Skip to main content
Erschienen in:

27.01.2022 | Invited Review

Adjuvant therapies for non-muscle-invasive bladder cancer: advances during BCG shortage

verfasst von: Adithya Balasubramanian, Ashray Gunjur, Andrew Weickhardt, Nathan Papa, Damien Bolton, Nathan Lawrentschuk, Marlon Perera

Erschienen in: World Journal of Urology | Ausgabe 5/2022

Einloggen, um Zugang zu erhalten

Abstract

Non-muscle-invasive bladder cancer (NMIBC) represents a significant global therapeutic challenge, particularly in the era of Bacillus Calmette–Guérin (BCG) shortage. High-risk NMIBC can progress to muscle invasive or metastatic disease in 25% of patients. Optimal treatment selection, according to risk stratification, is imperative. International guidelines slightly differ in their categorisation of low, intermediate and high-risk NMIBC. Nonetheless, a single post-operative instillation of chemotherapy with Mitomycin C (MMC) or Gemcitabine improves relapse-free survival (RFS) in low-risk NMIBC. Induction and maintenance intravesical BCG remains the historical gold standard for patients with intermediate or high-risk NMIBC. However, clinicians may be forced to consider alternatives given the current BCG shortage. Both intravesical MMC and Gemcitabine have been associated with similar efficacy to BCG, albeit in smaller studies. MMC may also be manipulated using a variety of methods to potentiate its effects. BCG treatment delivery may also be modified without affecting efficacy through dose reduction and abbreviation or omission of maintenance therapy. Preliminary data also highlight that directly proceeding to radical cystectomy may not adversely affect long-term quality of life measures. Access to new systemic and intravesical therapies must be prioritised for patients with BCG recurrent or unresponsive disease. When used in conjunction with molecularly defined biomarkers, these agents herald the potential for improved survival outcomes and alleviation of the current BCG shortage.
Literatur
1.
Zurück zum Zitat Schulz GB, Grimm T, Buchner A, Jokisch F, Kretschmer A, Stief CG et al (2019) Bladder Cancer Stage Development, 2004–2014 in Europe Compared With the United States: Analysis of European Population-based Cancer Registries, the United States SEER Database, and a Large Tertiary Institutional Cohort. Clin Genitourin Cancer. https://doi.org/10.1016/j.clgc.2019.10.008CrossRefPubMed Schulz GB, Grimm T, Buchner A, Jokisch F, Kretschmer A, Stief CG et al (2019) Bladder Cancer Stage Development, 2004–2014 in Europe Compared With the United States: Analysis of European Population-based Cancer Registries, the United States SEER Database, and a Large Tertiary Institutional Cohort. Clin Genitourin Cancer. https://​doi.​org/​10.​1016/​j.​clgc.​2019.​10.​008CrossRefPubMed
2.
Zurück zum Zitat Mossanen M, Gore JL (2014) The burden of bladder cancer care: direct and indirect costs. Curr Opin Urol 24:487–491PubMedCrossRef Mossanen M, Gore JL (2014) The burden of bladder cancer care: direct and indirect costs. Curr Opin Urol 24:487–491PubMedCrossRef
3.
Zurück zum Zitat Soukup V, Čapoun O, Cohen D, Hernández V, Babjuk M, Burger M et al (2017) Prognostic performance and reproducibility of the 1973 and 2004/2016 World Health Organization grading classification systems in non–muscle-invasive bladder cancer: A European Association of Urology Non-muscle Invasive Bladder Cancer Guidelines Panel Syst. Eur Urol 72:801–813PubMedCrossRef Soukup V, Čapoun O, Cohen D, Hernández V, Babjuk M, Burger M et al (2017) Prognostic performance and reproducibility of the 1973 and 2004/2016 World Health Organization grading classification systems in non–muscle-invasive bladder cancer: A European Association of Urology Non-muscle Invasive Bladder Cancer Guidelines Panel Syst. Eur Urol 72:801–813PubMedCrossRef
4.
Zurück zum Zitat Tully KH, Roghmann F, Noldus J, Chen X, Häuser L, Kibel AS et al (2020) Quantifying the overall survival benefit with early radical cystectomy for patients with histologically confirmed t1 non–muscle-invasive bladder cancer. Clin Genitourin Cancer 18:e651–e659PubMedCrossRef Tully KH, Roghmann F, Noldus J, Chen X, Häuser L, Kibel AS et al (2020) Quantifying the overall survival benefit with early radical cystectomy for patients with histologically confirmed t1 non–muscle-invasive bladder cancer. Clin Genitourin Cancer 18:e651–e659PubMedCrossRef
6.
Zurück zum Zitat Grimm M-O, van der Heijden AG, Colombel M, Muilwijk T, Martínez-Piñeiro L, Babjuk MM et al (2020) 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 78:690–698PubMedCrossRef Grimm M-O, van der Heijden AG, Colombel M, Muilwijk T, Martínez-Piñeiro L, Babjuk MM et al (2020) 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 78:690–698PubMedCrossRef
7.
Zurück zum Zitat Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR et al (2016) Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol 196:1021–1029PubMedCrossRef Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR et al (2016) Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol 196:1021–1029PubMedCrossRef
8.
