Efficacy and Safety of Adjuvant Intravesical Gemcitabine versus Bacillus Calmette Guérin in High-Risk Bladder Urothelial Carcinoma

Background: Bladder cancer is the second most common cancer of the genitourinary tract. At presentation 70% of bladder tumours are classified as non-muscle invasive bladder cancer (NMIBC) confined to the inner lining of the bladder with stage pTa or pT1(1). Objectives: To compare (1) Efficacy (Indicated by disease recurrence and progression), (2) Safety (Indicated by adverse events), of adjuvant intravesicalBacillus Calmette Guérin (BCG) immunotherapy versus intravesical gemcitabine (GEM) chemotherapy as complementary therapy for patients with a high risk of non-muscle invasive bladder urothelial carcinoma. Methods: Sample size of 82 patients with histologically confirmed non muscle invasive bladder cancer {NMIBC} (CIS, Ta, T1), in the high-risk group of urothelial carcinoma (UC), treated in the outpatient clinic of the Urology between 2021 and 2024 who received adjuvant intravesical therapy were simply randomized to group A (GEM group) and group B (BCG group), each group contained 41 patients were evaluated. Results: Every patient was assessed for a follow-up of 24 months post-treatment initiation. No statistically significant difference was found in the mean age and tumor characteristics. As regards safety, number of adverse events were clinically and statistically significant between both groups (p value: 0.046). There were statistically high significant differences among groups A and B in grade 1 (dysuria) adverse effects (p value: 0.001), more in BCG arm, but statistically not significant in grade 2 (fever, hematuria) adverse effects respectively (p value: 1.00, 0.402). No statistically significant differences were observed in the recurrence rate and progression rate of the disease across each group, as well as in the overall disease-free rate (p value: 0.475). Conclusion: The adjuvant intravesical GEM chemotherapy has equal efficacy for BCG in managing high risk non muscle invasive bladder cancer patients following TURBT. However, GEM is associated with reduced local and systemic toxicity compared with BCG.