Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial

Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial
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DOI:
10.1186/s12955-017-0704-y
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发表时间:
2017-06-23
影响因子:
3.6
通讯作者:
Holmstrom, Stefan
Holmstrom, Stefan
中科院分区:
医学3区
文献类型:
--
作者:
Devlin, Nancy;Herdman, Michael;Holmstrom, Stefan

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背景资料:在PREVAIL试验中,使用通用EQ-5D工具分析了Enzalutamide对未经化疗的转移性去势抵抗性前列腺癌男性健康相关生活质量(HRQoL)的影响。方法:患者接受口服Enzalutamide 160 mg/d(n = 872)或安慰剂(n = 845)。由于此后样本量减少,在基线、第13周和每12周一次直至第61周评价EQ-5D指数和EQ-5D视觉模拟量表(EQ-5D VAS)评分。对个体维度的变化进行了评估,并进行了Paretian健康变化分类(PCHC)和至事件发生时间分析。结果:与安慰剂相比,Enzalutamide组EQ-5D指数和EQ-5D VAS评分下降较慢,偏离完全健康状态的时间延长。EQ-5D指数平均下降(-0.042 vs. -0.070; P
Background: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naive men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument.Methods: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted.Results: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P