A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK

Study Overview
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Brief Summary
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Clinical experience with cabozantinib is limited in the UK and Ireland and there is anecdotal evidence of there being variability between clinicians in terms of where cabozantinib is used in the treatment pathway. The present study aims to collate and report the experiences of a sample of National Health Service (NHS) Trusts that enrolled patients onto the managed access programme. The study will describe the positioning of cabozantinib in the treatment pathway, associated clinical outcomes and characteristics of patients with advanced RCC receiving cabozantinib in this early clinical experience setting. The results will provide valuable information for collective learning on how to prescribe and manage cabozantinib and its optimal positioning in the patient pathway. Overall, the findings will contribute to a better understanding of how best to manage patients with advanced RCC in routine practice.

Official Title
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A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma in the United Kingdom (UK)

Conditions
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Advanced Renal Cell Carcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of advanced RCC Prescribed cabozantinib as part of the Managed Access Programme (MAP) (alive or deceased at study data collection) Aged ≥18 years at start of cabozantinib treatment. Exclusion Criteria: Decline or lack the capacity to consent for researcher access to their medical records (if living) Hospital medical records are unavailable for review

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positioning of cabozantinib in the treatment pathway | Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above) | 24 months | 
| Distribution of cabozantinib starting dose. | Distribution, mean (SD) and median (quartiles) cabozantinib starting dose. | Baseline | 
| Daily dose during treatment | Mean (SD) and median (quartiles) cabozantinib daily dose during treatment. | 24 months | 
| Proportion of patients with dose modifications | Proportion of patients with dose modifications and mean (SD) and median (quartiles) number of dose modifications per patient. | 24 months | 
| Median time to first dose modification |  | 24 months | 
| Distribution of reasons for dose modifications. |  | 24 months | 
| Proportion of patients permanently discontinuing cabozantinib. |  | 24 months | 
| Distribution of reasons for discontinuation of treatment |  | 24 months | 
| Median duration of cabozantinib treatment (months) |  | 24 months | 
| Distribution of relevant concomitant treatments | Radiation procedures, denosumab, bisphosphonates. | 24 months | 
| Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of RCC stage and histological type at initial RCC diagnosis |  | baseline | 
| Time (months) from advanced RCC diagnosis to cabozantinib initiation. | Mean (SD) and median (quartiles) time (months | baseline | 
| Distribution of RCC stage at cabozantinib initiation. |  | baseline | 
| Distribution of metastatic sites. | Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities. | baseline | 
| Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group | Distribution of IMDC risk group (favourable, intermediate, poor). From patient's medical records (if documented) or calculated from the individual components (haemoglobin, Karnofsky Performance Status, time from advanced RCC diagnosis to systemic treatment initiation, calcium, neutrophils, platelets). | baseline | 
| Progression Free Survival (PFS) | PFS is defined as the time from cabozantinib initiation until the date of first documented evidence of disease progression or death from any cause. Disease progression is defined as either radiological disease progression (according to RECIST criteria [if documented in routine practice] or other local investigator assessment]) or clinical progression | 3, 6, 9, 12, 18 and 24 months and median PFS. | 
| Overall Survival (OS) | OS will be measured from both cabozantinib initiation (time from cabozantinib initiation until death from any cause) and from advanced RCC diagnosis (from advanced RCC diagnosis until death from any cause). | 6, 12, 18 and 24 months | 
| Objective Response Rate (ORR) | ORR defined as the proportion of patients achieving a complete or partial response | 3, 6, 9 and 12 months |