文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

立体定向体部放射治疗局限性前列腺癌患者的生活质量结局和毒性特征:SCIMITAR 多中心 2 期试验。

Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial.

机构信息

Department of Radiation Oncology, University of California, Los Angeles, California.

Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California.

出版信息

Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):142-152. doi: 10.1016/j.ijrobp.2022.08.041. Epub 2022 Aug 23.


DOI:10.1016/j.ijrobp.2022.08.041
PMID:36007724
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11386273/
Abstract

PURPOSE: Postoperative radiation therapy (RT) is an underused standard-of-care intervention for patients with prostate cancer and recurrence/adverse pathologic features after radical prostatectomy. Although stereotactic body RT (SBRT) is a well-studied and convenient option for definitive treatment, data on the postprostatectomy setting are extremely limited. The purpose of this study was to evaluate short-term physician-scored genitourinary (GU) and gastrointestinal (GI) toxicities and patient-reported outcomes after postprostatectomy SBRT. METHODS AND MATERIALS: The SCIMITAR trial was a phase 2, dual-center, open-label, single-arm trial that enrolled patients with postoperative prostate-specific antigen >0.03 ng/mL or adverse pathologic features. Coprimary endpoints were 4-year biochemical recurrence-free survival, physician-scored acute and late GU and GI toxicities by the Common Terminology Criteria for Adverse Events (version 4.03) scale, and patient-reported quality-of-life (QOL) outcomes, as represented by the Expanded Prostate Cancer Index-26 and the International Prostate Symptom Score. Patients received SBRT 30 to 34 Gy/5 fractions to the prostate bed ± bed boost ± pelvic nodes with computed tomography (CTgRT) or magnetic resonance imaging guidance (MRgRT) in a nonrandomized fashion. Physician-scored toxicities and patient-reported QOL outcomes were collected at baseline and at 1, 3, and 6 months of follow-up. Univariable and multivariable analyses were performed to evaluate predictors of toxicities and QOL outcomes. RESULTS: One hundred participants were enrolled (CTgRT, n = 69; MRgRT, n = 31). The median follow-up was 29.5 months (CTgRT: 33.3 months, MRgRT: 22.6 months). The median (range) prostate bed dose was 32 (30-34) Gy. Acute and late grade 2 GU toxicities were both 9% while acute and late grade 2 GI toxicities were 5% and 0%, respectively. Three patients had grade 3 toxicity (n = 1 GU, n = 2 GI). No patient receiving MRgRT had grade 3 GU or grade ≥2 GI toxicity. Compared with CTgRT, MRgRT was associated with a 30.5% (95% confidence interval, 11.6%-49.5%) reduction in any-grade acute GI toxicity (P = .006). MRgRT was independently associated with improved any-grade GI toxicity and improved bowel QOL. CONCLUSIONS: Postprostatectomy SBRT was well tolerated at short-term follow-up. MRgRT may decrease GI toxicity. Longer toxicity and/or efficacy follow-up and randomized studies are needed.

摘要

目的:术后放疗(RT)是前列腺癌患者根治性前列腺切除术后复发/不良病理特征的标准治疗方法,但应用不足。立体定向体部放疗(SBRT)是一种已充分研究且方便的确定性治疗选择,但在前列腺切除术后的应用数据极为有限。本研究旨在评估前列腺切除术后 SBRT 后短期医生评分的泌尿生殖系统(GU)和胃肠道(GI)毒性和患者报告的结局。

方法和材料:SCIMITAR 试验是一项 2 期、双中心、开放标签、单臂试验,招募了前列腺特异性抗原(PSA)>0.03ng/ml 或有不良病理特征的术后患者。主要终点是 4 年生化无复发生存率、医生根据不良事件通用术语标准(第 4.03 版)评分的急性和晚期 GU 和 GI 毒性,以及患者报告的生活质量(QOL)结局,代表扩展前列腺癌指数-26 和国际前列腺症状评分。患者采用 CTgRT 或 MRgRT 以 30 至 34Gy/5 个剂量照射前列腺床±床增量±盆腔淋巴结,以非随机方式进行。医生评分的毒性和患者报告的 QOL 结局在基线以及随访 1、3 和 6 个月时收集。进行单变量和多变量分析以评估毒性和 QOL 结局的预测因素。

结果:共纳入 100 名参与者(CTgRT,n=69;MRgRT,n=31)。中位随访时间为 29.5 个月(CTgRT:33.3 个月,MRgRT:22.6 个月)。中位(范围)前列腺床剂量为 32(30-34)Gy。急性和晚期 2 级 GU 毒性均为 9%,而急性和晚期 2 级 GI 毒性分别为 5%和 0%。3 名患者出现 3 级毒性(GU 1 级,GI 2 级)。接受 MRgRT 的患者无 3 级 GU 或≥2 级 GI 毒性。与 CTgRT 相比,MRgRT 使任何级别急性 GI 毒性降低 30.5%(95%置信区间,11.6%-49.5%;P=0.006)。MRgRT 与改善的任何级别 GI 毒性和改善的肠道 QOL 相关。

结论:前列腺切除术后 SBRT 在短期随访中耐受性良好。MRgRT 可能降低 GI 毒性。需要进行更长时间的毒性和/或疗效随访和随机研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/3c9ff982192b/nihms-2013760-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/4c1327482582/nihms-2013760-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/c83a929fd4f5/nihms-2013760-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/3c9ff982192b/nihms-2013760-f0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/4c1327482582/nihms-2013760-f0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/c83a929fd4f5/nihms-2013760-f0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/acbc/11386273/3c9ff982192b/nihms-2013760-f0003.jpg

相似文献

[1]
Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial.

