Department of Radiation Oncology, Cross Cancer Institute, Edmonton, Alberta, Canada.
Int J Radiat Oncol Biol Phys. 2013 Oct 1;87(2):246-60. doi: 10.1016/j.ijrobp.2013.03.036. Epub 2013 May 15.
Central review of radiation therapy (RT) delivery within multicenter clinical trials was initiated in the early 1970s in the United States. Early quality assurance publications often focused on metrics related to process, logistics, and timing. Our objective was to review the available evidence supporting correlation of RT quality with clinical outcomes within cooperative group trials. A MEDLINE search was performed to identify multicenter studies that described central subjective assessment of RT protocol compliance (quality). Data abstracted included method of central review, definition of deviations, and clinical outcomes. Seventeen multicenter studies (1980-2012) were identified, plus one Patterns of Care Study. Disease sites were hematologic, head and neck, lung, breast, and pancreas. Between 0 and 97% of treatment plans received an overall grade of acceptable. In 7 trials, failure rates were significantly higher after inadequate versus adequate RT. Five of 9 and 2 of 5 trials reported significantly worse overall and progression-free survival after poor-quality RT, respectively. One reported a significant correlation, and 2 reported nonsignificant trends toward increased toxicity with noncompliant RT. Although more data are required, protocol-compliant RT may decrease failure rates and increase overall survival and likely contributes to the ability of collected data to answer the central trial question.
20 世纪 70 年代初,美国开始对多中心临床试验中的放射治疗(RT)实施中央审查。早期的质量保证出版物通常侧重于与过程、物流和时间相关的指标。我们的目的是回顾现有的证据,以支持合作组试验中 RT 质量与临床结果的相关性。进行了 MEDLINE 检索,以确定描述中央主观评估 RT 方案依从性(质量)的多中心研究。提取的数据包括中央审查的方法、偏差的定义和临床结果。确定了 17 项多中心研究(1980-2012 年),加上一项治疗模式研究。疾病部位包括血液、头颈部、肺部、乳腺和胰腺。在 0%至 97%的治疗计划中获得了整体可接受的等级。在 7 项试验中,不充分与充分 RT 相比,失败率明显更高。5 项试验中的 9 项和 5 项试验中的 2 项分别报告了较差的总生存率和无进展生存率,这表明 RT 质量较差。一项报告了显著相关性,2 项报告了非依从性 RT 与毒性增加的非显著趋势。尽管需要更多的数据,但符合方案的 RT 可能会降低失败率,提高总生存率,并且可能有助于收集的数据回答中心试验的问题。