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对前列腺床进行中等分割放疗,是否联合盆腔淋巴结照射:一项前瞻性试验。

Moderate hypofractionated radiotherapy to the prostate bed with or without pelvic lymph nodes: a prospective trial.

作者信息

Canales Juan P, Barnafi Esteban, Salazar Cristian, Reyes Paula, Merino Tomas, Calderón David, Cortés Analía

机构信息

Department of Hemato-oncology, Radiotherapy, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.

Medicine School, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile.

出版信息

Rep Pract Oncol Radiother. 2024 Jun 6;29(2):187-196. doi: 10.5603/rpor.99677. eCollection 2024.

DOI:10.5603/rpor.99677
PMID:39143977
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11321776/
Abstract

BACKGROUND

Hypofractionated radiotherapy in the treatment of prostate cancer has been widely studied. However, in the postoperative setting it has been less explored. The objective of this prospective study is to evaluate the safety and efficacy of hypofractionated radiotherapy in postoperative prostate cancer.

MATERIALS AND METHODS

A prospective study was designed to include patients with prostate cancer with an indication of postoperative radiotherapy as adjuvant or salvage. A hypofractionated radiotherapy scheme of 51 Gy in 17 fractions was performed with the possibility of treating the pelvis at a dose of 36 Gy in 12 fractions sequentially. Safety was evaluated based on acute and late toxicity [according to the Radiation Therapy Oncology Group (RTOG) scale and Common Terminology Criteria Adverse Events (CTCAE) v4.03], International Prognostic Scoring System (IPSS) over time, and quality of life.

RESULTS

From August 2020 to June 2022, 31 patients completed treatment and were included in this report. 35.5% of patients received elective treatment of the pelvic nodal areas. Most patients reported minimal or low acute toxicity, with an acute gastrointestinal (GI) and genitourinary (GU) grade 3 or greater toxicity of 3.2% and 0%, respectively. The evolution in time of the IPSS remained without significant differences (p = 0.42). With the exception of a significant improvement in the domains of hormonal and sexual symptoms of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire, the rest of the domains [EPIC, European Organization for Research and Treatment of Cancer (EORTC) Core quality of life questionnaire (C-30) and Prostate Cancer module (PR-25)] were maintained without significant differences over time. With a follow-up of 15.4 months, late GI and GU grade 2 toxicity was reported greater than 0% and 9.6%, respectively.

CONCLUSIONS

Hypofractionated radiotherapy in postoperative prostate cancer appears to be safe with low reports of relevant acute or late toxicity. Further follow-up is required to confirm these results.

TRIAL REGISTRATION

The protocol was approved by the accredited Medical Ethical Committee of Pontificia Universidad Católica de Chile. All participants accepted and wrote informed consent.

摘要

背景

前列腺癌的大分割放疗已得到广泛研究。然而,在术后情况下的研究较少。这项前瞻性研究的目的是评估大分割放疗在前列腺癌术后的安全性和有效性。

材料与方法

设计一项前瞻性研究,纳入有术后放疗指征作为辅助或挽救治疗的前列腺癌患者。采用17次分割给予51 Gy的大分割放疗方案,同时有可能依次给予盆腔12次分割36 Gy的剂量。根据急性和晚期毒性[依据放射治疗肿瘤学组(RTOG)标准和不良事件通用术语标准(CTCAE)v4.03]、随时间变化的国际预后评分系统(IPSS)以及生活质量评估安全性。

结果

2020年8月至2022年6月,31例患者完成治疗并纳入本报告。35.5%的患者接受了盆腔淋巴结区域的选择性治疗。大多数患者报告的急性毒性最小或较低,急性胃肠道(GI)和泌尿生殖系统(GU)3级或更高毒性分别为3.2%和0%。IPSS随时间的变化无显著差异(p = 0.42)。除了扩展前列腺癌指数综合问卷(EPIC)的激素和性症状领域有显著改善外,其余领域[EPIC、欧洲癌症研究与治疗组织(EORTC)核心生活质量问卷(C - 30)和前列腺癌模块(PR - 25)]随时间保持无显著差异。随访15.4个月时,晚期GI和GU 2级毒性报告分别大于0%和9.6%。

结论

前列腺癌术后大分割放疗似乎是安全的,相关急性或晚期毒性报告较少。需要进一步随访以证实这些结果。

试验注册

该方案已获得智利天主教大学认可的医学伦理委员会批准。所有参与者均接受并签署了知情同意书。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/6e50bdda5e93/rpor-29-2-187f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/c089558506bf/rpor-29-2-187f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/032eff7093b1/rpor-29-2-187f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/6e50bdda5e93/rpor-29-2-187f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/c089558506bf/rpor-29-2-187f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/032eff7093b1/rpor-29-2-187f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/34ee/11321776/6e50bdda5e93/rpor-29-2-187f3.jpg

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本文引用的文献

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Rep Pract Oncol Radiother. 2022 Dec 29;27(6):1094-1105. doi: 10.5603/RPOR.a2022.0108. eCollection 2022.
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Phase III randomised controlled trial on PSMA PET/CT guided hypofractionated salvage prostate bed radiotherapy of biochemical failure after radical prostatectomy for prostate cancer (PERYTON-trial): study protocol.PSMA PET/CT 引导下前列腺癌根治术后生化复发挽救性前列腺床放射治疗的 III 期随机对照试验(PERYTON 试验):研究方案。
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Hypofractionated Radiation Therapy to the Prostate Bed With Intensity-Modulated Radiation Therapy (IMRT): A Phase 2 Trial.
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Int J Radiat Oncol Biol Phys. 2021 Apr 1;109(5):1263-1270. doi: 10.1016/j.ijrobp.2020.12.020. Epub 2020 Dec 17.
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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.根治性前列腺切除术后局部前列腺癌男性患者的辅助放疗与早期挽救性放疗加短期雄激素剥夺治疗的比较(GETUG-AFU 17):一项随机、3 期试验。
Lancet Oncol. 2020 Oct;21(10):1341-1352. doi: 10.1016/S1470-2045(20)30454-X.
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Adjuvant radiotherapy versus early salvage radiotherapy following radical prostatectomy (TROG 08.03/ANZUP RAVES): a randomised, controlled, phase 3, non-inferiority trial.辅助放疗与根治性前列腺切除术后早期挽救性放疗(TROG 08.03/ANZUP RAVES):一项随机、对照、3 期、非劣效性试验。
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Adjuvant or early salvage radiotherapy for the treatment of localised and locally advanced prostate cancer: a prospectively planned systematic review and meta-analysis of aggregate data.辅助或早期挽救性放疗治疗局限性和局部进展性前列腺癌:汇总数据的前瞻性计划系统评价和荟萃分析。
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