Zurück zum Zitat Wroclawski ML, Schutz FA, Cha JD, Soares A (2019) Alternative therapies to Bacillus Calmette-Guérin shortage for nonmuscle invasive bladder cancer in Brazil and other underdeveloped countries: management considerations. J Glob Oncol 5:1–9PubMed Wroclawski ML, Schutz FA, Cha JD, Soares A (2019) Alternative therapies to Bacillus Calmette-Guérin shortage for nonmuscle invasive bladder cancer in Brazil and other underdeveloped countries: management considerations. J Glob Oncol 5:1–9PubMed
10.
Zurück zum Zitat Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A et al (2016) Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. Eur Urol 25:40–48 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A et al (2016) Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. Eur Urol 25:40–48
11.
Zurück zum Zitat National Collaborating Centre for Cancer (UK) (2015) Bladder cancer: diagnosis and management. National Institute for Health and Care Excellence (UK), London National Collaborating Centre for Cancer (UK) (2015) Bladder cancer: diagnosis and management. National Institute for Health and Care Excellence (UK), London
12.
Zurück zum Zitat Babjuk M, Böhle A, Burger M, Capoun O, Cohen D, Compérat EM et al (2017) EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2016. Eur Urol 71:447–461PubMedCrossRef Babjuk M, Böhle A, Burger M, Capoun O, Cohen D, Compérat EM et al (2017) EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2016. Eur Urol 71:447–461PubMedCrossRef
13.
Zurück zum Zitat Herr HW, Donat SM (2008) Quality control in transurethral resection of bladder tumours. BJU Int 102:1242–1246PubMedCrossRef Herr HW, Donat SM (2008) Quality control in transurethral resection of bladder tumours. BJU Int 102:1242–1246PubMedCrossRef
14.
Zurück zum Zitat Mariappan P, Zachou A, Grigor KM (2010) Detrusor muscle in the first, apparently complete transurethral resection of bladder tumour specimen is a surrogate marker of resection quality, predicts risk of early recurrence, and is dependent on operator experience. Eur Urol 57:843–849PubMedCrossRef Mariappan P, Zachou A, Grigor KM (2010) Detrusor muscle in the first, apparently complete transurethral resection of bladder tumour specimen is a surrogate marker of resection quality, predicts risk of early recurrence, and is dependent on operator experience. Eur Urol 57:843–849PubMedCrossRef
15.
Zurück zum Zitat Logan C, Brown M, Hayne D (2012) Intravesical therapies for bladder cancer—indications and limitations. BJU Int 110:12–21PubMedCrossRef Logan C, Brown M, Hayne D (2012) Intravesical therapies for bladder cancer—indications and limitations. BJU Int 110:12–21PubMedCrossRef
16.
Zurück zum Zitat (1994) The effect of intravesical thiotepa on tumour recurrence after endoscopic treatment of newly diagnosed superficial bladder cancer. A further report with long-term follow-up of a Medical Research Council randomized trial. Medical Research Council Working Party on Urological Cancer, Subgroup on Superficial Bladder Cancer. Br J Urol 73(6):632–638. https://doi.org/10.1111/j.1464-410x.1994.tb07547.x (1994) The effect of intravesical thiotepa on tumour recurrence after endoscopic treatment of newly diagnosed superficial bladder cancer. A further report with long-term follow-up of a Medical Research Council randomized trial. Medical Research Council Working Party on Urological Cancer, Subgroup on Superficial Bladder Cancer. Br J Urol 73(6):632–638. https://​doi.​org/​10.​1111/​j.​1464-410x.​1994.​tb07547.​x
17.
Zurück zum Zitat Gudjónsson S, Adell L, Merdasa F, Olsson R, Larsson B, Davidsson T et al (2009) Should all patients with non–muscle-invasive bladder cancer receive early intravesical chemotherapy after transurethral resection? The results of a prospective randomised multicentre study. Eur Urol 55:773–780PubMedCrossRef Gudjónsson S, Adell L, Merdasa F, Olsson R, Larsson B, Davidsson T et al (2009) Should all patients with non–muscle-invasive bladder cancer receive early intravesical chemotherapy after transurethral resection? The results of a prospective randomised multicentre study. Eur Urol 55:773–780PubMedCrossRef
18.
Zurück zum Zitat De Nunzio C, Carbone A, Albisinni S, Alpi G, Cantiani A, Liberti M et al (2011) Long-term experience with early single mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer: prospective, single-centre randomised trial. World J Urol 29:517–521PubMedCrossRef De Nunzio C, Carbone A, Albisinni S, Alpi G, Cantiani A, Liberti M et al (2011) Long-term experience with early single mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer: prospective, single-centre randomised trial. World J Urol 29:517–521PubMedCrossRef
19.
Zurück zum Zitat Sylvester RJ, Oosterlinck W, Holmang S, Sydes MR, Birtle A, Gudjonsson S et al (2016) Systematic review and individual patient data meta-analysis of randomized trials comparing a single immediate instillation of chemotherapy after transurethral resection with transurethral resection alone in patients with stage pTa–pT1 Urothelial Ca. Eur Urol 69:231–244PubMedCrossRef Sylvester RJ, Oosterlinck W, Holmang S, Sydes MR, Birtle A, Gudjonsson S et al (2016) Systematic review and individual patient data meta-analysis of randomized trials comparing a single immediate instillation of chemotherapy after transurethral resection with transurethral resection alone in patients with stage pTa–pT1 Urothelial Ca. Eur Urol 69:231–244PubMedCrossRef
20.
