Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial
Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial
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DOI：
10.1016/j.ijrobp.2016.12.024
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发表时间：
2017-04-01
影响因子：
7
通讯作者：
Michalski, Jeff
中科院分区：
文献类型：
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作者：
Hamstra, Daniel A.;Mariados, Neil;Michalski, Jeff
目的：SpaceOAR是美国食品和药物管理局批准的用于创造直肠前列腺间隙的水凝胶，在图像引导强度调制放射治疗的单盲III期试验中进行评估。222名男性以2:1的比例随机分为间隔组和对照组，接受79.2 Gy的治疗，每次治疗剂量为1.8 Gy，有或没有精囊。本研究报告了中位随访期为3年的最终结果。方法和材料：使用log-rank检验评估累积（不良事件通用术语标准，4.0版）毒性。使用扩展前列腺癌指数综合（EPIC）检查生活质量（QOL），并使用重复测量模型测试EPIC域从基线的平均变化。在每个领域中具有最小重要差异（MIDs）的男性比例使用预先指定阈值的重复测量逻辑模型进行测试。结果：>= 1级（9.2% vs 2.0%， P= 0.028）和>= 2级（5.7% vs 0%， P= 0.012）直肠毒性的3年发生率有利于间隔臂。隔离组的>= 1级尿失禁发生率也较低（15% vs 4%， P= 0.046）， >= 2级尿毒性无差异（7% vs 7%， P=0.7）。从6个月开始，肠道生活质量一直有利于间隔组（P= 0.002），差异在3年(5.8分；P
Purpose: SpaceOAR, a Food and Drug Administration approved hydrogel intended to create a rectal prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years.Methods and Materials: Cumulative (Common Terminology Criteria for Adverse Events, version 4.0) toxicity was evaluated using the log-rank test. Quality of life (QOL) was examined using the Expanded Prostate Cancer Index Composite (EPIC), and the mean changes from baseline in the EPIC domains were tested using repeated measures models. The proportions of men with minimally important differences (MIDs) in each domain were tested using repeated measures logistic models with pre specified thresholds.Results: The 3-year incidence of grade >= 1 (9.2% vs 2.0%; P=.028) and grade >= 2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade >= 1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade >= 2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P