IQWiG Institute for Quality and Efficiency in Health Care, Cologne, Germany.
Eur Urol. 2011 Nov;60(5):881-93. doi: 10.1016/j.eururo.2011.06.044. Epub 2011 Jun 29.
Prostate cancer (PCa) is the most common cancer in men. Permanent interstitial low-dose-rate brachytherapy (LDR-BT) is a short-distance radiation therapy in which low-energy radioactive sources are implanted permanently into the prostate.
To assess the effectiveness and safety of LDR-BT compared to treatment alternatives in men with localised PCa.
Bibliographic databases (Medline, Embase, and the Cochrane Library) were searched from inception until June 2010 for randomised and nonrandomised controlled trials comparing LDR-BT with radical prostatectomy (RP), external-beam radiation therapy (EBRT), or no primary therapy (NPT). Primary outcome was overall survival (OS). Secondary outcomes were disease-free survival (DFS), biochemical recurrence-free survival (bRFS), physician-reported severe adverse events (SAE), and patient-reported outcomes (PRO).
A total of 31 studies, including 1 randomised controlled trial (RCT), were identified. Risk of bias was high for all 31 studies. OS was reported in one nonrandomised controlled study; however, these data were not interpretable because of strong residual confounding. DFS was not reported. Comparison of bRFS between treatment groups is not validated; thus, results were not interpretable. Physician-reported urogenital late toxicity grade 2 to 3 was more common in the LDR-BT group when compared to the EBRT group. With respect to PRO, better scores for sexual and urinary function as well as urinary incontinence were reported for LDR-BT compared to RP. Better scores for bowel function were reported for LDR-BT compared to EBRT.
We found a low amount of evidence in studies that exclusively compared LDR-BT with other treatment modalities. LDR-BT may have some different physician-reported SAE and patient-reported outcomes. The current evidence is insufficient to allow a definitive conclusion about OS. Randomised trials focusing on long-term survival are needed to clarify the relevance of LDR-BT in patients with localised PCa.
前列腺癌（PCa）是男性最常见的癌症。永久性间质低剂量率近距离放射治疗（LDR-BT）是一种近距离放射治疗，其中低能放射性物质被永久性植入前列腺。
评估 LDR-BT 与局部 PCa 治疗选择相比的有效性和安全性。
从开始到 2010 年 6 月，在 Medline、Embase 和 Cochrane 图书馆等文献数据库中搜索了比较 LDR-BT 与根治性前列腺切除术（RP）、外照射放射治疗（EBRT）或无原发性治疗（NPT）的随机和非随机对照试验。主要结局是总生存（OS）。次要结局是无病生存（DFS）、生化无复发生存（bRFS）、医生报告的严重不良事件（SAE）和患者报告的结局（PRO）。
共确定了 31 项研究，包括 1 项随机对照试验（RCT）。所有 31 项研究的偏倚风险均较高。一项非随机对照研究报告了 OS 数据；然而，由于存在强烈的残余混杂，这些数据无法解释。DFS 未报告。治疗组之间的 bRFS 比较不可验证；因此，结果无法解释。与 EBRT 组相比，LDR-BT 组医生报告的中重度尿生殖系统晚期毒性 2-3 级更常见。关于 PRO，与 RP 相比，LDR-BT 的性功能和尿控功能以及尿失禁评分更好。与 EBRT 相比，LDR-BT 的肠功能评分更好。
我们发现，专门比较 LDR-BT 与其他治疗方式的研究证据很少。LDR-BT 可能有一些不同的医生报告的 SAE 和患者报告的结局。目前的证据不足以得出关于 OS 的明确结论。需要进行关注长期生存的随机试验，以阐明 LDR-BT 在局部 PCa 患者中的相关性。
