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辅助放疗不能改善局部晚期前列腺癌患者的无事件生存率
作者:小柯机器人 发布时间:2020/9/30 15:26:26

英国伦敦大学学院医院Claire L Vale团队对局部晚期前列腺癌辅助放疗或早期抢救性放疗进行了一项前瞻性计划系统评价和荟萃分析。2020年9月28日,该研究发表在《柳叶刀》杂志上。

目前尚不清楚根治性前列腺切除术后辅助或早期抢救性放疗是否更适合于患有局部或局部晚期前列腺癌的男性。为了对这些放疗方案的随机对照试验进行前瞻性计划系统评价,研究组对符合资格的试验进行了适应性荟萃分析。

研究组检索了截止到2020年7月8日的注册试验或会议记录,筛选出比较中危或高危,局部或局部晚期前列腺癌男性(≥18岁)进行根治性前列腺切除术后,接受即时辅助放疗或早期抢救性放疗的随机临床试验。

研究组使用无事件生存期的统一定义,即从随机化到任何一种生化进展、放射学进展、开始非试验治疗、因前列腺癌死亡、或随机分组后任意时间PSA水平至少为2.0 ng/mL的时间。

研究组最终确定了3项合格试验,且可获得2007年11月至2016年12月招募的2153例患者无事件生存的最新结果。中位随访时间从60个月至78个月不等,最长随访时间为132个月。1075例患者被随机分配接受辅助放疗,1078例接受早期抢救性放疗,其中421例(39.1%)在分析时已开始治疗,各组患者的临床特征保持平衡。

三项试验中,参与者的中位年龄为64岁或65岁,大多数患者的格里森评分为7分。所有试验的偏倚风险均较低。基于270个事件,荟萃分析没有证据表明辅助放疗比早期抢救性放疗能够改善无事件生存率,风险比为0.95,而5年无事件生存率只有1个百分点变化(89%对88%)。各试验结果一致。

研究结果表明,辅助放疗不能改善局部或局部晚期前列腺癌男性的无事件生存率。

附:英文原文

Title: Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data

Author: Claire L Vale, David Fisher, Andrew Kneebone, Christopher Parker, Maria Pearse, Pierre Richaud, Paul Sargos, Matthew R Sydes, Christopher Brawley, Meryem Brihoum, Chris Brown, Sylvie Chabaud, Adrian Cook, Silvia Forcat, Carol Fraser-Browne, Igor Latorzeff, Mahesh K B Parmar, Jayne F Tierney

Issue&Volume: 2020-09-28

Abstract:

Background

It is unclear whether adjuvant or early salvage radiotherapy following radical prostatectomy is more appropriate for men who present with localised or locally advanced prostate cancer. We aimed to prospectively plan a systematic review of randomised controlled trials (RCTs) comparing these radiotherapy approaches.

Methods

We used a prospective framework for adaptive meta-analysis (FAME), starting the review process while eligible trials were ongoing. RCTs were eligible if they aimed to compare immediate adjuvant radiotherapy versus early salvage radiotherapy, following radical prostatectomy in men (age ≥18 years) with intermediate-risk or high-risk, localised or locally advanced prostate cancer. We searched trial registers and conference proceedings until July 8, 2020, to identify eligible RCTs. By establishing the ARTISTIC collaboration with relevant trialists, we were able to anticipate when eligible trial results would emerge, and we developed and registered a protocol with PROSPERO before knowledge of the trial results (CRD42019132669). We used a harmonised definition of event-free survival, as the time from randomisation until the first evidence of either biochemical progression (prostate-specific antigen [PSA] ≥0·4 ng/mL and rising after completion of any postoperative radiotherapy), clinical or radiological progression, initiation of a non-trial treatment, death from prostate cancer, or a PSA level of at least 2·0 ng/mL at any time after randomisation. We predicted when we would have sufficient power to assess whether adjuvant radiotherapy was superior to early salvage radiotherapy. Investigators supplied results for event-free survival, both overall and within predefined patient subgroups. Hazard ratios (HRs) for the effects of radiotherapy timing on event-free survival and subgroup interactions were combined using fixed-effect meta-analysis.

Findings

We identified three eligible trials and were able to obtain updated results for event-free survival for 2153 patients recruited between November, 2007, and December, 2016. Median follow-up ranged from 60 months to 78 months, with a maximum follow-up of 132 months. 1075 patients were randomly assigned to receive adjuvant radiotherapy and 1078 to a policy of early salvage radiotherapy, of whom 421 (39·1%) had commenced treatment at the time of analysis. Patient characteristics were balanced within trials and overall. Median age was similar between trials at 64 or 65 years (with IQRs ranging from 59 to 68 years) across the three trials and most patients (1671 [77·6%]) had a Gleason score of 7. All trials were assessed as having low risk of bias. Based on 270 events, the meta-analysis showed no evidence that event-free survival was improved with adjuvant radiotherapy compared with early salvage radiotherapy (HR 0·95, 95% CI 0·75–1·21; p=0·70), with only a 1 percentage point (95% CI 2 to 3) change in 5-year event-free survival (89% vs 88%). Results were consistent across trials (heterogeneity p=0·18; I 2=42%).

Interpretation

This collaborative and prospectively designed systematic review and meta-analysis suggests that adjuvant radiotherapy does not improve event-free survival in men with localised or locally advanced prostate cancer. Until data on long-term outcomes are available, early salvage treatment would seem the preferable treatment policy as it offers the opportunity to spare many men radiotherapy and its associated side-effects.

DOI: 10.1016/S0140-6736(20)31952-8

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31952-8/fulltext

期刊信息

LANCET:《柳叶刀》,创刊于1823年。隶属于爱思唯尔出版社,最新IF:59.102
官方网址:http://www.thelancet.com/
投稿链接:http://ees.elsevier.com/thelancet