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转移性去势抵抗性前列腺癌患者的真实世界治疗顺序:来自前瞻性、国际性、观察性前列腺癌登记处的结果

Real-world Treatment Sequencing in Patients with Metastatic Castration-resistant Prostate Cancer: Results from the Prospective, International, Observational Prostate Cancer Registry.

作者信息

Bjartell Anders, Costa Luis, Kramer Gero, Zurawski Bogdan, Galli Luca, Werbrouck Patrick, Ecke Thorsten, Parikh Omi, Bennamoun Mostefa, Garcia Freire Camilo, Peer Avivit, Ljungberg Börje, Cicin Irfan, Smith Emma, Lukac Martin, Wapenaar Robert, Chowdhury Simon

机构信息

Department of Urology, Skåne University Hospital, Lund University, Malmö, Sweden.

Oncology Division, Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal.

出版信息

Eur Urol Open Sci. 2022 Sep 17;45:12-22. doi: 10.1016/j.euros.2022.08.018. eCollection 2022 Nov.

Abstract

BACKGROUND

Prostate cancer has a multifaceted treatment pattern. Evidence is lacking for optimal treatment sequences for metastatic castration-resistant prostate cancer (mCRPC).

OBJECTIVE

To increase the understanding of real-world treatment pathways and outcomes in patients with mCRPC.

DESIGN SETTING AND PARTICIPANTS

A prospective, noninterventional, real-world analysis of 3003 patients with mCRPC in the Prostate Cancer Registry (PCR; NCT02236637) from June 14, 2013 to July 9, 2018 was conducted.

INTERVENTION

Patients received first- and second-line hormonal treatment and chemotherapy as follows: abiraterone acetate plus prednisone (abiraterone)-docetaxel (ABI-DOCE), abiraterone-enzalutamide (ABI-ENZA), abiraterone-radium-223 (ABI-RAD), docetaxel-abiraterone (DOCE-ABI), docetaxel-cabazitaxel (DOCE-CABA), docetaxel-enzalutamide (DOCE-ENZA), and enzalutamide-docetaxel (ENZA-DOCE).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Baseline patient characteristics, quality of life, mCRPC treatments, and efficacy outcomes (progression and survival) were presented descriptively.

RESULTS AND LIMITATIONS

Data from 727 patients were eligible for the analysis (ABI-DOCE  = 178, ABI-ENZA  = 99, ABI-RAD  = 27, DOCE-ABI  = 191, DOCE-CABA  = 74, DOCE-ENZA  = 116, and ENZA-DOCE  = 42). Demographics and disease characteristics among patients between different sequences varied greatly. Most patients who started on abiraterone or enzalutamide stopped therapy because of disease progression. No randomisation to allow treatment/sequence comparisons limited this observational study.

CONCLUSIONS

The real-world PCR data complement clinical trial data, reflecting more highly selected patient populations than seen in routine clinical practice. Baseline characteristics play a role in mCRPC first-line treatment selection, but other factors, such as treatment availability, have an impact. Efficacy observations are limited and should be interpreted with caution.

PATIENT SUMMARY

Baseline characteristics appear to have a role in the first-line treatment selection of metastatic castration-resistant prostate cancer in the real-world setting. First-line abiraterone acetate plus prednisone seems to be the preferred treatment option for older patients and those with lower Gleason scores, first-line docetaxel for younger patients and those with more advanced disease, and first-line enzalutamide for patients with fewer metastases and more favourable performance status. The benefit to patients from these observations remains unknown.

摘要

背景

前列腺癌具有多方面的治疗模式。对于转移性去势抵抗性前列腺癌(mCRPC)的最佳治疗顺序,目前缺乏相关证据。

目的

加深对mCRPC患者真实世界治疗路径和结局的了解。

设计、设置和参与者:对2013年6月14日至2018年7月9日前列腺癌登记处(PCR;NCT02236637)的3003例mCRPC患者进行了一项前瞻性、非干预性的真实世界分析。

干预措施

患者接受一线和二线激素治疗及化疗,具体如下:醋酸阿比特龙加泼尼松(阿比特龙)-多西他赛(ABI-DOCE)、阿比特龙-恩杂鲁胺(ABI-ENZA)、阿比特龙-镭-223(ABI-RAD)、多西他赛-阿比特龙(DOCE-ABI)、多西他赛-卡巴他赛(DOCE-CABA)、多西他赛-恩杂鲁胺(DOCE-ENZA)以及恩杂鲁胺-多西他赛(ENZA-DOCE)。

结局测量和统计分析

对患者的基线特征、生活质量、mCRPC治疗情况以及疗效结局(疾病进展和生存)进行了描述性呈现。

结果与局限性

727例患者的数据符合分析要求(ABI-DOCE = 178例,ABI-ENZA = 99例,ABI-RAD = 27例,DOCE-ABI = 191例,DOCE-CABA = 74例,DOCE-ENZA = 116例,ENZA-DOCE = 42例)。不同治疗顺序的患者在人口统计学和疾病特征方面差异很大。大多数开始使用阿比特龙或恩杂鲁胺治疗的患者因疾病进展而停止治疗。由于未进行随机分组以允许进行治疗/顺序比较,限制了这项观察性研究。

结论

真实世界的PCR数据补充了临床试验数据,反映出比常规临床实践中选择更严格的患者群体。基线特征在mCRPC一线治疗选择中起作用,但其他因素,如治疗可及性,也有影响。疗效观察有限,应谨慎解读。

患者总结

在真实世界中,基线特征似乎在转移性去势抵抗性前列腺癌的一线治疗选择中起作用。一线醋酸阿比特龙加泼尼松似乎是老年患者以及Gleason评分较低患者的首选治疗方案,一线多西他赛适用于年轻患者以及疾病更晚期的患者,一线恩杂鲁胺适用于转移灶较少且身体状况较好的患者。这些观察结果对患者的益处尚不清楚。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e610/9637537/9ca49f637ba7/gr1.jpg

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