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基于250余例患者的经验,关于水凝胶间隔物在前列腺放疗中的适应症及应用的多学科共识声明。

Interdisciplinary consensus statement on indication and application of a hydrogel spacer for prostate radiotherapy based on experience in more than 250 patients.

作者信息

Müller Arndt-Christian, Mischinger Johannes, Klotz Theodor, Gagel Bernd, Habl Gregor, Hatiboglu Gencay, Pinkawa Michael

机构信息

Department of Radiation Oncology, Eberhard Karls University, Tübingen, Germany.

Department of Urology, Eberhard Karls University, Tübingen, Germany.

出版信息

Radiol Oncol. 2016 Jul 19;50(3):329-36. doi: 10.1515/raon-2016-0036. eCollection 2016 Sep 1.

Abstract

BACKGROUND

The aim of the study was to reach a consensus on indication and application of a hydrogel spacer based on multicentre experience and give new users important information to shorten the learning curve for this innovative technique.

METHODS

The interdisciplinary meeting was attended by radiation oncologists and urologists, each with experience of 23 - 138 hydrogel injections (SpaceOAR®) in prostate cancer patients before dose-escalated radiotherapy. User experience was discussed and questions were defined to comprise practical information relevant for successful hydrogel injection and treatment. Answers to the defined key questions were generated. Hydrogel-associated side effects were collected to estimate the percentage, treatment and prognosis of potential risks.

RESULTS

The main indication for hydrogel application was dose-escalated radiotherapy for histologically confirmed low or intermediate risk prostate cancer. It was not recommended in locally advanced prostate cancer. The injection or implantation was performed under transrectal ultrasound guidance via the transperineal approach after prior hydrodissection. The rate of injection-related G2-toxicity was 2% (n = 5) in a total of 258 hydrogel applications. The most frequent complication (n = 4) was rectal wall penetration, diagnosed at different intervals after hydrogel injection and treated conservatively.

CONCLUSIONS

A consensus was reached on the application of a hydrogel spacer. Current experience demonstrated feasibility, which could promote initiation of this method in more centres to reduce radiation-related gastrointestinal toxicity of dose-escalated IGRT. However, a very low rate of a potential serious adverse event could not be excluded. Therefore, the application should carefully be discussed with the patient and be balanced against potential benefits.

摘要

背景

本研究的目的是基于多中心经验就水凝胶间隔物的适应症和应用达成共识,并为新用户提供重要信息,以缩短这一创新技术的学习曲线。

方法

放射肿瘤学家和泌尿科医生参加了跨学科会议,他们在剂量递增放疗前均有23 - 138例前列腺癌患者水凝胶注射(SpaceOAR®)的经验。讨论了用户体验,并确定了问题,以包含与成功进行水凝胶注射和治疗相关的实用信息。针对确定的关键问题给出了答案。收集了与水凝胶相关的副作用,以评估潜在风险的发生率、治疗方法和预后。

结果

水凝胶应用的主要适应症是组织学确诊的低危或中危前列腺癌的剂量递增放疗。局部晚期前列腺癌不推荐使用。在先行水分离后,通过经会阴途径在经直肠超声引导下进行注射或植入。在总共258次水凝胶应用中,注射相关的2级毒性发生率为2%(n = 5)。最常见的并发症(n = 4)是直肠壁穿透,在水凝胶注射后的不同时间间隔被诊断出来,并进行保守治疗。

结论

就水凝胶间隔物的应用达成了共识。目前的经验证明了其可行性,这可以促使更多中心开展该方法,以降低剂量递增调强放疗相关的胃肠道毒性。然而,不能排除潜在严重不良事件的发生率极低的情况。因此,应与患者仔细讨论应用情况,并权衡潜在益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23de/5024663/6a44e3cf6077/j_raon-2016-0036_fig_001.jpg

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