The aim of this study was to describe the epidemiology, treatment pathway, treatment access, wastage of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), and health care resource use among adults with hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer (BC) in England, including their treatment pathway leading to progression to metastatic BC for those who were initially diagnosed with early BC. This was a retrospective cohort study using linked registry and administrative data.
Study Type
OBSERVATIONAL
Enrollment
218,677
Novartis
London, United Kingdom
Time Between Start of Endocrine Therapy (ET) and Disease Progression
Disease progression events include: * Return of breast cancer after initial treatment (non-metastatic recurrence) * Return and spread of breast cancer to other body parts after initial treatment (metastatic recurrence) * Death * Any other non-breast invasive cancer
Time frame: Up to approximately 12 years and 7 months
Time between Non-metastatic Recurrence and Disease Progression
Disease progression events include: * Further non-metastatic recurrence * Metastatic recurrence * Death
Time frame: Up to approximately 12 years and 7 months
Time Between Metastatic Recurrence and Death
Time frame: Up to approximately 12 years and 7 months
Number of Patients With Disease Progression by Health State Transition
Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Start of ET to any other non-breast invasive cancer * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Further non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Invasive Disease-Free Survival (iDFS)
iDFS was defined as time between start of ET to the first of any of non-metastatic recurrence, metastatic recurrence, non-breast invasive cancer, or death from any cause.
Time frame: Up to approximately 12 years and 7 months
Hazard Ratio for Disease Progression Between Health States
Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Further non-metastatic recurrence to death * Metastatic recurrence to death
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Time frame: Up to approximately 12 years and 7 months
Number of Patients by Number of Lines of Systemic Anti-cancer Therapy (SACT) Received
Time frame: Up to approximately 12 years and 7 months
Number of Patients who Received Radiotherapy
Time frame: Up to approximately 12 years and 7 months
Time From BC diagnosis to Treatment Initiation by Line of Therapy (LOT)
Time frame: Up to approximately 12 years and 7 months
Number of Patients by Treatment Received Within Each LOT Ranked by Frequency of Use
Treatments were ranked by most common (rank 1) to least common (rank 3).
Time frame: Up to approximately 12 years and 7 months
Duration of Treatment Received for Each LOT by Rank Order
Treatments were ranked by most common (rank 1) to least common (rank 3).
Time frame: Up to approximately 12 years and 7 months
Number of Patients by Treatment Classes per LOT
Time frame: Up to approximately 12 years and 7 months
Percentage of Patients by First SACT Used During Year of Diagnosis by Geographical Region
Time frame: Up to approximately 1 year
Number of Patients Diagnosed With Early BC and Metastatic BC by Year of Diagnosis
Time frame: 3 years
Number of Patients Diagnosed with Early BC and Metastatic BC by Geographical Region
Time frame: 3 years
Number of Metastatic BC Patients by First-line Chemotherapy and Age Group
Treatments were categorized as anthracycline with taxane, anthracycline without taxane, taxane without anthracycline, CDK4/6i, and other.
Time frame: Up to approximately 7 years and 10 months
Number of Metastatic BC Patients by First-line Chemotherapy and Ethnicity
Treatments were categorized as anthracycline with taxane, anthracycline without taxane, taxane without anthracycline, CDK4/6i, and other.
Time frame: Up to approximately 7 years and 10 months
Number of Metastatic BC Patients by First-line Chemotherapy and Deprivation Quintile
Deprivation quintiles ranged from 1 (least deprived) to 5 (most deprived). Treatments were categorized as anthracycline with taxane, anthracycline without taxane, taxane without anthracycline, CDK4/6i, and other.
Time frame: Up to approximately 7 years and 10 months
Number of Patients by Demographic Category
Demographics included: * Age * Gender * Ethnicity * Deprivation quintiles (1 \[least deprived\] to 5 \[most deprived\])
Time frame: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics include: * Charlson comorbidity index (CCI) score * Tumor stage * Eastern Cooperative Oncology Group (ECOG) performance status score * Comorbidities
Time frame: Baseline
Time From First Early BC Diagnosis to Metastatic BC Diagnosis
Time frame: Up to approximately 10 years and 7 months
Number of Early BC Patients who Discontinued Treatment Within 6 Months of Treatment Initiation
Time frame: 6 months
Number of Early BC Patients by Reason for Discontinuing Treatment Within 6 Months of Treatment Initiation
Time frame: 6 months
Number of Patients Adherent to Treatment Among Early BC Patients who Progressed to Metastatic BC
Patients were considered adherent when the number of completed treatment cycles was greater than or equal to the number of planned treatment cycles per patient.
