University of Chicago Medicine, Chicago, IL.
American Society of Clinical Oncology, Alexandria, VA.
J Clin Oncol. 2020 May 1;38(13):1474-1494. doi: 10.1200/JCO.19.02768. Epub 2019 Dec 12.
This guideline provides recommendations for available tissue-based prostate cancer biomarkers geared toward patient selection for active surveillance, identification of clinically significant disease, choice of postprostatectomy adjuvant versus salvage radiotherapy, and to address emerging questions such as the relative value of tissue biomarkers compared with magnetic resonance imaging.
An ASCO multidisciplinary Expert Panel, with representatives from the European Association of Urology, American Urological Association, and the College of American Pathologists, conducted a systematic literature review of localized prostate cancer biomarker studies between January 2013 and January 2019. Numerous tissue-based molecular biomarkers were evaluated for their prognostic capabilities and potential for improving management decisions. Here, the Panel makes recommendations regarding the clinical use and indications of these biomarkers.
Of 555 studies identified, 77 were selected for inclusion plus 32 additional references selected by the Expert Panel. Few biomarkers had rigorous testing involving multiple cohorts and only 5 of these tests are commercially available currently: Onco Dx Prostate, Prolaris, Decipher, Decipher PORTOS, and ProMark. With various degrees of value and validation, multiple biomarkers have been shown to refine risk stratification and can be considered for select men to improve management decisions. There is a paucity of prospective studies assessing short- and long-term outcomes of patients when these markers are integrated into clinical decision making.
Tissue-based molecular biomarkers (evaluating the sample with the highest volume of the highest Gleason pattern) may improve risk stratification when added to standard clinical parameters, but the Expert Panel endorses their use only in situations in which the assay results, when considered as a whole with routine clinical factors, are likely to affect a clinical decision. These assays are not recommended for routine use as they have not been prospectively tested or shown to improve long-term outcomes-for example, quality of life, need for treatment, or survival. Additional information is available at www.asco.org/genitourinary-cancer-guidelines.
本指南针对可用于前列腺癌患者选择主动监测、识别临床显著疾病、选择前列腺切除术后辅助或挽救性放疗的组织生物标志物提供建议，并解决一些新兴问题，例如组织生物标志物与磁共振成像相比的相对价值。
ASCO 多学科专家小组，成员来自欧洲泌尿外科学会、美国泌尿外科学会和美国病理学家学院，对 2013 年 1 月至 2019 年 1 月期间的局部前列腺癌生物标志物研究进行了系统的文献回顾。评估了许多组织分子生物标志物的预后能力及其改善管理决策的潜力。在此，专家组就这些生物标志物的临床应用和适应证提出建议。
在确定的 555 项研究中，有 77 项被纳入研究，专家组还额外选择了 32 项参考资料。很少有生物标志物经过涉及多个队列的严格测试，目前只有 5 种测试可供商业使用：OncoDxProstate、Prolaris、Decipher、DecipherPORTOS 和 ProMark。有多种不同程度的价值和验证的生物标志物已被证明可以细化风险分层，可考虑用于特定男性以改善管理决策。目前，在将这些标志物纳入临床决策时，评估患者短期和长期结果的前瞻性研究很少。
组织分子生物标志物（评估具有最高 Gleason 模式的最大体积的样本）在加入标准临床参数后可能会改善风险分层，但专家组仅在以下情况下支持使用这些标志物：当考虑到整个检测结果与常规临床因素一起时，很可能会影响临床决策。这些检测不适用于常规使用，因为它们尚未经过前瞻性测试或证明可以改善长期结果，例如生活质量、治疗需求或生存。更多信息可在 www.asco.org/genitourinary-cancer-guidelines 获取。
