Efficacy and Safety of Tailored Dose of BCG (40mg) Versus Standard Dose (80mg) Instillation Therapy in Non-Muscle Invasive Early Bladder Cancer Patients
DOI:
https://doi.org/10.54112/bcsrj.v6i10.2219Keywords:
Urinary Bladder Neoplasms, Carcinoma In Situ, Bacillus Calmette-Guérin, Immunotherapy, Intravesical Administration, Treatment OutcomeAbstract
Non-muscle-invasive bladder cancer (NMIBC) represents the majority of bladder cancer cases and is associated with high recurrence and progression rates. Intravesical Bacillus Calmette-Guérin (BCG) therapy remains the standard adjuvant treatment; however, standard-dose BCG (80 mg) is frequently associated with significant adverse events, which may limit treatment compliance. Dose reduction strategies have been proposed to improve tolerability while maintaining therapeutic efficacy. Objective: To compare the efficacy and safety of tailored low-dose (40 mg) versus standard-dose (80 mg) intravesical BCG therapy in patients with NMIBC in a tertiary care setting in Pakistan. Methods: This quasi-experimental study was conducted at the Department of Urology, Shaikh Zayed Hospital, Lahore, from 17 May 2025 to 17 September 2025. A total of 94 patients with NMIBC (Ta, T1, and Tis) were enrolled using non-probability consecutive sampling and allocated into two groups (n=47 each). Group A received 40 mg BCG, while Group B received 80 mg BCG, administered weekly for six weeks. Efficacy was assessed by cystoscopic evaluation at six weeks, with a complete response defined as the absence of tumour on cystoscopy and biopsy. Safety was evaluated by recording adverse events. Data were analysed using SPSS version 27.0, and a chi-square test was applied with p≤0.05 considered significant. Results: The mean age of participants was 58.4 ± 10.7 years, with a male predominance (78.7%). Complete response was observed in 80.9% of patients in the low-dose group and 85.1% in the standard-dose group, with no statistically significant difference (p=0.58). The overall incidence of adverse effects was significantly lower in the low-dose group (27.7%) compared to the standard-dose group (51.1%) (p=0.02). Most adverse events were mild to moderate, with fewer severe complications in the low-dose group. Post-stratification analysis showed no significant associations between age, gender, or tumor stage and treatment response. Conclusion: Low-dose intravesical BCG (40 mg) demonstrates comparable short-term efficacy to standard-dose BCG (80 mg) while significantly improving safety. This approach may represent a practical and effective alternative in resource-constrained settings.
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1. Soma T, Takemura K, Toide M, Ito M, Koga F. Bladder-sparing strategies for non-muscle-invasive bladder cancer after bacilli Calmette-Guérin failure: a systematic review. BMJ Oncol. 2026;5(1):e000753. DOI: https://doi.org/10.1136/bmjonc-2025-000753
2. Kawada T, Yanagisawa T, Bekku K, Laukhtina E, von Deimling M, Chlosta M, et al. The efficacy and safety outcomes of lower dose BCG compared to intravesical chemotherapy in non-muscle-invasive bladder cancer: a network meta-analysis. Urol Oncol. 2023;41(6):261-273. DOI: https://doi.org/10.1016/j.urolonc.2023.04.003
3. Ostrowski DA, Chelluri RR, Herzig M, Xia L, Cortese BD, Roberson DS, et al. Diminished short-term efficacy of reduced-dose induction BCG in the treatment of non-muscle invasive bladder cancer. Cancers (Basel). 2023;15(14):3746. DOI: https://doi.org/10.3390/cancers15143746
4. Grajales V, Contieri R, Tan WS, Flores M, Schultz M, Pinochet R, et al. Comparative analysis of very reduced vs full dose BCG treatment for high-risk non-muscle invasive bladder cancer: a contemporary experience from Chile. Bladder Cancer. 2023;9(4):327-334. DOI: https://doi.org/10.3233/BLC-230047
