Randomised Trial of No, Short-term, or Long-term Androgen Deprivation Therapy with Postoperative Radiotherapy After Radical Prostatectomy: Results from the Three-way Comparison of RADICALS-HD (NCT00541047)

IF 25.3 1区 医学 Q1 UROLOGY & NEPHROLOGY
Chris C. Parker , Noel W. Clarke , Adrian D. Cook , Peter M. Petersen , Charles N. Catton , William R. Cross , Howard Kynaston , Raj A. Persad , Fred Saad , John Logue , Heather Payne , Claire Amos , Lorna Bower , Rakesh Raman , Ian Sayers , Jane Worlding , Wendy R. Parulekar , Mahesh K.B. Parmar , Matthew R. Sydes , RADICALS Investigators
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引用次数: 0

Abstract

Background and objective

The use and duration of androgen deprivation therapy (ADT) with postoperative radiotherapy (RT) have been uncertain. RADICALS-HD compared adding no (“None”), 6-months (“Short”), or 24-mo (“Long”) ADT to study efficacy in the long term.

Methods

Participants with prostate cancer were indicated for postoperative RT and agreed randomisation between all durations. ADT was allocated for 0, 6, or 24 mo. The primary outcome measure (OM) was metastasis-free survival (MFS). The secondary OMs included freedom from distant metastasis, overall survival, and initiation of nonprotocol ADT. Sample size was determined by two-way comparisons. Analyses followed standard time-to-event approaches and intention-to-treat principles.

Key findings and limitations

Between 2007 and 2015, 492 participants were randomised one of three groups: 166 None, 164 Short, and 162 Long. The median age at randomisation was 66 yr; Gleason scores at surgery were as follows: <7 = 64 (13%), 3+4 = 229 (47%), 4+3 = 127 (26%), and 8+ = 72 (15%); T3b was 112 (23%); and T4 was 5 (1%). The median follow-up was 9.0 yr and, with MFS events reported for 89 participants (32 None, 31 Short, and 26 Long), there was no evidence of difference in MFS overall (logrank p = 0.98), and, for Long versus None, hazard ratio = 0.948 (95% confidence interval 0.54–1.68). After 10 yr, 80% None, 77% Short, and 81% Long patients were alive without metastatic disease. The three-way randomisation was not powered to conventional levels for assessment, yet provides a fair comparison.

Conclusions and clinical implications

Long-term outcomes after radical prostatectomy are usually favourable. In those indicated for postoperative RT and considered suitable for no, short-term, or long-term ADT, there was no evidence of improvement with addition of ADT. Future research should focus on patients at a higher risk of metastases in whom improvements are required more urgently.
根治性前列腺切除术后不使用、短期或长期雄激素剥夺疗法配合术后放疗的随机试验:RADICALS-HD的三方比较结果(NCT00541047)。
背景和目的:雄激素剥夺疗法(ADT)与术后放疗(RT)的使用和持续时间一直不确定。RADICALS-HD比较了无ADT("无")、6个月("短")或24个月("长")ADT的长期疗效:方法:前列腺癌患者均有接受术后 RT 的指征,并同意在所有持续时间之间进行随机分配。ADT疗程为0、6或24个月。主要结局指标(OM)为无转移生存期(MFS)。次要结局指标包括无远处转移生存期、总生存期和开始非协议 ADT。样本量通过双向比较确定。分析遵循标准的时间到事件方法和意向治疗原则:2007年至2015年期间,492名参与者被随机分为三组:166名无、164名短和162名长。随机分组时的中位年龄为66岁;手术时的格里森评分如下:结论和临床意义:前列腺癌根治术后的长期疗效通常良好。对于那些有术后 RT 适应症并被认为适合不使用、短期或长期 ADT 的患者,没有证据表明使用 ADT 会改善病情。未来的研究应重点关注转移风险较高的患者,因为他们更迫切需要改善治疗效果。
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来源期刊
European urology
European urology 医学-泌尿学与肾脏学
CiteScore
43.00
自引率
2.60%
发文量
1753
审稿时长
23 days
期刊介绍: European Urology is a peer-reviewed journal that publishes original articles and reviews on a broad spectrum of urological issues. Covering topics such as oncology, impotence, infertility, pediatrics, lithiasis and endourology, the journal also highlights recent advances in techniques, instrumentation, surgery, and pediatric urology. This comprehensive approach provides readers with an in-depth guide to international developments in urology.
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