Int J Radiat Oncol Biol Phys. 2023-1-1

[2]
A Prospective Single-Arm Phase 2 Study of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy for Prostate Cancer: Early Toxicity Results.

Int J Radiat Oncol Biol Phys. 2019-8-13

[3]
Toxicity and Patient-Reported Quality-of-Life Outcomes After Prostate Stereotactic Body Radiation Therapy With Focal Boost to Magnetic Resonance Imaging-Identified Prostate Cancer Lesions: Results of a Phase 2 Trial.

Int J Radiat Oncol Biol Phys. 2023-11-1

[4]
Hypofractionated Radiation Therapy to the Prostate Bed With Intensity-Modulated Radiation Therapy (IMRT): A Phase 2 Trial.

Int J Radiat Oncol Biol Phys. 2021-4-1

[5]
Risk adapted dose-intensified postoperative radiation therapy in prostate cancer patients using a simultaneous integrated boost technique applied with helical Tomotherapy.

Radiat Oncol. 2017-8-10

[6]
Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial.

BMC Cancer. 2021-5-11

[7]
Patient-reported Outcomes and Late Toxicity After Postprostatectomy Intensity-modulated Radiation Therapy.

Eur Urol. 2019-5-19

[8]
A randomized phase II trial of MR-guided prostate stereotactic body radiotherapy administered in 5 or 2 fractions for localized prostate cancer (FORT).

BMC Cancer. 2023-9-30

[9]
Image Guided Hypofractionated Postprostatectomy Intensity Modulated Radiation Therapy for Prostate Cancer.

Int J Radiat Oncol Biol Phys. 2015-12-2

[10]
Time-Driven Activity-Based Costing of CT-Guided vs MR-Guided Prostate SBRT.

Appl Radiat Oncol. 2021-9

引用本文的文献

[1]
Stereotactic Salvage Radiotherapy for Macroscopic Prostate Bed Recurrence After Prostatectomy: STARR (NCT05455736): An Early Analysis from the STARR Trial.

Cancers (Basel). 2025-6-23

[2]
From CBCT to MR-Linac in Image-Guided Prostate Cancer Radiotherapy Towards Treatment Personalization.

Curr Oncol. 2025-5-22

[3]
A Randomized Controlled Phase 2 Trial Comparing Salvage Radiotherapy for Prostate Cancer Delivered in 4 Versus 2 Weeks (SHORTER): Acute Genitourinary and Gastrointestinal Patient-reported Outcomes at a Single Institution.

Eur Urol Oncol. 2025-6-9

[4]
Patient-Reported Outcomes With Stereotactic Intensity Modulated Radiotherapy After Radical Prostatectomy: A Nonrandomized Clinical Trial.

JAMA Oncol. 2025-5-15

[5]
Translation, Cross-Cultural Adaptation, and Psychometric Validation of the Turkish Version of the "Expanded Prostate Cancer Index Composite (EPIC)" in Prostate Cancer Patients.

Prostate. 2025-5

[6]
MR-Guided Adaptive Radiotherapy in Localized Prostate Cancer.

Technol Cancer Res Treat. 2025

[7]
SABR tolerance after prostatectomy: pushing the boundaries of ultrahypofractionation.

Clin Transl Oncol. 2025-1-25

[8]
A systematic review of prostate bed motion and anisotropic margins in post-prostatectomy external beam radiotherapy.

Tech Innov Patient Support Radiat Oncol. 2024-10-29

[9]
Intra-fractional geometric and dose/volume metric variations of magnetic resonance imaging-guided stereotactic radiotherapy of prostate bed after radical prostatectomy.

Phys Imaging Radiat Oncol. 2024-3-23

[10]
HypoFocal SRT Trial: Ultra-hypofractionated focal salvage radiotherapy for isolated prostate bed recurrence after radical prostatectomy; single-arm phase II study; clinical trial protocol.

BMJ Open. 2024-1-30

本文引用的文献

[1]
Dosimetric impact of interfraction prostate and seminal vesicle volume changes and rotation: A post-hoc analysis of a phase III randomized trial of MRI-guided versus CT-guided stereotactic body radiotherapy.

Radiother Oncol. 2022-2

[2]
Interfractional Geometric Variations and Dosimetric Benefits of Stereotactic MRI Guided Online Adaptive Radiotherapy (SMART) of Prostate Bed after Radical Prostatectomy: Post-Hoc Analysis of a Phase II Trial.

Cancers (Basel). 2021-6-4

[3]
Dose-intensified Versus Conventional-dose Salvage Radiotherapy for Biochemically Recurrent Prostate Cancer After Prostatectomy: The SAKK 09/10 Randomized Phase 3 Trial.

Eur Urol. 2021-9

[4]
Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial.

BMC Cancer. 2021-5-11

[5]
Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer (HYPO-RT-PC): patient-reported quality-of-life outcomes of a randomised, controlled, non-inferiority, phase 3 trial.

Lancet Oncol. 2021-2

[6]
MR-Guided Radiotherapy for Prostate Cancer.

Front Oncol. 2020-12-9

[7]
Hypofractionated Radiation Therapy to the Prostate Bed With Intensity-Modulated Radiation Therapy (IMRT): A Phase 2 Trial.

Int J Radiat Oncol Biol Phys. 2021-4-1

[8]
Moderate hypofractionated radiotherapy for post-operative treatment of prostate cancer: long-term outcome and pattern of toxicity.

Strahlenther Onkol. 2021-2

[9]
Adjuvant radiotherapy versus early salvage radiotherapy plus short-term androgen deprivation therapy in men with localised prostate cancer after radical prostatectomy (GETUG-AFU 17): a randomised, phase 3 trial.

Lancet Oncol. 2020-10

[10]
Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial.

Lancet Oncol. 2020-10

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索