This is a multi-center, observational, retrospective study designed to characterize the effectiveness and safety of sunitinib or sorafenib monotherapy in the treatment of Chinese adult patients with unresectable and locally advanced or metastatic PRCC, who have not received any prior systemic anticancer therapy in the metastatic setting. Electronic medical record (EMR) data of patients with 1L sunitinib or sorafenib monotherapy will be screened from Grade-A Tertiary hospitals in China. The study period is from 1st September 2007 to 31st December 2024.
Age ≥ 18 years at the index date
Patients with papillary urothelial carcinoma or renal pelvis cancer of the kidney;
Patients with history of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years;
Patients with missing both day and month of index date;
Patients with severe conditions that are greater or equal to grade 3 by the definition of CTCAE 5.0 criteria when included into the study;
unresectable locally advanced or metastatic papillary renal cell carcinoma
Cohort
Retrospective
Observational, None intervention
Other interventionObservational, None intervention
The primary objective is to characterize the real-world PFS (rwPFS) with either sunitinib or sorafenib.
The rwPFS is defined as time from the initiation of first dose of sunitinib or sorafenib until investigator-reported disease progression (assessed by physician's notes or radiology report), or death due to any cause (in the absence of progression), whichever occurred first.
The secondary objective is to characterize the rwPFS with sunitinib.
The rwPFS is defined as time from the initiation of first dose of sunitinib until investigator-reported disease progression (assessed by physician's notes or radiology report), or death due to any cause (in the absence of progression), whichever occurred first.
To characterize the OS with either sunitinib or sorafenib monotherapy
OS is defined as time from initiation of sunitinib or sorafenib until the date of death due to any cause.
To characterize the real-world ORR (rwORR) with either sunitinib or sorafenib monotherapy
The measure of interest is rwORR, defined as the proportion of participants who have reached CR or PR as determined by investigator-reported assessment.
To characterize the time-to-treatment discontinuation (TTD) with either sunitinib or sorafenib monotherapy
The TTD is defined as time from the date of initiation of sunitinib or sorafenib till their discontinuation due to any reasons or death.
To characterize the OS with sunitinib monotherapy.
OS is defined as time from initiation of sunitinib until the date of death due to any cause.
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