Non-muscle-invasive Bladder Cancer

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328.Malmstrom, P.U., et al. An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guerin for non-muscle-invasive bladder cancer. Eur Urol, 2009. 56: 247. 
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329.Sylvester, R.J., et al. Long-term efficacy results of EORTC genito-urinary group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guerin, and bacillus Calmette-Guerin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder. Eur Urol, 2010. 57: 766. 
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330.Shang, P.F., et al. Intravesical Bacillus Calmette-Guerin versus epirubicin for Ta and T1 bladder cancer. Cochrane Database Syst Rev, 2011: CD006885. 
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331.Khene, Z.E., et al. Gemcitabine vs Bacillus Calmette-Guerin for Intravesical Therapy in Treatment-Naive Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer. J Urol, 2025. 213: 730. 
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332.Bosschieter, J., et al. Value of an Immediate Intravesical Instillation of Mitomycin C in Patients with Non-muscle-invasive Bladder Cancer: A Prospective Multicentre Randomised Study in 2243 patients. Eur Urol, 2018. 73: 226. 
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333.Bouffioux, C., et al. Intravesical adjuvant chemotherapy for superficial transitional cell bladder carcinoma: results of 2 European Organization for Research and Treatment of Cancer randomized trials with mitomycin C and doxorubicin comparing early versus delayed instillations and short-term versus long-term treatment. European Organization for Research and Treatment of Cancer Genitourinary Group. J Urol, 1995. 153: 934. 
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334.Kaasinen, E., et al. Factors explaining recurrence in patients undergoing chemoimmunotherapy regimens for frequently recurring superficial bladder carcinoma. Eur Urol, 2002. 42: 167. 
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335.Sylvester, R.J., et al. The schedule and duration of intravesical chemotherapy in patients with non-muscle-invasive bladder cancer: a systematic review of the published results of randomized clinical trials. Eur Urol, 2008. 53: 709. 
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336.Bosschieter, J., et al. An immediate, single intravesical instillation of mitomycin C is of benefit in patients with non-muscle-invasive bladder cancer irrespective of prognostic risk groups. Urol Oncol, 2018. 36: 400 e7. 
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337.Elsawy, A.A., et al. The value of immediate postoperative intravesical epirubicin instillation as an adjunct to standard adjuvant treatment in intermediate and high-risk non-muscle-invasive bladder cancer: A preliminary results of randomized controlled trial. Urol Oncol, 2019. 37: 179 e9. 
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338.Tabayoyong, W.B., et al. Systematic Review on the Utilization of Maintenance Intravesical Chemotherapy in the Management of Non-muscle-invasive Bladder Cancer. Eur Urol Focus, 2018. 4: 512. 
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339.Au, J.L., et al. Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial. J Natl Cancer Inst, 2001. 93: 597. 
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340.Miyata, Y., et al. Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non-muscle-invasive bladder cancer: a randomised clinical trial. BJU Int, 2022. 129: 534. 
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341.Myers, A.L., et al. Solubilization and Stability of Mitomycin C Solutions Prepared for Intravesical Administration. Drugs R D, 2017. 17: 297. 
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342.Giesbers, A.A., et al. Recurrence of superficial bladder carcinoma after intravesical instillation of mitomycin-C. Comparison of exposure times. Br J Urol, 1989. 63: 176. 
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343.Kuroda, M., et al. Effect of prophylactic treatment with intravesical epirubicin on recurrence of superficial bladder cancer--The 6th Trial of the Japanese Urological Cancer Research Group (JUCRG): a randomized trial of intravesical epirubicin at dose of 20mg/40ml, 30mg/40ml, 40mg/40ml. Eur Urol, 2004. 45: 600. 
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344.Zhao, H., et al. Intravesical Chemohyperthermia vs. Bacillus Calmette-Guerin Instillation for Intermediate- and High-Risk Non-muscle Invasive Bladder Cancer: A Systematic Review and Meta-Analysis. Front Surg, 2021. 8: 775527. 
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345.Arends, T.J., et al. Combined chemohyperthermia: 10-year single center experience in 160 patients with nonmuscle invasive bladder cancer. J Urol, 2014. 192: 708. 
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346.Arends, T.J., et al. Results of a Randomised Controlled Trial Comparing Intravesical Chemohyperthermia with Mitomycin C Versus Bacillus Calmette-Guerin for Adjuvant Treatment of Patients with Intermediate- and High-risk Non-Muscle-invasive Bladder Cancer. Eur Urol, 2016. 69: 1046. 
