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短期新辅助雄激素剥夺治疗对局部前列腺癌行外照射放疗患者勃起功能的影响:4 个月与 8 个月随机试验的分析(爱尔兰临床肿瘤学研究组 97-01)。

The effect of short term neo-adjuvant androgen deprivation on erectile function in patients treated with external beam radiotherapy for localised prostate cancer: an analysis of the 4- versus 8-month randomised trial (Irish Clinical Oncology Research Group 97-01).

机构信息

Department of Radiation Oncology, St. Luke's Hospital, Dublin, Ireland.

出版信息

Radiother Oncol. 2012 Jul;104(1):96-102. doi: 10.1016/j.radonc.2012.05.001. Epub 2012 Jun 9.

DOI:10.1016/j.radonc.2012.05.001
PMID:22682750
Abstract

BACKGROUND AND PURPOSE

Erectile dysfunction is a common consequence of external beam radiotherapy (EBRT) for prostate cancer. The addition of neo-adjuvant androgen deprivation (NAD) has an indeterminate additive effect. We examined the long-term effect on erectile function (EF) of two durations (4 months: arm 1 and 8 months: arm 2) of NAD prior to radiation (RT) for patients with localised prostate cancer from the Irish Clinical Oncology Research Group (ICORG 97-01) 4- versus 8-month trial. In this study we aimed to (1) analyse the overall effect on EF of NAD in an EBRT population, (2) compare the probability of retained EF over time in an EBRT population treated with either 4 or 8 months of NAD and (3) identify any variables such as risk group and age which may have an additive detrimental effect. This analysis provides unique long term follow up data.

MATERIALS AND METHODS

From 1997 to 2001, 276 patients with adenocarcinoma of the prostate were randomised to 4 or 8 months of NAD before RT. EF data were recorded at baseline and at each follow-up visit by physician directed questions, using a 4-point grading system.

RESULTS

Two hundred and thirty patients were included in the analysis of EF and were followed for a median of 80 months. One hundred and forty-one patients had EF at baseline. Neo-adjuvant androgen deprivation in addition to radiation therapy caused a significant reduction in EF. The most significant reduction in EF happens within the first year. The median time to grade 3-4 EF toxicity was 14.6 months, 17.6 months in arm 1 and 13.7 in arm 2. Freedom from late EF toxicity did not differ significantly between arms, overall or at 5 years (n=141). The cumulative probability of EF preservation at 5 years was 28% (22-34) in arm 1 and 24% (19-30) in arm 2. Age was a significant predictor of post-treatment EF.

CONCLUSIONS

The first year post ADT and EBRT poses the greatest risk to sexual function and a continued decline may be expected. However, 26% of men can expect to retain sexual function at 5 years.

摘要

背景与目的

勃起功能障碍是前列腺癌外照射放疗(EBRT)的常见后果。新辅助去势治疗(NAD)的加入具有不确定的附加作用。我们检查了爱尔兰临床肿瘤学研究组(ICORG 97-01)4-8 个月试验中,两种 NAD 持续时间(4 个月:臂 1 和 8 个月:臂 2)对局部前列腺癌患者放射治疗(RT)前的勃起功能(EF)的长期影响。在这项研究中,我们旨在(1)分析 NAD 对 EBRT 人群 EF 的总体影响,(2)比较接受 4 或 8 个月 NAD 治疗的 EBRT 人群中 EF 保留的概率随时间的变化,(3)确定任何可能具有附加不利影响的变量,如风险组和年龄。该分析提供了独特的长期随访数据。

材料与方法

1997 年至 2001 年,276 例前列腺腺癌患者被随机分为 4 或 8 个月的 NAD 治疗后放射治疗。EF 数据通过医生指导的问题在基线和每次随访时记录,使用 4 分制评分系统。

结果

230 例患者被纳入 EF 分析,并随访中位数为 80 个月。141 例患者在基线时有 EF。放射治疗加新辅助雄激素剥夺导致 EF 显著降低。EF 最显著的下降发生在第一年。3-4 级 EF 毒性的中位时间为 14.6 个月,臂 1 为 17.6 个月,臂 2 为 13.7 个月。在总体或 5 年时,两支手臂的晚期 EF 毒性无显著差异(n=141)。5 年时 EF 保留的累积概率在臂 1 为 28%(22-34),在臂 2 为 24%(19-30)。年龄是治疗后 EF 的显著预测因素。

结论

ADT 和 EBRT 后第一年对性功能的风险最大,可能会持续下降。然而,26%的男性可以在 5 年内保留性功能。

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