阿帕鲁胺治疗非转移性去势抵抗性前列腺癌(nmCRPC):一项多中心研究的实际数据。

IF 2.7 3区 医学 Q3 ONCOLOGY Journal of Cancer Research and Clinical Oncology Pub Date : 2024-09-09 DOI:10.1007/s00432-024-05928-7
Axel Hegele, Rainer Häußermann, Stefan Schultheis, Lennart Skrobek, Meike Vink, Sebastian Hollwegs, Martin Ludwig, Petra Huwe, Manfred Maywurm, Anke Bartsch-Polle, Jost Weber, Markus Thiemer, Denny Varughese
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引用次数: 0

摘要

目的:阿帕鲁胺联合雄激素剥夺疗法(ADT)可改善非转移性去势抵抗性前列腺癌(nmCRPC)患者的预后。然而,真实世界的数据非常有限。这项多中心研究旨在收集接受 ADT 加阿帕鲁胺治疗的 nmCRPC 患者的真实世界数据:在这项由研究者发起的观察性队列试验中,收集了接受阿帕鲁胺联合ADT治疗的nmCRPC患者的数据,重点关注患者的人口统计学数据、前列腺特异性抗原(PSA)下降情况、包括剂量调整/停药在内的安全性概况以及后续治疗和无转移生存期(MFS):结果:共记录了31名nmCRPC患者的数据。与III期研究相比,Spartan真实世界患者年龄更大,ECOG-PS更高,肿瘤更具侵袭性。队列中 PSA 下降了约 98.1%,74% 的患者 PSA 下降了 90%以上,54.8% 的患者达到了 PSA 水平:在现实世界中,阿帕鲁胺联合ADT可治疗更多ECOG-PS更高、肿瘤侵袭性更强的合并症nmCRPC患者。尽管如此,与斯巴达试验相比,阿帕鲁胺在真实世界中的疗效和副作用是相似的,同样显示出快速、持久和深入的 PSA 反应,中位 MFS 为 43 个月。
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Apalutamide for non-metastatic castration-resistant prostate cancer (nmCRPC): real world data of a multicenter study.

Purpose: Apalutamide plus androgen-deprivation therapy (ADT) improved outcomes in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Nevertheless real-world data are limited. The aim of this multicenter study was to generate real-world data from nmCRPC patients treated with ADT plus apalutamide.

Methods: In this observational cohort based investigator initiated trial data of nmCRPC patients receiving apalutamide plus ADT were collected focusing on patient demographic data, prostate-specific antigen (PSA) declines, safety profile including dose modification/discontinuation as well as subsequent therapy and metastasis-free survival (MFS).

Results: Data from a total of 31 nmCRPC patients were documented. Compared to the Phase III study Spartan real-world patients are older, showed a higher ECOG-PS and more aggressive tumors. In the cohort PSA decreased about 98.1%, 74% of patients showed a PSA decrease over 90% and 54.8% reached a PSA-level < 0.2ng/ml. Apalutamide was well tolerated in real world patients: adverse events occurred in 67.7% but were in the majority mild (≥ grade 3: 6.5%). Dose reduction was necessary in 38.7% and 32.2% discontinued apalutamide treatment. MFS was 43 months and majority of patients were subsequently treated with abiraterone.

Conclusion: In real world more comorbid nmCRPC patients with a higher ECOG-PS and more aggressive tumors are treated with apalutamide plus ADT. Nevertheless efficacy results as well as side effects are similar in real-world compared to Spartan trial showing also a rapid, durable and deep PSA response with a median MFS of 43 months.

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来源期刊
CiteScore
4.00
自引率
2.80%
发文量
577
审稿时长
2 months
期刊介绍: The "Journal of Cancer Research and Clinical Oncology" publishes significant and up-to-date articles within the fields of experimental and clinical oncology. The journal, which is chiefly devoted to Original papers, also includes Reviews as well as Editorials and Guest editorials on current, controversial topics. The section Letters to the editors provides a forum for a rapid exchange of comments and information concerning previously published papers and topics of current interest. Meeting reports provide current information on the latest results presented at important congresses. The following fields are covered: carcinogenesis - etiology, mechanisms; molecular biology; recent developments in tumor therapy; general diagnosis; laboratory diagnosis; diagnostic and experimental pathology; oncologic surgery; and epidemiology.
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