5. Arora A, Godse S, Pal M, Misra A, Sepuri RT, Mallikarjun NT, et al. Real-world oncological and toxicity outcomes with the Moscow strain of intravesical BCG for non-muscle invasive bladder cancer: implications for global shortage. BJUI Compass. 2025;6(6):e70034. DOI: https://doi.org/10.1002/bco2.70034
6. Isobe H, Shimizu F, Ieda T, Nakamura S, Takazawa N, Suetsugu H, et al. Comparison of BCG Tokyo172 strain induction therapy between low dose and standard dose for non-muscle invasive bladder cancer: intravesical instillation of BCG Tokyo172 strain. Biomedicines. 2025;13(1):174. DOI: https://doi.org/10.3390/biomedicines13010174
7. Shah KA, Shah SR, Khan WA, Nisar S, Zaidi SF, Asif M, et al. Comparison of intravesical Bacillus Calmette-Guérin and mitomycin C for the treatment of non-muscle-invasive bladder cancer. Cureus. 2025;17(6):e86524. DOI: https://doi.org/10.7759/cureus.86524
8. Suh J, Yoo S. Role of immunotherapy in Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer. Transl Cancer Res. 2020;9(10):6537-6545. DOI: https://doi.org/10.21037/tcr-20-758
9. Tan K, Viswambaram P, McCombie S, Moe A, Goodwin R, Kuan M, et al. Fremantle protocol: multicenter clinical outcomes for a pragmatic protocol for intravesical bacillus Calmette-Guérin. Asia Pac J Clin Oncol. 2023;19(6):697-705. DOI: https://doi.org/10.1111/ajco.13933
10. Thyavihally Y, Dev P, Waigankar S, Pednekar A, Athikari N, Raut A, et al. Intravesical bacillus Calmette-Guérin in treating non-muscle invasive bladder cancer: analysis of adverse effects and effectiveness of two strains of BCG (Danish 1331 and Moscow-I). Asian J Urol. 2022;9(2):157-164. DOI: https://doi.org/10.1016/j.ajur.2021.05.002
11. Shakhssalim N, Dadpour M, Sharifiaghdas F, Narouie B, Kabir S, Sepehran E, et al. Evaluating the effectiveness of intravesical instillation of BCG by modified maintenance method in patients with high-risk Ta and T1 bladder cancer: a randomized clinical trial. Clin Med Insights Oncol. 2023;17. DOI: https://doi.org/10.1177/11795549231184682
12. Schmidt S, Kunath F, Coles B, Draeger D, Krabbe LM, Dersch R, et al. Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer. Cochrane Database Syst Rev. 2020. DOI: https://doi.org/10.1002/14651858.CD011935.pub2
13. Angelopoulos P, Markopoulos T, Lazarou L, Skolarikos A, Stamatakos P, Papadopoulos G, et al. Retrospective, non-interventional, multicenter study on the effectiveness and safety of intravesical Bacillus Calmette-Guérin in patients with non-muscle-invasive bladder cancer: real-world experience from six hospital centers in Greece. Curr Oncol. 2024;32(1):18. DOI: https://doi.org/10.3390/curroncol32010018
14. Kluemper A, Morris K, Mellon M. From plague to the promise: the journey of Bacille Calmette-Guérin. Bladder. 2024;11(4):e21200022. DOI: https://doi.org/10.14440/bladder.2024.0035
15. Poletajew S, Krajewski W, Adamowicz J, Radziszewski P. A systematic review of preventive and therapeutic options for symptoms of cystitis in patients with bladder cancer receiving intravesical bacilli Calmette-Guérin immunotherapy. Anticancer Drugs. 2019;30(5):517-522. DOI: https://doi.org/10.1097/CAD.0000000000000775
16. Azuri W, Jaunarena J, Camean J, Chemi J, Villaronga A, Daneshmand S, et al. The impact of dose reduction of Bacillus Calmette-Guérin on oncological outcomes and toxicity in non-muscle invasive bladder cancer: a systematic review and meta-analysis. Bladder Cancer. 2023;9(3):227-236. DOI: https://doi.org/10.3233/BLC-230044
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Copyright (c) 2025 Muhammad Hamza Azhar, Abdul Rauf, Fazal Ur Rehman Khan, Muhammad Rizwan, Muhammad Labeed Khan, Ahmed Wahaj
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