The purpose of this study is to understand how the participants with high-risk non-muscle invasive bladder cancer are diagnosed, treated, and cared for in regular clinical practice in Portugal. HR-NMIBC is an early-stage bladder cancer that is limited to the inner lining of bladder but has a considerable high chance of cancer coming back or worsening.
Bladder cancer diagnosis between January 1, 2016 and December 31, 2020
Tumor stage N0/x and M0/x plus any of the following: Tis (primary CIS); TaG3/HG (high-grade non-invasive papillary carcinoma); or T1 (tumor invading subepithelial connective tissue)
Minimal follow-up time of 5 years unless there is premature death event
Tumor stage at diagnosis classified as TaG1-2, T2-T4, N1-3, or M1
History of radical cystectomy performed either prior to the HR-NMIBC index diagnosis or for an indication unrelated to the index HR-NMIBC
Participation in any interventional clinical trial during the observation period
The study population includes the participants from Portuguese hospitals that treat and manage High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) in routine clinical practice.
Cohort
Retrospective
Not listed
Treatment Patterns: Type of Therapeutic Approach
Number of participants receiving different types of therapeutic approach including bacillus calmette-guerin (BCG) therapy, chemotherapy, radiotherapy, immunotherapy, or targeted therapy will be reported.
Treatment Patterns: Type of Surgery
Number of participants undergoing different types of surgery, including transurethral resection of the bladder tumor (TURBT), repeat TURBT or cystectomy will be reported.
Treatment Patterns by Subpopulation: Tumor Stage
Number of participants by tumor stage will be reported.
Treatment Patterns by Subpopulation: Histology
Number of participants by histology will be reported.
Total Number of BCG Doses Administered
Total number of BCG doses administered will be reported.
Percentage of Participants With BCG Non-Responsive Disease
Percentage of participants with BCG non-responsive disease will be reported. This is defined as being one of the following: a) Persistent or recurrent carcinoma in situ (CIS) alone or with recurrent Ta/T1 (noninvasive papillary disease/tumor invades the subepithelial connective tissue) disease within 12 months of completion of adequate BCG therapy (defined as at least 5 of 6 induction doses, plus at least 2 of 3 maintenance doses or a second induction). b) Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy. c) T1 high-grade disease at the first evaluation following an induction BCG course.
Reasons for BCG Interruption
Number of participants with reasons for BCG interruption will be reported.
Therapy Choice at Recurrence
Therapy choice at recurrence for participants will be reported.
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