Study of adverse drug reaction of intravesical onco-BCG in non-muscle-invasive bladder cancer: a retrospective study

Background: Intravesical onco-BCG is mainstay therapy for intermediate and high‑risk NMIBC to reduce disease recurrence and progression. In India Danish 1331 strain was used till middle of last decade after that Moscow (Russia) strain is used. Methods: Retrospective study was conducted in intermediate and high risk NMIBC patients. Patients receiving were interviewed for ADR’s and were recorded as grade 1, grade 2, grade 3 symptoms (as per Cleveland clinic approach to management of BCG toxicity). The patients with NMIBC (Ta or T1 diseases as per TNM staging AJCC 8th edition) in intermediate and high-risk group were enrolled in the study. The diseases classified in low risk, intermediate risk and high risk as per EAU guidelines. Results: Sixty patients were enrolled in the study. Mean age of the patients is 62.75 years with male: female ratio 20:1. 46.6% of patients had intermediate and 53.4% had high risk disease. Mean follow-up period in the study was 32.27 weeks. 93.4% of patients had grade 1 symptoms and 6.6% had grade 2 symptoms. None of the patients had grade 3 serious complications. Conclusions: Intravesical OncoBCG (Moscow strain) is safe and well tolerated in study population.