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347.Tan, W.S., et al. Adjuvant Intravesical Chemohyperthermia Versus Passive Chemotherapy in Patients with Intermediate-risk Non-muscle-invasive Bladder Cancer (HIVEC-II): A Phase 2, Open-label, Randomised Controlled Trial. Eur Urol, 2023. 83: 497. 
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348.Angulo, J.C., et al. Hyperthermic Mitomycin C in Intermediate-risk Non-muscle-invasive Bladder Cancer: Results of the HIVEC-1 Trial. Eur Urol Oncol, 2023. 6: 58. 
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349.Sachan, A., et al. A 3-arm randomized control trial to compare the efficacy of re-circulant hyperthermic intravesical chemotherapy versus conventional intravesical mitomycin C and BCG therapy for intermediate-risk non-muscle invasive bladder cancer. World J Urol, 2024. 42: 609. 
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350.Guerrero-Ramos, F., et al. Recirculating hyperthermic intravesical chemotherapy with mitomycin C (HIVEC) versus BCG in high-risk non-muscle-invasive bladder cancer: results of the HIVEC-HR randomized clinical trial. World J Urol, 2022. 40: 999. 
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351.Di Stasi, S.M., et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Lancet Oncol, 2006. 7: 43. 
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352.Shelley, M.D., et al. A systematic review of intravesical bacillus Calmette-Guerin plus transurethral resection vs transurethral resection alone in Ta and T1 bladder cancer. BJU Int, 2001. 88: 209. 
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353.Han, R.F., et al. Can intravesical bacillus Calmette-Guerin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology, 2006. 67: 1216. 
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354.Shelley, M.D., et al. Intravesical bacillus Calmette-Guerin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer: a meta-analysis of randomized trials. BJU Int, 2004. 93: 485. 
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355.Bohle, A., et al. Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol, 2003. 169: 90. 
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356.Duchek, M., et al. Bacillus Calmette-Guerin is superior to a combination of epirubicin and interferon-alpha2b in the intravesical treatment of patients with stage T1 urinary bladder cancer. A prospective, randomized, Nordic study. Eur Urol, 2010. 57: 25. 
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357.Jarvinen, R., et al. Long-term efficacy of maintenance bacillus Calmette-Guerin versus maintenance mitomycin C instillation therapy in frequently recurrent TaT1 tumours without carcinoma in situ: a subgroup analysis of the prospective, randomised FinnBladder I study with a 20-year follow-up. Eur Urol, 2009. 56: 260. 
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358.Schmidt, S., et al. Intravesical Bacillus Calmette-Guerin versus mitomycin C for Ta and T1 bladder cancer. Cochrane Database Syst Rev, 2020. 1: CD011935. 
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359.Longoni, M., et al. Oncological Outcomes in Bacillus Calmette-Guerin-naive High-risk Non-muscle-invasive Bladder Cancer Patients: A Systematic Review on Current Treatment Strategies and Future Perspectives. Eur Urol Oncol, 2025. 
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360.Huncharek, M., et al. The influence of intravesical therapy on progression of superficial transitional cell carcinoma of the bladder: a metaanalytic comparison of chemotherapy versus bacilli Calmette-Guerin immunotherapy. Am J Clin Oncol, 2004. 27: 522. 
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361.Oddens, J.R., et al. The effect of age on the efficacy of maintenance bacillus Calmette-Guerin relative to maintenance epirubicin in patients with stage Ta T1 urothelial bladder cancer: results from EORTC genito-urinary group study 30911. Eur Urol, 2014. 66: 694. 
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362.Miyake, M., et al. Outcomes of subsequent non-muscle-invasive bladder cancer treated with intravesical Bacillus Calmette-Guerin after radical nephroureterectomy for upper urinary tract urothelial carcinoma. BJU Int, 2018. 121: 764. 
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363.Rentsch, C.A., et al. Bacillus Calmette-Guerin strain differences have an impact on clinical outcome in bladder cancer immunotherapy. Eur Urol, 2014. 66: 677. 
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364.Sengiku, A., et al. A prospective comparative study of intravesical bacillus Calmette-Guerin therapy with the Tokyo or Connaught strain for nonmuscle invasive bladder cancer. J Urol, 2013. 190: 50. 
