高危前列腺癌的分割放疗剂量递增：由GROUQ主导的PCS-5 III期临床试验的生存分析
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
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影响因子:25.2
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
DOI:
10.1016/j.eururo.2024.08.032
摘要
前列腺癌研究5（PCS5）比较了高危前列腺癌（PCa）患者中常规分割放疗（CFRT）与高剂量率分割放疗（HFRT），假设两者毒性和生存结局相似。本文为疗效分析。PCS5是一项加拿大多中心、开放标签、III期随机对照试验。符合条件的患者为组织学确诊、临床局限性PCa，具有一项或多项高危特征（T3/T4，Gleason评分≥8，前列腺特异性抗原[PSA] >20）。患者随机分配1:1接受CFRT（76 Gy/38次照射于前列腺，46 Gy/23次照射于盆腔淋巴结[PLNs]）或HFRT（68 Gy/25次照射于前列腺，45 Gy/25次照射于PLNs），并接受28个月的雄激素抑制治疗。主要终点为毒性；次要终点包括生存结局。共纳入329例患者，164例随机至HFRT组，165例至CFRT组，生存分析中包括159例HFRT和160例CFRT。随访中位时间5年，整体生存率（OS）无显著差异（90.3% vs 89.7%；风险比[RR]：1.01；95%置信区间[CI]：0.93-1.09）；前列腺癌特异性生存（PCSS）为97.4% vs 97.5%；RR：1.00；95% CI：0.93-1.07）；生化复发无病生存（BCRFS）为85.2% vs 85.2%；RR：1.00；95% CI：0.91-1.10）；远处转移无病生存（DMFS）为87.1% vs 87.1%；RR：1.00；95% CI：0.92-1.09。风险比为OS：0.92（95% CI：0.56-1.53）；PCSS：1.31（95% CI：0.46-3.78）；BCRFS：0.85（95% CI：0.56-1.30）；DMFS：0.90（95% CI：0.56-1.43）。样本量为限制因素。结果显示HFRT（68 Gy/25次）与CFRT（76 Gy/38次）在生存结局上无差异。包括PLN放疗和长期雄激素剥夺治疗的HFRT应被视为高危PCa患者接受外束放疗的新标准。
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.