Djavan Bob, Schlegel Peter, Salomon Georg, Eckersberger Elisabeth, Sadri Helen, Graefen Markus
Department of Urology, New York University Hospital, New York, New York 10016, USA.
Can J Urol. 2010 Aug;17(4):5265-71.
Androgen deprivation therapy (ADT) is the standard care in men with advanced prostate cancer. Continuous testosterone suppression is essential to treatment efficacy. Recently a 1 year depot compound, histrelin, (VANTAS: Orion Pharmaceuticals, Finland; Endo Pharmaceuticals, USA), a gonadotropin-releasing hormone (GnRH) analog, was approved for hormone therapy of prostate cancer. In the present study the therapeutic efficacy of this compound was investigated, in addition to its impact on testosterone values and velocity as well as PSA.
One hundred thirty-one patients with histologically confirmed prostate cancer and normal testosterone levels were prospectively evaluated over 1 year. Androgen deprivation therapy was performed using a once yearly implant of the GnRH agonist histrelin. Testosterone and PSA levels, and histrelin serum profile were measured prospectively every month for 1 year. In addition, patients were stratified according to their PSA results and D'Amico risk profile.
Testosterone suppression (testosterone < or = 50 ng/dL) was measured in all patients between weeks 4 and 52; 88% of patients had a continuous testosterone level under 20 ng/dL. The PSA level in the total population decreased significantly within the first 2 weeks compared with baseline, and after 52 weeks the median PSA level of the total population was 0.2 ng/mL. PSA responses were grouped into three typical therapeutic outcomes and correlated with the clinical risk distribution, and levels were lowered in all three risk groups.
The GnRH agonist histrelin successfully suppressed testosterone over the entire study period. This effect was measured across a number of different clinical definitions of PSA response and clinical risk. The GnRH agonist therefore offers an effective therapy option in hormone treatment of prostate cancer.
雄激素剥夺疗法（ADT）是晚期前列腺癌男性患者的标准治疗方法。持续抑制睾酮对治疗效果至关重要。最近，一种为期1年的长效制剂组氨瑞林（VANTAS：芬兰奥立安制药公司；美国Endo制药公司），一种促性腺激素释放激素（GnRH）类似物，已被批准用于前列腺癌的激素治疗。在本研究中，除了研究该化合物对睾酮值、睾酮变化速率以及前列腺特异性抗原（PSA）的影响外，还对其治疗效果进行了研究。
对131例经组织学确诊且睾酮水平正常的前列腺癌患者进行了为期1年的前瞻性评估。使用GnRH激动剂组氨瑞林每年植入一次进行雄激素剥夺治疗。前瞻性地测量患者1年内每月的睾酮和PSA水平以及组氨瑞林血清水平。此外，根据患者的PSA结果和达米科风险特征进行分层。
在第4至52周期间，所有患者均检测到睾酮抑制（睾酮≤50 ng/dL）；88%的患者睾酮水平持续低于20 ng/dL。与基线相比，总体人群的PSA水平在最初2周内显著下降，52周后总体人群的PSA中位数水平为0.2 ng/mL。PSA反应分为三种典型治疗结果，并与临床风险分布相关，且在所有三个风险组中PSA水平均降低。
在整个研究期间，GnRH激动剂组氨瑞林成功抑制了睾酮。在PSA反应和临床风险的多种不同临床定义中均观察到了这种效果。因此，GnRH激动剂为前列腺癌的激素治疗提供了一种有效的治疗选择。