Zurück zum Zitat Elsawy AA, El-Assmy AM, Bazeed MA, Ali-El-Dein B (2019) 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 Semin Orig Invest 37:179918 Elsawy AA, El-Assmy AM, Bazeed MA, Ali-El-Dein B (2019) 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 Semin Orig Invest 37:179918
21.
Zurück zum Zitat Bosschieter J, Nieuwenhuijzen JA, van Ginkel T, Vis AN, Witte B, Newling D et al (2018) 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 73:226–232PubMedCrossRef Bosschieter J, Nieuwenhuijzen JA, van Ginkel T, Vis AN, Witte B, Newling D et al (2018) 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 73:226–232PubMedCrossRef
22.
Zurück zum Zitat Bosschieter J, van Moorselaar RJA, Vis AN, van Ginkel T, Lissenberg-Witte BI, Beckers GMA et al (2018) The effect of timing of an immediate instillation of mitomycin C after transurethral resection in 941 patients with non-muscle-invasive bladder cancer. BJU Int 122:571–575PubMedCrossRef Bosschieter J, van Moorselaar RJA, Vis AN, van Ginkel T, Lissenberg-Witte BI, Beckers GMA et al (2018) The effect of timing of an immediate instillation of mitomycin C after transurethral resection in 941 patients with non-muscle-invasive bladder cancer. BJU Int 122:571–575PubMedCrossRef
23.
Zurück zum Zitat Messing EM, Tangen CM, Lerner SP, Sahasrabudhe DM, Koppie TM, Wood DP Jr et al (2018) Effect of intravesical instillation of gemcitabine vs saline immediately following resection of suspected low-grade non–muscle-invasive bladder cancer on tumor recurrence: SWOG S0337 randomized clinical trial. JAMA 319:1880–1888PubMedPubMedCentralCrossRef Messing EM, Tangen CM, Lerner SP, Sahasrabudhe DM, Koppie TM, Wood DP Jr et al (2018) Effect of intravesical instillation of gemcitabine vs saline immediately following resection of suspected low-grade non–muscle-invasive bladder cancer on tumor recurrence: SWOG S0337 randomized clinical trial. JAMA 319:1880–1888PubMedPubMedCentralCrossRef
24.
Zurück zum Zitat Addeo R, Caraglia M, Bellini S, Abbruzzese A, Vincenzi B, Montella L et al (2010) Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance. J Clin Oncol 28:543–548PubMedCrossRef Addeo R, Caraglia M, Bellini S, Abbruzzese A, Vincenzi B, Montella L et al (2010) Randomized phase III trial on gemcitabine versus mytomicin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance. J Clin Oncol 28:543–548PubMedCrossRef
25.
Zurück zum Zitat Böhle A, Leyh H, Frei C, Kühn M, Tschada R, Pottek T et al (2009) Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder: a randomised, double-blind, placebo-controlled phase III multicentre study. Eur Urol 56:495–503PubMedCrossRef Böhle A, Leyh H, Frei C, Kühn M, Tschada R, Pottek T et al (2009) Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder: a randomised, double-blind, placebo-controlled phase III multicentre study. Eur Urol 56:495–503PubMedCrossRef
26.
Zurück zum Zitat Babjuk M, Burger M, Compérat EM, Gontero P, Mostafid HA, Palou J et al (2018) Indication for a single postoperative instillation of chemotherapy in non–muscle-invasive bladder cancer: what factors should be considered? Eur Urol Focus 4:525–528PubMedCrossRef Babjuk M, Burger M, Compérat EM, Gontero P, Mostafid HA, Palou J et al (2018) Indication for a single postoperative instillation of chemotherapy in non–muscle-invasive bladder cancer: what factors should be considered? Eur Urol Focus 4:525–528PubMedCrossRef
27.
Zurück zum Zitat Onishi T, Sugino Y, Shibahara T, Masui S, Yabana T, Sasaki T (2017) Randomized controlled study of the efficacy and safety of continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle-invasive bladder cancer. BJU Int 119:276–282PubMedCrossRef Onishi T, Sugino Y, Shibahara T, Masui S, Yabana T, Sasaki T (2017) Randomized controlled study of the efficacy and safety of continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle-invasive bladder cancer. BJU Int 119:276–282PubMedCrossRef
28.
Zurück zum Zitat Redelman-Sidi G, Glickman MS, Bochner BH (2014) The mechanism of action of BCG therapy for bladder cancer—a current perspective. Nat Rev Urol 11:153–162PubMedCrossRef Redelman-Sidi G, Glickman MS, Bochner BH (2014) The mechanism of action of BCG therapy for bladder cancer—a current perspective. Nat Rev Urol 11:153–162PubMedCrossRef
29.
Zurück zum Zitat Bohle A, Jocham D, Bock PR (2003) Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol 169:90–95PubMedCrossRef Bohle A, Jocham D, Bock PR (2003) Intravesical bacillus Calmette-Guerin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol 169:90–95PubMedCrossRef
30.
