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在亚洲开展的关于使用亮丙瑞林治疗前列腺癌的临床研究。

Clinical studies investigating the use of leuprorelin for prostate cancer in Asia.

作者信息

Chung Byung Ha, Horie Shigeo, Chiong Edmund

机构信息

Department of Urology, Yonsei University College of Medicine, Seoul, 135-720, korea.

Department of Urology, Juntendo University Graduate School of Medicine, Tokyo, 113-0033, Japan.

出版信息

Prostate Int. 2020 Mar;8(1):1-9. doi: 10.1016/j.prnil.2019.06.001. Epub 2019 Jul 4.

Abstract

BACKGROUND

Leuprorelin is a well-established treatment for prostate cancer (PCa); however, there is limited information on its use in Asian males. This review of English language publications between January 2000 and 2016 describes the outcomes of clinical trials on leuprorelin in Asian males with PCa of any grade, stage, or histopathology.

METHODS

The literature search was undertaken using PubMed, Cochrane Library, and ClinicalTrials.gov databases.

RESULTS

We identified nine studies from Japan, two studies from South Korea, and one international, multisite study which included Asian sites, with a total of 1,652 males previously diagnosed with PCa. All studies included subcutaneous or depot administration of leuprorelin at varying dose levels including 3.75 mg four weekly, 11.25 mg 12 weekly, or 22.5 mg every 12 or 24 weeks. Leuprorelin was administered as monotherapy or in combination with chemotherapy or hormonal therapy. Leuprorelin appears well tolerated in Asian males and is effective in reducing serum testosterone to castration levels (<50 ng/dL (<1.7 nmol/L)) and prostate-specific antigen levels. Common adverse events included hot flushes and mild hepatic dysfunction. Leuprorelin was shown to provide reasonable survival rates in PCa (T1b-T3N0M0) and in metastatic disease; another reasonable option for these patients is radiation therapy. Leuprorelin treatment also improved the quality of life.

CONCLUSION

Leuprorelin may be an appropriate and efficacious treatment for males with PCa (T1b-T3N0M0). Leuprorelin treatment was well tolerated and associated with improvement in the quality of life.

摘要

背景

亮丙瑞林是一种成熟的前列腺癌(PCa)治疗药物;然而,关于其在亚洲男性中的使用信息有限。本综述对2000年1月至2016年间的英文出版物进行了分析,描述了亮丙瑞林在不同分级、分期或组织病理学类型的亚洲PCa男性患者中的临床试验结果。

方法

通过PubMed、Cochrane图书馆和ClinicalTrials.gov数据库进行文献检索。

结果

我们确定了9项来自日本的研究、2项来自韩国的研究以及1项包括亚洲研究点的国际多中心研究,共有1652名先前被诊断为PCa的男性患者。所有研究均包括皮下或长效注射亮丙瑞林,剂量水平各不相同,包括每四周3.75毫克、每12周11.25毫克或每12或24周22.5毫克。亮丙瑞林作为单一疗法或与化疗或激素疗法联合使用。亮丙瑞林在亚洲男性中似乎耐受性良好,并且能有效将血清睾酮降低至去势水平(<50 ng/dL(<1.7 nmol/L))以及前列腺特异性抗原水平。常见的不良事件包括潮热和轻度肝功能障碍。亮丙瑞林在PCa(T1b - T3N0M0)和转移性疾病中显示出合理的生存率;对于这些患者,另一个合理的选择是放射治疗。亮丙瑞林治疗还改善了生活质量。

结论

亮丙瑞林可能是PCa(T1b - T3N0M0)男性患者的一种合适且有效的治疗方法。亮丙瑞林治疗耐受性良好,并与生活质量的改善相关。

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