近日，美国加州大学洛杉矶分校Amar U Kishan团队研究了复发性前列腺癌内分泌治疗的使用和术后放疗的持续时间对患者预后的影响。这一研究成果发表在2026年2月26日出版的《柳叶刀》杂志上。

将内分泌治疗加入局限性前列腺癌的根治性放疗可提高总生存期，但在根治性前列腺切除术后的术后放疗（PORT）背景下，其是否能同样提高总生存期尚不清楚。研究组报告了一项针对随机试验的个体患者数据（IPD）荟萃分析，旨在量化在PORT基础上加用内分泌治疗的获益。

这是一项IPD荟萃分析，检索了比较PORT联合或不联合内分泌治疗的随机III期试验。研究组于2024年12月15日对MEDLINE、Embase、试验注册库、Web of Science、Scopus以及相关会议论文集进行了系统性文献检索。IPD通过MARCAP联盟获取。主要结局是总生存期。荟萃分析评估了在PORT基础上加用内分泌治疗、加用短期内分泌治疗（4-6个月）或加用长期内分泌治疗（24个月）的获益。评估了基于PORT前前列腺特异性抗原（PSA）水平与内分泌治疗持续时间的交互作用检验，并对PORT前PSA水平与总生存期之间的非线性关联进行了建模。本研究根据MARCAP联盟的总方案进行（PROSPERO注册号CRD42019134376）。

研究组共获取了6项随机试验的IPD，包括6057例患者，中位随访时间为9.0年（IQR 7.2–10.7年）。在放疗基础上加用内分泌治疗未能显著改善总生存期（风险比[HR] 0.87，95% CI 0.76–1.01，p=0.06）。内分泌治疗持续时间与该效应之间无显著交互作用（p交互=0.17），但PORT前PSA > 0.5 ng/mL 对比 ≤ 0.5 ng/mL 存在显著的交互作用（p交互=0.02）。对于所有PORT前PSA值，被随机分配至PORT联合或不联合短期内分泌治疗（n=3938）的患者，其总生存期HR的95% CI上限均超过1.0。对于被随机分配至PORT联合或不联合长期内分泌治疗（n=1088）的患者，当PSA > 1.6 ng/mL时，其总生存期HR的95% CI上限低于1.0。

研究结果表明，该研究结果提供了迄今为止最高级别的证据，表明对于PSA ≤ 0.5 ng/mL的患者，在PORT基础上加用内分泌治疗（无论是短期还是长期内分泌治疗）可能无显著的总生存期获益，且短期与长期内分泌治疗的疗效无明显差异。目前尚未满足确定生物标志物以预测潜在内分泌治疗获益的需求。

附：英文原文

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

Author: Amar U Kishan, Yilun Sun, Christopher C Parker, Paul Sargos, Matthew R Sydes, Sylvie Chabaud, Meryem Brihoum, Tahmineh Romero Kalbasi, Michael L Steinberg, Luca F Valle, Kekoa Taparra, Jonathan E Shoag, Jorge A Garcia, Jason R Brown, Matthew B Rettig, Adam E Singer, Robert E Reiter, Scott Eggener, Wayne Brisbane, Soumyajit Roy, Nicholas G Zaorsky, Angela Y Jia, Ting Martin Ma, Nicholas G Nickols, Jason A Efstathiou, Osama Mohamad, James J Dignam, Wendy F Seiferheld, Alan Pollack, Howard M Sandler, Paul L Nguyen, Pascal Pommier, Daniel E Spratt

Issue&Volume: 2026-02-26

Abstract:

Background

Adding hormone therapy to definitive radiotherapy in localised prostate cancer improves overall survival, but whether it similarly improves overall survival in the context of postoperative radiotherapy (PORT) after radical prostatectomy is unclear. Herein, we report an individual patient data (IPD) meta-analysis of randomised trials aimed at quantifying the benefit of adding hormonal therapy to PORT.

Methods

This was an IPD meta-analysis that identified randomised, phase 3 trials of PORT with or without hormone therapy. A systematic literature search of MEDLINE, Embase, trial registries, the Web of Science, Scopus, and relevant conference proceedings was done on Dec 15, 2024. IPD were available via the MARCAP consortium. 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. 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 survival were modelled. This study was done under the master protocol of the MARCAP Consortium (PROSPERO registration CRD42019134376).

Findings

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). 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). 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). For all pre-PORT PSA values, the upper bounds of the 95% CI of the HR for overall survival crossed 1·0 for patients randomly assigned to PORT with or without short-term hormone therapy (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 survival HR fell below 1·0 at PSA greater than 1·6 ng/mL.

Interpretation

Our findings, we believe, provide the strongest level of evidence to date suggesting there might be no meaningful overall survival benefit 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. There is an unmet need to identify biomarkers to predict potential hormone therapy benefit.

DOI: 10.1016/S0140-6736(26)00137-6

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(26)00137-6/abstract