Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
J Natl Compr Canc Netw. 2013 Mar 1;11(3):286-90. doi: 10.6004/jnccn.2013.0040.
Firm evidence shows that prostate-specific antigen (PSA) velocity is statistically associated with many prostate cancer outcomes, including those related to early detection. However, the clinical use of a marker depends on clinical and statistical significance. Before PSA velocity is used to inform decisions such as whether to perform a biopsy, evidence should be clear that doing so would improve clinical outcome. A systematic review on PSA velocity found that almost no studies had evaluated whether PSA velocity aids in clinical decision-making. Since that time, several reports have indicated that including PSA in a statistical model alongside standard predictors (eg, PSA, digital rectal examination) does not improve predictive accuracy. Specifically, performing a biopsy on men with high PSA velocity in the absence of other indications, as recommended by the NCCN Clinical Practice Guidelines in Oncology for Prostate Cancer Early Detection, would lead to many millions of unnecessary biopsies, without a corresponding number of aggressive cancers being detected. Advocates of PSA velocity have been reduced to citing a single article claiming that PSA velocity aids in clinical decision-making. The article involves selective reporting of an unusual subgroup analysis based on an extremely limited number of events. This is not to say that, in clinical practice, urologists should ignore prior PSA values: clinical judgment can be aided by careful longitudinal evaluation of PSA changes, interpreted in the context of symptoms and treatments. However, the literature clearly shows that simplistic application of PSA velocity cutoffs is not of value for early detection of prostate cancer.
确凿的证据表明，前列腺特异性抗原（PSA）速度在统计学上与许多前列腺癌的结果相关，包括与早期检测相关的结果。然而，标志物的临床应用取决于临床和统计学意义。在 PSA 速度用于告知是否进行活检等决策之前，应该明确这样做是否会改善临床结果。一项关于 PSA 速度的系统评价发现，几乎没有研究评估 PSA 速度是否有助于临床决策。从那时起，有几项报告表明，将 PSA 与标准预测因子（例如 PSA、直肠指检）一起纳入统计模型并不能提高预测准确性。具体来说，按照 NCCN 肿瘤学前列腺癌早期检测临床实践指南的建议，对 PSA 速度较高但没有其他指征的男性进行活检，将导致数以百万计的不必要的活检，而不会发现相应数量的侵袭性癌症。PSA 速度的支持者现在只能引用一篇声称 PSA 速度有助于临床决策的文章。该文章涉及对基于极其有限数量事件的异常亚组分析的选择性报告。这并不是说，在临床实践中，泌尿科医生应该忽视之前的 PSA 值：可以通过仔细的纵向评估 PSA 变化来辅助临床判断，这些变化要结合症状和治疗进行解释。然而，文献清楚地表明，简单地应用 PSA 速度截止值对于前列腺癌的早期检测没有价值。
