Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD])
Timing of androgen-deprivation therapy in patients with prostate cancer with a rising PSA (TROG 03.06 and VCOG PR 01-03 [TOAD])
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PSA 升高的前列腺癌患者的雄激素剥夺治疗时机（TROG 03.06 和 VCOG PR 01-03 [TOAD]）
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发表时间：
2016
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通讯作者：
B. Tombal
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作者：
B. Tombal
雄激素剥夺疗法适用于治疗后前列腺特异性抗原升高（PSA 复发）或被认为不适合治疗的前列腺癌男性；然而，其引入的最佳时机尚不确定。我们的目的是评估与延迟治疗相比，立即雄激素剥夺治疗是否可以提高总体生存率。在这项随机、多中心、3 期非盲试验中，我们通过澳大利亚、新西兰和加拿大的 29 个肿瘤中心招募了男性。如果患有前列腺癌的男性在先前尝试的治疗性治疗（放射治疗或手术，有或没有术后放射治疗）后出现 PSA 复发，或者如果他们被认为不适合治疗（由于年龄、合并症或局部晚期疾病），则符合资格。我们使用了由维多利亚癌症委员会协调的数据库嵌入、动态平衡、随机化算法，将参与者（1:1）随机分配至立即雄激素剥夺治疗（立即治疗组）或延迟雄激素剥夺治疗（延迟治疗组），建议间隔至少 2 年，除非临床禁忌。 PSA 复发参与者的随机分组根据既往治疗类型、无复发间隔和 PSA 倍增时间进行分层；非治愈性疾病患者的随机分组按转移状态进行分层；两组的随机分组均按计划的治疗计划（连续或间歇）和治疗中心进行分层。临床医生可以开具任何形式和时间表的雄激素剥夺治疗，并且分组分配不会被掩盖。主要结局是意向治疗人群的总体生存率。该试验经独立数据监测委员会审查后于 2012 年结束，但数据收集持续了 18 个月，直至 2014 年 2 月 26 日。该试验已在澳大利亚新西兰临床试验注册中心 (ACTRN12606000301561) 和 ClinicalTrials.gov (NCT00110162) 注册。 2004年9月3日至2012年7月13日期间，我们招募了293名男性（其中261名PSA复发，32名患有不可治愈的疾病）。我们随机将 142 名男性分配到立即治疗组，将 151 名男性分配到延迟治疗组。自随机分组之日起，中位随访时间为 5 年（IQR 3·3-6·2）。立即治疗组有 16 名 (11%) 男性死亡，延迟治疗组有 30 名 (20%) 男性死亡。延迟治疗组的 5 年总生存率为 86·4% (95% CI 78·5-91·5)，而立即治疗组的 5 年总生存率为 91·2% (84·2-95·2)（对数秩 p=0·047）。 After Cox 摘要 1 2 3 4 5 6 7 3 8 9 10 3 3 11 12 13 14 15 作者信息 全文链接 前列腺癌患者雄激素剥夺治疗的时机... http://www.ncbi.nlm.nih.gov/pubmed/?term=27155740 1 di 2 21/06/2016 15.50
Androgen-deprivation therapy is offered to men with prostate cancer who have a rising prostate-specific antigen after curative therapy (PSA relapse) or who are considered not suitable for curative treatment; however, the optimal timing for its introduction is uncertain. We aimed to assess whether immediate androgen-deprivation therapy improves overall survival compared with delayed therapy. In this randomised, multicentre, phase 3, non-blinded trial, we recruited men through 29 oncology centres in Australia, New Zealand, and Canada. Men with prostate cancer were eligible if they had a PSA relapse after previous attempted curative therapy (radiotherapy or surgery, with or without postoperative radiotherapy) or if they were not considered suitable for curative treatment (because of age, comorbidity, or locally advanced disease). We used a database-embedded, dynamically balanced, randomisation algorithm, coordinated by the Cancer Council Victoria, to randomly assign participants (1:1) to immediate androgen-deprivation therapy (immediate therapy arm) or to delayed androgen-deprivation therapy (delayed therapy arm) with a recommended interval of at least 2 years unless clinically contraindicated. Randomisation for participants with PSA relapse was stratified by type of previous therapy, relapse-free interval, and PSA doubling time; randomisation for those with non-curative disease was stratified by metastatic status; and randomisation in both groups was stratified by planned treatment schedule (continuous or intermittent) and treatment centre. Clinicians could prescribe any form and schedule of androgen-deprivation therapy and group assignment was not masked. The primary outcome was overall survival in the intention-to-treat population. The trial closed to accrual in 2012 after review by the independent data monitoring committee, but data collection continued for 18 months until Feb 26, 2014. It is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12606000301561) and ClinicalTrials.gov (NCT00110162). Between Sept 3, 2004, and July 13, 2012, we recruited 293 men (261 with PSA relapse and 32 with non-curable disease). We randomly assigned 142 men to the immediate therapy arm and 151 to the delayed therapy arm. Median follow-up was 5 years (IQR 3·3-6·2) from the date of randomisation. 16 (11%) men died in the immediate therapy arm and 30 (20%) died in the delayed therapy arm. 5-year overall survival was 86·4% (95% CI 78·5-91·5) in the delayed therapy arm versus 91·2% (84·2-95·2) in the immediate therapy arm (log-rank p=0·047). After Cox Abstract 1 2 3 4 5 6 7 3 8 9 10 3 3 11 12 13 14 15 Author information Full text links Timing of androgen-deprivation therapy in patients with prostate canc... http://www.ncbi.nlm.nih.gov/pubmed/?term=27155740 1 di 2 21/06/2016 15.50