The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.
Study Type
OBSERVATIONAL
Enrollment
400
Local Institution
City, State, Japan
Disease-free survival (DFS)
The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.
Time frame: Up to 4 years
Non-urothelial tract recurrence free survival (NUTRFS)
The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.
Time frame: Up to 4 years
Number of participants with adverse events (AEs)
Time frame: Up to 4 years
Number of participants with treatment-related adverse events (TRAEs)
Time frame: Up to 4 years
Actual treatment status: dosing frequency
Time frame: Up to 4 years
Actual treatment status: treatment duration
The time from the start date of nivolumab administration to the last administration date
Time frame: Up to 4 years
Actual treatment status: treatment completion rate
The treatment completion rate will be calculated\* according to the following formula: Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100
Time frame: Up to 4 years
Actual treatment status: reason for discontinuation
Time frame: Up to 4 years
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DFS
The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.
Time frame: Up to 4 years
NUTRFS
The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.
Time frame: Up to 4 years
Number of participants with AEs
Time frame: Up to 4 years
Number of participants with TRAEs
Time frame: Up to 4 years
Actual treatment status: dosing frequency
Time frame: Up to 4 years
Actual treatment status: treatment duration
The time from the start date of nivolumab administration to the last administration date
Time frame: Up to 4 years
Actual treatment status: treatment completion rate
The treatment completion rate will be calculated\* according to the following formula: Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100
Time frame: Up to 4 years
Actual treatment status: reason for discontinuation
Time frame: Up to 4 years
Overall survival (OS)
The time from the date of nivolumab initiation to the date of death from any cause
Time frame: Up to 4 years
Disease-specific survival (DSS）
The time from the date of nivolumab initiation to the date of death due to the primary disease
Time frame: Up to 4 years
Number of participants with immune-mediated adverse events (IMAEs) according to the Common Terminology Criteria for Adverse Events (CTCAEs) version 5.0
Time frame: Up to 4 years
Number of participants with TRAEs leading to treatment discontinuation
Time frame: Up to 4 years
Actual treatment status: treatment continuation rate
Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100
Time frame: Up to 4 years
Actual treatment status: dosing intensity
Dose intensity (%)=(Actual dose)/(Total dose planned)×100
Time frame: Up to 4 years
Post-recurrence treatment status: The number of participants transitioning to treatment
The proportion of eligible patients who completed and started treatment after recurrence.
Time frame: Up to 4 years
The number of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence
Time frame: Up to 4 years
The number of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence
Time frame: Up to 4 years
The proportion of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence
Time frame: Up to 4 years
The proportion of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence
Time frame: Up to 4 years
The number of participants in each BOR category (CR/PR/stable disease (SD)/progressive disease (PD)/ not evaluated (NE)) receiving treatment after recurrence
Time frame: Up to 4 years
The proportion of eligible participants with evaluable disease
Time frame: Up to 4 years
Duration of treatment
The time from the start date of treatment administration to the last administration date after recurrence.
Time frame: Up to 4 years
Time to treatment
The time from the start date of nivolumab to the start date of treatment after recurrence.
Time frame: Up to 4 years
Estimated glomerular filtration rate (eGFR)
Measured before NAC, before radical resection, immediately before nivolumab treatment, at the time of recurrence, or at the start of post-recurrence treatment
Time frame: Up to 4 years
The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants
Time frame: Up to 4 years
The number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants
Time frame: Up to 4 years
The clinical stage prior to NAC
Time frame: Up to 4 years
The pathologic stage at the time of radical resection
Time frame: Up to 4 years
Treatment completion rate (%)
(Participants who completed treatment)/(All eligible participants)x100
Time frame: Up to 4 years