After institutional review board approval, patient medical records were retrospectively reviewed, and data were stored in a Research Electronic Data Capture (REDCap) database supported by the University of Iowa (via funding from the National Institutes of Health/Clinical and Translational Science Awards program). Patients’ clinicopathological features, treatment history, tolerance to therapy, and oncological outcomes were analyzed. The primary outcome was high-grade recurrence-free survival (RFS). Secondary outcomes included RFS, progression-free survival (PFS), cystectomy-free survival (CFS), cancer-specific survival (CSS), and overall survival (OS). Adverse events were classified using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5. When symptoms had a unifying cause (eg, lower urinary tract symptoms during urinary tract infection), only the latter unifying CTCAE term was reported. Intolerance was defined as an inability to continue treatment due to the development of AEs.
We used χ2 tests to compare categorical variables and t tests to compare continuous variables (baseline characteristics and AEs) between treatment groups. Survival probabilities were estimated and plotted using the Kaplan-Meier method. Estimates along with pointwise 95% CIs were reported.
Recurrence-free survival was defined as time from the start of therapy induction to recurrence, and high-grade RFS was defined as time from the start of therapy induction to high-grade recurrence, respectively. Recurrence was defined as tumor relapse in the bladder or prostatic urethra (for male patients). Progression-free survival was defined as time from the start of therapy induction to progression, with progression defined as the development of a T2 or greater disease, lymph node or metastatic disease, or receipt of any cystectomy. Otherwise, patients were censored at the last urological follow-up visit. Cancer-specific survival was defined as time from the start of therapy induction to death due to bladder cancer. Patients were censored at the date of death due to other causes or at the date they were last known to be alive. Overall survival was defined as time from the start of therapy induction to death due to any cause. Duration of response was defined as time from initial surveillance to recurrence (high or low grade) among those who hadn’t experienced recurrence at the initial surveillance visit. Patients still alive were censored at the last known follow-up visit.
Cox regression models were used to evaluate the associations of patient, disease, and treatment characteristics with RFS and high-grade RFS. All statistical testing was 2-sided, with P = .05 set as the significance threshold. Data were analyzed using SAS software, version 9.4 (SAS Institute Inc).
We used χ2 tests to compare categorical variables and t tests to compare continuous variables (baseline characteristics and AEs) between treatment groups. Survival probabilities were estimated and plotted using the Kaplan-Meier method. Estimates along with pointwise 95% CIs were reported.
Recurrence-free survival was defined as time from the start of therapy induction to recurrence, and high-grade RFS was defined as time from the start of therapy induction to high-grade recurrence, respectively. Recurrence was defined as tumor relapse in the bladder or prostatic urethra (for male patients). Progression-free survival was defined as time from the start of therapy induction to progression, with progression defined as the development of a T2 or greater disease, lymph node or metastatic disease, or receipt of any cystectomy. Otherwise, patients were censored at the last urological follow-up visit. Cancer-specific survival was defined as time from the start of therapy induction to death due to bladder cancer. Patients were censored at the date of death due to other causes or at the date they were last known to be alive. Overall survival was defined as time from the start of therapy induction to death due to any cause. Duration of response was defined as time from initial surveillance to recurrence (high or low grade) among those who hadn’t experienced recurrence at the initial surveillance visit. Patients still alive were censored at the last known follow-up visit.
Cox regression models were used to evaluate the associations of patient, disease, and treatment characteristics with RFS and high-grade RFS. All statistical testing was 2-sided, with P = .05 set as the significance threshold. Data were analyzed using SAS software, version 9.4 (SAS Institute Inc).
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