Efficacy of Testosterone Suppression with Sustained-Release Triptorelin in Advanced Prostate Cancer
Efficacy of Testosterone Suppression with Sustained-Release Triptorelin in Advanced Prostate Cancer
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DOI：
10.1007/s12325-016-0466-7
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发表时间：
2017-02-01
影响因子：
3.8
通讯作者：
Goldfischer, Evan R.
中科院分区：
文献类型：
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作者：
Breul, Jurgen;Lundstrom, Eija;Goldfischer, Evan R.
雄激素剥夺疗法（ADT）是治疗晚期前列腺癌（PC）的主要方法。作为治疗目标，几十年来已经确立了将血浆睾酮水平抑制至< 50 ng/dl。越来越多的证据表明，即使抑制到更低的水平也可能增加进一步的临床益处。因此，我们对促性腺激素释放激素（GnRH）激动剂曲普瑞林的1个月、3个月和6个月缓释（SR）制剂抑制血清睾酮浓度超过当前标准的疗效进行了汇总回顾性分析，将920例PC男性患者的数据汇总在9项前瞻性研究中，以睾酮血清浓度为主要终点。年龄为42-96岁的患者必须有资格接受ADT，并且在入组前未接受过激素治疗或已接受过适当的洗脱。患者接受曲普瑞林SR制剂治疗2-12个月。该分析的主要终点是治疗下的血清睾酮浓度以及基于睾酮目标阈值20 ng/dl的总体和每种制剂的成功率。在治疗1、3、6、9和12个月后，分别有79%、92%、93%、90%和91%的患者达到睾酮水平< 20 ng/dl。对于1个月、3个月和6个月制剂，成功率范围为80- 92%、83- 93%和65-97%，中位（四分位距）血清睾酮值为2.9（2.9-6.5）、5.0（2.9-8.7）和8.7（5.8-14.1）ng/dl。在大多数患者中，曲普瑞林SR制剂抑制血清睾酮浓度至甚至< 20 ng/dl。在接受ADT治疗的PC患者中，应常规监测睾酮，但仍需进一步研究极低睾酮水平和目标浓度的临床获益。
Androgen deprivation therapy (ADT) is a mainstay of treatment against advanced prostate cancer (PC). As a treatment goal, suppression of plasma testosterone levels to < 50 ng/dl has been established over decades. Evidence is growing though that suppression to even lower levels may add further clinical benefit. Therefore, we undertook a pooled retrospective analysis on the efficacy of 1-, 3-, and 6-month sustained-release (SR) formulations of the gonadotropin-releasing hormone (GnRH) agonist triptorelin to suppress serum testosterone concentrations beyond current standards.Data of 920 male patients with PC enrolled in 9 prospective studies using testosterone serum concentrations as primary endpoint were pooled. Patients aged 42-96 years had to be eligible for ADT and to be either na < ve to hormonal treatment or have undergone appropriate washout prior to enrolment. Patients were treated with triptorelin SR formulations for 2-12 months. Primary endpoints of this analysis were serum testosterone concentrations under treatment and success rates overall and per formulation, based on a testosterone target threshold of 20 ng/dl.After 1, 3, 6, 9, and 12 months of treatment, 79%, 92%, 93%, 90%, and 91% of patients reached testosterone levels < 20 ng/dl, respectively. For the 1-, 3-, and 6-month formulations success rates ranged from 80-92%, from 83-93%, and from 65-97% with median (interquartile range) serum testosterone values of 2.9 (2.9-6.5), 5.0 (2.9-8.7), and 8.7 (5.8-14.1) ng/dl at study end, respectively.In the large majority of patients, triptorelin SR formulations suppressed serum testosterone concentrations to even < 20 ng/dl. Testosterone should be routinely monitored in PC patients on ADT although further studies on the clinical benefit of very low testosterone levels and the target concentrations are still warranted.