Efficacy Outcomes by Baseline Prostate-specific Antigen Quartile in the AFFIRM Trial
Efficacy Outcomes by Baseline Prostate-specific Antigen Quartile in the AFFIRM Trial
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DOI：
10.1016/j.eururo.2014.08.025
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发表时间：
2015-02-01
期刊：
影响因子：
23.4
通讯作者：
Scher, Howard I.
中科院分区：
文献类型：
--
作者：
Saad, Fred;de Bono, Johann;Scher, Howard I.
背景资料：在一项随机、III期、双盲、安慰剂对照、多国、既往接受过多西他赛化疗的进行性去势抵抗性前列腺癌患者（AFFIRM）试验（NCT 00974311）中，Enzalutamide显著延长了多西他赛治疗后转移性去势抵抗性前列腺癌（PCa）男性患者的生存期。前列腺特异性抗原（PSA）通常被用作前列腺癌疾病负担的标志物，基线PSA水平与后续治疗效果的关系具有临床意义。目的：探索性分析以评估AFFIRM试验中基线PSA水平在患者特征和疗效结局方面的任何差异。设计、设置和参与者：所有随机化患者的事后亚组分析（n = 1199）来自AFFIRM试验。干预：受试者以2：1的比例随机分配接受口服Enzalutamide 160 mg/d或安慰剂。结局测量和统计分析：主要临床疗效终点是总生存期（OS）、放射学无进展生存期（rPFS）和至PSA进展时间（TTPP）与安慰剂相比;基线特征、治疗持续时间和随后的PSA治疗通过基线PSA四分位数进行比较。基线PSA四分位数对应于以下PSA组：
Background: Enzalutamide significantly prolonged the survival of men with metastatic castration-resistant prostate cancer (PCa) after docetaxel in the randomised, phase 3, double-blind, placebo-controlled, multinational Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy (AFFIRM) trial (NCT00974311). Prostate-specific antigen (PSA) is commonly used as a marker of PCa disease burden, and the relationship of baseline PSA level to consequent treatment effect is of clinical interest.Objective: Exploratory analysis to evaluate any differences in patient characteristics and efficacy outcomes by baseline PSA level in the AFFIRM trial.Design, setting, and participants: Post hoc subanalysis of all randomised patients (n = 1199) from the AFFIRM trial.Intervention: Participants were randomly assigned in a two-to-one ratio to receive oral enzalutamide 160 mg/d or placebo.Outcome measurements and statistical analysis: The major clinical efficacy end points were overall survival (OS), radiographic progression-free survival (rPFS), and time to PSA progression (TTPP) versus placebo; baseline characteristics, treatment duration, and subsequent antineoplastic therapy were compared by baseline PSA quartile.Results and limitations: Baseline PSA quartiles corresponded to the following PSA groups: