A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,650
- 试验地点
- 1
- 主要终点
- Number of participants with no use of concomitant medications
研究概览
简要总结
This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims database.
详细描述
This is a retrospective cohort study utilizing the US Optum research administrative claims database. Adult female patients who had HR+/HER2- mBC were identified and included in the study. These patients were stratified into three cohorts based on the first CDK4/6i received (ribociclib, palbociclib, or abemaciclib).
- Study period: Period during which all relevant medical and pharmacy information in the database was retrieved
- Index event identification period: time frame during which index treatment was identified
- First CDK4/6i: the date on which patients initiated their first treatment after being diagnosed with HR+/HER2- mBC; this date was considered as the index date
- Baseline period: Time frame during which patient characteristics, prior mBC treatments, and concomitant treatments received by CDK4/6i-naïve patients were evaluated
- Follow-up period: time frame on and after the index date during which patients' treatments and dosing patterns were observed
Establishment of baseline period Health plan enrollment in the three months prior to the index treatment was included in the baseline period. Patient demographics, clinical characteristics, National Cancer Institute (NCI) comorbidity index, concomitant medication use that can potentially lead to a DDI, and other BC treatments prior to the index treatment were evaluated during this period.
Establishment of follow-up period Patients were observed for ≥3 months starting from the index date until the end of the study period or continuous enrollment or until the time when patients switched to another therapy (including another CDK4/6i), whichever came first. Dosing patterns for CDK4/6i were evaluated in the follow-up period. Analyses were conducted at key time points of 3, 6, and 12 months
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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Treated with CDK4/6i from 2015-02-01 to 2019-06-30
- •≥2 claims with a BC diagnosis recorded ≥30 days apart from the index date
- •≥2 claims with an mBC diagnosis, with a time interval between the first BC diagnosis date and the first mBC diagnosis date no longer than 30 days
- •Female patients aged ≥18 years
- •Continuous health plan enrollment for ≥3 months prior to the index date and ≥3 months post-index date
排除标准
- 未提供
研究组 & 干预措施
Ribociclib
Participants who initiated CDK4/6i therapy
干预措施: Ribiciclib (Drug)
Palbociclib
Participants who initiated CDK4/6i therapy
干预措施: Palbociclib (Drug)
Abemaciclib
Participants who initiated CDK4/6i therapy
干预措施: Abemaciclib (Drug)
结局指标
主要结局
Number of participants with no use of concomitant medications
时间窗: Baseline period (3 months)
Adherence to concomitant medications during the baseline period was reported
Number of participants with proportion of days covered (PDC) >80%
时间窗: Baseline period (3 months)
Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC): PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period
Number of participants with proportion of days covered (PDC) ≤80%
时间窗: Baseline period (3 months)
Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC): PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period
Number of participants with a prescription fill of ribociclib, palbociclib, or abemaciclib
时间窗: Index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time)
Distribution of patients with a prescription fill of ribociclib, palbociclib, or abemaciclib at index treatment date will be present by frequency among all patients treated with CDK4/6
Number of participants who took concomitant medications in baseline period, by drug name
时间窗: Baseline period (3 months)
Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.
Number of participants who took concomitant medications in follow-up period, by drug name
时间窗: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.
Number of other breast cancer medications used
时间窗: Baseline period (3 months)
Number of other breast cancer medications used in baseline period, by drug class (HR+/Endocrine, Chemotherapy, Other treatments), for breast cancer regimens was reported
次要结局
- Number of participants discontinuing each CDK4/6i (ribociclib, palbociclib, or abemaciclib)(From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date))
- Mean starting dose for each CDK4/6(From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date))
- Number of participants who had any dose change (increase, decrease)(From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date))
- Number of participants who had a dose increase(From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date))
- Median duration of treatment (in months) by each CDK4/6i (ribociclib, palbociclib, or abemaciclib)(From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date))
- Number of participants who had a dose decrease(From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date))