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阿比特龙治疗转移性去势抵抗性前列腺癌的单中心经验。

A single-center experience with abiraterone as treatment for metastatic castration-resistant prostate cancer.

作者信息

Thortzen Anita, Thim Stine, Røder Martin Andreas, Brasso Klaus

机构信息

Department of Urology, Copenhagen Prostate Cancer Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

Department of Urology, Copenhagen Prostate Cancer Center, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.

出版信息

Urol Oncol. 2016 Jul;34(7):291.e1-7. doi: 10.1016/j.urolonc.2016.02.013. Epub 2016 Mar 9.

Abstract

BACKGROUND

Continuous stimulation of the androgen receptor (AR) axis is a prerequisite for growth in castration-resistant prostate cancer (CRPC). Abiraterone acetate (AA) is a potent inhibitor of extracellular and intracellular androgen synthesis by inhibition of the CYP-17 enzyme system, which has been shown to be up-regulated in CRPC. AA was recently introduced in the management of patients with metastatic CRPC (mCRPC) both before and after taxane-based chemotherapy. The purpose of this study is to report the initial clinical experience obtained from mCRPC patients managed on AA at Rigshospitalet, Denmark, and compare the results with phase III trial outcomes.

MATERIAL AND METHODS

Single-centre, retrospective study including consecutive patients managed on AA for more than 2-year period. Treatment consisted of 1,000mg AA and 5mg prednisone twice daily. Outcomes of interest were prostate-specific antigen (PSA) response, clinical and radiological progression, and overall survival.

RESULTS

A total of 73 consecutive patients with mCRPC undergoing treatment with AA between November 2012 and October 2014 were included. Median follow-up was 9.9 (0.9-23.4) months. PSA decline>50% was found in 39% of the patients. Time to biochemical and radiological progression was 3.5 and 4.9 months, respectively. Overall survival was 13.2 months (95% CI: 9.0-17.4).

CONCLUSION

Our initial experience with AA in the routine management of patients with mCRPC demonstrates an efficacy-effectiveness gap compared with clinical trial. Except for PSA response (>50% decline) in patients managed with AA, postchemotherapy results were inferior to phase III studies. This is most likely because of patient selection, which is a typical weakness when transferring results from phase III trials into clinical practice.

摘要

背景

持续刺激雄激素受体(AR)轴是去势抵抗性前列腺癌(CRPC)生长的前提条件。醋酸阿比特龙(AA)是一种通过抑制CYP-17酶系统来有效抑制细胞外和细胞内雄激素合成的药物,该酶系统在CRPC中已被证明上调。AA最近已被引入转移性CRPC(mCRPC)患者在基于紫杉烷的化疗前后的治疗管理中。本研究的目的是报告在丹麦里格霍斯医院接受AA治疗的mCRPC患者的初步临床经验,并将结果与III期试验结果进行比较。

材料与方法

单中心回顾性研究,纳入连续接受AA治疗超过2年的患者。治疗方案为每日两次服用1000mg AA和5mg泼尼松。感兴趣的结果包括前列腺特异性抗原(PSA)反应、临床和影像学进展以及总生存期。

结果

纳入了2012年11月至2014年10月期间连续73例接受AA治疗的mCRPC患者。中位随访时间为9.9(0.9 - 23.4)个月。39%的患者PSA下降>50%。生化和影像学进展时间分别为3.5个月和4.9个月。总生存期为13.2个月(95%CI:9.0 - 17.4)。

结论

我们在mCRPC患者常规管理中使用AA的初步经验表明,与临床试验相比存在疗效 - 有效性差距。除了接受AA治疗患者的PSA反应(下降>50%)外,化疗后结果不如III期研究。这很可能是由于患者选择,这是将III期试验结果转化为临床实践时的一个典型弱点。

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