Zurück zum Zitat Lamm DL, van der Meijden PM, Morales A, Brosman SA, Catalona WJ, Herr HW et al (1992) Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol 147:596–600PubMedCrossRef Lamm DL, van der Meijden PM, Morales A, Brosman SA, Catalona WJ, Herr HW et al (1992) Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol 147:596–600PubMedCrossRef
31.
Zurück zum Zitat Herr HW, Laudone VP, Badalament RA, Oettgen HF, Sogani PC, Freedman BD et al (1988) Bacillus Calmette-Guérin therapy alters the progression of superficial bladder cancer. J Clin Oncol 6:1450–1455PubMedCrossRef Herr HW, Laudone VP, Badalament RA, Oettgen HF, Sogani PC, Freedman BD et al (1988) Bacillus Calmette-Guérin therapy alters the progression of superficial bladder cancer. J Clin Oncol 6:1450–1455PubMedCrossRef
32.
Zurück zum Zitat Järvinen R, Kaasinen E, Sankila A, Rintala E (2009) Long-term efficacy of maintenance bacillus Calmette-Guérin 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. Eur Urol 56:260–265PubMedCrossRef Järvinen R, Kaasinen E, Sankila A, Rintala E (2009) Long-term efficacy of maintenance bacillus Calmette-Guérin 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. Eur Urol 56:260–265PubMedCrossRef
33.
Zurück zum Zitat Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J et al (1990) Bacillus Calmette-Guerin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol 143:502–506PubMedCrossRef Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J et al (1990) Bacillus Calmette-Guerin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol 143:502–506PubMedCrossRef
34.
Zurück zum Zitat de Reijke TM, Kurth KH, Sylvester RJ, Hall RR, Brausi M, van de Beek K et al (2005) Bacillus Calmette-Guerin versus epirubicin for primary, secondary or concurrent carcinoma in situ of the bladder: results of a European Organization for the Research and Treatment of Cancer–Genito-Urinary Group Phase III Trial (30906). J Urol 173:405–409PubMedCrossRef de Reijke TM, Kurth KH, Sylvester RJ, Hall RR, Brausi M, van de Beek K et al (2005) Bacillus Calmette-Guerin versus epirubicin for primary, secondary or concurrent carcinoma in situ of the bladder: results of a European Organization for the Research and Treatment of Cancer–Genito-Urinary Group Phase III Trial (30906). J Urol 173:405–409PubMedCrossRef
35.
Zurück zum Zitat Pinsky CM, Camacho FJ, Kerr D, Geller NL, Klein FA, Herr HA et al (1985) Intravesical administration of bacillus Calmette-Guérin in patients with recurrent superficial carcinoma of the urinary bladder: report of a prospective, randomized trial. Cancer Treat Rep 69:47–53PubMed Pinsky CM, Camacho FJ, Kerr D, Geller NL, Klein FA, Herr HA et al (1985) Intravesical administration of bacillus Calmette-Guérin in patients with recurrent superficial carcinoma of the urinary bladder: report of a prospective, randomized trial. Cancer Treat Rep 69:47–53PubMed
36.
38.
Zurück zum Zitat Chen S, Zhang N, Shao J, Wang X (2018) Maintenance versus non-maintenance intravesical Bacillus Calmette-Guerin instillation for non-muscle invasive bladder cancer: a systematic review and meta-analysis of randomized clinical trials. Int J Surg (London, England) 52:248–257CrossRef Chen S, Zhang N, Shao J, Wang X (2018) Maintenance versus non-maintenance intravesical Bacillus Calmette-Guerin instillation for non-muscle invasive bladder cancer: a systematic review and meta-analysis of randomized clinical trials. Int J Surg (London, England) 52:248–257CrossRef
39.
Zurück zum Zitat Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G et al (2013) Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin 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 63:462–472PubMedCrossRef Oddens J, Brausi M, Sylvester R, Bono A, van de Beek C, van Andel G et al (2013) Final results of an EORTC-GU cancers group randomized study of maintenance bacillus Calmette-Guérin 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 63:462–472PubMedCrossRef
40.
Zurück zum Zitat Lamm DL, Blumenstein BA, Crissman JD, Montie JE, Gottesman JE, Lowe BA et al (2000) 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 163:1124–1129PubMedCrossRef Lamm DL, Blumenstein BA, Crissman JD, Montie JE, Gottesman JE, Lowe BA et al (2000) 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 163:1124–1129PubMedCrossRef
41.
Zurück zum Zitat Akaza H, Hinotsu S, Aso Y, Kakizoe T, Koiso K (1995) Bacillus Calmette-Guérin treatment of existing papillary bladder cancer and carcinoma in situ of the bladder. Four-year results. The Bladder Cancer BCG Study Group. Cancer 75:5529–9--9CrossRef Akaza H, Hinotsu S, Aso Y, Kakizoe T, Koiso K (1995) Bacillus Calmette-Guérin treatment of existing papillary bladder cancer and carcinoma in situ of the bladder. Four-year results. The Bladder Cancer BCG Study Group. Cancer 75:5529–9--9CrossRef
42.
