A Non-interventional Retrospective Study to Describe Early Clinical Experience With Cabozantinib in Patients With Advanced Renal Cell Carcinoma (RCC) in the UK
- Conditions
- Advanced Renal Cell Carcinoma
- Registration Number
- NCT03696407
- Lead Sponsor
- Ipsen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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.
- Decline or lack the capacity to consent for researcher access to their medical records (if living)
- Hospital medical records are unavailable for review
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Distribution of cabozantinib starting dose. Baseline Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.
Distribution of reasons for dose modifications. 24 months Median time to first dose modification 24 months Positioning of cabozantinib in the treatment pathway 24 months Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)
Daily dose during treatment 24 months Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.
Proportion of patients with dose modifications 24 months Proportion of patients with dose modifications and mean (SD) and median (quartiles) number of dose modifications per patient.
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 24 months Radiation procedures, denosumab, bisphosphonates.
Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib. 24 months
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 3, 6, 9, 12, 18 and 24 months and median 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
Overall Survival (OS) 6, 12, 18 and 24 months 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).
Distribution of RCC stage and histological type at initial RCC diagnosis baseline Distribution of metastatic sites. baseline Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities.
Distribution of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk group baseline 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).
Time (months) from advanced RCC diagnosis to cabozantinib initiation. baseline Mean (SD) and median (quartiles) time (months
Distribution of RCC stage at cabozantinib initiation. baseline Objective Response Rate (ORR) 3, 6, 9 and 12 months ORR defined as the proportion of patients achieving a complete or partial response
Trial Locations
- Locations (6)
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Royal Surrey County Hospital
🇬🇧Guildford, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
The Christie Hospital
🇬🇧Manchester, United Kingdom