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The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subgroup 1 | Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib. |
| |
| Subgroup 2 | Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib. |
| |
| Subgroup 3 | Patients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+) |
| |
| Subgroup 4 | Patients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cabozantinib | Drug | oral therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of therapy for the index treatments of interest stratified by line of therapy (LoT) | Duration of therapy will be measured from the initiation of the index treatment until the projected end date of the index treatment (or start of the subsequent therapy). (subgroups 1 to 4) | From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020) |
| Time between subsequent treatment lines | Time gap between the projected end date of the index treatment (cabozantinib or axitinib) until the start of the subsequent treatment. (subgroups 1 to 4) | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death) | Treatment sequencing will be presented using a Sankey diagram that visualises the regimens received within each line of therapy and the number and percentage of patients who received those particular regimens. | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from aRCC diagnosis to initial SACT initiation | Defined as the time from diagnosis of aRCC until the start date of the first cycle of the SACT regimen (i.e., 1st LoT start). (subgroups 1 to 4) | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Time from RCC diagnosis to initial SACT initiation |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include all adult patients diagnosed with aRCC during the study period and identified in the study data source (CAS).
The study population will comprise two types of aRCC patients:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipsen Facility | Slough | Sl1 3XE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38265633 | Derived | Brown J, Harrow B, Marciniak A, McCarthy C, Houchard A, Cirneanu L, Protheroe A. Cabozantinib and Axitinib After Vascular Endothelial Growth Factor Therapy in Patients with Advanced Renal Cell Carcinoma: A Retrospective Cohort Study from England. Drugs Real World Outcomes. 2024 Jun;11(2):195-207. doi: 10.1007/s40801-023-00415-w. Epub 2024 Jan 24. |
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C558660 | cabozantinib |
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 |
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| Axitinib |
| Drug |
oral therapy |
|
Time from RCC diagnosis to initial SACT initiation will be defined as the time from diagnosis of RCC until the start date of the first cycle of the SACT regimen. (subgroups 1 to 4) |
| From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Time from RCC diagnosis to treatment initiation of cabozantinib | Time from diagnosis of RCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3) | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Time from RCC diagnosis to treatment initiation of axitinib | Time from diagnosis of RCC until the start of the prescription of axitinib. | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Time from aRCC diagnosis to treatment initiation of cabozantinib | Time from diagnosis of aRCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3) | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Time from aRCC diagnosis to treatment initiation of axitinib | Time from diagnosis of aRCC until the start of the first prescription of axitinib. (subgroups 2 and 4) | From baseline until the end of data collection period (01 January 2011 and 31 January 2020) |
| Overall survival (OS) | Time from start of index treatment (cabozantinib/axitinib) until the date of death (from any cause) during the study period. (subgroups 1 to 4) | From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first |
| Landmark survival | Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4) | 12 months |
| Landmark survival | Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4) | 18 months |
| Landmark survival | Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4) | 24 months |
| Time to next treatment (or death) (TTNT) | Time to next treatment (or death) (TTNT) will be defined as the time from start of index treatment until the start of the subsequent LoT (subgroups 1 to 4) | From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020) |
| Time to treatment discontinuation (TTTD) | Time to treatment discontinuation (TTTD) will be defined as time from treatment initiation until treatment discontinuation or death. (subgroups 1 to 4) | From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020) |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |