恩扎卢胺或醋酸阿比特龙联合泼尼松治疗转移性去势抵抗性前列腺癌患者的疲劳、健康相关生活质量和代谢变化：一项随机临床试验（HEAT）。
Fatigue, health-related quality-of-life and metabolic changes in men treated with enzalutamide or abiraterone acetate plus prednisone for metastatic castration-resistant prostate cancer: A randomised clinical trial (HEAT).
机构信息
Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Urology, Copenhagen University Hospital, Herlev and Gentofte, Herlev, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
Eur J Cancer. 2022 Aug;171:75-84. doi: 10.1016/j.ejca.2022.04.034. Epub 2022 Jun 13.
INTRODUCTION
Enzalutamide and abiraterone acetate plus prednisone (AAP) have similar efficacy in metastatic castration-resistant prostate cancer (mCRPC). Herein, we compare fatigue, health-related quality-of-life (HRQoL) and metabolic changes in men with mCRPC treated with enzalutamide and AAP.
MATERIALS AND METHODS
In this single-centre, open-labelled, phase IV trial, patients with metastatic prostate cancer progressing on androgen deprivation therapy were randomly assigned to enzalutamide (160 mg daily) or AAP (1000 mg abiraterone acetate and 10 mg prednisone daily) as first-line mCRPC treatment. The primary outcome was the difference in changed fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire). The secondary outcomes were differences in changed HRQoL (Functional Assessment of Cancer Therapy-Prostate questionnaire), body composition, weight, glucose homeostasis, lipid profile and blood pressure. All outcomes were assessed at baseline and at 12-week follow-up.
TRIAL REGISTRATION
clinicaltrialsregister.eu (2017-000099-27).
RESULTS
170 patients were randomised (1:1) to enzalutamide or AAP. The primary outcome was positive with a clinically meaningful difference in fatigue, favouring AAP (3.4 points, 95% CI 1.2; 5.6, P = 0.003). The group difference in changed HRQoL did not reach clinical significance. The most important metabolic finding was a higher increase in glycated haemoglobin (HbA1c) for AAP than enzalutamide (3.4 mmol/mol, 95% CI 2.1; 4.8, P = 0.001). Eight patients developed type 2 diabetes (T2D) in the AAP group and none in the enzalutamide group. No treatment-related serious adverse event was observed.
CONCLUSIONS
AAP resulted in less fatigue than enzalutamide in a randomised setting. This was at the expense of a higher HbA1c increase and incidence of T2D.
简介
恩扎卢胺和醋酸阿比特龙联合泼尼松（AAP）在转移性去势抵抗性前列腺癌（mCRPC）中的疗效相当。在此，我们比较了接受恩扎卢胺和 AAP 治疗的 mCRPC 男性的疲劳、健康相关生活质量（HRQoL）和代谢变化。
材料和方法
在这项单中心、开放性、IV 期临床试验中，正在接受雄激素剥夺治疗的转移性前列腺癌患者被随机分配接受恩扎卢胺（每日 160mg）或 AAP（每日 1000mg 醋酸阿比特龙和 10mg 泼尼松）作为一线 mCRPC 治疗。主要结局是疲劳变化的差异（慢性疾病治疗功能评估-疲劳问卷）。次要结局是 HRQoL（癌症治疗功能评估-前列腺问卷）、身体成分、体重、葡萄糖稳态、血脂谱和血压变化的差异。所有结局均在基线和 12 周随访时评估。
试验注册
clinicaltrialsregister.eu（2017-000099-27）。
结果
170 名患者被随机（1:1）分配至恩扎卢胺或 AAP 组。主要结局为阳性，且 AAP 组的疲劳改善具有临床意义（3.4 分，95%CI 1.2; 5.6，P=0.003）。HRQoL 变化的组间差异无统计学意义。最重要的代谢发现是 AAP 组糖化血红蛋白（HbA1c）升高幅度大于恩扎卢胺组（3.4mmol/mol，95%CI 2.1; 4.8，P=0.001）。AAP 组有 8 名患者发生 2 型糖尿病（T2D），而恩扎卢胺组无患者发生 T2D。未观察到与治疗相关的严重不良事件。
结论
在随机分组中，AAP 导致的疲劳少于恩扎卢胺，但代价是 HbA1c 升高幅度更大和 T2D 发生率更高。
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