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在进行中的 EORTC 1420“最佳”早期口咽、声门上和下咽癌试验中放射治疗的质量保证:基准病例程序的结果。

Quality assurance of radiotherapy in the ongoing EORTC 1420 "Best of" trial for early stage oropharyngeal, supraglottic and hypopharyngeal carcinoma: results of the benchmark case procedure.

机构信息

Radiation Oncology Department, Oncology Institute of Southern Switzerland, Via Athos Gallino 12, 6500, Bellinzona, Switzerland.

Department of Radiation Oncology, Kantonsspital St. Gallen, St. Gallen, Switzerland.

出版信息

Radiat Oncol. 2021 May 1;16(1):81. doi: 10.1186/s13014-021-01809-2.

Abstract

INTRODUCTION

The current phase III EORTC 1420 Best-of trial (NCT02984410) compares the swallowing function after transoral surgery versus intensity modulated radiotherapy (RT) in patients with early-stage carcinoma of the oropharynx, supraglottis and hypopharynx. We report the analysis of the Benchmark Case (BC) procedures before patient recruitment with special attention to dysphagia/aspiration related structures (DARS).

MATERIALS AND METHODS

Submitted RT volumes and plans from participating centers were analyzed and compared against the gold-standard expert delineations and dose distributions. Descriptive analysis of protocol deviations was conducted. Mean Sorensen-Dice similarity index (mDSI) and Hausdorff distance (mHD) were applied to evaluate the inter-observer variability (IOV).

RESULTS

65% (23/35) of the institutions needed more than one submission to achieve Quality assurance (RTQA) clearance. OAR volume delineations were the cause for rejection in 53% (40/76) of cases. IOV could be improved in 5 out of 12 OARs by more than 10 mm after resubmission (mHD). Despite this, final IOV for critical OARs in delineation remained significant among DARS by choosing an aleatory threshold of 0.7 (mDSI) and 15 mm (mHD).

CONCLUSIONS

This is to our knowledge the largest BC analysis among Head and neck RTQA programs performed in the framework of a prospective trial. Benchmarking identified non-common OARs and target delineations errors as the main source of deviations and IOV could be reduced in a significant number of cases after this process. Due to the substantial resources involved with benchmarking, future benchmark analyses should assess fully the impact on patients' clinical outcome.

摘要

简介

目前,EORTC1420 期最佳试验(NCT02984410)正在比较经口手术后与调强放疗(RT)在口咽、喉上和下咽早期癌患者中的吞咽功能。我们报告了在招募患者之前对基准病例(BC)程序的分析,特别关注与吞咽/误吸相关的结构(DARS)。

材料和方法

对参与中心提交的 RT 体积和计划进行了分析,并与黄金标准专家勾画和剂量分布进行了比较。对方案偏差进行了描述性分析。应用平均 Sorensen-Dice 相似指数(mDSI)和 Hausdorff 距离(mHD)来评估观察者间变异性(IOV)。

结果

65%(23/35)的机构需要提交不止一次才能达到质量保证(RTQA)标准。53%(40/76)的病例因 OAR 体积勾画被拒绝。在重新提交后,12 个 OAR 中有 5 个 OAR 的 IOV 可以提高 10mm 以上(mHD)。尽管如此,在选择 0.7(mDSI)和 15mm(mHD)的随机阈值后,DARS 中关键 OAR 的最终 IOV 仍有显著差异。

结论

这是我们所知的在前瞻性试验框架内进行的最大的头颈部 RTQA 方案的 BC 分析。基准确定了非常见的 OAR 和目标勾画误差是偏差和 IOV 的主要来源,在这个过程之后,大量的病例中的 IOV 可以降低。由于基准分析涉及大量资源,未来的基准分析应充分评估对患者临床结果的影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db84/8088557/1e1ae3948f1d/13014_2021_1809_Fig1_HTML.jpg

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