Miller Scientific, Johnson City, Tennessee.
Department of Radiation Oncology, Harvard Medical School, Massachusetts General Hospital, Boston.
JAMA Netw Open. 2020 Jun 1;3(6):e208221. doi: 10.1001/jamanetworkopen.2020.8221.
Perirectal spacers are intended to lower the risk of rectal toxic effects associated with prostate radiotherapy. A quantitative synthesis of typical clinical results with specific perirectal spacers is limited.
To evaluate the association between perirectal hydrogel spacer placement and clinical outcomes of men receiving radiotherapy for prostate cancer.
A systematic search was performed of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase for articles published through September 2019.
Studies comparing men who received a hydrogel spacer vs men who did not receive a spacer (controls) prior to prostate radiotherapy.
Via random-effects meta-analysis, group comparisons were reported using the weighted mean difference for continuous measures and the risk ratio for binary measures.
Procedural results, the percentage volume of rectum receiving at least 70 Gy radiation (v70), early (≤3 months) and late (>3 months) rectal toxic effects, and early and late changes in bowel-related quality of life on the Expanded Prostate Cancer Index Composite (minimal clinically important difference, 4 points).
The review included 7 studies (1 randomized clinical trial and 6 cohort studies) involving 1011 men (486 who received a hydrogel spacer and 525 controls), with a median duration of patient follow-up of 26 months (range, 3-63 months). The success rate of hydrogel spacer placement was 97.0% (95% CI, 94.4%-98.8% [5 studies]), and the weighted mean perirectal separation distance was 11.2 mm (95% CI, 10.1-12.3 mm [5 studies]). Procedural complications were mild and transient, occurring in 0% to 10% of patients within the studies. The hydrogel spacer group received 66% less v70 rectal irradiation compared with controls (3.5% vs 10.4%; mean difference, -6.5%; 95% CI, -10.5% to -2.5%; P = .001 [6 studies]). The risk of grade 2 or higher rectal toxic effects was comparable between groups in early follow-up (4.5% in hydrogel spacer group vs 4.1% in control group; risk ratio, 0.82; 95% CI, 0.52-1.28; P = .38 [6 studies]) but was 77% lower in the hydrogel spacer group in late follow-up (1.5% vs 5.7%; risk ratio, 0.23; 95% CI, 0.06-0.99; P = .05 [4 studies]). Changes in bowel-related quality of life were comparable between groups in early follow-up (mean difference, 0.2; 95% CI, -3.1 to 3.4; P = .92 [2 studies]) but were greater in the hydrogel spacer group in late follow-up (mean difference, 5.4; 95% CI, 2.8-8.0; P < .001 [2 studies]).
For men receiving prostate radiotherapy, injection of a hydrogel spacer was safe, provided prostate-rectum separation sufficient to reduce v70 rectal irradiation, and was associated with fewer rectal toxic effects and higher bowel-related quality of life in late follow-up.
直肠周围间隔物的目的是降低与前列腺放射治疗相关的直肠毒性作用的风险。使用特定的直肠周围间隔物对典型临床结果进行定量综合的研究有限。
评估直肠周围水凝胶间隔物放置与接受前列腺癌放射治疗的男性的临床结果之间的关系。
对 Cochrane 对照试验中心注册库、MEDLINE 和 Embase 进行了系统搜索，以获取截至 2019 年 9 月发表的文章。
比较接受水凝胶间隔物与未接受前列腺放射治疗前接受水凝胶间隔物（对照组）的男性的研究。
通过随机效应荟萃分析，使用连续测量的加权均数差和二项测量的风险比报告组间比较。
程序结果、至少接受 70 Gy 放射治疗的直肠体积百分比（v70）、早期（≤3 个月）和晚期（>3 个月）直肠毒性作用，以及早期和晚期肠相关生活质量的变化使用扩展前列腺癌指数综合（最小临床重要差异，4 分）。
综述包括 7 项研究（1 项随机临床试验和 6 项队列研究），涉及 1011 名男性（486 名接受水凝胶间隔物，525 名对照组），患者随访中位数为 26 个月（范围，3-63 个月）。水凝胶间隔物放置的成功率为 97.0%（95%CI，94.4%-98.8%[5 项研究]），直肠周围分离的加权平均距离为 11.2 毫米（95%CI，10.1-12.3 毫米[5 项研究]）。程序并发症轻微且短暂，在研究中，0%至 10%的患者出现。与对照组相比，水凝胶间隔物组接受的 v70 直肠照射量减少了 66%（3.5%比 10.4%；平均差异，-6.5%；95%CI，-10.5%至-2.5%；P = .001[6 项研究]）。在早期随访中，两组之间发生 2 级或更高级别直肠毒性作用的风险相似（水凝胶间隔物组为 4.5%，对照组为 4.1%；风险比，0.82；95%CI，0.52-1.28；P = .38[6 项研究]），但在晚期随访中，水凝胶间隔物组的风险降低了 77%（1.5%比 5.7%；风险比，0.23；95%CI，0.06-0.99；P = .05[4 项研究]）。早期随访中两组之间的肠相关生活质量变化相似（平均差异，0.2；95%CI，-3.1 至 3.4；P = .92[2 项研究]），但晚期随访中水凝胶间隔物组的差异更大（平均差异，5.4；95%CI，2.8-8.0；P < .001[2 项研究]）。
对于接受前列腺放射治疗的男性，注射水凝胶间隔物是安全的，提供了足以降低 v70 直肠照射量的前列腺-直肠分离，并且与晚期随访中较低的直肠毒性作用和更高的肠相关生活质量相关。
Zotero 插件