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365.Boehm, B.E., et al. Efficacy of bacillus Calmette-Guerin Strains for Treatment of Nonmuscle Invasive Bladder Cancer: A Systematic Review and Network Meta-Analysis. J Urol, 2017. 198: 503. 
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366.Unda-Urzaiz, M., et al. Safety and efficacy of various strains of bacille Calmette-Guerin in the treatment of bladder tumours in standard clinical practice. Actas Urol Esp (Engl Ed), 2018. 42: 238. 
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367.Steinberg, R.L., et al. Bacillus Calmette-Guerin strain may not effect recurrence-free survival when used intravesically with interferon-alpha2b for non-muscle-invasive bladder cancer. Urol Oncol, 2017. 35: 201. 
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368.van der Meijden, A.P., et al. Maintenance Bacillus Calmette-Guerin for Ta T1 bladder tumors is not associated with increased toxicity: results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial. Eur Urol, 2003. 44: 429. 
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369.Larsen, E.S., et al. The epidemiology of bacille Calmette-Guerin infections after bladder instillation from 2002 through 2017: a nationwide retrospective cohort study. BJU Int, 2019. 124: 910. 
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370.Holmberg, L., et al. Cumulative incidence of and risk factors for BCG infection after adjuvant BCG instillations. BJU Int, 2024. 134: 229. 
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371.Brausi, M., et al. Side effects of Bacillus Calmette-Guerin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG. Eur Urol, 2014. 65: 69. 
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372.Grimm, M.O., et al. Treatment of High-grade Non-muscle-invasive Bladder Carcinoma by Standard Number and Dose of BCG Instillations Versus Reduced Number and Standard Dose of BCG Instillations: Results of the European Association of Urology Research Foundation Randomised Phase III Clinical Trial “NIMBUS”. Eur Urol, 2020. 78: 690. 
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373.Shore, N.D., et al. Sasanlimab plus BCG in BCG-naive, high-risk non-muscle invasive bladder cancer: the randomized phase 3 CREST trial. Nat Med, 2025. 31: 2806. 
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374.Oddens, J.R., et al. Increasing age is not associated with toxicity leading to discontinuation of treatment in patients with urothelial non-muscle-invasive bladder cancer randomised to receive 3 years of maintenance bacille Calmette-Guerin: results from European Organisation for Research and Treatment of Cancer Genito-Urinary Group study 30911. BJU Int, 2016. 118: 423. 
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375.Danielsson, G., et al. Bladder health in patients treated with BCG instillations for T1G2-G3 bladder cancer - a follow-up five years after the start of treatment. Scand J Urol, 2018. 52: 377. 
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376.Herr, H.W. Intravesical bacillus Calmette-Guerin outcomes in patients with bladder cancer and asymptomatic bacteriuria. J Urol, 2012. 187: 435. 
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377.Colombel, M., et al. The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study. J Urol, 2006. 176: 935. 
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378.Damiano, R., et al. Short-term administration of prulifloxacin in patients with nonmuscle-invasive bladder cancer: an effective option for the prevention of bacillus Calmette-Guerin-induced toxicity? BJU Int, 2009. 104: 633. 
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379.Numakura, K., et al. Effect of Levofloxacin on the Efficacy and Adverse Events in Intravesical Bacillus Calmette-Guerin Treatment for Bladder Cancer: Results of a Randomized, Prospective, Multicenter Study. Eur Urol Focus, 2022. 8: 1666. 
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380.Wong, C.H., et al. A Systematic Review and Meta-analysis of the Clinical Impact of Prophylactic Quinolones with Adjuvant Bacillus Calmette-Guerin Instillation for Non-muscle-invasive Bladder Cancer. Eur Urol Oncol, 2025. 8: 571. 
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381.Lamm, D.L., et al. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol, 1992. 147: 596. 
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382.Messing, E.M. BCG in Immunocompromised Patients: Is it effective? Is it safe? Bladder Cancer, 2024. 10: 89. 
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383.Palou, J., et al. Intravesical bacillus Calmette-Guerin for the treatment of superficial bladder cancer in renal transplant patients. Transplantation, 2003. 76: 1514. 
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384.Yossepowitch, O., et al. Safety and efficacy of intravesical bacillus Calmette-Guerin instillations in steroid treated and immunocompromised patients. J Urol, 2006. 176: 482. 
