Triskel Integrated Services, 4 rue des Terreaux-du-Temple, 1201 Geneva, Switzerland.
Adv Ther. 2013 Mar;30(3):271-85. doi: 10.1007/s12325-013-0010-y. Epub 2013 Mar 1.
This study set out to examine the efficacy and tolerability of two innovative implant forms of leuprorelin acetate in men with advanced hormone-dependent prostate cancer in everyday clinical practice.
Data were collected from 818 patients (from 273 centers across Germany) who were pretreated with slow-release luteinizing hormone-releasing hormone (LHRH) agonist formulations and who were about to be switched to the leuprorelin implants. Patients received three injections of 1- or 3-month leuprorelin implant and physicians were asked to complete a case report form specific to each of the three clinic visits. Documented parameters included laboratory measurements, such as testosterone and prostate-specific antigen (PSA) levels, adverse events, and patient- and physician-rated assessments of the therapy.
Compared with baseline, a significant decrease in both testosterone and PSA levels were measured after the first and second injections of leuprorelin implant. These results were confirmed for both the 1-month and 3-month implants in separate analyses. Switching, without treatment interruption, from Trenantone® (Takeda Pharma GmBH, Aachen, Germany) to the leuprorelin implant resulted in a significant decrease in the mean serum testosterone concentrations (P < 0.05) and a nonsignificant increase in the proportion of patients reaching castrate testosterone levels, while the number of patients with PSA values ≤ 4 ng/mL significantly increased (P = 0.045). Similar results were obtained for patients previously treated with goserelin who switched to leuprorelin implant. For 94% of patients, treating physicians rated the efficacy of leuprorelin implant as "very good" or "good." Treatment with leuprorelin implant was well tolerated, with only 61 adverse events reported in 42 (5.1%) patients. Patients and physicians rated the tolerability of leuprorelin implant as "very good" or "good" in 95% and 91% of cases, respectively.
These results confirm the efficacy, tolerability, and ease of use of the leuprorelin implants among a large population of men with advanced, hormone-dependent prostate cancer treated in a clinical practice setting.
本研究旨在考察两种新型醋酸亮丙瑞林植入剂在接受长效促黄体生成素释放激素（LHRH）激动剂治疗的晚期激素依赖性前列腺癌男性患者中的疗效和耐受性。
共纳入 818 例（来自德国 273 家中心）患者，这些患者此前接受过缓释型 LHRH 激动剂治疗，现拟转为使用亮丙瑞林植入剂。患者接受了 3 次 1 个月或 3 个月的亮丙瑞林植入治疗，每位医生需填写与每次就诊相对应的特定病例报告表。记录的参数包括实验室测量值，如睾酮和前列腺特异性抗原（PSA）水平、不良事件以及患者和医生对治疗的评估。
与基线相比，亮丙瑞林植入后的第 1 次和第 2 次注射后，均观察到睾酮和 PSA 水平显著下降。这一结果在分别对 1 个月和 3 个月植入物进行的分析中得到了证实。从 Trenantone（武田制药，德国亚琛）转换为亮丙瑞林植入物而不中断治疗，可使平均血清睾酮浓度显著下降（P < 0.05），达到去势睾酮水平的患者比例略有增加，而 PSA 值≤4ng/ml 的患者比例显著增加（P = 0.045）。先前接受戈舍瑞林治疗后转为亮丙瑞林植入物的患者也得到了类似的结果。对于 94%的患者，治疗医生将亮丙瑞林植入物的疗效评为“非常好”或“好”。亮丙瑞林植入物的治疗耐受性良好，仅有 61 例（5.1%）患者报告了 42 例不良事件。患者和医生对亮丙瑞林植入物的耐受性评分分别为 95%和 91%为“非常好”或“好”。
这些结果证实了亮丙瑞林植入物在临床实践环境中治疗晚期激素依赖性前列腺癌男性患者的疗效、耐受性和易用性。
