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一项在 574 例亚洲转移性激素敏感性前列腺癌患者中比较醋酸阿比特龙与多西他赛的全地域真实世界疗效和毒性的分析。

A territory-wide real-world efficacy and toxicity analysis of abiraterone acetate versus docetaxel in 574 Asian patients with metastatic hormone-sensitive prostate cancer.

机构信息

Department of Clinical Oncology, State Key Laboratory of Translational Oncology, Sir YK Pao Centre for Cancer, Hong Kong Cancer Institute, The Chinese University of Hong Kong, Hong Kong SAR, China.

Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR, China.

出版信息

Clin Genitourin Cancer. 2024 Feb;22(1):e75-e85.e1. doi: 10.1016/j.clgc.2023.07.012. Epub 2023 Aug 2.

Abstract

INTRODUCTION

Abiraterone acetate (ABI) or docetaxel (DOC), in addition to androgen-deprivation therapy (ADT), are current treatment options for metastatic hormone-sensitive prostate cancer (mHSPC). No randomized head-to-head trial has compared these 2 mHSPC treatments, and real-world data regarding their outcomes in Asian patients are lacking.

PATIENTS AND METHODS

The medical records of mHSPC patients who began upfront ABI or DOC treatment in addition to ADT at seven public oncology centers in Hong Kong between 2015 and 2021 were reviewed. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), prostate-specific antigen (PSA) response, and toxicities. Kaplan-Meier and multivariate Cox regression analyses were performed.

RESULTS

A total of 574 patients were included, of whom 419 received DOC and 155 received ABI. The median follow-up duration was 22.4 (DOC group: 23.8; ABI group: 17.3) months. The ABI group demonstrated significantly better PFS than the DOC group (not reached vs. 15.1 months: hazard ratio = 0.37; 95% confidence interval = 0.28-0.50; P < .001). No significant OS difference was observed (P = .58). Failure to achieve a ≥ 90% decline in PSA level at 3 months and failure to achieve an undetectable PSA nadir were each associated with unfavorable PFS and OS. Patients who received DOC had a higher rate of febrile neutropenia, whereas those who received ABI had higher rates of grade ≥ 3 hypokalemia and elevated alanine transaminase. Treatment discontinuation due to toxicities was more common in the DOC (3.6%) than the ABI (0.6%) group.

CONCLUSION

In Asian mHSPC patients, upfront ABI + ADT was associated with better PFS than DOC + ADT, with no significant OS difference. PSA kinetics may help stratify the prognosis for treatment intensification. Toxicity profiles were different, with a higher rate of toxicity-related treatment discontinuation in the DOC group.

摘要

简介

醋酸阿比特龙(ABI)或多西他赛(DOC)除雄激素剥夺疗法(ADT)外,也是转移性激素敏感前列腺癌(mHSPC)的当前治疗选择。目前尚无比较这两种 mHSPC 治疗方法的随机头对头试验,并且亚洲患者的实际数据缺乏。

方法

我们回顾了 2015 年至 2021 年间香港 7 家公立肿瘤中心的 mHSPC 患者在接受 ADT 治疗的基础上开始使用 ABI 或 DOC 治疗的病历。主要终点为无进展生存期(PFS)。次要终点包括总生存期(OS)、前列腺特异性抗原(PSA)反应和毒性。进行了 Kaplan-Meier 和多变量 Cox 回归分析。

结果

共纳入 574 例患者,其中 419 例接受 DOC 治疗,155 例接受 ABI 治疗。中位随访时间为 22.4 个月(DOC 组:23.8 个月;ABI 组:17.3 个月)。ABI 组的 PFS 明显优于 DOC 组(未达到 vs. 15.1 个月:风险比=0.37;95%置信区间=0.28-0.50;P<.001)。两组 OS 无显著差异(P=0.58)。3 个月时 PSA 水平未下降≥90%和未达到 PSA 最低点无法检测,均与不良 PFS 和 OS 相关。接受 DOC 治疗的患者中性粒细胞减少性发热发生率较高,而接受 ABI 治疗的患者发生≥3 级低钾血症和丙氨酸转氨酶升高的比例较高。由于毒性而停药的情况在 DOC(3.6%)组比 ABI(0.6%)组更常见。

结论

在亚洲 mHSPC 患者中,ABI+ADT 作为一线治疗与 DOC+ADT 相比,PFS 更好,OS 无显著差异。PSA 动力学可能有助于对治疗强化的预后进行分层。毒性谱不同,DOC 组因毒性相关治疗停药率较高。

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