Ottawa Hospital Research Institute, Division of Radiation Oncology, The Ottawa Hospital & University of Ottawa, Ottawa, Ontario, Canada.
Radiother Oncol. 2013 Jan;106(1):5-14. doi: 10.1016/j.radonc.2012.12.009. Epub 2013 Jan 13.
To determine the optimal dose of single fraction conventional palliative radiation therapy for the relief of pain caused by bone metastases.
Ovid version of EMBASE and EMBASE Classic, MEDLINE, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials were searched for relevant randomised controlled trials. Pain response data were standardised according to the clinical trial endpoints recommended by the International Bone Metastases Consensus Working Party.
From 2696 references we selected 26 articles for review. These described 24 trials that cumulatively randomised 3233 patients to 28 single fraction arms: two arms received 4 Gy, one 5 Gy, one 6 Gy, twenty-two 8 Gy, one 10 Gy and one 8-15 Gy. Eighty-four percent of all patients received 8 Gy and this imbalance precluded formal modelling analyses for different doses. Efficacy endpoints and pain assessment times varied. In general, higher doses produced better pain response rates. The overall (OR) and complete (CR) pain response rates for different doses according to available intention-to-treat (ITT) and assessable patient (A) figures were: 4 Gy [OR(ITT)=23-47%, OR(A)=44-47%, CR(ITT)=15-18%, CR(A)=15-26%], 5 Gy [OR(A)=72%, CR(A)=55%], 6 Gy [OR(ITT&A)=65%, CR(ITT&A)=21%], 8 Gy [OR(ITT)=21-81%, OR(A)=31-93%, CR(ITT)=9-52%, CR(A)=14-57%], 10 Gy [OR(A)=84%, CR(A)=39%]. In trials that directly compared different single fraction doses, 8 Gy was statistically superior to 4 Gy.
8 Gy was by far the most commonly administered single fraction dose within 24 randomised trials of conventional radiation therapy for the palliation of bone metastases. 8 Gy should be the standard dose against which future treatments are compared due to its reproducible pain response rate and its established safe profile. The optimal dose for the relief of pain remains an open question, however, 8 Gy produced statistically superior pain response rates compared to 4 Gy in trials directly comparing those doses, and in general across all trials doses of 8 Gy or more produced numerically superior pain response rates compared to doses less than 8 Gy.
确定单次常规姑息性放射治疗缓解骨转移疼痛的最佳剂量。
检索了 Ovid 版 EMBASE 和 EMBASE Classic、MEDLINE、Cochrane 系统评价数据库和 Cochrane 对照试验中心注册库，以寻找相关的随机对照试验。根据国际骨转移共识工作组推荐的临床试验终点，对疼痛缓解数据进行了标准化。
从 2696 条参考文献中，我们选择了 26 篇文章进行综述。这些文章描述了 24 项试验，共有 3233 名患者被随机分配到 28 个单次分割组：两组接受 4 Gy，一组接受 5 Gy，一组接受 6 Gy，22 组接受 8 Gy，一组接受 10 Gy，一组接受 8-15 Gy。所有患者中有 84%接受了 8 Gy，这种不平衡使得不同剂量的正式模型分析变得不可能。疗效终点和疼痛评估时间各不相同。一般来说，较高的剂量会产生更好的疼痛缓解率。根据可获得的意向治疗（ITT）和可评估患者（A）数据，不同剂量的总体（OR）和完全（CR）疼痛缓解率为：4 Gy [OR（ITT）=23-47%，OR（A）=44-47%，CR（ITT）=15-18%，CR（A）=15-26%]，5 Gy [OR（A）=72%，CR（A）=55%]，6 Gy [OR（ITT&A）=65%，CR（ITT&A）=21%]，8 Gy [OR（ITT）=21-81%，OR（A）=31-93%，CR（ITT）=9-52%，CR（A）=14-57%]，10 Gy [OR（A）=84%，CR（A）=39%]。在直接比较不同单次分割剂量的试验中，8 Gy 在统计学上优于 4 Gy。
在 24 项常规放射治疗缓解骨转移疼痛的随机试验中，8 Gy 是迄今为止最常用的单次分割剂量。由于其可重复的疼痛缓解率和已建立的安全性，8 Gy 应该成为未来治疗的标准剂量。然而，缓解疼痛的最佳剂量仍然是一个悬而未决的问题，但是在直接比较这些剂量的试验中，8 Gy 比 4 Gy 产生了统计学上更好的疼痛缓解率，并且在所有试验中，8 Gy 或更高剂量的疼痛缓解率通常优于 8 Gy 以下剂量。
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