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

NCT04637204 | Completed

• 1 other identifier: CLIN-60000-450
• Study Type: observational
• Target: 1,540
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Time from aRCC diagnosis to initial SACT initiation

  From baseline until the end of data collection period (01 January 2011 and 31 January 2020)

• Time from RCC diagnosis to initial SACT initiation

  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

  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

  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

  From baseline until the end of data collection period (01 January 2011 and 31 January 2020)

Study Arms (4)

Subgroup 1

Patients with index treatment: cabozantinib treatment post vascular endothelial growth factor (VEGF)-targeted therapy in any line, except axitinib.

Drug: Cabozantinib

Subgroup 2

Patients with index treatment: axitinib treatment post VEGF-targeted therapy in any line, except cabozantinib.

Drug: Axitinib

Subgroup 3

Patients with index treatment: cabozantinib treatment post axitinib by line of therapy (2L, 3L, 3L+)

Drug: Cabozantinib

Subgroup 4

Patients with index treatment: axitinib treatment post cabozantinib by line of therapy (2L, 3L, 3L+)

Drug: Axitinib

Interventions

Cabozantinib DRUG

oral therapy

Subgroup 1; Subgroup 3

Axitinib DRUG

oral therapy

Subgroup 2; Subgroup 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Ipsen Facility

Slough, Sl1 3XE, United Kingdom

Location

Related Publications (1)

• Brown J, Harrow B, Marciniak A, McCarthy C, Houchard A, Cirneanu L, Protheroe A. Cabozantinib and Axitinib After Vascular Endothelial Growth Factor Therapy in Patients with Advanced Renal Cell Carcinoma: A Retrospective Cohort Study from England. Drugs Real World Outcomes. 2024 Jun;11(2):195-207. doi: 10.1007/s40801-023-00415-w. Epub 2024 Jan 24.

  PMID: 38265633 DERIVED

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

cabozantinib; Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 19, 2020
• Study Start: November 24, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

GB (1)