Am J Epidemiol. 2021 Feb 1;190(3):413-422. doi: 10.1093/aje/kwaa190.
Abiraterone acetate (ABI) and enzalutamide (ENZ) are considered to be clinically relevant comparators among chemotherapy-naive patients with castration-resistant prostate cancer. No clinical trials comparing overall survival with ABI versus ENZ in a head-to-head approach have been published so far. A few observational studies with low power suggested a potential benefit of ENZ. We used the French National Health Data System to compare overall survival of new users of ABI and ENZ among chemotherapy-naive patients with castration-resistant prostate cancer in 2014-2017, followed through 2018 (the SPEAR cohort, a 2014-2018 cohort study). With an intent-to-treat approach, a survival analysis was performed, estimating hazard ratios for overall survival with the inverse probability weighted Cox model method. Among 10,308 new users, 64% were treated with ABI and 36% with ENZ. The crude mortality rate was 25.2 per 100 person-years (95% confidence interval (CI): 24.4, 26.0) for ABI and 23.7 per 100 person-years (95% CI: 22.6, 24.9) for ENZ. In the weighted analysis, ENZ was associated with better overall survival compared with ABI (hazard ratio = 0.90 (95% CI: 0.85, 0.96) with a median overall survival of 31.7 months for ABI and 34.2 months for ENZ). When restricting to 2015-2017 new users, the effect estimate shifted up to a hazard ratio of 0.93 (95% CI: 0.86, 1.01).
醋酸阿比特龙（ABI）和恩扎鲁胺（ENZ）被认为是化疗初治去势抵抗性前列腺癌患者中具有临床相关性的对照药物。目前尚未发表头对头比较 ABI 和 ENZ 总生存的临床试验。少数研究显示 ENZ 可能具有潜在获益，但这些研究的效能较低。我们使用法国国家健康数据系统（National Health Data System），比较了 2014 年至 2017 年期间化疗初治去势抵抗性前列腺癌新使用 ABI 和 ENZ 的患者的总生存情况，随访至 2018 年（SPEAR 队列，一项 2014 年至 2018 年的队列研究）。采用意向治疗分析，通过逆概率加权 Cox 模型方法估计总生存的风险比。在 10308 名新使用者中，64%接受 ABI 治疗，36%接受 ENZ 治疗。ABI 的粗死亡率为每 100 人年 25.2（95%置信区间[CI]：24.4，26.0），ENZ 为每 100 人年 23.7（95%CI：22.6，24.9）。在加权分析中，与 ABI 相比，ENZ 与更好的总生存相关（风险比=0.90（95%CI：0.85，0.96），ABI 的总生存中位数为 31.7 个月，ENZ 为 34.2 个月）。当将新使用者限制在 2015 年至 2017 年时，效应估计值上升至风险比为 0.93（95%CI：0.86，1.01）。
