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真实世界证据:阿比特龙在多西他赛后用于转移性去势抵抗性前列腺癌的情况。

Real world evidence: Abiraterone use post-docetaxel in metastatic castrate-resistant prostate cancer.

作者信息

Shivji Alisha, Ali Raafi, North Scott, Sawyer Michael, Ghosh Sunita, Chambers Carole

机构信息

1 Tom Baker Cancer Center, Calgary, Canada.

2 Cross Cancer Institute, Edmonton, Canada.

出版信息

J Oncol Pharm Pract. 2019 Sep;25(6):1293-1300. doi: 10.1177/1078155218784716. Epub 2018 Jun 27.

Abstract

OBJECTIVES

The COU-AA-301 trial demonstrated that in men with metastatic castrate-resistant prostate cancer using abiraterone post-docetaxel increased overall survival. This study aims to assess this conclusion in a real world context.

DESIGN

Retrospective chart review of a provincial Pharmacy BDM Database (a pharmacy dispensing software) and a provincial Electronic Chart (ARIA). Dispensing data, information on the state of the disease before and after abiraterone use, and information regarding effects of abiraterone were gathered.

SETTING

Cancer centers in Alberta, Canada.

PATIENTS

Metastatic castrate-resistant prostate cancer (CRPC) patients on abiraterone outside of a clinical trial who have previously had docetaxel chemotherapy for CRPC between February 2012 and May 2014.

PRIMARY OUTCOME

Overall survival from the time of abiraterone initiation.

RESULTS

Overall survival increase of 17 months was consistent with the survival increase of 14.8 months observed in the pivotal trial.

CONCLUSION

Abiraterone is a valuable therapy post-docetaxel for metastatic CRPC, as in a real world context it demonstrated an increase in overall survival that was consistent with the findings of the clinical trial despite including a patient population of older age and lower performance status.

摘要

目的

COU-AA-301试验表明,在多西他赛后使用阿比特龙的转移性去势抵抗性前列腺癌男性患者中,总生存期有所延长。本研究旨在在现实世界背景下评估这一结论。

设计

对省级药房BDM数据库(一种药房配药软件)和省级电子病历(ARIA)进行回顾性图表审查。收集了配药数据、阿比特龙使用前后的疾病状态信息以及阿比特龙的疗效信息。

地点

加拿大艾伯塔省的癌症中心。

患者

2012年2月至2014年5月期间在临床试验之外接受阿比特龙治疗的转移性去势抵抗性前列腺癌(CRPC)患者,这些患者之前曾接受过CRPC的多西他赛化疗。

主要结局

从开始使用阿比特龙起的总生存期。

结果

总生存期增加17个月,与关键试验中观察到的生存期增加14.8个月一致。

结论

阿比特龙是多西他赛后治疗转移性CRPC的一种有价值的疗法,因为在现实世界背景下,尽管纳入了年龄较大和体能状态较差的患者群体,但它显示出总生存期的增加与临床试验结果一致。

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