Time frame: Up to approximately 12 years and 7 months
Number of Patients With Metastatic BC Treated With a CDK4/6i
CDK4/6is included ribociclib, palbociclib and abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Time From Metastatic BC Diagnosis to Initiation of CDK4/6i Treatment
CDK4/6is included ribociclib, palbociclib and abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Duration of CDK4/6i Treatment Among Patients With Metastatic BC
CDK4/6is included ribociclib, palbociclib and abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Number of Patients With Metastatic BC Treated With a CDK4/6i who Received Electrocardiograms (ECGs) Outside of Standard of Care Recommendations
CDK4/6is included ribociclib, palbociclib and abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Hazard Ratio for Factors Associated With Progression Free Survival (PFS) Among Patients With HR+/HER2- BC
Factors included age group, ethnicity, deprivation quintile, geographical region, and first LOT. PFS for early BC patients was defined as the time from date of first breast surgery (or diagnosis if no surgery) until the earliest of: new surgical procedures (breast surgery); change in category A SACT treatment or new radiotherapy at least 3 months after initial surgery (or diagnosis if no surgery); non-metastatic recurrence, metastatic recurrence, death. PFS for metastatic BC patients was defined as the time from date of diagnosis with metastatic BC until the earliest of: change in category A SACT treatment or new radiotherapy at least 3 months after diagnosis with metastatic BC; a new metastasis record after diagnosis with metastatic BC; death. Category A treatment classes were categorized as anthracycline without taxane, taxane without anthracycline, anthracycline with taxane, CDK4/6i, and other.
Time frame: Up to approximately 12 years and 7 months
Odds Ratio for Factors Associated With Timeliness of Initiating Treatment Following Metastatic BC Diagnosis
Factors included age group, ethnicity, deprivation quintile, and geographical region. Timeliness of treatment was defined as having received treatment within 31 days of decision to treat for metastatic BC diagnosis.
Time frame: Up to approximately 12 years and 7 months
Odds Ratio for Factors Associated With Metastatic Status at First Presentation
Factors included age group, ethnicity, deprivation quintile, and geographical region. Metastatic status at first presentation was defined as de novo or progressed metastatic disease.
Time frame: Up to approximately 12 years and 7 months
Number of Metastatic BC Patients Treated With a CDK4/6i by Number of Dose Reductions Experienced
CDK4/6is included ribociclib, palbociclib, or abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Length of CDK4/6i Treatment for Patients With Metastatic BC by Number of Dose Reductions
CDK4/6is included ribociclib, palbociclib, or abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Number of CDK4/6i Treatment Cycles Received Before a Dose Reduction
CDK4/6is included ribociclib, palbociclib, or abemaciclib. A treatment cycle is 28 days.
Time frame: Up to approximately 7 years and 10 months
Cost Associated With CDK4/6i Wastage due to Dose Reduction
CDK4/6is included ribociclib, palbociclib, or abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Number of Metastatic BC Patients who Switched CDK4/6i Categorized by the Treatment Patients Switched From and To
CDK4/6is included ribociclib, palbociclib, or abemaciclib.
Time frame: Up to approximately 7 years and 10 months
Number of Patients by All-cause Healthcare Admission and Health State Transition
Healthcare admissions included inpatient admissions, outpatient appointments, and emergency care visits. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of All-cause Healthcare Admissions per Patient per Month (PPPM) by Health State Transition
Healthcare admissions included inpatient admissions, outpatient appointments, and emergency care visits. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of BC-related Healthcare Admissions PPPM by Health State Transition
BC-related healthcare admissions included inpatient admissions and outpatient appointments. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of Inpatient Bed Days PPPM by Health State Transition
Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of Patients by Toxicity-related Inpatient Admission and Health State Transition
Toxicity-related admissions were defined as those with a record of a chemotherapy side effect, including but not limited to neutropenic sepsis, cardiotoxicity and arrhythmia, diarrhea and vomiting causing dehydration requiring admission to hospital, and fragility fractures. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of Patients by Toxicity-related Outpatient Appointment and Health State Transition
Toxicity-related care was defined as an outpatient appointment with a specialty that corresponds to the specified toxicity, including but not limited to cardiology, gastroenterology, and rheumatology or orthopedic surgery. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of Toxicity-related Inpatient Admissions PPPM by Health State Transition
Toxicity-related admissions were defined as those with a record of a chemotherapy side effect, including but not limited to neutropenic sepsis, cardiotoxicity and arrhythmia, diarrhea and vomiting causing dehydration requiring admission to hospital, and fragility fractures. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Number of Toxicity-related Outpatient Appointments PPPM by Health State Transition
Toxicity-related care was defined as an outpatient appointment with a specialty that corresponds to the specified toxicity, including but not limited to cardiology, gastroenterology, and rheumatology or orthopedic surgery. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Median Cost PPPM of All-cause Healthcare Admissions by Health State Transition
Healthcare admissions included inpatient admissions, outpatient appointments, and emergency care visits. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Median Cost PPPM of BC-related Healthcare Admissions by Health State Transition
BC-related healthcare admissions included inpatient admissions and outpatient appointments. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Median Cost PPPM of Toxicity-related Inpatient Admissions by Health State Transition
Toxicity-related admissions were defined as those with a record of a chemotherapy side effect, including but not limited to neutropenic sepsis, cardiotoxicity and arrhythmia, diarrhea and vomiting causing dehydration requiring admission to hospital, and fragility fractures. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months
Median Cost PPPM of Toxicity-related Outpatient Appointments by Health State Transition
Toxicity-related care was defined as an outpatient appointment with a specialty that corresponds to the specified toxicity, including but not limited to cardiology, gastroenterology, and rheumatology or orthopedic surgery. Health states: * Start of ET to non-metastatic recurrence * Start of ET to metastatic recurrence * Start of ET to death * Non-metastatic recurrence to further non-metastatic recurrence * Non-metastatic recurrence to metastatic recurrence * Non-metastatic recurrence to death * Metastatic recurrence to death
Time frame: Up to approximately 12 years and 7 months