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阿帕他胺与阿比特龙联合雄激素剥夺疗法治疗转移性激素敏感性前列腺癌的真实世界临床结局

Real-world clinical outcomes of apalutamide versus abiraterone with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer.

作者信息

Pons-Fuster Eduardo, Gonzalez-Ponce Celia Maria, Ros-Martinez Silverio, Fernández-Ávila Juan José, Díaz-Carrasco María Sacramento, Espuny-Miró Alberto

机构信息

Clinical Pharmacy and Therapeutics Research Group, Servicio de Farmacia Hospitalaria, Virgen de la Arrixaca University Clinical Hospital (HCUVA), Ctra. Madrid-Cartagena, s/n, 30120, El Palmar, Spain.

Clinical and Translational Oncology Research Group, Clinical Oncology Unit, Virgen de la Arrixaca University Clinical Hospital (HCUVA), El Palmar, Spain.

出版信息

Int J Clin Pharm. 2025 May 6. doi: 10.1007/s11096-025-01920-4.

Abstract

BACKGROUND

Metastatic hormone-sensitive prostate cancer (mHSPC) is an aggressive disease with a poor prognosis. Current treatment guidelines recommend combining androgen receptor axis-targeted therapies (ARATs) with androgen deprivation therapy (ADT) for mHSPC. While individual ARATs have shown success, few studies directly compare their effects.

AIM

To compare the safety and clinical outcomes of abiraterone acetate (abiraterone) and apalutamide in chemotherapy-naïve mHSPC patients, focusing on prostate-specific antigen (PSA) kinetics, safety, and survival outcomes.

METHOD

A retrospective, single-centre study included 107 chemotherapy-naïve mHSPC patients treated with abiraterone or apalutamide plus ADT. PSA levels were measured at baseline and during treatment. Primary outcomes were PSA progression-free survival (PSA-PFS) and overall survival (OS). Adverse events were recorded. Inverse probability treatment weighting adjusted baseline differences.

RESULTS

Median PSA-PFS significantly favoured apalutamide (log-rank p = 0.015). Achieving PSA ≤ 0.02 ng/mL was strongly associated with delayed progression (HR 0.07, 95% CI 0.02-0.28; p < 0.001). OS did not differ significantly between groups (p = 0.504). Apalutamide achieved lower median nadir PSA (0.02 ng/mL vs. 0.23 ng/mL, p < 0.001) and shorter mean time to nadir (4.5 vs. 7.2 months, p = 0.001), with more patients reaching ultralow PSA levels (≤ 0.02 ng/mL) during follow-up. Adverse events occurred more frequently with apalutamide (71.2% vs. 46.5%, p = 0.015), with fatigue and rash being the most common.

CONCLUSION

Apalutamide demonstrated deeper and more sustained PSA reductions, translating into delayed disease progression compared to abiraterone. Both treatments were generally well tolerated, though adverse events were more prevalent with apalutamide.

摘要

背景

转移性激素敏感性前列腺癌(mHSPC)是一种侵袭性疾病,预后较差。当前的治疗指南推荐将雄激素受体轴靶向疗法(ARATs)与雄激素剥夺疗法(ADT)联合用于mHSPC的治疗。虽然个别ARATs已显示出疗效,但很少有研究直接比较它们的效果。

目的

比较醋酸阿比特龙(阿比特龙)和阿帕鲁胺在未经化疗的mHSPC患者中的安全性和临床结局,重点关注前列腺特异性抗原(PSA)动力学、安全性和生存结局。

方法

一项回顾性单中心研究纳入了107例接受阿比特龙或阿帕鲁胺加ADT治疗的未经化疗的mHSPC患者。在基线和治疗期间测量PSA水平。主要结局为PSA无进展生存期(PSA-PFS)和总生存期(OS)。记录不良事件。采用逆概率处理加权法调整基线差异。

结果

阿帕鲁胺组的中位PSA-PFS显著更优(对数秩检验p = 0.015)。PSA≤0.02 ng/mL与疾病进展延迟密切相关(风险比0.07,95%置信区间0.02 - 0.28;p < 0.001)。两组间OS无显著差异(p = 0.504)。阿帕鲁胺组的中位最低PSA更低(0.02 ng/mL对0.23 ng/mL,p < 0.001),达到最低PSA的平均时间更短(4.5个月对7.2个月,p = 0.001),随访期间更多患者达到超低PSA水平(≤0.02 ng/mL)。阿帕鲁胺组不良事件发生频率更高(71.2%对46.5%,p = 0.015),最常见的是疲劳和皮疹。

结论

与阿比特龙相比,阿帕鲁胺可使PSA更深度、更持久地降低,从而延缓疾病进展。两种治疗总体耐受性良好,但阿帕鲁胺的不良事件更普遍。

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