Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, MD, USA.
Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY, USA.
J Natl Cancer Inst. 2021 Jun 1;113(6):727-734. doi: 10.1093/jnci/djaa154.
In the era of widespread prostate-specific antigen testing, it is important to focus etiologic research on the outcome of aggressive prostate cancer, but studies have defined this outcome differently. We aimed to develop an evidence-based consensus definition of aggressive prostate cancer using clinical features at diagnosis for etiologic epidemiologic research.
Among prostate cancer cases diagnosed in 2007 in the National Cancer Institute's Surveillance, Epidemiology, and End Results-18 database with follow-up through 2017, we compared the performance of categorizations of aggressive prostate cancer in discriminating fatal prostate cancer within 10 years of diagnosis, placing the most emphasis on sensitivity and positive predictive value (PPV).
In our case population (n = 55 900), 3073 men died of prostate cancer within 10 years. Among 12 definitions that included TNM staging and Gleason score, sensitivities ranged from 0.64 to 0.89 and PPVs ranged from 0.09 to 0.23. We propose defining aggressive prostate cancer as diagnosis of category T4 or N1 or M1 or Gleason score of 8 or greater prostate cancer, because this definition had one of the higher PPVs (0.23, 95% confidence interval = 0.22 to 0.24) and reasonable sensitivity (0.66, 95% confidence interval = 0.64 to 0.67) for prostate cancer death within 10 years. Results were similar across sensitivity analyses.
We recommend that etiologic epidemiologic studies of prostate cancer report results for this definition of aggressive prostate cancer. We also recommend that studies separately report results for advanced category (T4 or N1 or M1), high-grade (Gleason score ≥8), and fatal prostate cancer. Use of this comprehensive set of endpoints will facilitate comparison of results from different studies and help elucidate prostate cancer etiology.
在广泛进行前列腺特异性抗原检测的时代，将病因学研究重点放在侵袭性前列腺癌的结局上很重要，但研究对这一结局的定义各不相同。我们旨在使用诊断时的临床特征为病因流行病学研究制定侵袭性前列腺癌的循证共识定义。
我们比较了 2007 年在国家癌症研究所监测、流行病学和最终结果-18 数据库中诊断的前列腺癌病例（随访至 2017 年）的侵袭性前列腺癌分类在 10 年内诊断出致命性前列腺癌的表现，最强调敏感性和阳性预测值（PPV）。
在我们的病例人群（n=55900）中，3073 名男性在 10 年内死于前列腺癌。在包括 TNM 分期和 Gleason 评分的 12 种定义中，敏感性范围为 0.64 至 0.89，PPV 范围为 0.09 至 0.23。我们建议将侵袭性前列腺癌定义为 T4 或 N1 或 M1 或 Gleason 评分≥8 的前列腺癌诊断，因为该定义的 PPV（0.23，95%置信区间=0.22 至 0.24）较高，10 年内前列腺癌死亡的敏感性（0.66，95%置信区间=0.64 至 0.67）也较高。敏感性分析结果相似。
我们建议前列腺癌病因流行病学研究报告使用该侵袭性前列腺癌定义的结果。我们还建议研究分别报告晚期（T4 或 N1 或 M1）、高级别（Gleason 评分≥8）和致命性前列腺癌的结果。使用这一套全面的终点将有助于比较不同研究的结果，并有助于阐明前列腺癌的病因。
