Comparative study between intravesical gemcitabine versus bacillus Calmette– Guérin in high risk superficial bladder cancer

Objectives. To study the efficacy and safety of intravesical gemcitabine (GEM) in comparison to intravesical bacillus Calmette–Guérin (BCG) for patients with high risk non-muscle invasive tumors.

Methods. 100 patients with histologically confirmed non-muscle invasive bladder cancer (carcinoma in situ, Ta, T1), in the high-risk group of urothelial carcinoma, treated in the outpatient clinic of the Urology between 2021 and 2023 who received adjuvant intravesical therapy were simply randomized to group A (BCG group) and group B (GEM group) following single postoperative intravesical instillation of (GEM) chemotherapy after transurethral resection of bladder tumor, each group contained 50 patients were evaluated.

Results. All patients were evaluated for a follow-up of 24 months after treatment. There is no significant statistical difference in clinical and pathological characteristics between the groups. There was no statistically significant difference in the recurrence rate and progression rate of the disease in each group respectively (p = 0.2, 0.06) also overall diseasefree rate (p = 0.128). Regarding safety, free cases of any adverse events were clinically and statistically significant between both groups (p = 0.002). There were statistically significant differences between groups A and B in grade II (hematuria, fever) and grade III (allergy, BCGosis) adverse effects respectively (p = 0.001, 0.003). Although grade I complications were more in the BCG arm, but it was not statistically significant.

Conclusion. The adjuvant intravesical GEM chemotherapy has equal efficacy for BCG immuno-therapy in the treatment of high-risk superficial bladder cancer patients following transurethral resection of bladder tumor. In addition, GEM is associated with reduced local and systemic toxicity compared with BCG.