Zurück zum Zitat Palou J, Laguna P, Millán-Rodríguez F, Hall RR, Salvador-Bayarri J, Vicente-Rodríguez J (2001) Control group and maintenance treatment with bacillus Calmette-Guerin for carcinoma in situ and/or high grade bladder tumors. J Urol 165:1488–1491PubMedCrossRef Palou J, Laguna P, Millán-Rodríguez F, Hall RR, Salvador-Bayarri J, Vicente-Rodríguez J (2001) Control group and maintenance treatment with bacillus Calmette-Guerin for carcinoma in situ and/or high grade bladder tumors. J Urol 165:1488–1491PubMedCrossRef
43.
Zurück zum Zitat Babjuk M, Burger M, Compérat EM, Gontero P, Mostafid AH, Palou J et al (2019) European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ)—2019 Update. Eur Urol 76:639–657PubMedCrossRef Babjuk M, Burger M, Compérat EM, Gontero P, Mostafid AH, Palou J et al (2019) European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ)—2019 Update. Eur Urol 76:639–657PubMedCrossRef
44.
Zurück zum Zitat Sylvester RJ, van der Meijden APM, Witjes JA, Kurth K (2005) Bacillus calmette-guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials. J Urol 174:82–86CrossRef Sylvester RJ, van der Meijden APM, Witjes JA, Kurth K (2005) Bacillus calmette-guerin versus chemotherapy for the intravesical treatment of patients with carcinoma in situ of the bladder: a meta-analysis of the published results of randomized clinical trials. J Urol 174:82–86CrossRef
45.
Zurück zum Zitat Chade DC, Shariat SF, Godoy G, Savage CJ, Cronin AM, Bochner BH et al (2010) Clinical outcomes of primary bladder carcinoma in situ in a contemporary series. J Urol 184:74–80PubMedPubMedCentralCrossRef Chade DC, Shariat SF, Godoy G, Savage CJ, Cronin AM, Bochner BH et al (2010) Clinical outcomes of primary bladder carcinoma in situ in a contemporary series. J Urol 184:74–80PubMedPubMedCentralCrossRef
46.
Zurück zum Zitat van der Meijden APM, Sylvester RJ, Oosterlinck W, Hoeltl W, Bono AV (2003) 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 44:429–434PubMedCrossRef van der Meijden APM, Sylvester RJ, Oosterlinck W, Hoeltl W, Bono AV (2003) 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 44:429–434PubMedCrossRef
47.
Zurück zum Zitat Koya MP, Simon MA, Soloway MS (2006) Complications of intravesical therapy for urothelial cancer of the bladder. J Urol 175:2004–2010PubMedCrossRef Koya MP, Simon MA, Soloway MS (2006) Complications of intravesical therapy for urothelial cancer of the bladder. J Urol 175:2004–2010PubMedCrossRef
48.
Zurück zum Zitat Lamm DL (2000) Efficacy and Safety of Bacille Calmette-Guérin immunotherapy in superficial bladder cancer. Clin Infect Dis 31:S86–S90PubMedCrossRef Lamm DL (2000) Efficacy and Safety of Bacille Calmette-Guérin immunotherapy in superficial bladder cancer. Clin Infect Dis 31:S86–S90PubMedCrossRef
49.
Zurück zum Zitat Agrawal MS, Agrawal M, Bansal S, Agarwal M, Lavania P, Goyal J (2007) The safety and efficacy of different doses of bacillus Calmette Guérin in superficial bladder transitional cell carcinoma. Urology 70:1075–1078PubMedCrossRef Agrawal MS, Agrawal M, Bansal S, Agarwal M, Lavania P, Goyal J (2007) The safety and efficacy of different doses of bacillus Calmette Guérin in superficial bladder transitional cell carcinoma. Urology 70:1075–1078PubMedCrossRef
50.
Zurück zum Zitat Rentsch CA, Birkhäuser FD, Biot C, Gsponer JR, Bisiaux A, Wetterauer C et al (2014) Bacillus Calmette-Guérin strain differences have an impact on clinical outcome in bladder cancer immunotherapy. Eur Urol 66:677–688PubMedCrossRef Rentsch CA, Birkhäuser FD, Biot C, Gsponer JR, Bisiaux A, Wetterauer C et al (2014) Bacillus Calmette-Guérin strain differences have an impact on clinical outcome in bladder cancer immunotherapy. Eur Urol 66:677–688PubMedCrossRef
51.
Zurück zum Zitat Witjes JA, Dalbagni G, Karnes RJ, Shariat S, Joniau S, Palou J et al (2016) The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer. Urol Oncol Semin Orig Invest 34:484.e195-.e25 Witjes JA, Dalbagni G, Karnes RJ, Shariat S, Joniau S, Palou J et al (2016) The efficacy of BCG TICE and BCG Connaught in a cohort of 2,099 patients with T1G3 non–muscle-invasive bladder cancer. Urol Oncol Semin Orig Invest 34:484.e195-.e25
53.
Zurück zum Zitat Zargar H, Aning J, Ischia J, So A, Black P (2014) Optimizing intravesical mitomycin C therapy in non-muscle-invasive bladder cancer. Nat Rev Urol 11:220–230PubMedCrossRef Zargar H, Aning J, Ischia J, So A, Black P (2014) Optimizing intravesical mitomycin C therapy in non-muscle-invasive bladder cancer. Nat Rev Urol 11:220–230PubMedCrossRef
54.
