Jocham D
Department of Urology, Medical University of Lübeck, Germany.
Urol Int. 1998;60 Suppl 2:18-24; discussion 35. doi: 10.1159/000056547.
To determine median survival time, median time to tumor progression and maintenance of testosterone suppression (i.e. < or = 50 ng/dl) during long-term treatment with subcutaneous injections of leuprorelin acetate 3-month depot (LAD-3M). In Germany 62 patients with advanced prostate cancer participated in a prospective, randomized, multicenter phase II trial as part of a European study. Of these, 37 patients entered the follow-up study.
Standard clinical investigations and methods were employed in the study.
Twenty-five of the 62 (40.3%) patients died during the course of the study. No death had a causal relationship with the study drug. Median survival time, median time to tumor progression and median period of progression-free survival were 1,149 (3.1 years), 1,015 (2.8 years) and 680 days (1.9 years), respectively. Adequate suppression of testosterone serum levels to the castration range was confirmed. Objective and subjective response as well as the safety profile were comparable to previously published results with LAD-3M, LAD-1 M and other LHRH analogues.
The results of this follow-up study confirm long-term efficacy and safety of LAD-3M for treatment in advanced prostate cancer. LAD-3M is a suitable alternative to the established shorter-acting LHRH-a depot formulations.
确定皮下注射醋酸亮丙瑞林3个月长效剂型（LAD-3M）进行长期治疗期间的中位生存时间、肿瘤进展中位时间以及睾酮抑制的维持情况（即≤50 ng/dl）。在德国，62例晚期前列腺癌患者参与了一项前瞻性、随机、多中心II期试验，作为一项欧洲研究的一部分。其中，37例患者进入随访研究。
研究采用标准的临床调查和方法。
62例患者中有25例（40.3%）在研究过程中死亡。没有死亡与研究药物有因果关系。中位生存时间、肿瘤进展中位时间和无进展生存中位期分别为1149天（3.1年）、1015天（2.8年）和680天（1.9年）。证实睾酮血清水平充分抑制至去势范围。客观和主观反应以及安全性概况与先前发表的LAD-3M、LAD-1M和其他促性腺激素释放激素类似物的结果相当。
这项随访研究的结果证实了LAD-3M治疗晚期前列腺癌的长期疗效和安全性。LAD-3M是已确立的短效促性腺激素释放激素激动剂长效剂型的合适替代物。
