Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

Real-world Treatment Patterns and Effectiveness of Palbociclib in Combination With an Aromatase Inhibitor as Initial Endocrine Based Therapy in Metastatic/Advanced Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04176354

Enrollment

813

Registered

2019-11-25

Start date

2019-01-25

Completion date

2019-09-27

Last updated

2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer, Palbociclib, Real-world data, Retrospective study, Effectiveness

Brief summary

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.

Detailed description

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.

Interventions

DRUGPalbociclib + an aromatase inhibitor

Palbociclib + an aromatase inhibitor therapy

DRUGPalbociclib + Letrozole

Palbociclib + Letrozole therapy

DRUGLetrozole

Letrozole monotherapy

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Female sex 2. At least 18 years old at MBC diagnosis 3. Diagnosis of MBC at any point in patient history 1. ICD-9 (174.x, 175.x) or ICD-10 (C50.xx) diagnosis of BC 2. Confirmation of metastatic disease 3. At least 2 document clinical visits 4. Evidence of stage IV or recurrent MBC with a metastatic diagnosis date on or after 2011, as confirmed by unstructured clinical documents 4. HR+/HER2- 1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis 2. HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis 5. Palbociclib + AI or letrozole as first-line therapy for MBC during the period from February/2015 through August /31/2018 (or 3 months prior to study cut-off date) to allow for a possible minimum follow-up time of 90 days until the study cutoff date. AI was administered within (±) 28 days of Palbociclib index date.

Exclusion criteria

1. Evidence of prior treatment with other CDK4/6I (Ribociclib or Abemaciclib), AI (Letrozole, Exemestane, and Anastrazole), Tamoxifen, Raloxifene, Toremifene, or Fulvestrant for MBC 2. First structured activity greater than 90 days after MBC diagnostic date 3. Treatment with a CDK4/6 inhibitor as part of a clinical trial

Design outcomes

Primary

Measure	Time frame	Description
Real-World Progression Free Survival (rwPFS): Using Kaplan-Meier Method	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)	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.

Secondary

Measure	Time frame	Description
Number of Participants With Real World Tumour Response (rwTR)	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)	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.
Response Rate	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)	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.
Overall Survival (OS): Using Kaplan-Meier Method	From index date to death, maximum up to approximately 43 months (data was retrieved and observed during 9 months of this retrospective study)	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 From Index Date to Next Line of Anti-Cancer Therapy: Using Kaplan-Meier Method	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)	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 to First Use of Chemotherapy: Using Kaplan-Meier Method	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)	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.
Real-World Duration of Treatment (rwDOT): Using Kaplan-Meier Method	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)	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.

Countries

United States

Participant flow

Recruitment details

Data of participants diagnosed with hormone receptor positive(HR+)/human epidermal growth factor receptor 2negative (HER2-)metastatic breast cancer(MBC),who received palbociclib in combination with aromatase inhibitor(AI)\[letrozole,anastrozole or exemestane\]during 03-February-2015 to 31-August-2018(approximately 3.6years)were observed retrospectively.

Pre-assignment details

Data of participants was retrieved from Flatiron Health Analytic database. Available data was evaluated in 9 months of retrospective observational study.

Participants by arm

Arm	Count
Palbociclib + AI Participants who received palbociclib in combination with AI under standard real world clinical practice for HR+/HER2- MBC during the period 03-February-2015 to 31-August-2018 were included in this retrospective observational study. Available data were evaluated in 9 months of this retrospective, observational study.	813
Total	813

Baseline characteristics

Characteristic	Palbociclib + AI
Age, Continuous	64.5 Years STANDARD_DEVIATION 11.4
Race/Ethnicity, Customized Asian	18 Participants
Race/Ethnicity, Customized Black	63 Participants
Race/Ethnicity, Customized Hispanic or Latino	23 Participants
Race/Ethnicity, Customized Other/Unknown	154 Participants
Race/Ethnicity, Customized White	555 Participants
Sex: Female, Male Female	813 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	176 / 813
other Total, other adverse events	0 / 0
serious Total, serious adverse events	0 / 0

Outcome results

Primary

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)