列中观察到的 2 类肿瘤患者的 MFS（3 年：67% [95% CI，59%-77%]；5 年：47% [95% CI，37%-61%]）和已发表的研究（3 年：62% [95% CI，57%-66%]；5 年：40% [95% CI，34%-46%]）优于预测（3 年和 5 年分别为 50% 和 28%）分别为 5 年）。在 2 类肿瘤患者中，与非转移性肿瘤相比，转移性肿瘤患者的肿瘤更大（平均最大基底直径差，1.7 [95% CI，0.5-3.0] mm；P = 0.01；平均厚度比，1.3 [95% CI ，1.04-1.5]；P = .01，分别）。肿瘤大小的增加与转移风险比的增加显着相关（1.16 [95% CI，1.06-1.27]；P < .001）。结论和相关性 这些研究结果表明，转移性肿瘤（2 类）的预测 MFS 似乎比此处观察到的和其他人报告的更差。将肿瘤大小纳入预测模型可以提高其准确性。辅助治疗试验可能无法依赖预测的 MFS 来高度可信地计算疗效。