Randomized trial of short-versus long-course radiotherapy for palliation of painful bone metastases
Randomized trial of short-versus long-course radiotherapy for palliation of painful bone metastases
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DOI：
10.1093/jnci/dji139
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发表时间：
2005-06-01
影响因子：
10.3
通讯作者：
DeSilvio, M
中科院分区：
文献类型：
--
作者：
Hartsell, WF;Scott, CB;DeSilvio, M
背景。放射治疗能有效缓解骨转移引起的疼痛。我们研究了在2周内，在10个治疗组中给予30 Gy的标准治疗过程中，单个治疗组给予的8 Gy是否能提供与标准治疗过程相同的疼痛和麻醉缓解。方法：一项前瞻性，III期随机研究姑息性放射治疗的乳腺癌或前列腺癌患者谁有一个到三个部位的疼痛骨转移和中度至重度疼痛。患者被随机分配到8 Gy的一个治疗组（8 Gy组）或30 Gy的10个治疗组（30 Gy组）。随机分组后3个月的疼痛缓解用简短疼痛量表评估。采用Wilcoxon-Mann-Whitney检验比较两组患者在疼痛和麻醉缓解方面对治疗的反应，并对每个分层变量进行比较。所有统计比较均为双侧比较。结果：8gy组455例，30gy组443例；预处理特性在两组间均衡。30-Gy组2-4级急性毒性发生率（17%）高于8-Gy组（10%）（差异= 7%,95% CI = 3% ~ 12%； P= 0.002）。两组的晚期毒性均罕见（4%）。总体应答率为66%。8 gy组的完全缓解率和部分缓解率分别为15%和50%，而30 gy组的完全缓解率和部分缓解率分别为18%和48% （P= 0.6）。3个月时，33%的患者不再需要麻醉药物。随后病理性骨折的发生率在8-Gy组为5%，在30-Gy组为4%。8-Gy组的再治疗率（18%）显著高于30-Gy组（9%）(P
Background. Radiation therapy is effective in palliating pain from bone metastases. We investigated whether 8 Gy delivered in a single treatment fraction provides pain and narcotic relief that is equivalent to that of the standard treatment course of 30 Gy delivered in 10 treatment fractions over 2 weeks. Methods: A prospective, phase III randomized study of palliative radiation therapy was conducted for patients with breast or prostate cancer who had one to three sites of painful bone metastases and moderate to severe pain. Patients were randomly assigned to 8 Gy in one treatment fraction (8-Gy arm) or to 30 Gy in 10 treatment fractions (30-Gy arm). Pain relief at 3 months after randomization was evaluated with the Brief Pain Inventory. The Wilcoxon-Mann-Whitney test was used to compare response to treatment in terms of pain and narcotic relief between the two arms an for each stratification variable. All statistical comparisons were two-sided. Results: There were 455 patients in the 8-Gy arm and 443 in the 30-Gy arm; pretreatment characteristics were equally balanced between arms. Grade 2-4 acute toxicity was more frequent in the 30-Gy arm (17%) than in the 8-Gy arm (10%) (difference = 7%, 95% CI = 3% to 12%; P=.002). Late toxicity was rare (4%) in both arms. The overall response rate was 66%. Complete and partial response rates were 15% and 50%, respectively, in the 8-Gy arm compared with 18% and 48% in the 30-Gy arm (P=.6). At 3 months, 33% of all patients no longer required narcotic medications. The incidence of subsequent pathologic fracture was 5% for the 8-Gy arm and 4% for the 30-Gy arm. The retreatment rate was statistically significantly higher in the 8-Gy arm (18%) than in the 30-Gy arm (9%) (P