A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.
Utilizing de-identified data derived from the Flatiron Health Analytic Database, the retrospective observational study is to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2-MBC in the US real-world clinical practice setting. Patients will be evaluated retrospectively from index therapy date to death, or last visit in the database, whichever comes first. Descriptive and multivariate statistical analyses will be performed.
Study Type
OBSERVATIONAL
Enrollment
813
Palbociclib + an aromatase inhibitor therapy
Palbociclib + Letrozole therapy
Letrozole monotherapy
Pfizer
New York, New York, United States
Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method
rwPFS was defined as time (in months) from index date to death or disease progression (growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment) or end of record or end of data availability, whichever occurred first. If participants did not die or had disease progression, they were censored at the date of initiation of next line of therapy for participants with two or more lines of therapy or their last visit date for participants with only one line of therapy. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Time frame: From index date to death or disease progression or end of record/data availability or censored date, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
Overall Survival (OS): Using Kaplan-Meier Method
OS was defined as time (in months) from index date to the date of death. Participants who did not die during the period were censored at the time of data cut-off. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Time frame: From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
Number of Participants With Real World Tumour Response (rwTR)
rwTR was determined based on complete response (CR), partial response (PR), stable disease (SD), progressive disease(PD), indeterminate and not documented. CR was defined as complete resolution of all visible disease. PR was defined as partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease. SD was defined as no change in overall size of visible disease; also included cases where some lesions increased in size and some lesions decreased in size. PD was determined based on growth or worsening in the disease concluded by the treating clinician based on radiology, laboratory evidence, pathology, or clinical assessment. Index date was defined as the start date of the first line therapy for Palbociclib + AI.
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Time frame: From index date to CR/PR/PD/SD pr PD, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
Response Rate
Response rate was defined as number of participants with complete response or partial response divided by the number of participants with at least one tumor assessment while on the index treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. The result of this outcome measure was measured in terms of proportion of participants.
Time frame: From index date to CR or PR, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method
rwDOT was defined as time (in months) from index treatment initiation to end of the treatment. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Time frame: From index treatment initiation up to end of treatment, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
Time From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method
The time (in months) from index treatment initiation to next line of anti-cancer therapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Time frame: From index treatment initiation up to next line of anti-cancer therapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)
Time to First Use of Chemotherapy: Using Kaplan-Meier Method
The time (in months) from index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first was reported in this outcome measure. Index date was defined as the start date of the first line therapy for Palbociclib + AI. Kaplan-Meier method was used for analysis.
Time frame: From index treatment initiation to first use of chemotherapy or death from any cause, whichever occurred first, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)