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长期使用与主要不良心脏事件风险:比较恩杂鲁胺和阿比特龙在化疗初治转移性去势抵抗性前列腺癌患者中的应用。

Long-term use and risk of major adverse cardiac events: Comparing enzalutamide and abiraterone in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer.

机构信息

Division of Hematology Oncology, Department of Internal Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.

Department of Pharmacy, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.

出版信息

Int J Cancer. 2023 Mar 15;152(6):1191-1201. doi: 10.1002/ijc.34348. Epub 2022 Dec 9.

DOI:10.1002/ijc.34348
PMID:36346116
Abstract

This is a retrospective cohort study by analyzing a multi-institutional electronic medical records database in Taiwan to compare long-term effectiveness and risk of major adverse cardiac events (MACE) in chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) patients treated with enzalutamide (ENZ) or abiraterone (AA). Patients aged 20 years and older and newly receiving androgen receptor targeted therapies ENZ or AA from September 2016 to December 2019 were included. We followed patients from initiation of therapies to the occurrence of outcomes (prostate-specific antigen (PSA) response rate, PSA progression free survival (PFS), overall survival (OS), and MACE), death, the last clinical visit, or December 31, 2020. We performed multivariable Cox proportional hazard models to compare ENZ and AA groups for the measured outcomes. A total of 363 patients treated with either ENZ (n = 157) or AA (n = 206) were identified. The analysis found a significantly higher proportion of patients with a PSA response rate higher than 50% among those receiving ENZ than among those receiving AA (ENZ vs AA: 75.80% vs 63.59%, P = .01). However, there was no significant difference in PSA PFS (adjusted hazard ratio: 0.86; 95% CI 0.63-1.17) and OS (0.68: 0.41-1.14) between the use of ENZ and AA in chemotherapy-naïve mCRPC patients. Regarding the cardiovascular (CV) safety outcome, there was a significantly lower risk of MACE in patients receiving ENZ, compared to patients receiving AA (0.20: 0.07-0.55). The findings suggest that enzalutamide may be more efficacious for PSA response and suitable for chemotherapy-naïve mCRPC patients with high CV risk profile.

摘要

这是一项通过分析台湾多机构电子病历数据库的回顾性队列研究,旨在比较化疗初治转移性去势抵抗性前列腺癌(mCRPC)患者接受恩扎卢胺(ENZ)或阿比特龙(AA)治疗的长期疗效和主要不良心脏事件(MACE)风险。纳入年龄≥20 岁且新接受雄激素受体靶向治疗的患者,包括 2016 年 9 月至 2019 年 12 月期间接受 ENZ 或 AA 治疗的患者。我们从开始治疗到发生结局(前列腺特异性抗原(PSA)反应率、PSA 无进展生存期(PFS)、总生存期(OS)和 MACE)、死亡、最后一次临床就诊或 2020 年 12 月 31 日对患者进行随访。我们采用多变量 Cox 比例风险模型比较接受 ENZ 和 AA 治疗的患者的测量结局。共确定了 363 例接受 ENZ(n=157)或 AA(n=206)治疗的患者。分析发现,接受 ENZ 治疗的患者 PSA 反应率高于 50%的比例显著高于接受 AA 治疗的患者(ENZ 比 AA:75.80%比 63.59%,P=0.01)。然而,在化疗初治 mCRPC 患者中,ENZ 和 AA 的 PSA PFS(调整后的危险比:0.86;95%CI 0.63-1.17)和 OS(0.68:0.41-1.14)无显著差异。关于心血管(CV)安全性结局,接受 ENZ 治疗的患者发生 MACE 的风险显著低于接受 AA 治疗的患者(0.20:0.07-0.55)。这些发现表明,与接受 AA 治疗的患者相比,恩扎卢胺可能对 PSA 反应更有效,适合具有高 CV 风险特征的化疗初治 mCRPC 患者。

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