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

Ipsen108 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Advanced Renal Cell Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

Outcomes

Primary Outcomes

Positioning of cabozantinib in the treatment pathway

Positioning of cabozantinib in the treatment pathway (second line, third line, fourth line or above)

Time frame: 24 months

Distribution of cabozantinib starting dose.

Distribution, mean (SD) and median (quartiles) cabozantinib starting dose.

Time frame: Baseline

Daily dose during treatment

Mean (SD) and median (quartiles) cabozantinib daily dose during treatment.

Time frame: 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.

Time frame: 24 months

Median time to first dose modification

Time frame: 24 months

Distribution of reasons for dose modifications.

Time frame: 24 months

Proportion of patients permanently discontinuing cabozantinib.

Time frame: 24 months

Distribution of reasons for discontinuation of treatment

Time frame: 24 months

Median duration of cabozantinib treatment (months)

Time frame: 24 months

Distribution of relevant concomitant treatments

Radiation procedures, denosumab, bisphosphonates.

Time frame: 24 months

Distribution of systemic therapies prescribed for advanced RCC after discontinuation of cabozantinib.

Time frame: 24 months

Secondary Outcomes

Distribution of RCC stage and histological type at initial RCC diagnosis

Time frame: baseline

Time (months) from advanced RCC diagnosis to cabozantinib initiation.

Mean (SD) and median (quartiles) time (months

Time frame: baseline

Distribution of RCC stage at cabozantinib initiation.

Time frame: baseline

Distribution of metastatic sites.

Metastatic sites (lung / liver / bone / lymph node / brain / visceral other) documented co-morbidities and distribution of relevant co-morbidities.

Time frame: 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).

Time frame: 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

Time frame: 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).

Time frame: 6, 12, 18 and 24 months