Duke Cancer Institute, Durham, NC, USA.
Pfizer Inc., New York, NY, USA.
Prostate Cancer Prostatic Dis. 2024 Dec;27(4):756-764. doi: 10.1038/s41391-024-00816-0. Epub 2024 Mar 27.
There are no large head-to-head phase 3 clinical trials comparing overall survival (OS) for abiraterone and enzalutamide. This study used Medicare claims data to compare OS in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) who initiated abiraterone or enzalutamide.
This retrospective analysis of the Medicare database (2009-2020) included adult men with ≥1 claim for prostate cancer, metastatic diagnosis, and no prior chemotherapy or novel hormone therapy who initiated first-line (1L) abiraterone or enzalutamide in the index period (September 10, 2014 to May 31, 2017). Cox proportional-hazards models with inverse probability treatment-weighting (IPTW) were used to compare OS between abiraterone- and enzalutamide-treated patients, adjusting for baseline characteristics. Subgroup analyses by baseline characteristics were also conducted.
Overall, 5506 patients who received 1L abiraterone (n = 2911) or enzalutamide (n = 2595) were included. Median follow-up was comparable in both cohorts (abiraterone, 19.1 months; enzalutamide, 20.3 months). IPTW-adjusted median OS (95% CI) was 20.6 months (19.7‒21.4) for abiraterone and 22.5 months (21.2‒23.8) for enzalutamide, with an IPTW-adjusted hazard ratio (95% CI) of 1.10 (1.04-1.16). Median OS was significantly shorter for abiraterone versus enzalutamide in patients ≥75 years old; White patients; patients with baseline diabetes, cardiovascular disease, both diabetes and cardiovascular disease, and renal disease; and across all socioeconomic strata.
In the Medicare chemotherapy-naïve mCRPC population, 1L abiraterone was associated with worse OS versus enzalutamide in the overall population and among subgroups with older age and comorbidities, supporting findings from previous real-world studies and demonstrating a disparity in outcomes.
目前尚无头对头的大型 3 期临床试验比较阿比特龙和恩扎卢胺的总生存期(OS)。本研究使用医疗保险索赔数据比较了起始阿比特龙或恩扎卢胺的化疗初治转移性去势抵抗性前列腺癌(mCRPC)患者的 OS。
本项回顾性医疗保险数据库分析(2009-2020 年)纳入≥1 次前列腺癌、转移性诊断、无既往化疗或新型激素治疗的成年男性患者,这些患者在索引期(2014 年 9 月 10 日至 2017 年 5 月 31 日)起始一线(1L)阿比特龙或恩扎卢胺治疗。使用逆概率治疗加权(IPTW)的 Cox 比例风险模型比较阿比特龙和恩扎卢胺治疗患者的 OS,调整基线特征。还进行了基于基线特征的亚组分析。
总体而言,5506 例接受 1L 阿比特龙(n=2911)或恩扎卢胺(n=2595)治疗的患者纳入研究。两组的中位随访时间相似(阿比特龙,19.1 个月;恩扎卢胺,20.3 个月)。阿比特龙的 IPTW 调整后中位 OS(95%CI)为 20.6 个月(19.7-21.4),恩扎卢胺为 22.5 个月(21.2-23.8),IPTW 调整后的风险比(95%CI)为 1.10(1.04-1.16)。在年龄≥75 岁、白种人、基线时患有糖尿病、心血管疾病、同时患有糖尿病和心血管疾病、以及患有肾脏疾病的患者中,阿比特龙的中位 OS 显著短于恩扎卢胺。在所有社会经济阶层中也观察到类似的结果。
在医疗保险化疗初治 mCRPC 人群中,1L 阿比特龙的 OS 劣于恩扎卢胺,这在总体人群以及年龄较大和合并症较多的亚组中均有体现,这与之前的真实世界研究结果一致,并表明结局存在差异。