A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): Ribiciclib; Palbociclib; Abemaciclib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants who initiated CDK4/6i therapy; Participants who initiated CDK4/6i therapy; Participants who initiated CDK4/6i therapy
Intervention MeSH terms: Palbociclib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Study analyses were conducted among adult women with HR+/HER2- mBC receiving ribociclib,
        palbociclib, or abemaciclib, regardless of the line of therapy. Patients were identified
        from the US Optum Claims Data.
      
Keywords: Concomitant medication,; drug-drug interaction,; CDK4/6 inihibitor,; HR+/HER2-metastatic breast cancer