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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HR+/HER2- Early BC Cohort | Adults with a diagnosis of HR+/HER2- early BC between 01 April 2012 and 31 December 2022. | ||
| HR+/HER2- Metastatic BC Cohort | Adults with a diagnosis of HR+/HER2- de novo or progressed metastatic BC between 01 April 2012 and 31 December 2022. | ||
| NATALEE Trial-aligned Sub-cohort | Patients from the HR+/HER2- Early BC Cohort consisting of patients with stage II BC and stage III BC. This sub-group closely resembled the NATALEE trial population. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time Between Start of Endocrine Therapy (ET) and Disease Progression | Disease progression events include:
| Up to approximately 12 years and 7 months |
| Time between Non-metastatic Recurrence and Disease Progression | Disease progression events include:
| Up to approximately 12 years and 7 months |
| Time Between Metastatic Recurrence and Death | Up to approximately 12 years and 7 months | |
| Number of Patients With Disease Progression by Health State Transition | Health states:
| 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. | Up to approximately 12 years and 7 months |
| Hazard Ratio for Disease Progression Between Health States | Health states:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients by Demographic Category | Demographics included:
| Baseline |
| Number of Patients by Clinical Characteristic Category |
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Inclusion criteria:
Additional inclusion criteria for patients with metastatic BC were defined as:
An additional inclusion criterion for patients with early BC was:
• No evidence of metastatic disease (defined above) before or up to 100 days after the first BC diagnosis date.
Additional inclusion criteria for patients in the NATALEE Trial-aligned sub-cohort:
Exclusion criteria:
Patient's sex unknown.
Patient with ductal carcinoma in situ (DCIS), or lobular carcinoma in situ (LCIS).
Patient with a diagnosis of Second Edition of the International Classification of Diseases for Oncology (ICD-0-O2) code 0, 1, or 2 denoting non-malignant disease.
Patient with any indication of co-positive disease before or within 6 months after diagnosis (i.e., HR+ and HER2+) including:
Any registered BC tumor or evidence of metastatic cancer prior to index date.
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Adults captured in the cancer registry with a diagnosis of HR+/HER2- early BC or metastatic BC between 01 April 2012 and 31 December 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | London | W12 7FQ | United Kingdom |
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| Label | URL |
|---|---|
| Link to study results | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Up to approximately 12 years and 7 months |
| Number of Patients by Number of Lines of Systemic Anti-cancer Therapy (SACT) Received | Up to approximately 12 years and 7 months |
| Number of Patients who Received Radiotherapy | Up to approximately 12 years and 7 months |
| Time From BC diagnosis to Treatment Initiation by Line of Therapy (LOT) | 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). | 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). | Up to approximately 12 years and 7 months |
| Number of Patients by Treatment Classes per LOT | Up to approximately 12 years and 7 months |
| Percentage of Patients by First SACT Used During Year of Diagnosis by Geographical Region | Up to approximately 1 year |
| Number of Patients Diagnosed With Early BC and Metastatic BC by Year of Diagnosis | 3 years |
| Number of Patients Diagnosed with Early BC and Metastatic BC by Geographical Region | 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. | 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. | 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. | Up to approximately 7 years and 10 months |
Clinical characteristics include:
| Baseline |
| Time From First Early BC Diagnosis to Metastatic BC Diagnosis | Up to approximately 10 years and 7 months |
| Number of Early BC Patients who Discontinued Treatment Within 6 Months of Treatment Initiation | 6 months |
| Number of Early BC Patients by Reason for Discontinuing Treatment Within 6 Months of Treatment Initiation | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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:
| 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:
| 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:
| Up to approximately 12 years and 7 months |
| Number of Inpatient Bed Days PPPM by Health State Transition | Health states:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| 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:
| Up to approximately 12 years and 7 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |