Copenhagen Prostate Cancer Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Copenhagen Prostate Cancer Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Lancet Oncol. 2017 Feb;18(2):221-229. doi: 10.1016/S1470-2045(17)30025-6. Epub 2017 Jan 14.
The risk of missing prostate cancer in the transrectal ultrasound-guided systematic biopsies of the prostate in men with suspected prostate cancer is a key problem in urological oncology. Repeat biopsy or MRI-guided biopsies have been suggested to increase sensitivity for diagnosis of prostate cancer, but the risk of disease-specific mortality in men who present with raised prostate-specific antigen (PSA) concentration and a benign initial biopsy result remains unknown. We investigated the risk of overall and prostate cancer-specific mortality in men with a benign initial biopsy set.
Data were extracted from the Danish Prostate Cancer Registry-a population-based registry including all men undergoing histopathological assessment of prostate tissue. All men who were referred for transrectal ultrasound-guided biopsy for assessment of suspected prostate cancer between Jan 1, 1995, and Dec 31, 2011, in Denmark were eligible for inclusion. Follow-up data were obtained on April 28, 2015. The primary endpoint was the cumulative incidence of prostate cancer-specific mortality, analysed in a competing risk setting, with death from other causes as the competing event.
Between Jan 1, 1995, and Dec 31, 2011, 64 430 men were referred for transrectal ultrasound-guided biopsy, of whom 63 454 were eligible for inclusion. Median follow-up was 5·9 years (IQR 3·8-8·5) and the total follow-up time, from the enrolment of the first patient on Jan 1, 1995, until the extraction of causes of death on April 28, 2015, was 20 years. 10 407 (30%) of 35 159 men with malignant initial biopsy sets died from prostate cancer, compared with 541 (2%) of 27 181 men with benign initial biopsy sets. Estimated overall 20-year mortality was 76·1% (95% CI 73·0-79·2). In all men referred for transrectal ultrasound-guided biopsy, the cumulative incidence of prostate cancer-specific mortality after 20 years was 25·6% (24·7-26·5) versus 50·5% (47·5-53·5) for mortality from other causes. In men with benign initial biopsy sets, the cumulative incidence of prostate cancer-specific mortality was 5·2% (3·9-6·5) versus 59·9% (55·2-64·6) for mortality from other causes. In men with PSA concentrations 10 μg/L or lower and benign initial biopsy sets (2779 men), the cumulative incidence of prostate cancer-specific mortality was 0·7% (0·2-1·3). Cumulative incidence of prostate cancer specific mortality in men with benign initial biopsy sets was 3·6% (95% CI 0·1-7·2) for men with a PSA higher than 10 ng/mL but 20 ng/mL or less (855 men) and 17·6% (12·7-22·4) and for men with a PSA higher than 20 ng/mL (454 men).
The first systematic transrectal ultrasound-guided biopsy set holds important prognostic information. The 20-year risk of prostate cancer-specific mortality in men with benign initial results is low. Our findings question whether men with low PSA concentration and a benign initial biopsy set should undergo further diagnostic assessment in view of the high risk of mortality from other causes.
Capital Region of Denmark's Fund for Health Research, Danish Cancer Society, Danish Association for Cancer Research, and Krista and Viggo Petersen's Foundation.
在疑似前列腺癌患者的经直肠超声引导前列腺系统活检中，遗漏前列腺癌的风险是泌尿外科肿瘤学的一个关键问题。已经有人建议进行重复活检或 MRI 引导活检，以提高前列腺癌诊断的敏感性，但在前列腺特异性抗原（PSA）浓度升高和初次活检结果为良性的患者中，疾病特异性死亡率的风险仍然未知。我们研究了初次活检为良性的患者的总死亡率和前列腺癌特异性死亡率的风险。
从丹麦前列腺癌登记处提取数据-该登记处包括所有接受前列腺组织组织学评估的男性。所有在 1995 年 1 月 1 日至 2011 年 12 月 31 日期间因疑似前列腺癌接受经直肠超声引导活检的丹麦男性都有资格入选。于 2015 年 4 月 28 日获得随访数据。主要终点是前列腺癌特异性死亡率的累积发生率，在竞争风险环境中进行分析，其他原因的死亡为竞争事件。
在 1995 年 1 月 1 日至 2011 年 12 月 31 日期间，有 64430 名男性因疑似前列腺癌接受经直肠超声引导活检，其中 63454 名符合入选条件。中位随访时间为 5.9 年（IQR 3.8-8.5），从 1995 年 1 月 1 日首位患者入组到 2015 年 4 月 28 日提取死因的总随访时间为 20 年。在 35159 名恶性初次活检组中，有 10407 名（30%）死于前列腺癌，而在 27181 名良性初次活检组中，有 541 名（2%）死于前列腺癌。所有因经直肠超声引导活检而转诊的男性 20 年总死亡率估计为 76.1%（95%CI 73.0-79.2）。在所有因经直肠超声引导活检而转诊的男性中，20 年后前列腺癌特异性死亡率的累积发生率为 25.6%（24.7-26.5），而其他原因的死亡率为 50.5%（47.5-53.5）。在初次活检为良性的男性中，前列腺癌特异性死亡率的累积发生率为 5.2%（3.9-6.5），而其他原因的死亡率为 59.9%（55.2-64.6）。在 PSA 浓度为 10μg/L 或更低且初次活检为良性的 2779 名男性中，前列腺癌特异性死亡率的累积发生率为 0.7%（0.2-1.3）。初次活检为良性的男性中，PSA 高于 10ng/ml 但低于 20ng/ml 的 855 名男性的前列腺癌特异性死亡率累积发生率为 3.6%（95%CI 0.1-7.2），PSA 高于 20ng/ml 的 454 名男性的累积发生率为 17.6%（12.7-22.4）。
初次系统经直肠超声引导活检具有重要的预后信息。初次结果为良性的男性 20 年内前列腺癌特异性死亡率的风险较低。我们的研究结果质疑在 PSA 浓度较低且初次活检为良性的男性中，是否应该进行进一步的诊断评估，因为他们死于其他原因的风险很高。
丹麦首都大区的健康研究基金、丹麦癌症协会、丹麦癌症研究协会以及 Krista 和 Viggo Petersen 基金会。
