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多西他赛与醋酸阿比特龙治疗转移性激素敏感性前列腺癌的真实世界比较。

A real-world comparison of docetaxel versus abiraterone acetate for metastatic hormone-sensitive prostate cancer.

机构信息

Department of Urology and Pediatric Urology, University Medicine Mainz, Mainz, Germany.

Department of Urology, Medical University Innsbruck, Innsbruck, Austria.

出版信息

Cancer Med. 2021 Sep;10(18):6354-6364. doi: 10.1002/cam4.4184. Epub 2021 Aug 10.

Abstract

BACKGROUND

Docetaxel (D) or secondary hormonal therapy (SHT) each combined with androgen deprivation therapy (ADT) represent possible treatment options in males with metastasized hormone-sensitive prostate cancer (mHSPC). Real-world data comparing different protocols are lacking yet. Thus, our objective was to compare the efficacy and safety of abiraterone acetate (AA)+ADT versus D+ADT in mHSPC.

METHODS

In a retrospective multicenter analysis including males with mHSPC treated with either of the aforementioned protocols, overall survival (OS), progression-free survival 1 (PFS1), and progression-free survival 2 (PFS2) were assessed for both cohorts. Median time to event was tested by Kaplan-Meier method and log-rank test. The Cox-proportional hazards model was used for univariate and multivariate regression analyses.

RESULTS

Overall, 196 patients were included. The AA+ADT cohort had a longer PFS1 in the log-rank testing (23 vs. 13 mos., p < 0.001), a longer PFS2 (48 vs. 33 mos., p = 0.006), and longer OS (80 vs. 61 mos., p = 0.040). In the multivariate analyses AA+ADT outperformed D+ADT in terms of PFS1 (HR = 0.34, 95% CI = 0.183-0.623; p = 0.001) and PFS2 (HR = 0.33 95% CI = 0.128-0.827; p = 0.018), respectively, while OS and toxicity rate were similar between both groups.

CONCLUSIONS

AA+ADT is mainly associated with a similar efficacy and overall toxicity rate as D+ADT. Further prospective research is required for validation of the clinical value of the observed benefit of AA+ADT for progression-free end-points.

摘要

背景

多西他赛(D)或二线激素治疗(SHT)分别联合雄激素剥夺治疗(ADT)是转移性去势敏感前列腺癌(mHSPC)男性患者的可能治疗选择。然而,目前缺乏比较不同方案的真实世界数据。因此,我们的目的是比较醋酸阿比特龙(AA)+ADT 与 D+ADT 在 mHSPC 中的疗效和安全性。

方法

在一项回顾性多中心分析中,纳入了接受上述方案治疗的 mHSPC 男性患者,对两组患者的总生存期(OS)、无进展生存期 1(PFS1)和无进展生存期 2(PFS2)进行评估。采用 Kaplan-Meier 法和对数秩检验检测中位时间至事件。Cox 比例风险模型用于单因素和多因素回归分析。

结果

共有 196 例患者纳入研究。AA+ADT 组的 PFS1 在对数秩检验中更长(23 与 13 个月,p<0.001),PFS2 更长(48 与 33 个月,p=0.006),OS 更长(80 与 61 个月,p=0.040)。在多因素分析中,AA+ADT 在 PFS1(HR=0.34,95%CI=0.183-0.623;p=0.001)和 PFS2(HR=0.33,95%CI=0.128-0.827;p=0.018)方面优于 D+ADT,而两组之间的 OS 和毒性发生率相似。

结论

AA+ADT 主要与 D+ADT 相似的疗效和总体毒性发生率相关。需要进一步的前瞻性研究来验证 AA+ADT 在无进展终点方面观察到的获益的临床价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f3ab/8446402/a3d8a6ab5e93/CAM4-10-6354-g002.jpg

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