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385.Roumeguere, T., et al. Bacillus Calmette-Guerin therapy in non-muscle-invasive bladder carcinoma after renal transplantation for end-stage aristolochic acid nephropathy. Transpl Int, 2015. 28: 199. 
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386.Jue, J.S., et al. Risk factors, management, and survival of bladder cancer after kidney transplantation. Actas Urol Esp (Engl Ed), 2021. 45: 427. 
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387.Mori, K., et al. Low compliance to guidelines in nonmuscle-invasive bladder carcinoma: A systematic review. Urol Oncol, 2020. 38: 774. 
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388.Thoft Jensen, B., et al. EAUN Guidelines on Intravesical instillation with mitomycin C and bacillus Calmette-Guérin in non-muscle-invasive bladder cancer. 2026. 
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389.Witjes JA, P.J., Soloway M, et al. . Clinical practice recommendations for the prevention and management of intravesical therapy-associated adverse events. Eur Urol Suppl, 2008. 7: 667. 
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390.Palou, J., et al. Intravesical treatment of severe bacillus Calmette-Guerin cystitis. Int Urol Nephrol, 2001. 33: 485. 
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391.Falkensammer, C., et al. Late occurrence of bilateral tuberculous-like epididymo-orchitis after intravesical bacille Calmette-Guerin therapy for superficial bladder carcinoma. Urology, 2005. 65: 175. 
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392.Tinazzi, E., et al. Reactive arthritis following BCG immunotherapy for urinary bladder carcinoma: a systematic review. Rheumatol Int, 2006. 26: 481. 
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393.Sun, K., et al. Mirabegron improves the irritative symptoms caused by BCG immunotherapy after transurethral resection of bladder tumors. Cancer Med, 2021. 10: 7534. 
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394.Chen, Z., et al. Comparison of treatments for preventing lower urinary tract symptoms after BCG immunotherapy of bladder tumors : a systematic review and network meta-analysis. BMC Urol, 2025. 25: 19. 
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395.European Medicines Agency. Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics. 2019. 2022. 
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396.Bonkat, G., et al. EAU Guidelines on Urological Infections. Edn. presented at the 41st EAU Annual Congress London 2026, 2026. 
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397.Perez-Jacoiste Asin, M.A., et al. Bacillus Calmette-Guerin (BCG) infection following intravesical BCG administration as adjunctive therapy for bladder cancer: incidence, risk factors, and outcome in a single-institution series and review of the literature. Medicine (Baltimore), 2014. 93: 236. 
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398.Durek, C., et al. The fate of bacillus Calmette-Guerin after intravesical instillation. J Urol, 2001. 165: 1765. 
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399.Morales, A., et al. Intracavitary Bacillus Calmette-Guerin in the treatment of superficial bladder tumors. J Urol, 1976. 116: 180. 
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400.Lamm, D.L., et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. J Urol, 2000. 163: 1124. 
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401.Martinez-Pineiro, L., et al. Maintenance Therapy with 3-monthly Bacillus Calmette-Guerin for 3 Years is Not Superior to Standard Induction Therapy in High-risk Non-muscle-invasive Urothelial Bladder Carcinoma: Final Results of Randomised CUETO Study 98013. Eur Urol, 2015. 68: 256. 
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402.Oddens, J., et al. Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guerin in intermediate- and high-risk Ta, T1 papillary carcinoma of the urinary bladder: one-third dose versus full dose and 1 year versus 3 years of maintenance. Eur Urol, 2013. 63: 462. 
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403.Martinez-Pineiro, J.A., et al. Long-term follow-up of a randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette-Guerin with a reduced dose of 27 mg in superficial bladder cancer. BJU Int, 2002. 89: 671. 
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404.Martinez-Pineiro, J.A., et al. Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol, 2005. 174: 1242. 
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405.Ojea, A., et al. A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27 mg) versus very low-dose bacillus Calmette-Guerin (13.5 mg) versus mitomycin C. Eur Urol, 2007. 52: 1398. 
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406.Choi, S.Y., et al. Low-dose versus standard-dose bacille Calmette-Guerin for non-muscle-invasive bladder cancer: Systematic review and meta-analysis of randomized controlled trials. Investig Clin Urol, 2022. 63: 140. 
