高危前列腺癌的降低剂量升级放疗：前列腺癌研究-5（PCS-5）的生存分析，这是一项由GROUQ领导的III期试验

Hypofractionated Dose Escalation Radiotherapy for High-Risk Prostate Cancer: the survival analysis of the Prostate Cancer Study-5 (PCS-5), a GROUQ-led phase III trial

EUROPEAN UROLOGY

影响因子:25.20000

分区:医学1区 Top / 泌尿学与肾脏学1区

发表日期:2025 Mar

作者: Tamim Niazi, Abdenour Nabid, Talia Malagon, Steven Tisseverasinghe, Redouane Bettahar, Rafika Dahmane, Andre-Guy Martin, Marjory Jolicoeur, Michael Yassa, Maroie Barkati, Levon Igidbashian, Boris Bahoric, Robert Archambault, Hugo Villeneuve, Md Mohiuddin

摘要

前列腺癌研究5（PCS5）在高危前列腺癌（PCA）患者中比较了常规分离放疗（CFRT）和低分化放射疗法（HFRT），假设相似的毒性和生存结果。本报告介绍了疗效分析。pcs5是加拿大多中心，开放标签，3阶段随机对照试验。具有组织学证明，临床局部PCA的男性具有一个或多种高风险特征（T3/T4，Gleason评分≥8和前列腺特异性抗原> 20）。 Patients were randomized 1:1 to CFRT (76 Gy/38 fractions [Fx] to the prostate and 46 Gy/23 Fx to the pelvic lymph nodes [PLNs]) or HFRT (68 Gy/25 Fx to the prostate and 45 Gy/25 Fx to the PLNs) and 28 mo of androgen suppression.主要终点是毒性。次要终点包括329例患者的生存结果，164例被随机分配给HFRT，而CFRT为165例，在HFRT ARM中为159例，生存分析中的CFRT ARM中有160例。 At the 5-yr median follow-up, there were no significant differences in overall survival (OS; 90.3% vs 89.7%; risk ratio [RR]: 1.01; 95% confidence interval [CI]: 0.93-1.09), PCa-specific survival (PCSS; 97.4% vs 97.5%; RR: 1.00; 95% CI: 0.93-1.07), biochemical无复发的生存期（BCRF； 85.2％vs 85.2％; RR：1.00; 95％CI：0.91-1.10）或远处的无转移生存期（DMFS; 87.1％vs 87.1％vs 87.1％; RR：1.00; RR：1.00; 95％CI：0.92-1.09）。 OS的危险比为0.92（95％CI：0.56-1.53），PCSS的危险比为1.31（95％CI：0.46-3.78），BCRFS的危险比为0.85（95％CI：0.56-1.30），DMFS的危险比率为0.90（95％CI：0.90（95％CI：0.56-1.43）。样本量是一个限制因素，HFRT（68 GY/25 FX）和CFRT（76 GY/38 FX）之间的存活率没有差异。 HFRT，包括PLN放射疗法和长期雄激素剥夺疗法，应被认为是接受外部束放疗的高风险PCA患者的新标准护理标准。

Abstract

Prostate Cancer Study 5 (PCS5) compared conventional fractionated radiotherapy (CFRT) with hypofractionated radiotherapy (HFRT) in high-risk prostate cancer (PCa) patients, hypothesizing similar toxicity and survival outcomes. This report presents the efficacy analysis.PCS5 is a Canadian multicenter, open-label, phase 3 randomized control trial. Men with histologically proven, clinically localized PCa with one or more high-risk features (T3/T4, Gleason score ≥8, and prostate-specific antigen >20) were eligible. Patients were randomized 1:1 to CFRT (76 Gy/38 fractions [Fx] to the prostate and 46 Gy/23 Fx to the pelvic lymph nodes [PLNs]) or HFRT (68 Gy/25 Fx to the prostate and 45 Gy/25 Fx to the PLNs) and 28 mo of androgen suppression. The primary endpoint was toxicity; secondary endpoints included survival outcomes.Of 329 patients, 164 were randomized to HFRT and 165 to CFRT, with 159 in the HFRT arm and 160 in the CFRT arm included in survival analyses. At the 5-yr median follow-up, there were no significant differences in overall survival (OS; 90.3% vs 89.7%; risk ratio [RR]: 1.01; 95% confidence interval [CI]: 0.93-1.09), PCa-specific survival (PCSS; 97.4% vs 97.5%; RR: 1.00; 95% CI: 0.93-1.07), biochemical recurrence-free survival (BCRFS; 85.2% vs 85.2%; RR: 1.00; 95% CI: 0.91-1.10), or distant metastasis-free survival (DMFS; 87.1% vs 87.1%; RR: 1.00; 95% CI: 0.92-1.09). Hazard ratios were 0.92 (95% CI: 0.56-1.53) for OS, 1.31 (95% CI: 0.46-3.78) for PCSS, 0.85 (95% CI: 0.56-1.30) for BCRFS, and 0.90 (95% CI: 0.56-1.43) for DMFS. Sample size was a limiting factor.There were no differences in survival outcomes between HFRT (68 Gy/25 Fx) and CFRT (76 Gy/38 Fx). HFRT, including PLN radiotherapy and long-term androgen deprivation therapy, should be considered a new standard of care for high-risk PCa patients undergoing external beam radiotherapy.