目的:雄激素剥夺治疗(ADT)与术后放疗(RT)的使用和持续时间尚不确定。RADICALS-HD比较添加不(“无”),6个月(“短”),或24个月(“长”)ADT以长期研究疗效。
方法:前列腺癌患者接受了术后放疗,并在所有持续时间之间进行了一致的随机分组。ADT分配给0、6或24个月。主要结果指标(OM)为无转移生存期(MFS)。继发性OMs包括无远处转移,总生存率,并启动非协议ADT。通过双向比较确定样本量。分析遵循标准的事件时间方法和意向治疗原则。
■在2007年至2015年之间,492名参与者被随机分为三组:166名,164短,162长随机分组的中位年龄为66岁;手术时的格里森评分如下:<7=64(13%),3+4=229(47%),4+3=127(26%),8+=72(15%);T3b为112(23%);T4为5(1%)。中位随访时间为9.0年,报告了89名参与者的MFS事件(32无,31短,和26长),整体MFS没有差异的证据(logrankp=0.98),and,长与无,风险比=0.948(95%置信区间0.54-1.68)。10年后,80%无,77%短,81%的Long患者存活,无转移性疾病。三向随机化没有被授权到常规水平进行评估,但提供了一个公平的比较。
结论:前列腺癌根治术后的长期结局通常是有利的。在那些需要进行术后RT并被认为不适合的患者中,短期,或长期ADT,没有证据表明ADT的增加有改善.未来的研究应集中于转移风险较高的患者,这些患者更迫切需要改善。
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.
UNASSIGNED: 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: 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.