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醋酸亮丙瑞林(抑那通®)在德国日常临床实践中的疗效与耐受性:两项前瞻性非干预性研究的汇总数据,研究对象为晚期前列腺癌患者,使用3个月或6个月长效剂型

Efficacy and Tolerability of Leuprorelin Acetate (Eligard®) in Daily Practice in Germany: Pooled Data from 2 Prospective, Non-Interventional Studies with 3- or 6-Month Depot Formulations in Patients with Advanced Prostate Cancer.

作者信息

Ohlmann Carsten-Henning, Gross-Langenhoff Marco

机构信息

Department of Urology, Saarland University Medical Centre, Homburg, Germany.

Astellas Pharma GmbH, Munich, Germany.

出版信息

Urol Int. 2018;100(1):66-71. doi: 10.1159/000479187. Epub 2017 Dec 1.

DOI:10.1159/000479187
PMID:29197875
Abstract

INTRODUCTION

We evaluated the efficacy and tolerability of 3- and 6-month leuprorelin acetate (LA) depot formulations (Eligard®, Astellas Pharma GmbH) in patients with advanced prostate cancer treated in routine clinical practice in Germany.

MATERIALS AND METHODS

Data was pooled from 2 prospective, open-label, non-interventional studies in which 1,906 patients were treated for 12 months with either the 3-month (n = 633) or 6-month (n = 1,273) LA formulation.

RESULTS

Median prostate-specific antigen levels in the pooled patient population declined from 12.0 ng/mL at baseline to 0.5 ng/mL after 12 months. Prostate-specific antigen reduction was achieved in treatment-naïve and pre-treated patients. Adverse events were documented in 8.8% of patients.

CONCLUSIONS

These pooled data from routine clinical practice in Germany indicate that LA 3- and 6-month depot injections can effectively reduce prostate-specific antigen levels in a broad patient population with advanced prostate cancer.

摘要

引言

我们评估了3个月和6个月长效醋酸亮丙瑞林(LA)注射剂(Eligard®,安斯泰来制药有限公司)在德国常规临床实践中治疗晚期前列腺癌患者的疗效和耐受性。

材料与方法

数据来自2项前瞻性、开放标签、非干预性研究,其中1906例患者接受了3个月(n = 633)或6个月(n = 1273)LA注射剂治疗12个月。

结果

汇总患者群体的前列腺特异性抗原(PSA)水平中位数从基线时的12.0 ng/mL降至12个月后的0.5 ng/mL。初治患者和经治患者均实现了PSA降低。8.8%的患者记录到不良事件。

结论

来自德国常规临床实践的这些汇总数据表明,3个月和6个月的LA长效注射剂可有效降低广泛晚期前列腺癌患者群体的PSA水平。

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