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新的延长转移性去势抵抗性前列腺癌(mCRPC)患者生命的药物在真实人群中的效果。

The effects of new life-prolonging drugs for metastatic castration-resistant prostate cancer (mCRPC) patients in a real-world population.

机构信息

Department of Internal Medicine, Amphia Hospital, Breda, the Netherlands.

Institute for Medical Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, the Netherlands.

出版信息

Prostate Cancer Prostatic Dis. 2021 Sep;24(3):871-879. doi: 10.1038/s41391-021-00344-1. Epub 2021 Mar 21.

Abstract

BACKGROUND

In 2004 docetaxel was the first life-prolonging drug (LPD) registered for metastatic castration-resistant prostate cancer (mCRPC) patients. Between 2011 and 2014 new LPDs for mCRPC (cabazitaxel, abiraterone, enzalutamide, and radium-223) were introduced in the Netherlands. The objective of this study is to assess the impact of the introduction of new LPDs on treatment patterns and overall survival (OS) over time.

PATIENTS AND METHODS

CRPC patients diagnosed in the years 2010-2016 in the observational, retrospective CAPRI registry (20 hospitals) were included and followed up to 2018. Two subgroups were analyzed: treatment-naïve patients (subgroup 1, n = 3600) and post-docetaxel patients (subgroup 2, n = 1355).

RESULTS

In both subgroups, the use of any LPD increased: from 57% (2010-2011) to 69% (2014-2015) in subgroup 1 and from 65% (2011-2012) to 79% (2015-2016) in subgroup 2. Chemotherapy as first mCRPC-treatment (i.e., docetaxel) and first post-docetaxel treatment (i.e., cabazitaxel or docetaxel rechallenge) decreased (46-29% and 20-9% in subgroup 1 and 2, respectively), while the use of androgen-receptor targeting treatments (ART) increased from 11% to 39% and 46% to 64% in subgroup 1 and 2, respectively. In subgroup 1, median OS (mOS) from diagnosis CRPC increased from 28.5 months to 31.0 months (p = 0.196). In subgroup 2, mOS from progression on docetaxel increased from 7.9 months to 12.5 months (p < 0.001). After multiple imputations of missing values, in multivariable cox-regression analysis with known prognostic parameters, the treatment period was independent significant for OS in subgroup 1 (2014-2015 vs. 2010-2011 with HR 0.749, p < 0.001) and subgroup 2 (2015-2016 vs. 2011-2012 with HR 0.811, p = 0.037).

CONCLUSION

Since 2010, a larger proportion of mCRPC patients was treated with LPDs, which was related to an increased mOS.

摘要

背景

2004 年,多西他赛成为首个获批用于转移性去势抵抗性前列腺癌(mCRPC)患者的延长生命药物(LPD)。2011 年至 2014 年间,荷兰又引入了三种新的 mCRPC LPD(卡巴他赛、阿比特龙、恩杂鲁胺和镭-223)。本研究旨在评估新 LPD 的引入对治疗模式和总生存期(OS)的影响。

患者和方法

纳入 2010 年至 2016 年在观察性、回顾性 CAPRI 登记处(20 家医院)诊断为 CRPC 的患者,并随访至 2018 年。分析了两个亚组:治疗初治患者(亚组 1,n=3600)和多西他赛治疗后患者(亚组 2,n=1355)。

结果

两个亚组中,任何 LPD 的使用率均增加:亚组 1 从 2010-2011 年的 57%增加至 2014-2015 年的 69%,亚组 2 从 2011-2012 年的 65%增加至 2015-2016 年的 79%。作为 mCRPC 一线治疗(即多西他赛)和多西他赛治疗后一线治疗(即卡巴他赛或多西他赛再挑战)的化疗使用率下降(亚组 1 和 2 分别为 46%-29%和 20%-9%),而雄激素受体靶向治疗(ART)的使用率则分别从 11%增加至 39%和 46%增加至 64%。亚组 1 中,CRPC 诊断后的中位 OS(mOS)从 28.5 个月增加至 31.0 个月(p=0.196)。亚组 2 中,多西他赛治疗进展后的 mOS 从 7.9 个月增加至 12.5 个月(p<0.001)。对缺失值进行多次插补后,在多变量 cox 回归分析中纳入已知预后参数,治疗期间是亚组 1(2014-2015 年 vs. 2010-2011 年,HR 0.749,p<0.001)和亚组 2(2015-2016 年 vs. 2011-2012 年,HR 0.811,p=0.037)中 OS 的独立显著预测因素。

结论

自 2010 年以来,更多的 mCRPC 患者接受了 LPD 治疗,这与 OS 的延长有关。

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