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醋酸阿比特龙在高危前列腺癌患者中的疗效与安全性:一项基于六项随机对照试验的荟萃分析。

The efficacy and safety of abiraterone acetate in patients with high-risk prostate cancer: a meta-analysis based on six randomized control trials.

作者信息

Tan Guobin, Xuan Zijun, Li Zhiqin, Huang Shuitong, Chen Guangming, Wu Yonglu, Chen Xianxi, Liang Zhijin, Wu Aiming

机构信息

Department of Urology, Maoming People's Hospital, Maoming, China.

Department of Urology, Dongguan Kanghua Hospital, Dongguan, China.

出版信息

Transl Androl Urol. 2020 Aug;9(4):1691-1699. doi: 10.21037/tau-20-1058.

DOI:10.21037/tau-20-1058
PMID:32944530
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7475664/
Abstract

BACKGROUND

Abiraterone acetate, a CYP17 enzyme inhibitor, can block the synthesis of androgens in the adrenal gland, prostate, and testis. The purpose of this study was to investigate the efficacy and safety of abiraterone acetate in high-risk prostate cancer patients, including metastatic castration-resistant prostate cancer (mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).

METHODS

A meta-analysis based on 6 randomized controlled trials (RCTs) was undertaken in compliance with the guidelines of systematic reviews and meta-analyses. Databases including PubMed, EMBASE, and Cochrane library were searched for relevant literature through to September 2019.

RESULTS

The pooled analysis reported abiraterone acetate showed significant efficacy in high-risk prostate cancer patients, including overall survival (OS) [HR 0.66, 95% confidence interval (CI), 0.61-0.73, P<0.001], the time to prostate-specific antigen (PSA) progression (HR 0.45, 95% CI, 0.34-0.59, P<0.001), progression-free survival (PFS) (according to radiographic evidence) (HR 0.55, 95% CI, 0.45-0.68, P<0.001) and PSA response rate (RR 2.49, 95% CI, 1.47-4.22, P<0.001). A subgroup analysis was carried out due to the significant heterogeneity between the studies. The incidence of arthralgia (RR 1.19), hypokalemia (RR 2.47), cardiac disorder (RR 1.48), and hypertension (RR 1.57) in the abiraterone acetate group was moderately higher than the control group.

CONCLUSIONS

The efficacy and safety of abiraterone acetate as an androgen receptor (AR) pathway targeted drug in high-risk prostate cancer patients was confirmed.

摘要

背景

醋酸阿比特龙是一种细胞色素P450 17α酶(CYP17)抑制剂,可阻断肾上腺、前列腺和睾丸中的雄激素合成。本研究旨在探讨醋酸阿比特龙在高危前列腺癌患者中的疗效和安全性,包括转移性去势抵抗性前列腺癌(mCRPC)和转移性去势敏感性前列腺癌(mCSPC)。

方法

根据系统评价和荟萃分析的指南,对6项随机对照试验(RCT)进行荟萃分析。通过检索包括PubMed、EMBASE和Cochrane图书馆在内的数据库,查找截至2019年9月的相关文献。

结果

汇总分析显示,醋酸阿比特龙在高危前列腺癌患者中显示出显著疗效,包括总生存期(OS)[风险比(HR)0.66,95%置信区间(CI),0.61 - 0.73,P<0.001]、前列腺特异性抗原(PSA)进展时间(HR 0.45,95% CI,0.34 - 0.59,P<0.001)、无进展生存期(PFS)(根据影像学证据)(HR 0.55,95% CI,0.45 - 0.68,P<0.001)和PSA缓解率(RR 2.49,95% CI,1.47 - 4.22,P<0.001)。由于研究之间存在显著异质性,进行了亚组分析。醋酸阿比特龙组关节痛(RR 1.19)、低钾血症(RR 2.47)、心脏疾病(RR 1.48)和高血压(RR 1.57)的发生率略高于对照组。

结论

证实了醋酸阿比特龙作为雄激素受体(AR)通路靶向药物在高危前列腺癌患者中的疗效和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcad/7475664/1349ff85eec6/tau-09-04-1691-fS.4.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcad/7475664/e3f726e6d860/tau-09-04-1691-f6.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcad/7475664/2cace267c171/tau-09-04-1691-fS.1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcad/7475664/3ae447be9230/tau-09-04-1691-fS.2.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcad/7475664/1349ff85eec6/tau-09-04-1691-fS.4.jpg

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Indirect Comparisons of Efficacy between Combination Approaches in Metastatic Hormone-sensitive Prostate Cancer: A Systematic Review and Network Meta-analysis.转移性激素敏感性前列腺癌联合治疗方法之间疗效的间接比较:一项系统评价和网状Meta分析
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新型激素疗法在非转移性去势抵抗性前列腺癌治疗中的作用:基于随机试验的文献荟萃分析。
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Abiraterone acetate plus prednisone in patients with newly diagnosed high-risk metastatic castration-sensitive prostate cancer (LATITUDE): final overall survival analysis of a randomised, double-blind, phase 3 trial.醋酸阿比特龙联合泼尼松治疗新诊断的高危转移性去势敏感性前列腺癌(LATITUDE):一项随机、双盲、III 期临床试验的最终总生存分析。
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Asian J Urol. 2017 Apr;4(2):75-85. doi: 10.1016/j.ajur.2017.01.002. Epub 2017 Jan 23.
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Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.阿比特龙用于既往未接受过激素治疗的前列腺癌患者
N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3.
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N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4.
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