提高前列腺特异抗原（PSA）临界值以在前列腺活检前进行额外生物标志物检测的效果。
Effects of increasing the PSA cutoff to perform additional biomarker tests before prostate biopsy.
作者信息
Nordström Tobias, Adolfsson Jan, Grönberg Henrik, Eklund Martin
机构信息
Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, S-171 77, Stockholm, Sweden.
Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, S-182 88, Stockholm, Sweden.
出版信息
BMC Urol. 2017 Oct 3;17(1):92. doi: 10.1186/s12894-017-0281-8.
BACKGROUND
Multi-step testing might enhance performance of the prostate cancer diagnostic pipeline. Using PSA >1 ng/ml for first-line risk stratification and the Stockholm 3 Model (S3M) blood-test >10% risk of Gleason Score > 7 prostate cancer to inform biopsy decisions has been suggested. We aimed to determine the effects of changing the PSA cutoff to perform reflex testing with S3M and the subsequent S3M cutoff to recommend prostate biopsy while maintaining the sensitivity to detect Gleason Score ≥ 7 prostate cancer.
METHODS
We used data from the prospective, population-based, paired, diagnostic Stockholm 3 (STHLM3) study with participants invited by date of birth from the Swedish Population Register during 2012-2014. All participants underwent testing with PSA and S3M (a combination of plasma protein biomarkers [PSA, free PSA, intact PSA, hK2, MSMB, MIC1], genetic polymorphisms, and clinical variables [age, family, history, previous prostate biopsy, prostate exam]). Of 47,688 men in the STHLM3 main study, we used data from 3133 men with S3M >10% and prostate biopsy data. Logistic regression models were used to calculate prostate cancer detection rates and proportion saved biopsies.
RESULTS
44.2%, 62.5% and 67.9% of the participants had PSA <1, <1.5 and <1.7 ng/ml, respectively. Increasing the PSA cut-off for additional work-up from 1 ng/ml to 1.5 ng/ml would thus save 18.3% of the performed tests, 4.9% of the biopsies and 1.3% (10/765) of Gleason Grade ≥ 7 cancers would be un-detected. By lowering the S3M cutoff to recommend biopsy, sensitivity to high-grade prostate cancer can be restored, to the cost of increasing the number of performed biopsies modestly.
CONCLUSION
The sensitivity to detect prostate cancer can be maintained when using different PSA cutoffs to perform additional testing. Biomarker cut-offs have implications on number of tests and prostate biopsies performed. A PSA cutoff of 1.5 ng/ml to perform additional testing such as the S3M test might be considered.
TRIAL REGISTRATION
ISRCTN84445406 .
背景
多步骤检测可能会提高前列腺癌诊断流程的性能。有人建议使用PSA>1 ng/ml进行一线风险分层，并使用斯德哥尔摩3模型（S3M）血液检测，即Gleason评分>7的前列腺癌风险>10%，以指导活检决策。我们旨在确定改变PSA临界值以进行S3M反射检测以及随后改变S3M临界值以推荐前列腺活检的效果，同时保持检测Gleason评分≥7的前列腺癌的敏感性。
方法
我们使用了基于人群的前瞻性配对诊断斯德哥尔摩3（STHLM3）研究的数据，研究对象是2012年至2014年期间根据瑞典人口登记册的出生日期邀请的参与者。所有参与者都接受了PSA和S3M检测（血浆蛋白生物标志物[PSA、游离PSA、完整PSA、hK2、MSMB、MIC1]、基因多态性和临床变量[年龄、家族史、既往前列腺活检、前列腺检查]的组合）。在STHLM3主要研究的47688名男性中，我们使用了3133名S3M>10%的男性的数据和前列腺活检数据。使用逻辑回归模型计算前列腺癌检测率和节省的活检比例。
结果
分别有44.2%、62.5%和67.9%的参与者PSA<1、<1.5和<1.7 ng/ml。因此，将用于进一步检查的PSA临界值从1 ng/ml提高到1.5 ng/ml将节省18.3%的已进行检测、4.9%的活检，并且1.3%（10/765）Gleason分级≥7的癌症将无法被检测到。通过降低推荐活检的S3M临界值，可以恢复对高级别前列腺癌的敏感性，但代价是适度增加活检数量。
结论
使用不同的PSA临界值进行进一步检测时，可以保持检测前列腺癌的敏感性。生物标志物临界值对检测次数和进行的前列腺活检数量有影响。可以考虑使用1.5 ng/ml的PSA临界值进行进一步检测，如S3M检测。
试验注册
ISRCTN84445406 。
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