Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center, Tampa, Florida.
Department of Urology, University of South Florida, Tampa, Florida.
J Urol. 2021 Jun;205(6):1569-1576. doi: 10.1097/JU.0000000000001685. Epub 2021 Feb 22.
Men with nonseminomatous germ cell tumors of the testicle without evidence of residual disease after radical orchiectomy (clinical stage I) are increasingly managed with active surveillance. The guideline-recommended cornerstones of surveillance are conventional serum tumor markers and computerized tomography. The reliability of serum tumor markers as a tool to diagnose early recurrence of clinical stage I nonseminomatous germ cell tumors is unclear. The study objective was to conduct a systematic review of the currently available evidence assessing the reliability of serum tumor markers as a test to diagnose recurrence in patients with clinical stage I nonseminomatous germ cell tumors under active surveillance.
A systematic review was conducted in accordance with PRISMA guidelines, with no language or date restrictions. Studies were included that readily identified the tumor marker status of patients with clinical stage I nonseminomatous germ cell tumors who had a recurrence on active surveillance. The primary outcome was marker positivity at the time of recurrence. Risk of bias assessment was undertaken.
A total of 2,157 studies were identified and independently screened by 2 reviewers, with 37 studies ultimately being included. A relatively high risk of bias was identified among the studies, with the vast majority being retrospective series. The total population for the included studies was 8,545 patients with clinical stage I nonseminomatous germ cell tumors managed by active surveillance, and 2,254 ultimately relapsed. Serum tumor markers were elevated in 28% to 75% of patients at the time of recurrence and were the only indication of recurrence in 4% to 39%. The unavailability of patient-level data is the major limitation to the present findings.
In patients with clinical stage I nonseminomatous germ cell tumors managed by active surveillance, the use of serum tumor markers cannot obviate the need for computerized tomography. More reliable serum markers are needed in order to limit radiation exposure for these patients.
根治性睾丸切除术（临床Ⅰ期）后无残留疾病证据的非精原细胞瘤性生殖细胞肿瘤男性患者，越来越多地接受主动监测。监测的指南推荐基石是常规血清肿瘤标志物和计算机断层扫描。血清肿瘤标志物作为诊断临床Ⅰ期非精原细胞瘤性生殖细胞肿瘤早期复发的工具的可靠性尚不清楚。本研究的目的是对目前评估血清肿瘤标志物作为诊断临床Ⅰ期非精原细胞瘤性生殖细胞肿瘤患者主动监测时复发的检测工具的可靠性的可用证据进行系统评价。
按照 PRISMA 指南进行系统评价，无语言或日期限制。纳入的研究是那些能够明确临床Ⅰ期非精原细胞瘤性生殖细胞肿瘤患者肿瘤标志物状态的研究，这些患者在主动监测时发生了复发。主要结局是复发时标志物阳性。进行了偏倚风险评估。
共确定了 2157 项研究，并由 2 名评审员独立筛选，最终纳入了 37 项研究。研究中存在相对较高的偏倚风险，绝大多数是回顾性系列研究。纳入研究的总人群为 8545 例接受主动监测的临床Ⅰ期非精原细胞瘤性生殖细胞肿瘤患者，最终有 2254 例复发。在复发时，28%至 75%的患者血清肿瘤标志物升高，4%至 39%的患者仅出现标志物升高。目前研究结果的主要局限性是缺乏患者水平的数据。
在接受主动监测的临床Ⅰ期非精原细胞瘤性生殖细胞肿瘤患者中，血清肿瘤标志物的使用不能排除计算机断层扫描的需要。为了限制这些患者的辐射暴露，需要更可靠的血清标志物。
