Locally Advanced or Metastatic Renal Cell Carcinoma
Conditions
Brief summary
To understand the epidemiology, treatment patterns and outcomes of patients with metastatic Renal Cell Carcinoma (mRCC). Data from mRCC patients who received cabozantinib versus non-cabozantinib Tyrosine Kinase Inhibitor (TKI) (a type of targeted cancer drug) immediately after Check Point Inhibitor (CPI) treatment (a type of immunotherapy that blocks proteins that stop the immune system from attacking the cancer cells) in US community oncology practices will be analyzed.
Interventions
DRUGCabozantinib monotherapy
Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
DRUGAll authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC
As per authorized FDA label in advanced RCC
Sponsors
Ipsen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Evidence of metastatic Renal Cell Carcinoma (mRCC) during the study period (May 01, 2016 to March 31, 2020); * Patients who received cabozantinib or non-cabozantinib TKI regimens during identification period (May 01, 2016 to September 30, 2019); * Patients who received CPIs, as monotherapy, or in combination with a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor (e.g. ipilimumab+nivolumab), as the latest treatment for mRCC administrated before cabozantinib or other TKI therapy; * Patients ≥ 18 years of age as of their index date * Patients who received care at a US Oncology Network site * Patients with ≥ 2 visits within the US Oncology Network.
Exclusion criteria
* Patients enrolled in a clinical trial at any time during index period * Patients receiving treatment for another documented primary cancer diagnoses during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6 months Real-World Response Rate | From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment dose reductions | From start of index treatment until treatment discontinuation | Number of patients who had dose reduction/change as compared to the starting dose during index period |
| Treatment duration | From start of index treatment until treatment discontinuation | — |
| Rate of hospitalisations | From start of index treatment until treatment discontinuation | Number of patients who had been hospitalized (with reason of hospitalization when available) |
| Real-World Overall Response Rate | From start of index treatment until end of the treatment or death whichever occurs first | — |
| Time to treatment discontinuation | From start of index treatment until treatment discontinuation | — |
| Real-World Duration of Response | From date of index treatment response and the earliest date of progressive disease | — |
| Real-World Progression Free Survival | From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease | — |
| Drug discontinuation due to its toxicity | From start of index treatment until treatment discontinuation (through study completion) | Number of patients discontinuing index regimens due to its toxicity |
| Overall Survival | From start of index treatment until death or end of the study whichever occurs first | — |
Countries
United States
Outcome results
None listed