Zurück zum Zitat Lamm DL, Blumenstein BA, David Crawford E, Crissman JD, Lowe BA, Smith JA et al (1995) Randomized intergroup comparison of bacillus calmette-guerin immunotherapy and mitomycin C chemotherapy prophylaxis in superficial transitional cell carcinoma of the bladder a southwest oncology group study. Urol Oncol Semin Orig Invest 1:119–126 Lamm DL, Blumenstein BA, David Crawford E, Crissman JD, Lowe BA, Smith JA et al (1995) Randomized intergroup comparison of bacillus calmette-guerin immunotherapy and mitomycin C chemotherapy prophylaxis in superficial transitional cell carcinoma of the bladder a southwest oncology group study. Urol Oncol Semin Orig Invest 1:119–126
55.
Zurück zum Zitat Vegt PDJ, Witjes JA, Witjes WPJ, Doesburg WH, Debruyne FMJ, van der Meijden APM et al (1995) Original Articles: bladder cancer: a randomized study of intravesical mitomycin c, bacillus calmette-guerin tice and bacillus calmette-guerin RIVM treatment in pTa-pT1 papillary carcinoma and carcinoma in situ of the bladder. J Urol 153:929–933PubMedCrossRef Vegt PDJ, Witjes JA, Witjes WPJ, Doesburg WH, Debruyne FMJ, van der Meijden APM et al (1995) Original Articles: bladder cancer: a randomized study of intravesical mitomycin c, bacillus calmette-guerin tice and bacillus calmette-guerin RIVM treatment in pTa-pT1 papillary carcinoma and carcinoma in situ of the bladder. J Urol 153:929–933PubMedCrossRef
56.
Zurück zum Zitat Friedrich MG, Pichlmeier U, Schwaibold H, Conrad S, Huland H (2007) Long-term intravesical adjuvant chemotherapy further reduces recurrence rate compared with short-term intravesical chemotherapy and short-term therapy with Bacillus Calmette-Guérin (BCG) in patients with non-muscle-invasive bladder carcinoma. Eur Urol 52:1123–1129PubMedCrossRef Friedrich MG, Pichlmeier U, Schwaibold H, Conrad S, Huland H (2007) Long-term intravesical adjuvant chemotherapy further reduces recurrence rate compared with short-term intravesical chemotherapy and short-term therapy with Bacillus Calmette-Guérin (BCG) in patients with non-muscle-invasive bladder carcinoma. Eur Urol 52:1123–1129PubMedCrossRef
57.
Zurück zum Zitat Au JLS, Badalament RA, Wientjes MG, Young DC, Warner JA, Venema PL et al (2001) Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III Trial. J Nat Cancer Inst 93:597–604PubMedCrossRef Au JLS, Badalament RA, Wientjes MG, Young DC, Warner JA, Venema PL et al (2001) Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III Trial. J Nat Cancer Inst 93:597–604PubMedCrossRef
58.
Zurück zum Zitat Schmidt S, Kunath F, Coles B, Draeger DL, Krabbe L-M, Dersch R et al (2020) Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer. Cochrane Database Syst Rev 1:CD011935-CDPubMed Schmidt S, Kunath F, Coles B, Draeger DL, Krabbe L-M, Dersch R et al (2020) Intravesical Bacillus Calmette-Guérin versus mitomycin C for Ta and T1 bladder cancer. Cochrane Database Syst Rev 1:CD011935-CDPubMed
59.
Zurück zum Zitat Witjes JA, van der Heijden AG, Vriesema JLJ, Peters GJ, Laan A, Schalken JA (2004) Intravesical gemcitabine: a phase 1 and pharmacokinetic study. Eur Urol 45:182–186PubMedCrossRef Witjes JA, van der Heijden AG, Vriesema JLJ, Peters GJ, Laan A, Schalken JA (2004) Intravesical gemcitabine: a phase 1 and pharmacokinetic study. Eur Urol 45:182–186PubMedCrossRef
60.
Zurück zum Zitat de Sousa CL, Monteiro G (2014) Gemcitabine: metabolism and molecular mechanisms of action, sensitivity and chemoresistance in pancreatic cancer. Eur J Pharmacol 741:8–16CrossRef de Sousa CL, Monteiro G (2014) Gemcitabine: metabolism and molecular mechanisms of action, sensitivity and chemoresistance in pancreatic cancer. Eur J Pharmacol 741:8–16CrossRef
61.
Zurück zum Zitat Ye Z, Chen J, Hong Y, Xin W, Yang S, Rao Y (2018) The efficacy and safety of intravesical gemcitabine vs Bacille Calmette-Guérin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis. Onco Targets Ther 11:4641–4649PubMedPubMedCentralCrossRef Ye Z, Chen J, Hong Y, Xin W, Yang S, Rao Y (2018) The efficacy and safety of intravesical gemcitabine vs Bacille Calmette-Guérin for adjuvant treatment of non-muscle invasive bladder cancer: a meta-analysis. Onco Targets Ther 11:4641–4649PubMedPubMedCentralCrossRef
62.
