Weill Cornell Medicine, New York, NY, USA.
Pfizer Inc., New York, NY, USA.
Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1032-1040. doi: 10.1038/s41391-021-00318-3. Epub 2021 Feb 21.
Evaluation of the comparative effectiveness of enzalutamide and abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) is limited to meta-analyses of randomized trials that exclude patients with significant comorbidities. We evaluated overall survival (OS) in patients with chemotherapy-naive mCRPC treated with enzalutamide or abiraterone acetate (abiraterone) in a real-world single payer setting.
A retrospective analysis (4/1/2014-3/31/2018) of the Veterans Health Administration (VHA) database was conducted. Patients with mCRPC had ≥1 pharmacy claim for enzalutamide or abiraterone (first claim date = index date) following disease progression on surgical/medical castration, without chemotherapy <12 months prior to index date. Patients had continuous VHA enrollment for ≥12 months pre-index date and were followed until death, disenrollment, or end of study. Kaplan-Meier analysis and multivariable Cox proportional hazards regression models examined the OS treatment effect.
Patients with chemotherapy-naive mCRPC (N = 3174; enzalutamide, n = 1229; abiraterone, n = 1945) had mean ages of 74 and 73 years, respectively. Median follow-up was 18.27 and 19.07 months with enzalutamide and abiraterone, respectively. Enzalutamide-treated patients had longer median treatment duration than abiraterone-treated patients (9.93 vs 8.47 months, respectively, p = 0.0008). After baseline comorbidity adjustment, enzalutamide-treated patients had a 16% reduced risk of death (hazard ratio [HR] = 0.84; 95% CI, 0.76-0.94; p = 0.0012). For patients who remained on first line-therapy only, enzalutamide-treated patients had improved OS versus abiraterone-treated patients (HR = 0.71; 95% CI, 0.62-0.82). Enzalutamide-treated patients who crossed over to abiraterone had a comparable risk of death versus abiraterone-treated patients who crossed over to enzalutamide (HR = 1.10; 95% CI, 0.89-1.35). These results were confirmed by sensitivity analysis, which considered prognostic variables.
Retrospective analysis of the VHA database indicated that chemotherapy-naive patients with mCRPC initiating therapy with enzalutamide had improved survival versus abiraterone.
在转移性去势抵抗性前列腺癌(mCRPC)患者中,恩扎鲁胺和阿比特龙的疗效比较仅限于排除有严重合并症患者的随机试验的荟萃分析。我们在真实世界的单一支付者环境中评估了化疗初治 mCRPC 患者接受恩扎鲁胺或醋酸阿比特龙(阿比特龙)治疗的总生存期(OS)。
对退伍军人健康管理局(VHA)数据库进行回顾性分析(2014 年 4 月 1 日至 2018 年 3 月 31 日)。mCRPC 患者在疾病进展后接受了至少 1 次恩扎鲁胺或阿比特龙的药房配药(首次配药日期=索引日期),并且在索引日期前 12 个月内没有接受过化疗。患者在索引日期前至少有 12 个月的连续 VHA 入组,并随访至死亡、退出或研究结束。Kaplan-Meier 分析和多变量 Cox 比例风险回归模型检查了 OS 的治疗效果。
化疗初治 mCRPC 患者(N=3174;恩扎鲁胺组,n=1229;阿比特龙组,n=1945)的平均年龄分别为 74 岁和 73 岁。恩扎鲁胺和阿比特龙的中位随访时间分别为 18.27 个月和 19.07 个月。与阿比特龙组相比,恩扎鲁胺组的中位治疗持续时间更长(分别为 9.93 个月和 8.47 个月,p=0.0008)。在调整基线合并症后,恩扎鲁胺组患者的死亡风险降低了 16%(风险比[HR]=0.84;95%CI,0.76-0.94;p=0.0012)。对于仅接受一线治疗的患者,与阿比特龙组相比,恩扎鲁胺组的 OS 得到改善(HR=0.71;95%CI,0.62-0.82)。从恩扎鲁胺组交叉到阿比特龙组的患者与从阿比特龙组交叉到恩扎鲁胺组的患者的死亡风险相当(HR=1.10;95%CI,0.89-1.35)。这些结果通过考虑预后变量的敏感性分析得到了证实。
对 VHA 数据库的回顾性分析表明,化疗初治 mCRPC 患者接受恩扎鲁胺治疗的生存情况优于阿比特龙。