Abstract
BACKGROUND/OBJECTIVES: Knowledge of the symptoms and side effects (SSEs) of Bacille Calmette-Guerin (BCG) therapy for non-muscle invasive bladder cancer (NMIBC) is critical when establishing selecting appropriate therapies for patients. The aim of our study was to systematically review the common patient-reported SSEs associated with BCG-based and other intravesical chemotherapy treatment options for NMIBC. METHODS: A systematic search of AMED, MEDLINE, EMBASE, PsycINFO, Web of Knowledge, and Scopus was conducted from inception to July 2024. The PRISMA process was followed. Prospective studies with an adult cohort that assessed SSEs through direct patient reports with standardized patient-reported outcome measures were included in this study. A narrative synthesis was performed to compare the frequency of SSEs reported by treatment options. Statistical analysis was performed using chi square and Fisher's exact tests, with statistical significance at p < 0.05. RESULTS: Thirty-four studies met the eligibility criteria. The main findings indicated that BCG induction is more toxic than BCG induction with maintenance; however, severe SSEs resulting in treatment cessation occurred almost twice as often in patients on BCG induction with maintenance. Patients who received full-dose BCG were more likely to have SSEs compared to those receiving a low dose. BCG monotherapy alone caused more SSEs compared to BCG with chemotherapy. Patients reported more SSEs with BCG compared to chemotherapy alone for induction with maintenance. Limitations of the study include the varied length of maintenance regimes affecting nature of data reported. CONCLUSIONS: The findings of this study allow for improved counselling of patients regarding expected side effects in accordance with their recommended treatment options for NMIBC.