CONTEXT Patients with clinical stage I (CS I) seminoma testis with large primary tumours and/or rete testis invasion (RTI) might have an increased risk of relapse. In recent years, these risk factors have frequently been employed to decide on adjuvant treatment. OBJECTIVE To systematically review the literature on tumour size and RTI as risk factors for relapse in CS I seminoma testis patients under surveillance. EVIDENCE ACQUISITION Relevant databases including Medline, Embase, and the Cochrane Library were searched up to November 2016. Randomised controlled trials (RCTs) or quasi-RCTs, prospective observational studies with controls, retrospective matched-pair studies, and comparative studies from well-defined registries/databases were included. The primary outcome was the rate of relapse and relapse-free survival (RFS). The risk of bias was assessed by the Quality in Prognosis Studies tool. EVIDENCE SYNTHESIS After assessing 3068 abstracts and 80 full-text articles, 20 studies met the inclusion criteria. Although evidence to justify a cut-off of 4cm for size was lacking, it was the most frequently studied. The reported hazard ratio (HR) for the RFS for tumours >4cm was 1.59-2.8. Accordingly, the reported 5-yr RFS ranged from 86.6% to 95.5% and from 73.0% to 82.6% for patients having tumours ≤4 and >4cm, respectively. For tumours with RTI present, the reported HR was 1.4-1.7. The 5-yr RFS ranged from 86.0% to 92.0% and 74.9% to 79.5% for patients without versus those with RTI present, respectively. A meta-analysis was considered inappropriate due to data heterogeneity. CONCLUSIONS Primary tumour size and RTI are associated with the risk of relapse in CS I seminoma testis patients during surveillance. However, in the presence of either risk factor, the vast majority of patients are cured by orchiectomy alone and will not relapse. Furthermore, the evidence on the prognostic value of size and RTI has significant limitations, so prudency is warranted on their routine use in clinical practice. PATIENT SUMMARY Primary testicular tumour size and rete testis invasion are considered to be important prognostic factors for the risk of relapse in patients with clinical stage I seminoma testis. We systematically reviewed all the literature on the prognostic value of these two postulated risk factors. The outcome is that the prognostic power of these factors in the published literature is too low to advocate their routine use in clinical practice and to drive the choice on adjuvant treatment in clinical stage I seminoma testis patients.

中文翻译：

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睾丸肿瘤大小和睾丸网浸润作为监测下临床 I 期精原细胞瘤患者复发风险的预后因素：睾丸癌指南小组的系统评价。

背景 临床 I 期 (CS I) 睾丸精原细胞瘤伴大原发肿瘤和/或睾丸网侵犯 (RTI) 的患者复发风险可能增加。近年来，这些风险因素经常被用来决定辅助治疗。目的 系统回顾关于肿瘤大小和 RTI 作为受监测的 CS I 睾丸精原细胞瘤患者复发危险因素的文献。证据获取 检索了截至 2016 年 11 月的相关数据库，包括 Medline、Embase 和 Cochrane 图书馆。随机对照试验 (RCT) 或准随机对照试验、具有对照的前瞻性观察研究、回顾性配对研究以及来自明确定义的比较研究包括登记处/数据库。主要结果是复发率和无复发生存率（RFS）。偏倚风险通过预后研究质量工具进行评估。证据综合 在评估了 3068 篇摘要和 80 篇全文文章后，20 项研究符合纳入标准。虽然缺乏证据来证明 4 厘米的尺寸是合理的，但它是最常研究的。对于 > 4 cm 的肿瘤，RFS 报告的风险比 (HR) 为 1.59-2.8。因此，对于肿瘤≤4 厘米和 >4cm 的患者，报告的 5 年 RFS 范围分别为 86.6% 至 95.5% 和 73.0% 至 82.6%。对于存在 RTI 的肿瘤，报告的 HR 为 1.4-1.7。没有 RTI 的患者和有 RTI 的患者的 5 年 RFS 分别为 86.0% 至 92.0% 和 74.9% 至 79.5%。由于数据异质性，荟萃分析被认为是不合适的。结论 原发肿瘤大小和 RTI 与 CS I 睾丸精原细胞瘤患者在监测期间的复发风险相关。然而，在存在任一风险因素的情况下，绝大多数患者仅通过睾丸切除术即可治愈，并且不会复发。此外，关于大小和 RTI 的预后价值的证据有很大的局限性，因此在临床实践中常规使用它们是有必要的。患者总结 原发性睾丸肿瘤大小和睾丸网浸润被认为是临床 I 期睾丸精原细胞瘤患者复发风险的重要预后因素。我们系统地回顾了所有关于这两个假定危险因素的预后价值的文献。