Oncology- Metastatic renal cell carcinoma (mRCC)
Conditions
Interventions
N/A as we are not assigning patients into a specific treatment group
Sponsors
Novartis
Eligibility
Inclusion criteria
Inclusion criteria: • Adult patients (age ≥18 years, males and females) diagnosed with mRCC per medical chart • The patient received 1st targeted therapy with either sunitinib or pazopanib (i.e. a TKI other than sorafenib or axitinib) • The patient experienced disease progression during their 1st targeted therapy and subsequently initiated one of the following 2nd targeted therapies: (1) Everolimus (2) Sorafenib (3) Axitinib • The date of initiating 2nd targeted therapy was during a defined time period from the time when everolimus, sorafenib, and axitinib all became available in the local market, to 20 months (tentative, pending on sample size) prior to the data extraction time • Treatment history and outcomes related to mRCC are available for chart review
Exclusion criteria
Exclusion criteria: • The patient used an mTOR inhibitor, bevacizumab or cytokines [IL-2, IFN- α2a] prior to initiation of the 2nd targeted therapy • The patient used a combination therapy with ≥2 targeted agents prior to or upon the initiation of the 2nd targeted therapy • The patient initiated the 2nd targeted therapy in an interventional trial in the mRCC setting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Characterize differences in the following outcomes in mRCC patients receiving 2nd targeted therapy with everolimus, sorafenib, or axitinib following a 1st targeted therapy with sunitinib or pazopanib: a. OS from the initiation of 2nd targeted therapy b. Treatment duration of the 2nd targeted therapy c. PFS from the initiation of 2nd targeted therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize differences in the primary outcomes within subgroups stratified by the following groups: a. Type of 1st targeted therapy used b. Long/short duration of 1st targeted therapy Describe real-world treatment patterns: a. Treatment duration of targeted therapies (by lines of treatment), and reasons for discontinuation b. Dose, dose adjustment and underlying reasons for dose adjustment during 2nd targeted therapy; estimated total dose received for the 2nd-targeted therapy c. Utilization and types of 3rd targeted therapies Characterize differences in resource use following initiation of 2nd targeted therapy | — |
Contacts
Public ContactDony Patel
Woolgate Exchange
Outcome results
None listed