Zurück zum Zitat Lotfy B, Salem K, Ashraf S, Nashwa N (2011) 1655 intravesical gemcitabine versus bacillus calmette-guerin (BCG) in treatment of non-muscle invasive bladder cancer: short term comparative study. J Urol 185:e664–e665 Lotfy B, Salem K, Ashraf S, Nashwa N (2011) 1655 intravesical gemcitabine versus bacillus calmette-guerin (BCG) in treatment of non-muscle invasive bladder cancer: short term comparative study. J Urol 185:e664–e665
63.
Zurück zum Zitat Lu JL, Xia QD, Lu YH, Liu Z, Zhou P, Hu HL et al (2020) Efficacy of intravesical therapies on the prevention of recurrence and progression of non-muscle-invasive bladder cancer: a systematic review and network meta-analysis. Cancer Med 9:7800–7809PubMedPubMedCentralCrossRef Lu JL, Xia QD, Lu YH, Liu Z, Zhou P, Hu HL et al (2020) Efficacy of intravesical therapies on the prevention of recurrence and progression of non-muscle-invasive bladder cancer: a systematic review and network meta-analysis. Cancer Med 9:7800–7809PubMedPubMedCentralCrossRef
64.
Zurück zum Zitat V MM, E GJ, Neal S, D GG, Hugh M, C BP (2019) Emerging immunotherapy options for bacillus calmette-guérin unresponsive nonmuscle invasive bladder cancer. J Urol 202:1111–9CrossRef V MM, E GJ, Neal S, D GG, Hugh M, C BP (2019) Emerging immunotherapy options for bacillus calmette-guérin unresponsive nonmuscle invasive bladder cancer. J Urol 202:1111–9CrossRef
65.
Zurück zum Zitat Dinney CPN, Greenberg RE, Steinberg GD (2013) Intravesical valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus Calmette-Guérin. Urol Oncol Semin Orig Invest 31:1635–1642 Dinney CPN, Greenberg RE, Steinberg GD (2013) Intravesical valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus Calmette-Guérin. Urol Oncol Semin Orig Invest 31:1635–1642
66.
Zurück zum Zitat Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M (2000) Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol 163:761–7PubMedCrossRef Steinberg G, Bahnson R, Brosman S, Middleton R, Wajsman Z, Wehle M (2000) Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder. The Valrubicin Study Group. J Urol 163:761–7PubMedCrossRef
67.
Zurück zum Zitat Huang D, Jin Y-H, Weng H, Huang Q, Zeng X-T, Wang X-H (2019) Combination of Intravesical Bacille Calmette-Guérin and chemotherapy vs Bacille Calmette-Guérin alone in non-muscle invasive bladder cancer: a meta-analysis. Front Oncol 9:121PubMedPubMedCentralCrossRef Huang D, Jin Y-H, Weng H, Huang Q, Zeng X-T, Wang X-H (2019) Combination of Intravesical Bacille Calmette-Guérin and chemotherapy vs Bacille Calmette-Guérin alone in non-muscle invasive bladder cancer: a meta-analysis. Front Oncol 9:121PubMedPubMedCentralCrossRef
68.
Zurück zum Zitat Houghton BB, Chalasani V, Hayne D, Grimison P, Brown CSB, Patel MI et al (2013) Intravesical chemotherapy plus bacille Calmette-Guérin in non-muscle invasive bladder cancer: a systematic review with meta-analysis. BJU Int 111:977–983PubMedCrossRef Houghton BB, Chalasani V, Hayne D, Grimison P, Brown CSB, Patel MI et al (2013) Intravesical chemotherapy plus bacille Calmette-Guérin in non-muscle invasive bladder cancer: a systematic review with meta-analysis. BJU Int 111:977–983PubMedCrossRef
69.
Zurück zum Zitat Hayne D, Stockler M, McCombie SP, Chalasani V, Long A, Martin A et al (2015) BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301). BMC Cancer 15:432PubMedPubMedCentralCrossRef Hayne D, Stockler M, McCombie SP, Chalasani V, Long A, Martin A et al (2015) BCG+MMC trial: adding mitomycin C to BCG as adjuvant intravesical therapy for high-risk, non-muscle-invasive bladder cancer: a randomised phase III trial (ANZUP 1301). BMC Cancer 15:432PubMedPubMedCentralCrossRef
70.
Zurück zum Zitat Steinberg RL, Thomas LJ, Brooks N, Mott SL, Vitale A, Crump T et al (2020) Multi-institution evaluation of sequential gemcitabine and docetaxel as rescue therapy for nonmuscle invasive bladder cancer. J Urol 203:902–909PubMedCrossRef Steinberg RL, Thomas LJ, Brooks N, Mott SL, Vitale A, Crump T et al (2020) Multi-institution evaluation of sequential gemcitabine and docetaxel as rescue therapy for nonmuscle invasive bladder cancer. J Urol 203:902–909PubMedCrossRef
71.
Zurück zum Zitat Babajide R, Labbate C, Saoud R, Agarwal PK (2020) Early experience with intravesical gemcitabine-docetaxel for BCG-naïve patients with high grade non-muscle invasive bladder cancer. Urol Oncol Semin Orig Invest 38:901 Babajide R, Labbate C, Saoud R, Agarwal PK (2020) Early experience with intravesical gemcitabine-docetaxel for BCG-naïve patients with high grade non-muscle invasive bladder cancer. Urol Oncol Semin Orig Invest 38:901
72.
