Hormone therapy use and duration with postoperative radiotherapy for recurrent prostate cancer: an individual patient data meta-analysis.

Herein, we report an individual patient data (IPD) meta-analysisof randomised trials aimed at quantifying the benefit of adding hormonal therapy to PORT.

在此，我们报告了一项针对随机试验的个体患者数据（IPD）荟萃分析，旨在量化将激素治疗添加到术后放疗（PORT）中的益处。

Methods

This was an IPD meta-analysisthat identified randomised, phase 3 trials of PORT with or without hormone therapy.

这是一项个体患者数据(IPD)荟萃分析，识别了接受或不接受激素治疗的PORT的随机化、III期试验。

A systematic literature search of MEDLINE, Embase, trial registries, the Web of Science, Scopus, and relevant conference proceedings was done on Dec 15, 2024.

在2024年12月15日，对MEDLINE、Embase、试验注册处、Web of Science、Scopus以及相关会议记录进行了系统的文献检索。

IPD were available via the MARCAP consortium.

通过 MARCAP 联盟可以获得个体患者数据（IPD）。

The primary outcome was overall survival. Meta-analyses evaluated the benefit of adding hormone therapy, short-term hormone therapy (4-6 months), or long-term hormone therapy (24 months) to PORT.

主要结果指标是总生存期。

Tests for interaction based on pre-PORT prostate-specific antigen (PSA) and duration of hormone therapy were evaluated and non-linear associations between pre-PORT PSA and overall survivalwere modelled.

基于术前前列腺特异性抗原（PSA）和激素治疗持续时间的交互作用测试被评估，并建立了术前PSA与总生存之间的非线性关联模型。

This study was done under the master protocol of the MARCAP Consortium (PROSPERO registration CRD42019134376).

本研究是在MARCAP联盟的主协议下进行的（PROSPERO注册号CRD42019134376）。

Results

IPD were available for six randomised trials including 6057 patients with a median follow-up of 9·0 years (IQR 7·2-10·7 years).

共有六项随机试验的个体患者数据可用于分析，涉及6057名患者，中位随访时间为9.0年（四分位数间距为7.2-10.7年）。

Adding hormone therapy to radiotherapy did not significantly improve overall survival(hazard ratio[HR] 0·87, 95% CI 0·76-1·01, p=0·06).

将激素治疗添加到放射治疗中，并没有显著改善总生存期（风险比[HR] 0.87，95%置信区间0.76-1.01，p=0.06）。

There was no significant interaction between hormone therapy duration and this effect (pinteraction=0·17), although there was a significant interaction with pre-PORT PSA greater than 0·5 ng/mL versus 0·5 ng/mL or less (pinteraction=0·02).

激素治疗持续时间与该效应之间没有显著的相互作用（pinteraction=0.17），尽管与PORT前PSA大于0.5 ng/mL与0.5 ng/mL或更少之间存在显著的相互作用（pinteraction=0.02）。

For all pre-PORT PSA values, the upper bounds of the 95% CI of the HR for overall survivalcrossed 1·0 for patients randomly assigned to PORT with or without short-term hormone therapy (n=3938).

对于所有PORT前的PSA值，接受PORT治疗的患者（无论是否接受短期激素治疗）的总生存风险比的95%置信区间的上限均超过1.0（n=3938）。

For patients randomly assigned to PORT with or without long-term hormone therapy (n=1088), the upper bounds of the 95% CI for overall survivalHR fell below 1·0 at PSA greater than 1·6 ng/mL.

对于被随机分配到 PORT（放疗）组，无论是否接受长期激素治疗的患者（n=1088），当 PSA（前列腺特异性抗原）大于 1.6 ng/mL 时，总生存期的危险比（HR）的 95% 置信区间上限低于 1.0。

interpretation

Our findings, we believe, provide the strongest level of evidence to date suggesting there might be no meaningful overall survivalbenefit to adding hormone therapy, either short-term or long-term hormone therapy, to PORT for PSA 0·5 ng/mL or less, with no apparent difference in efficacy for short-term versus long-term hormone therapy.

我们认为，我们的研究结果提供了迄今为止最强的证据，表明对于 PSA（前列腺特异性抗原）0.5 ng/mL 或更低的患者，无论是短期还是长期激素治疗，添加到 PORT（放疗）中可能没有明显的总生存益处，短期与长期激素治疗的疗效没有明显差异。

There is an unmet need to identify biomarkers to predict potential hormone therapy benefit.

迫切需要识别生物标志物以预测潜在的激素治疗益处。

funding

National Institutes of Health.

国家卫生研究院。