HERMES: Randomised trial of 2-fraction or 5-fraction MRI-guided adaptive prostate radiotherapy.

IF 6.4 1区医学 Q1 ONCOLOGY

International Journal of Radiation Oncology Biology Physics Pub Date : 2025-05-20 DOI:10.1016/j.ijrobp.2025.05.008

Sian Cooper, Rosalyne L Westley, Katie Biscombe, Alex Dunlop, Adam Mitchell, Uwe Oelfke, Simeon Nill, Georgina Manning, Stephanie Burnett, Julia Murray, Anna Wilkins, Nina Tunariu, Derek Price, Aidan Adkins, Angela Pathmanathan, Greta Bucinskaite, Shaista Hafeez, Chris Parker, Ragu Ratnakumaran, Helena Verkooijen, Sophie Alexander, Trina Herbert, Emma Hall, Alison C Tree

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引用次数: 0

Abstract

Objective: To demonstrate safety and feasibility of 2-fraction stereotactic body radiotherapy (SBRT) for prostate cancer.

Methods: This single centre, non-comparative, phase II/R-IDEAL2b trial randomised 46 patients with intermediate/lower high-risk prostate cancer with visible gross tumour volume (GTV) on multiparametric magnetic resonance imaging (MRI) to receive 36.25Gy in 5 fractions over 10 days or 24Gy in 2 fractions with a GTV boost up to 27Gy over 8 days. All treatment was delivered on an MR-linac with daily adaptive replanning. The primary endpoint was acute grade ≥2 (G2+) genitourinary (GU) toxicity (CTCAEv5). Secondary endpoints include gastrointestinal (GI) toxicity and patient reported outcomes.

Results: G2+GU acute toxicity was observed in 6/22 (27.3%; 95% CI (0.11-0.50) of patients in the 2-fraction group and 7/24 (29.2%; 95% CI (0.13-0.50) in the 5-fraction group. There were no grade 3(G3) GU toxicities. G2+ urinary frequency rose from 4.5% (1/22) at week 2 to 13.6% (3/22) at week 4 in 2-fraction SBRT. G2+ urinary frequency peaked earlier in 5-fraction SBRT at 16.7% (4/24) in week 2, falling to 12.5% (3/24) at week 4. At 12 weeks, median EPIC-26 urinary-incontinence score was 85.5, IQR 75-100) for 2-fraction SBRT and 100, IQR 93.8-100) for 5-fraction SBRT. Urinary irritative-obstructive scores were higher at 12 weeks in the 2-fraction group (93.8, IQR 87.5-100) and 87.5, IQR 81.3-93.8 in the 5-fraction group. Peak IPSS score was lower in the 2-fraction group (8, IQR 4-11) and 13.5, IQR 10-17) in the 5-fraction group. G2+ GI acute toxicity occurred in 3/24 (6.8%) after 5-fraction SBRT, but none after 2-fraction SBRT.

Conclusions: Acceptable acute GU toxicity was seen after 2-fraction SBRT. Acute GI toxicity was low. Randomised trials are warranted to explore late toxicity and biochemical control.

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HERMES: 2分位或5分位mri引导的适应性前列腺放疗的随机试验。

目的：探讨二段式立体定向放射治疗前列腺癌的安全性和可行性。方法：这项单中心、非比较、II期/R-IDEAL2b试验随机选取了46例多参数磁共振成像（MRI）上可见总肿瘤体积（GTV）的中/低高危前列腺癌患者，分5次接受36.25Gy， 10天或2次接受24Gy， GTV在8天内增加至27Gy。所有治疗均在MR-linac上进行，每日进行适应性重新规划。主要终点为急性≥2级（G2+）泌尿生殖系统（GU）毒性（CTCAEv5）。次要终点包括胃肠道（GI）毒性和患者报告的结果。结果：6/22例（27.3%）出现G2+GU急性毒性；2分组患者的95% CI（0.11-0.50）和7/24 (29.2%；5分组95% CI（0.13-0.50）。无3级（G3） GU毒性反应。2-分数SBRT组G2+尿频从第2周的4.5%（1/22）上升到第4周的13.6%（3/22）。5分SBRT组G2+尿频峰值较早，第2周为16.7%(4/24)，第4周降至12.5%（3/24）。12周时，2分SBRT组EPIC-26尿失禁评分中位数为85.5 (IQR 75-100)， 5分SBRT组为100 （IQR 93.8-100）。12周时，2分组尿刺激梗阻性评分较高（93.8,IQR 87.5-100）， 5分组87.5,IQR 81.3-93.8。2分组IPSS峰值评分（8分，IQR 4-11分）低于5分组（13.5分，IQR 10-17分）。5份SBRT治疗组有3/24（6.8%）出现G2+ GI急性毒性，2份SBRT治疗组无急性毒性。结论：2次SBRT治疗后急性GU毒性可接受。急性胃肠道毒性较低。有必要进行随机试验以探索晚期毒性和生化控制。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Radiation Oncology Biology Physics 医学-核医学

CiteScore

11.00

自引率

7.10%

发文量

2538

审稿时长

6.6 weeks

期刊介绍： International Journal of Radiation Oncology • Biology • Physics (IJROBP), known in the field as the Red Journal, publishes original laboratory and clinical investigations related to radiation oncology, radiation biology, medical physics, and both education and health policy as it relates to the field. This journal has a particular interest in original contributions of the following types: prospective clinical trials, outcomes research, and large database interrogation. In addition, it seeks reports of high-impact innovations in single or combined modality treatment, tumor sensitization, normal tissue protection (including both precision avoidance and pharmacologic means), brachytherapy, particle irradiation, and cancer imaging. Technical advances related to dosimetry and conformal radiation treatment planning are of interest, as are basic science studies investigating tumor physiology and the molecular biology underlying cancer and normal tissue radiation response.