Department of Urology, University of Texas Southwestern Medical Center Dallas, Dallas, TX.
Nomadic EBM Methodology.
Urol Oncol. 2021 Nov;39(11):787.e1-787.e7. doi: 10.1016/j.urolonc.2021.03.022. Epub 2021 Apr 12.
The 2020 AUA microhematuria (MH) guideline stratifies patients into low, intermediate and high-risk for urologic malignancy based on established risk-factors for urothelial carcinoma. Notably, urine-based tumor markers (UBTMs) were not included in the risk classification. We evaluated the impact of incorporating UBTMs (cytology and multiple commercially available UBTMs) into this risk stratification.
We performed a systematic review of performance characteristics of UBTMs for the detection of bladder cancer during hematuria evaluation, pooled the reported sensitivity and specificity, and calculated positive and negative likelihood ratios (LR). These were then applied to the estimated pre-test probability for the diagnosis for each AUA risk strata: low-risk 0.5%, intermediate-risk 1.0%, and high-risk (2%-3%) in order to calculate a post-test probability of bladder cancer in the event of a positive or negative test.
The pooled sensitivity for urinary cytology and commercially available UBTMs was 68% and 58%-95%, respectively while the specificity was estimated at 91% and 34%-90%, respectively. The positive LRs of UBTMs ranged from 2.1-7.67 and negative LRs ranged from 0.07-0.48. A negative UBTM was associated with a post-test probability of cancer for low, intermediate, and high-risk patients of 0-0.2%, 0.2%-0.5%, and 0.4%-1.1%, respectively. In the setting of a positive UBTM, the post-test probability of cancer for low, intermediate, and high-risk patients was 1.1%-3.7%, 2.1%-7.8%, 4.2%-19.2%, respectively.
Pending prospective validation, UBTMs may be able to enhance risk stratification and inform shared decision-making over clinical factors alone and allow for re-classification of patients into higher or lower risk categories.
2020 年美国泌尿外科学会（AUA）微量血尿（MH）指南根据尿路上皮癌的既定风险因素，将患者分为低、中、高危。值得注意的是，尿液肿瘤标志物（UBTMs）并未纳入风险分类。我们评估了将 UBTMs（细胞学和多种市售 UBTMs）纳入该风险分层的影响。
我们对 UBTMs 在血尿评估中检测膀胱癌的性能特征进行了系统评价，汇总了报告的敏感性和特异性，并计算了阳性和阴性似然比（LR）。然后，将这些结果应用于每个 AUA 风险分层的估计术前概率：低危 0.5%，中危 1.0%，高危（2%-3%），以便在检测结果阳性或阴性时计算膀胱癌的术后概率。
尿细胞学和市售 UBTMs 的汇总敏感性分别为 68%和 58%-95%，特异性分别估计为 91%和 34%-90%。UBTMs 的阳性 LR 范围为 2.1-7.67，阴性 LR 范围为 0.07-0.48。阴性 UBTM 与低危、中危和高危患者的术后癌症概率分别为 0-0.2%、0.2%-0.5%和 0.4%-1.1%相关。在 UBTM 阳性的情况下，低危、中危和高危患者的术后癌症概率分别为 1.1%-3.7%、2.1%-7.8%、4.2%-19.2%。
在等待前瞻性验证的情况下，UBTMs 可能能够增强风险分层，并在仅基于临床因素的情况下为共同决策提供信息，允许将患者重新分类为更高或更低的风险类别。
