A Real-World Comparison of Clinical Outcomes in Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Initiated Enzalutamide vs. Abiraterone Acetate (Abiraterone) in the 100% Medicare Fee-For-Service (FFS) Data (2009-2020)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 5,506
- 试验地点
- 1
- 主要终点
- Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW)
研究概览
简要总结
This study will be a retrospective data analysis to compare outcomes between patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) who initiated enzalutamide and those who initiated abiraterone using the 100% Fee-For-Service Medicare claims data. The study will address the following objectives:
Primary objective: To compare overall survival (OS) in patients with chemotherapy-naïve mCRPC who initiated enzalutamide vs. abiraterone
Secondary objectives:
- To compare OS in patients with chemotherapy-naïve mCRPC who received only enzalutamide without any subsequent therapy vs. abiraterone without any subsequent therapy
- To compare treatment duration and time to subsequent therapy in chemotherapy-naïve mCRPC patients initiating enzalutamide vs. abiraterone
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male with ≥ 1 diagnosis claim for prostate cancer
- •Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
- •Have initiated enzalutamide or abiraterone within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of enzalutamide or abiraterone will be defined as the index date.
- •Have evidence of surgical or medical castration before the index date
- •At least 18 years old at the index date
- •Continuous eligibility for ≥ 12 months prior to the index date
排除标准
- •Received chemotherapy, novel hormonal therapy, radium-223, or immunotherapy prior to the index date
- •Had a prior history of other cancers
研究组 & 干预措施
Enzalutamide cohort
Patients with mCRPC initiating enzalutamide
干预措施: Enzalutamide (Drug)
Abiraterone cohort
Patients with mCRPC initiating abiraterone
干预措施: Abiraterone acetate (Drug)
结局指标
主要结局
Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW)
时间窗: From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)
OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.
次要结局
- OS Among Participants Without Any Subsequent Therapy: IPTW(From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months))
- Treatment Duration: IPTW(From index date to date of discontinuation event or censoring date, whichever occurred first(from 10-Sep-2014 to 31-Dec-2020, approximately 76months); retrospective data extracted and evaluated from start date and until completion(approximately 10months))
- Time to Subsequent Therapy: IPTW(From index date to start of next line of therapy (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months))