The Department of Radiation Oncology, Beaumont Hospital, Dearborn, Michigan.
Associated Medical Professionals of NY PLLC, Syracuse, New York.
Pract Radiat Oncol. 2018 Jan-Feb;8(1):e7-e15. doi: 10.1016/j.prro.2017.07.008. Epub 2017 Jul 19.
We previously reported the results of a phase 3 trial evaluating a prostate/rectal hydrogel spacer during prostate intensity modulated radiation therapy, which resulted in decreased rectal dose and toxicity and less decline in bowel quality of life (QOL). A secondary analysis was performed to correlate penile bulb dose and sexual QOL.
Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean scores, the proportion of patients with a minimal clinically important difference (MID), and analyses of the different items composing the sexual domain.
A total of 222 men enrolled with median follow-up of 37 months. Hydrogel reduced penile bulb mean dose, maximum dose, and percentage of penile bulb receiving 10 to 30 Gy (all P < .05) with mean dose indirectly correlated with erections sufficient for intercourse at 15 months (P = .03). Baseline EPIC was low (53 [standard deviation ± 24]) with no difference between arms (P > .1). A total of 41% (88/222) of men had adequate baseline sexual QOL (EPIC >60 (mean, 77 [± 8.3]). This subgroup at 3 years had better sexual function (P = .03) with a spacer with a smaller difference in sexual bother (P = .1), which resulted in a higher EPIC summary on the spacer arm (58 [±24.1] vs control 45 [± 24.4]) meeting threshold for MID without statistical significance (P = .07). There were statistically nonsignificant differences favoring spacer for the proportion of men with MID and 2× MID declines in sexual QOL with 53% vs 75% having an 11-point decline (P = .064) and 41% vs 60% with a 22-point decline (P = .11). At 3 years, more men potent at baseline and treated with spacer had "erections sufficient for intercourse" (control 37.5% vs spacer 66.7%, P = .046) as well as statistically higher scores on 7 of 13 items in the sexual domain (all P < .05).
The use of a hydrogel spacer decreased dose to the penile bulb, which was associated with improved erectile function compared with the control group based on patient-reported sexual QOL.
我们之前报告了一项评估前列腺直肠水凝胶间隔器在前列腺调强放疗中的 3 期试验结果，该结果导致直肠剂量和毒性降低，且肠道生活质量（QOL）下降较少。进行了二次分析以关联阴茎球部剂量和性 QOL。
通过平均评分、有最小临床重要差异（MID）的患者比例以及组成性领域的不同项目的分析，使用扩展前列腺癌指数综合评分（EPIC）来测量性 QOL。
共纳入 222 例中位随访 37 个月的男性。水凝胶降低了阴茎球部的平均剂量、最大剂量和接受 10 至 30Gy 的阴茎球部百分比（所有 P<.05），平均剂量与 15 个月时足以进行性交的勃起间接相关（P=.03）。基线 EPIC 较低（53[标准偏差±24]），臂间无差异（P>.1）。共有 41%（88/222）的男性具有足够的基线性 QOL（EPIC>60（平均值，77[±8.3]）。该亚组在 3 年内具有更好的性功能（P=.03），使用间隔器时，性困扰的差异较小（P=.1），这导致间隔器臂上的 EPIC 总评分更高（58[±24.1]vs 对照组 45[±24.4]），但无统计学意义（P=.07）。在性 QOL 中，有统计学意义的优势偏向于间隔器，MID 比例和 2×MID 下降的男性比例分别为 53%和 75%（P=.064）和 41%和 60%（P=.11）。在 3 年时，更多基线时勃起功能良好且接受间隔器治疗的男性具有“足以进行性交的勃起”（对照组 37.5%vs 间隔器 66.7%，P=.046），并且在性领域的 13 个项目中有 7 个项目的评分更高（所有 P<.05）。
使用水凝胶间隔器降低了阴茎球部的剂量，与对照组相比，这与基于患者报告的性 QOL 的勃起功能改善相关。
