本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00548-8

摘要内容如下：

背景

先前的证据表明，辅助、短程雄激素剥夺疗法（ADT）可提高中危和高危局限性前列腺癌患者的无转移生存率。然而，ADT与根治性前列腺切除术后放疗的价值尚不清楚。

方法

Radicals-HD是一项国际随机对照试验，旨在测试ADT联合术后放疗治疗前列腺癌的疗效。主要入选标准为前列腺癌根治性前列腺切除术后的放疗指征、前列腺特异性抗原低于5 ng/mL、无转移性疾病和书面同意。参与者被随机分配（1:1）接受单纯放疗（无ADT）或放疗加6个月ADT（短程ADT），每月皮下注射促性腺激素释放激素类似物，每日口服比卡鲁胺150 mg，或每月皮下注射地加瑞林。在计算机系统中，通过随机元素的最小化集中进行随机化，根据Gleason评分、阳性切缘、放疗时间、计划的放疗时间表和计划的ADT类型进行分层。分配的治疗未被屏蔽。主要结果指标是无转移生存率，定义为前列腺癌引起的远处转移或任何原因引起的死亡。使用标准生存分析方法，说明随机分层因素。该试验具有80%的功效，双侧α为5%，检测到10年无转移生存率从80%绝对增加到86%（风险比[HR]0.67）。分析遵循意向治疗原则。该试验已在ISRCTN Registry（ISRCTN40814031）和ClinicalTrials.gov（NCT00541047）注册。

调查结果

2007年11月22日至2015年6月29日，在加拿大、丹麦、爱尔兰和英国的121个中心，1480名患者（中位年龄66岁[IQR 61-69]）被随机分配接受无ADT（n=737）或短程ADT（n=743）以及术后放疗。中位随访时间为9.0年（IQR 7.1-10.1），268名参与者报告了无转移生存事件（无ADT组142例，短程ADT组126例；HR 0.886[95%CI 0.688-1.140]，P=0.35）。无ADT组10年无转移生存率为79.2%（95%CI 75.4~82.5），短程ADT组为80.4%（95%CI 76.6~83.6）。无ADT组737名参与者中有121名（17%）报告了3级或更高的毒性，短程ADT组743名参与者中有100名（14%）报告了3级或更高的毒性（P=0.15），无治疗相关死亡。

解释

转移性疾病在根治性前列腺切除术后的术后床上放疗中并不常见。与无ADT相比，在放疗基础上增加6个月的ADT并不能提高无转移生存率。这些发现不支持在该患者人群中使用短程ADT和术后放疗。

英文原文如下：

Abstracts

BACKGROUND  Previous evidence indicates that adjuvant, short-course androgen deprivation therapy (ADT) improves metastasis-free survival when given with primary radiotherapy for intermediate-risk and high-risk localised prostate cancer. However, the value of ADT with postoperative radiotherapy after radical prostatectomy is unclear.

METHODS  RADICALS-HD was an international randomised controlled trial to test the efficacy of ADT used in combination with postoperative radiotherapy for prostate cancer. Key eligibility criteria were indication for radiotherapy after radical prostatectomy for prostate cancer, prostate-specific antigen less than 5 ng/mL, absence of metastatic disease, and written consent. Participants were randomly assigned (1:1) to radiotherapy alone (no ADT) or radiotherapy with 6 months of ADT (short-course ADT), using monthly subcutaneous gonadotropin-releasing hormone analogue injections, daily oral bicalutamide monotherapy 150 mg, or monthly subcutaneous degarelix. Randomisation was done centrally through minimisation with a random element, stratified by Gleason score, positive margins, radiotherapy timing, planned radiotherapy schedule, and planned type of ADT, in a computerised system. The allocated treatment was not masked. The primary outcome measure was metastasis-free survival, defined as distant metastasis arising from prostate cancer or death from any cause. Standard survival analysis methods were used, accounting for randomisation stratification factors. The trial had 80% power with two-sided α of 5% to detect an absolute increase in 10-year metastasis-free survival from 80% to 86% (hazard ratio [HR] 0·67). Analyses followed the intention-to-treat principle. The trial is registered with the ISRCTN registry, ISRCTN40814031, and ClinicalTrials.gov, NCT00541047.

FINDINGS  Between Nov 22, 2007, and June 29, 2015, 1480 patients (median age 66 years [IQR 61-69]) were randomly assigned to receive no ADT (n=737) or short-course ADT (n=743) in addition to postoperative radiotherapy at 121 centres in Canada, Denmark, Ireland, and the UK. With a median follow-up of 9·0 years (IQR 7·1-10·1), metastasis-free survival events were reported for 268 participants (142 in the no ADT group and 126 in the short-course ADT group; HR 0·886 [95% CI 0·688-1·140], p=0·35). 10-year metastasis-free survival was 79·2% (95% CI 75·4-82·5) in the no ADT group and 80·4% (76·6-83·6) in the short-course ADT group. Toxicity of grade 3 or higher was reported for 121 (17%) of 737 participants in the no ADT group and 100 (14%) of 743 in the short-course ADT group (p=0·15), with no treatment-related deaths.

INTERPRETATION  Metastatic disease is uncommon following postoperative bed radiotherapy after radical prostatectomy. Adding 6 months of ADT to this radiotherapy did not improve metastasis-free survival compared with no ADT. These findings do not support the use of short-course ADT with postoperative radiotherapy in this patient population.

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