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.
Study Type
OBSERVATIONAL
Enrollment
281
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Royal Surrey County Hospital
Guildford, United Kingdom
Barts Cancer Institute
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Description of the treatment sequence pathway from 1L up to 2L for patients with aRCC
To be described for patients with aRCC receiving 2L treatment following a 1L IO containing combination therapy.
Time frame: 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)
Description of the treatment sequence pathway from 1L up to the 2L for cabozantinib patients with aRCC
To be described for patients with aRCC receiving 2L treatment and subsequent lines of treatment following a 1L IO containing combination therapy.
Time frame: 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)
Time frame: 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
Time frame: 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)
Physician defined Best Response by line - complete response, partial response, stable disease, progressive disease
Time frame: 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
Time frame: 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)
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Christie NHS Foundation Trust
Manchester, United Kingdom
Clatterbridge Road, Bebington
Metropolitan Borough of Wirral, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Royal Preston Hospital
Preston, United Kingdom
Mount Vernon Cencer Centre
Welwyn Garden City, United Kingdom
Duration of treatment by line
Time frame: 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
Descriptive statistics using following parameters: no dose change, dose change, dose increase and dose decrease
Time frame: 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)
Disease Control Rate (DCR) by line - complete response, partial response and stable disease
Time frame: 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
Time frame: 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
Descriptive statistics using the following parameters: radiological disease progression, clinical deterioration, AE, subject's decision, Investigator's decision, end of predefined treatment, other
Time frame: 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 dose change (Disease progression, AE, subject non-compliance, subject decision, clinical / Investigator decision, radiotherapy(s), surgery(s), COVID-19 pandemic, other)
Time frame: 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
Time frame: 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)
Time frame: 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)