Department of Radiation Oncology, LAC+USC Medical Center, Los Angeles, California, USA.
Department of Radiation Oncology, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Pediatr Blood Cancer. 2023 May;70(5):e30270. doi: 10.1002/pbc.30270. Epub 2023 Mar 7.
Radiation therapy normal tissue dose constraints are critical when treating pediatric patients. However, there is limited evidence supporting proposed constraints, which has led to variations in constraints over the years. In this study, we identify these variations in dose constraints within pediatric trials both in the United States and in Europe used in the past 30 years.
All pediatric trials from the Children's Oncology Group website were queried from inception until January 2022 and a sampling of European studies was included. Dose constraints were identified and built into an organ-based interactive web application with filters to display data by organs at risk (OAR), protocol, start date, dose, volume, and fractionation scheme. Dose constraints were evaluated for consistency over time and compared between pediatric US and European trials RESULTS: One hundred five closed trials were included-93 US trials and 12 European trials. Thirty-eight separate OAR were found with high-dose constraint variability. Across all trials, nine organs had greater than 10 different constraints (median 16, range 11-26), including serial organs. When comparing US versus European dose tolerances, the United States constraints were higher for seven OAR, lower for one, and identical for five. No OAR had constraints change systematically over the last 30 years.
Review of pediatric dose-volume constraints in clinical trials showed substantial variability for all OAR. Continued efforts focused on standardization of OAR dose constraints and risk profiles are essential to increase consistency of protocol outcomes and ultimately to reduce radiation toxicities in the pediatric population.
在治疗儿科患者时，放射治疗正常组织剂量限制至关重要。然而，支持建议限制的证据有限，这导致多年来限制的变化。在这项研究中，我们确定了过去 30 年来美国和欧洲儿科试验中剂量限制的这些变化。
从成立到 2022 年 1 月，从儿童肿瘤学组网站查询了所有儿科试验，并纳入了一些欧洲研究。确定了剂量限制，并将其构建到一个基于器官的交互式网络应用程序中，该应用程序具有过滤器，可按风险器官 (OAR)、协议、开始日期、剂量、体积和分割方案显示数据。评估了剂量限制随时间的一致性，并比较了美国和欧洲儿科试验的结果。
共纳入 105 项已关闭试验-93 项美国试验和 12 项欧洲试验。发现 38 个单独的 OAR，高剂量限制变化很大。在所有试验中，有九个器官有超过 10 个不同的限制（中位数为 16，范围为 11-26），包括连续器官。当比较美国和欧洲的剂量耐受性时，美国对七个 OAR 的限制更高，一个限制更低，五个限制相同。过去 30 年来，没有 OAR 的限制系统地发生变化。
对临床试验中儿科剂量-体积限制的回顾显示，所有 OAR 的变化都很大。继续努力专注于 OAR 剂量限制和风险概况的标准化，对于提高协议结果的一致性并最终减少儿科人群的放射毒性至关重要。