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407.Solsona, E., et al. Sequential combination of mitomycin C plus bacillus Calmette-Guerin (BCG) is more effective but more toxic than BCG alone in patients with non-muscle-invasive bladder cancer in intermediate- and high-risk patients: final outcome of CUETO 93009, a randomized prospective trial. Eur Urol, 2015. 67: 508. 
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408.Cui, J., et al. Combination of Intravesical Chemotherapy and Bacillus Calmette-Guerin Versus Bacillus Calmette-Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer: A Systematic Review and Meta-analysis. Medicine (Baltimore), 2016. 95: e2572. 
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409.Huang, D., et al. Combination of Intravesical Bacille Calmette-Guerin and Chemotherapy vs. Bacille Calmette-Guerin Alone in Non-muscle Invasive Bladder Cancer: A Meta-Analysis. Front Oncol, 2019. 9: 121. 
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410.Shepherd, A.R., et al. Intravesical Bacillus Calmette-Guerin with interferon-alpha versus intravesical Bacillus Calmette-Guerin for treating non-muscle-invasive bladder cancer. Cochrane Database Syst Rev, 2017. 3: CD012112. 
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411.Jarvinen, R., et al. Long-term outcome of patients with frequently recurrent non-muscle-invasive bladder carcinoma treated with one perioperative plus four weekly instillations of mitomycin C followed by monthly bacillus Calmette-Guerin (BCG) or alternating BCG and interferon-alpha2b instillations: prospective randomised FinnBladder-4 study. Eur Urol, 2015. 68: 611. 
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412.Marttila, T., et al. Intravesical Bacillus Calmette-Guerin Versus Combination of Epirubicin and Interferon-alpha2a in Reducing Recurrence of Non-Muscle-invasive Bladder Carcinoma: FinnBladder-6 Study. Eur Urol, 2016. 70: 341. 
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413.Delto, J. Preclinical analyses of intravesical chemotherapy for prevention of bladder cancer.Oncotarget, 2013. 2: 269. 
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414.Steinberg, R.L., et al. Sequential Intravesical Gemcitabine and Docetaxel for the Salvage Treatment of Non-Muscle Invasive Bladder Cancer. Bladder Cancer, 2015. 1: 65. 
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415.McElree, I.M., et al. Sequential Intravesical Valrubicin and Docetaxel for the Salvage Treatment of Non-Muscle-Invasive Bladder Cancer. J Urol, 2022. 208: 969. 
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416.Steinberg, R.L., et al. Multi-Institution Evaluation of Sequential Gemcitabine and Docetaxel as Rescue Therapy for Nonmuscle Invasive Bladder Cancer. J Urol, 2020. 203: 902. 
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417.Taylor, J., et al. Oncologic Outcomes of Sequential Intravesical Gemcitabine and Docetaxel Compared with Bacillus Calmette-Guerin in Patients with Bacillus Calmette-Guerin-Unresponsive Non-Muscle Invasive Bladder Cancer. Eur Urol Oncol, 2025. 8: 469. 
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418.Steinberg, R.L., et al. Intravesical sequential gemcitabine and docetaxel versus bacillus calmette-guerin (BCG) plus interferon in patients with recurrent non-muscle invasive bladder cancer following a single induction course of BCG. Urol Oncol, 2022. 40: 9 e1. 
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419.McElree, I.M., et al. Sequential Intravesical Gemcitabine and Docetaxel for bacillus Calmette-Guerin-Naive High-Risk Nonmuscle-Invasive Bladder Cancer. J Urol, 2022. 208: 589. 
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420.Kolanukuduru, K.P., et al. Comparative Effectiveness of Bacillus Calmette-Guerin and Sequential Intravesical Gemcitabine and Docetaxel for Treatment-naive Intermediate-risk Non-muscle-invasive Bladder Cancer. Eur Urol Focus, 2025. 11: 142. 
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421.Maas, M., et al. PD-L1 Expression in High-Risk Non-Muscle-Invasive Bladder Cancer Is Influenced by Intravesical Bacillus Calmette-Guerin (BCG) Therapy. Cancers (Basel), 2024. 16. 
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422.De Santis, M., et al. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet, 2025. 406: 2221. 
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423.Roupret, M., et al. ALBAN (GETUG-AFU 37): a phase III, randomized, open-label international trial of intravenous atezolizumab and intravesical Bacillus Calmette-Guerin (BCG) versus BCG alone in BCG-naive high-risk, non-muscle-invasive bladder cancer (NMIBC). Ann Oncol, 2025. 
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