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阿比特龙、恩杂鲁胺和卡巴他赛用于转移性去势抵抗性前列腺癌一线和二线治疗的真实世界数据——一项来自葡萄牙的多中心研究

Real-life Data on First- and Second-Line Treatment of Metastatic Castration-Resistant Prostate Cancer With Abiraterone, Enzalutamide and Cabazitaxel - A multicentric Study From Portugal.

作者信息

Botelho Francisco, Braga Isaac, Leão Ricardo, Teves Frederico, Dias Jorge, Rodrigues Filipe, Oliveira Jorge, Augusto Isabel, Portela Catarina, Febra Joana, Custódio Sandra, Liu Patrícia, Gago Patrícia, Miranda André, Silva Carlos, Pacheco-Figueiredo Luís

机构信息

Department of Urology, Centro Hospitalar Universitário S. João, Porto, Portugal; Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal.

Life and Health Sciences Research Institute (ICVS), School of Medicine, University of Minho, Braga, Portugal; Department of Urology, Instituto Português de Oncologia do Porto Francisco Gentil, Porto, Portugal.

出版信息

Clin Genitourin Cancer. 2024 Dec;22(6):102169. doi: 10.1016/j.clgc.2024.102169. Epub 2024 Jul 18.

Abstract

INTRODUCTION AND OBJECTIVES

New drugs for metastatic castrate resistant prostate cancer (mCRPC) were approved, first in the pos-docetaxel and then in the pre-docetaxel setting. We aim to assess the real daily practice benefit of abiraterone (Abi), enzalutamide (Enz) and cabazitaxel (Cab) in patients with mCRPC, compare it with RCT results and compare Abi vs Enz.

MATERIALS AND METHODS

We retrospectively collected the data of all consecutive mCRPC patients treated with Abi, Enz or Cab in the six major oncological hospitals in the north of Portugal until December 2020.

RESULTS

A total of 470 treatments pre-docetaxel (163 Abi and 307 Enz) and 373 pos-docetaxel (160 Abi, 148 Enz and 59 Cab) were included, with median follow-up time of 35 months. Mean age was 73.1, 84.4% had ECOG status < 2, ISUP grade was ≥ 4 in 59% and 28.0% had oligometastatic disease. In first line, for Abi and for Enz respectively, the proportion of patients with PSA reduction > 50% was 64.4% and 80.4% (P < .001), the mean duration of treatment (DT) was 10 and 14 months (P = .037) and the median overall survival (OS) was 25 months and 30 months (P = .17). In second line the results for Abi, Enz and Cab were respectively: proportion of patients with PSA reduction > 50% was 40.4%, 57.4% and 24.6% (p for Abi vs Enz=0.004); DT was 7, 8, and 3 months (p for Abi vs Enz = 0.27); OS was 17, 22 and 10 months (p for Abi vs. Enz = 0,07).

CONCLUSION

These drugs have good efficacy in real-world evidence, similar to those reported in randomized clinical trials, with the expected exception of lower OS due to the inclusion of a broader sample of patients. Our results add to the evidence that Enz might have better efficacy in this setting compared with Abi.

摘要

引言与目的

用于转移性去势抵抗性前列腺癌(mCRPC)的新药已获批,先是在多西他赛治疗后阶段,然后是在多西他赛治疗前阶段。我们旨在评估阿比特龙(Abi)、恩杂鲁胺(Enz)和卡巴他赛(Cab)在mCRPC患者中的实际日常应用获益,将其与随机对照试验(RCT)结果进行比较,并比较阿比特龙与恩杂鲁胺。

材料与方法

我们回顾性收集了葡萄牙北部六家主要肿瘤医院中所有连续接受阿比特龙、恩杂鲁胺或卡巴他赛治疗的mCRPC患者的数据,直至2020年12月。

结果

共纳入多西他赛治疗前的470例治疗(163例阿比特龙和307例恩杂鲁胺)以及多西他赛治疗后的373例治疗(160例阿比特龙、148例恩杂鲁胺和59例卡巴他赛),中位随访时间为35个月。平均年龄为73.1岁,84.4%的患者东部肿瘤协作组(ECOG)状态<2,59%的患者国际泌尿病理学会(ISUP)分级≥4,28.0%的患者有寡转移疾病。在一线治疗中,阿比特龙和恩杂鲁胺的患者中前列腺特异性抗原(PSA)降低>50%的比例分别为64.4%和80.4%(P<0.001),平均治疗持续时间(DT)分别为10个月和14个月(P = 0.037),中位总生存期(OS)分别为25个月和30个月(P = 0.17)。在二线治疗中,阿比特龙、恩杂鲁胺和卡巴他赛的结果分别为:PSA降低>50%的患者比例分别为40.4%、57.4%和24.6%(阿比特龙与恩杂鲁胺比较的P值 = 0.004);DT分别为7个月、8个月和3个月(阿比特龙与恩杂鲁胺比较的P值 = 0.27);OS分别为17个月、22个月和10个月(阿比特龙与恩杂鲁胺比较的P值 = 0.07)。

结论

这些药物在真实世界证据中有良好疗效,与随机临床试验中报道的相似,由于纳入了更广泛的患者样本,总生存期较低是预期的例外情况。我们的结果进一步证明,在这种情况下,恩杂鲁胺可能比阿比特龙具有更好的疗效。

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