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放疗局部前列腺癌的随机对照试验的系统评价。

A systematic review of randomised controlled trials of radiotherapy for localised prostate cancer.

机构信息

Kleijnen Systematic Reviews Ltd, York, UK.

Kleijnen Systematic Reviews Ltd, York, UK.

出版信息

Eur J Cancer. 2015 Nov;51(16):2345-67. doi: 10.1016/j.ejca.2015.07.019. Epub 2015 Aug 5.

Abstract

BACKGROUND

Prostate cancer is the second most frequently diagnosed cancer and the sixth leading cause of cancer death in males. A systematic review of randomised controlled trials (RCTs) of radiotherapy and other non-pharmacological management options for localised prostate cancer was undertaken.

METHODS

A search of thirteen databases was carried out until March 2014. RCTs comparing radiotherapy (brachytherapy (BT) or external beam radiotherapy (EBRT)) to other management options i.e. radical prostatectomy (RP), active surveillance, watchful waiting, high intensity focused ultrasound (HIFU), or cryotherapy; each alone or in combination, e.g. with adjuvant hormone therapy (HT), were included. Methods followed guidance by the Centre for Reviews and Dissemination and the Cochrane Collaboration. Indirect comparisons were calculated using the Bucher method.

RESULTS

Thirty-six randomised controlled trials (RCTs, 134 references) were included. EBRT, BT and RP were found to be effective in the management of localised prostate cancer. While higher doses of EBRT seem to be related to favourable survival-related outcomes they might, depending on technique, involve more adverse events, e.g. gastrointestinal and genitourinary toxicity. Combining EBRT with hormone therapy shows a statistically significant advantage regarding overall survival when compared to EBRT alone (Relative risk 1.21, 95% confidence interval 1.12-1.30). Aside from mixed findings regarding urinary function, BT and radical prostatectomy were comparable in terms of quality of life and biochemical progression-free survival while favouring BT regarding patient satisfaction and sexual function. There might be advantages of EBRT (with/without HT) compared to cryoablation (with/without HT). No studies on HIFU were identified.

CONCLUSIONS

Based on this systematic review, there is no strong evidence to support one therapy over another as EBRT, BT and RP can all be considered as effective monotherapies for localised disease with EBRT also effective for post-operative management. All treatments have unique adverse events profiles. Further large, robust RCTs which report treatment-specific and treatment combination-specific outcomes in defined prostate cancer risk groups following established reporting standards are needed. These will strengthen the evidence base for newer technologies, help reinforce current consensus guidelines and establish greater standardisation across practices.

摘要

背景

前列腺癌是男性中第二常见的癌症,也是第六大癌症死亡原因。对放射治疗和其他局部前列腺癌非药物治疗选择的随机对照试验(RCT)进行了系统评价。

方法

对 13 个数据库进行了搜索,截至 2014 年 3 月。RCT 比较了放射治疗(近距离治疗(BT)或外部束放射治疗(EBRT))与其他治疗选择,即根治性前列腺切除术(RP)、主动监测、观察等待、高强度聚焦超声(HIFU)或冷冻治疗;单独或联合使用,例如联合辅助激素治疗(HT)。方法遵循了考科兰协作中心和考科兰协作组的指导。使用 Bucher 法计算间接比较。

结果

纳入了 36 项随机对照试验(RCT,134 个参考文献)。EBRT、BT 和 RP 被发现对局部前列腺癌的治疗有效。虽然更高剂量的 EBRT 似乎与有利的生存相关结果有关,但它们可能取决于技术,涉及更多的不良反应,例如胃肠道和泌尿生殖毒性。与单独 EBRT 相比,EBRT 联合激素治疗在总生存方面具有统计学上的优势(相对风险 1.21,95%置信区间 1.12-1.30)。除了关于尿功能的混合发现外,BT 和根治性前列腺切除术在生活质量和生化无进展生存方面相当,而在患者满意度和性功能方面有利于 BT。EBRT(联合/不联合 HT)可能比冷冻消融(联合/不联合 HT)有优势。没有发现关于 HIFU 的研究。

结论

基于这项系统评价,没有强有力的证据支持一种治疗方法优于另一种,因为 EBRT、BT 和 RP 都可以被认为是局部疾病的有效单一疗法,EBRT 也可以有效地用于术后管理。所有治疗方法都有独特的不良反应特征。需要进一步进行大型、稳健的 RCT,按照既定的报告标准,在明确的前列腺癌风险组中报告特定治疗和特定治疗组合的结果,以加强新技术的证据基础,帮助加强当前的共识指南,并在实践中实现更大的标准化。

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