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

• Distribution of RCC stage and histological type at initial RCC diagnosis[ Time Frame: baseline ]
• Time (months) from advanced RCC diagnosis to cabozantinib initiation.[ Time Frame: baseline ]
  Mean (SD) and median (quartiles) time (months
• Distribution of RCC stage at cabozantinib initiation.[ Time Frame: baseline ]
• Distribution of metastatic sites.[ Time Frame: 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[ Time Frame: 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).
• Progression Free Survival (PFS)[ Time Frame: 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)[ Time Frame: 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).
• Objective Response Rate (ORR)[ Time Frame: 3, 6, 9 and 12 months ]
  ORR defined as the proportion of patients achieving a complete or partial response

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.

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