Zurück zum Zitat van der Heijden AG, Verhaegh G, Jansen CFJ, Schalken JA, Witjes JA (2005) Effect of hyperthermia on the cytotoxicity of 4 chemotherapeutic agents currently used for the treatment of transitional cell carcinoma of the bladder: an in vitro study. J Urol 173:1375–1380PubMedCrossRef van der Heijden AG, Verhaegh G, Jansen CFJ, Schalken JA, Witjes JA (2005) Effect of hyperthermia on the cytotoxicity of 4 chemotherapeutic agents currently used for the treatment of transitional cell carcinoma of the bladder: an in vitro study. J Urol 173:1375–1380PubMedCrossRef
73.
Zurück zum Zitat Di Stasi SM, Giannantoni A, Massoud R, Dolci S, Navarra P, Vespasiani G et al (1999) Electromotive versus passive diffusion of mitomycin C into human bladder wall: concentration-depth profiles studies. Cancer Res 59:4912–4918PubMed Di Stasi SM, Giannantoni A, Massoud R, Dolci S, Navarra P, Vespasiani G et al (1999) Electromotive versus passive diffusion of mitomycin C into human bladder wall: concentration-depth profiles studies. Cancer Res 59:4912–4918PubMed
74.
Zurück zum Zitat Dietrich MF, Gerber DE (2016) Chemotherapy for advanced non-small cell lung cancer. Cancer Treat Res 170:119–149PubMedCrossRef Dietrich MF, Gerber DE (2016) Chemotherapy for advanced non-small cell lung cancer. Cancer Treat Res 170:119–149PubMedCrossRef
75.
Zurück zum Zitat Arends TJH, Nativ O, Maffezzini M, de Cobelli O, Canepa G, Verweij F et al (2016) Results of a randomised controlled trial comparing intravesical chemohyperthermia with mitomycin c versus bacillus calmette-guérin for adjuvant treatment of patients with intermediate- and high-risk non–muscle-invasive bladder cancer. Eur Urol 69:1046–1052PubMedCrossRef Arends TJH, Nativ O, Maffezzini M, de Cobelli O, Canepa G, Verweij F et al (2016) Results of a randomised controlled trial comparing intravesical chemohyperthermia with mitomycin c versus bacillus calmette-guérin for adjuvant treatment of patients with intermediate- and high-risk non–muscle-invasive bladder cancer. Eur Urol 69:1046–1052PubMedCrossRef
76.
Zurück zum Zitat Tan WS, Panchal A, Buckley L, Devall AJ, Loubière LS, Pope AM et al (2019) Radiofrequency-induced thermo-chemotherapy effect versus a second course of Bacillus Calmette-Guérin or institutional standard in patients with recurrence of non-muscle-invasive bladder cancer following induction or maintenance bacillus Calmette-Guérin T. Eur Urol 75:63–71PubMedCrossRef Tan WS, Panchal A, Buckley L, Devall AJ, Loubière LS, Pope AM et al (2019) Radiofrequency-induced thermo-chemotherapy effect versus a second course of Bacillus Calmette-Guérin or institutional standard in patients with recurrence of non-muscle-invasive bladder cancer following induction or maintenance bacillus Calmette-Guérin T. Eur Urol 75:63–71PubMedCrossRef
77.
Zurück zum Zitat Kleinmann N, Matin SF, Pierorazio PM, Gore JL, Shabsigh A, Hu B et al (2020) Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol 21:776–785PubMedCrossRef Kleinmann N, Matin SF, Pierorazio PM, Gore JL, Shabsigh A, Hu B et al (2020) Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): an open-label, single-arm, phase 3 trial. Lancet Oncol 21:776–785PubMedCrossRef
78.
Zurück zum Zitat FDA approves mitomycin for low-grade upper tract urothelial cancer | FDA. FDA approves mitomycin for low-grade upper tract urothelial cancer | FDA.
79.
Zurück zum Zitat Kates M, Nirschl T, Sopko NA, Matsui H, Kochel CM, Reis LO et al (2017) Intravesical BCG induces CD4(+) T-Cell expansion in an immune competent model of bladder cancer. Cancer Immunol Res 5:594–603PubMedPubMedCentralCrossRef Kates M, Nirschl T, Sopko NA, Matsui H, Kochel CM, Reis LO et al (2017) Intravesical BCG induces CD4(+) T-Cell expansion in an immune competent model of bladder cancer. Cancer Immunol Res 5:594–603PubMedPubMedCentralCrossRef
80.
Zurück zum Zitat Balar AV, Kamat AM, Kulkarni GS, Uchio EM, Boormans JL, Roumiguié M et al (2021) Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol 22:919–930PubMedCrossRef Balar AV, Kamat AM, Kulkarni GS, Uchio EM, Boormans JL, Roumiguié M et al (2021) Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol 22:919–930PubMedCrossRef
81.
Zurück zum Zitat Balar AV, Kulkarni GS, Uchio EM, Boormans J, Mourey L, Krieger LEM et al (2019) Keynote 057: Phase II trial of Pembrolizumab (pembro) for patients (pts) with high-risk (HR) nonmuscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG). J Clin Oncol 37:350CrossRef Balar AV, Kulkarni GS, Uchio EM, Boormans J, Mourey L, Krieger LEM et al (2019) