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

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

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 Overview

• Status: Completed
• Conditions: Advanced Renal Cell Carcinoma

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom, BN2 5BE
    • Royal Sussex County Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • Guildford, United Kingdom, GU27XX
    • Royal Surrey County Hospital
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Secondary/tertiary care service

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: A-GB-60000-017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No