Advanced Renal Cell Carcinoma (aRCC)
Conditions
Brief summary
This study will collect real-world data for the new treatment pathways for all patients with Advanced Renal Cell Carcinoma (ARCC) who were treated with a 1L IO (first-line, Immuno-Oncology checkpoint inhibitor) combination therapy and progressed to a 2L treatment with particular focus to understanding where cabozantinib is prescribed after 1L IO containing combination therapy.
Interventions
None listed
Sponsors
Ipsen
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with a diagnosis of aRCC. * Patients aged ≥18 years at aRCC diagnosis treated with a 1L IO containing combination therapy who have progressed to a 2L treatment.
Exclusion criteria
* Patient's hospital medical records are unavailable for review; * Patients have started a 2L treatment as part of a Renal Carcinoma Treatment (RCT).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy. |
| Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Overall Response Rate (ORR) by line -complete response or partial response | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Duration of treatment by line | From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022) | — |
| Drug start and end dose by line | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | Descriptive statistics using following parameters: no dose change, dose change, dose increase and dose decrease |
| Disease Control Rate (DCR) by line - complete response, partial response and stable disease | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Overall Survival (OS) | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Reason for stopping cabozantinib | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | Descriptive statistics using the following parameters: radiological disease progression, clinical deterioration, AE, subject's decision, Investigator's decision, end of predefined treatment, other |
| Reason for dose change (Disease progression, AE, subject non-compliance, subject decision, clinical / Investigator decision, radiotherapy(s), surgery(s), COVID-19 pandemic, other) | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Describe interruptions for cabozantinib | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Cause of death (RCC or non RCC related) | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Progression Free Survival (PFS) by line for cabozantinib patients | From start of treatment to last hospital follow-up or date of death whichever occurs first assessed during data collection period (from 15th of January 2015 until September 2022) | — |
| Time to Treatment Discontinuation (TTD) by line | From start date of first cycle of treatment to start date of last cycle of treatment during data collection period (from 15th of January 2015 until September 2022) | — |
Countries
United Kingdom
Outcome results
None listed