Dharmarajan Kavita V, Friedman Debra L, FitzGerald T J, McCarten Kathleen M, Constine Louis S, Chen Lu, Kessel Sandy K, Iandoli Matt, Laurie Fran, Schwartz Cindy L, Wolden Suzanne L
Mount Sinai Medical Center, New York, New York.
Vanderbilt University, Nashville, Tennessee.
Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):1065-71. doi: 10.1016/j.ijrobp.2014.11.034. Epub 2015 Feb 7.
A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy (IFRT) and imaging records by a centralized review center to maximize protocol compliance. We report the impact of centralized radiation therapy review on protocol compliance.
Review of simulation films, port films, and dosimetry records was required before and after treatment. Records were reviewed by study-affiliated or review center-affiliated radiation oncologists. A deviation of 6% to 10% from protocol-specified dose was scored as "minor"; a deviation of >10% was "major." A volume deviation was scored as "minor" if margins were less than specified or "major" if fields transected disease-bearing areas. Interventional review and final compliance review scores were assigned to each radiation therapy case and compared.
Of 1712 patients enrolled, 1173 underwent IFRT at 256 institutions in 7 countries. An interventional review was performed in 88% of patients and a final review in 98%. Overall, minor and major deviations were found in 12% and 6% of patients, respectively. Among the cases for which ≥1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution, 100% were made compliant on final review. By contrast, among the cases for which ≥1 modification was requested but not made by the treating institution, 10% were deemed compliant on final review.
In a large trial with complex treatment pathways and heterogeneous radiation therapy fields, central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner. When suggested modifications were performed by the institutions, deviations were almost eliminated.
一项评估中危霍奇金淋巴瘤基于反应的治疗的3期试验要求由一个集中审查中心对受累野放射治疗（IFRT）和影像记录进行实时中央审查，以最大限度地提高方案依从性。我们报告了集中放射治疗审查对方案依从性的影响。
治疗前后需要对模拟片、射野片和剂量记录进行审查。记录由研究附属或审查中心附属的放射肿瘤学家进行审查。与方案规定剂量的偏差在6%至10%被评为“轻微”；偏差>10%为“严重”。如果边缘小于规定值，则体积偏差被评为“轻微”；如果射野横断了病变区域，则为“严重”。为每个放射治疗病例分配介入审查和最终依从性审查分数并进行比较。
在入组的1712例患者中，1173例在7个国家的256家机构接受了IFRT。88%的患者进行了介入审查，98%的患者进行了最终审查。总体而言，分别在12%和6%的患者中发现了轻微和严重偏差。在质量保证审查中心要求并随后由治疗机构进行≥1次IFRT前修改的病例中，100%在最终审查时达到了依从性。相比之下，在要求进行≥1次修改但治疗机构未进行修改的病例中，10%在最终审查时被认为达到了依从性。
在一项具有复杂治疗路径和异质性放射治疗野的大型试验中，在IFRT前对很大比例的病例进行了中央审查，并及时发现了频繁的潜在偏差。当机构执行建议的修改时，偏差几乎消除。
