Department of Radiation Oncology, National Cancer Center / National Clinical Research Center for Cancer / Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Radiation Oncology, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China.
Pract Radiat Oncol. 2022 Sep-Oct;12(5):397-408. doi: 10.1016/j.prro.2021.12.018. Epub 2022 Jul 13.
To estimate the variations in clinical target volumes (CTVs) and organs at risk delineation within the quality assurance (QA) program of the POTENTIAL trial, which is a multicenter, randomized phase 3 trial evaluating postmastectomy radiation therapy (RT), with or without internal mammary nodal irradiation, for patients with high-risk breast cancer.
The simulating computed tomography scan data set of a benchmark case was sent to the participating centers, and the delineation of CTVs and organs at risk was required to be completed by the investigators following protocol guidelines. All submitted contours were reviewed and compared with the reference contours created by the QA team, using quantitative geometric analysis regarding volume and the Jaccard Index (JCI), Dice similarity coefficient, Geographic Miss Index, Discordance Index, and mean distance to agreement. In addition to the whole-volume analysis of all structures, the combination contour of the supraclavicular fossa and level III and II axilla (CTVsc + axIII + axII) was further analyzed on a slice-by-slice basis.
The contours from 26 centers were reviewed and variations were observed between submission and reference. The variations of the CTV of the chest wall, contralateral breast, and heart were small, for which the mean JCI values were 0.62, 0.68, and 0.87, respectively. However, the mean JCI values of the CTV of the internal mammary nodal region, ipsilateral brachial plexus, left anterior descending coronary artery, and right coronary artery were 0.38, 0.21, 0.29, and 0.18, respectively, suggesting marked variations. In addition, marked under- and overoutlining variations were identified on 4 slices of CTVsc + axIII + axII on slice-by-slice analysis.
There were residual contouring variations despite a detailed protocol being provided, confirming the importance of pretrial QA in RT and highlighting the need for education and consideration of a real-time central review of the target delineation before the trial participants begin RT.
评估 POTENTIAL 试验质量保证 (QA) 计划中临床靶区 (CTV) 和危及器官勾画的变化，该试验为多中心随机 3 期试验，评估了高危乳腺癌患者接受乳房切除术放疗 (RT) 联合或不联合内乳淋巴结照射的效果。
基准病例的模拟 CT 扫描数据集被发送至参与中心，要求研究者按照方案指南完成 CTV 和危及器官的勾画。所有提交的轮廓都经过审查，并与 QA 团队创建的参考轮廓进行比较，使用有关体积和 Jaccard 指数 (JCI)、骰子相似系数、地理漏失指数、不吻合指数和平均一致性距离的定量几何分析。除了对所有结构的全体积分析外，还进一步对锁骨上窝和水平 III 和 II 腋窝的联合轮廓 (CTVsc+axIII+axII) 进行了逐层分析。
共审查了 26 个中心的轮廓，观察到提交的轮廓与参考轮廓之间存在差异。胸壁、对侧乳房和心脏的 CTV 变化较小，其平均 JCI 值分别为 0.62、0.68 和 0.87。然而，内乳淋巴结区域、同侧臂丛神经、左前降支冠状动脉和右冠状动脉的 CTV 的平均 JCI 值分别为 0.38、0.21、0.29 和 0.18，表明存在明显的变化。此外，在逐层分析中，对 4 个 CTVsc+axIII+axII 层面的勾画进行了细致的分析，发现存在明显的勾画不足和过度的情况。
尽管提供了详细的方案，但仍存在残留的勾画差异，这证实了 RT 前 QA 的重要性，并强调了在试验参与者开始 RT 之前，需要进行目标勾画的教育和考虑，并进行实时的中央审查。
