Real-world Treatment Patterns and Outcomes Among aRCC Patients on Cabozantinib or Axitinib in England

Treatment Patterns and Outcomes Among Advanced Renal Cell Carcinoma (aRCC) Patients Treated With Cabozantinib or Axitinib Therapy: Non Interventional, Retrospective Study Using Data From Public Health England's Cancer Analysis System

The present study will aim to describe and understand, in the real-world, the clinical characteristics, treatment patterns and outcomes of advanced renal cell carcinoma (aRCC) patients treated with cabozantinib or axitinib monotherapy in England using the existing data source, Cancer Analysis System (CAS).

Study Overview

• Status: Completed
• Conditions: Renal Cell Carcinoma
• Intervention / Treatment: Drug: Cabozantinib; Drug: Axitinib

• Study Type: Observational
• Enrollment (Actual): 1540

Contacts and Locations

Study Locations

• United Kingdom
  • Slough, United Kingdom, Sl1 3XE
    • Ipsen Facility

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

The study population will include all adult patients diagnosed with aRCC during the study period and identified in the study data source (CAS).

The study population will comprise two types of aRCC patients:

• Patients who had advanced disease (Stage III/IV) at diagnosis, and
• Patients who had non-advanced disease (Stage I/II or missing information on Staging) at diagnosis but advanced at a later date during the study period (proxied by receipt of a SACT treatment indicative of advanced RCC)

Description

Inclusion Criteria:

• Patients with initial renal cancer diagnosis
• Patients diagnosed at Stage III or Stage IV (as defined in CAS): as evidence for advanced/metastatic RCC
• For patients with Stage I/II or patients with missing information on Staging
• Patients who received SACT1 treatment following initial renal cancer diagnosis through end of enrolment (31 July 2019)
• Patients who received cabozantinib or axitinib treatment

Exclusion Criteria:

• Diagnosis of concomitant tumour apart from non-melanoma skin cancer in the three years prior to the diagnosis of aRCC
• Less than 18 years of age at the time of initial aRCC diagnosis
• SACT treatment more than 30 days prior to initial aRCC diagnosis

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subgroup 1; Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib.	Drug: Cabozantinib; oral therapy
Subgroup 2; Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib.	Drug: Axitinib; oral therapy
Subgroup 3; Patients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+)	Drug: Cabozantinib; oral therapy
Subgroup 4; Patients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+)	Drug: Axitinib; oral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of therapy for the index treatments of interest stratified by line of therapy (LoT)	Duration of therapy will be measured from the initiation of the index treatment until the projected end date of the index treatment (or start of the subsequent therapy). (subgroups 1 to 4)	From start of index treatment up to the end of treatment or start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Time between subsequent treatment lines	Time gap between the projected end date of the index treatment (cabozantinib or axitinib) until the start of the subsequent treatment. (subgroups 1 to 4)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Sequencing of treatments (any treatments received from aRCC diagnosis until the end of follow up or death)	Treatment sequencing will be presented using a Sankey diagram that visualises the regimens received within each line of therapy and the number and percentage of patients who received those particular regimens.	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from aRCC diagnosis to initial SACT initiation	Defined as the time from diagnosis of aRCC until the start date of the first cycle of the SACT regimen (i.e., 1st LoT start). (subgroups 1 to 4)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to initial SACT initiation	Time from RCC diagnosis to initial SACT initiation will be defined as the time from diagnosis of RCC until the start date of the first cycle of the SACT regimen. (subgroups 1 to 4)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to treatment initiation of cabozantinib	Time from diagnosis of RCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from RCC diagnosis to treatment initiation of axitinib	Time from diagnosis of RCC until the start of the prescription of axitinib.	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from aRCC diagnosis to treatment initiation of cabozantinib	Time from diagnosis of aRCC until the start of the first prescription of cabozantinib. (subgroups 1 and 3)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Time from aRCC diagnosis to treatment initiation of axitinib	Time from diagnosis of aRCC until the start of the first prescription of axitinib. (subgroups 2 and 4)	From baseline until the end of data collection period (01 January 2011 and 31 January 2020)
Overall survival (OS)	Time from start of index treatment (cabozantinib/axitinib) until the date of death (from any cause) during the study period. (subgroups 1 to 4)	From start of index treatment until death or end of data collection period (01 January 2011 and 31 January 2020 whichever occurs first
Landmark survival	Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)	12 months
Landmark survival	Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)	18 months
Landmark survival	Landmark survival will be defined as the time from start of the index treatment until date of death (from any cause) at specific time points (12, 18, and 24 months). (subgroups 1 to 4)	24 months
Time to next treatment (or death) (TTNT)	Time to next treatment (or death) (TTNT) will be defined as the time from start of index treatment until the start of the subsequent LoT (subgroups 1 to 4)	From start of index treatment until the start of subsequent therapy during data collection period (01 January 2011 and 31 January 2020)
Time to treatment discontinuation (TTTD)	Time to treatment discontinuation (TTTD) will be defined as time from treatment initiation until treatment discontinuation or death. (subgroups 1 to 4)	From start of index treatment until discontinuation or death during data collection period (01 January 2011 and 31 January 2020)

Collaborators and Investigators

• Sponsor: Ipsen

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Actual): December 11, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Axitinib
• Other Study ID Numbers: CLIN-60000-450

Drug and device information, study documents

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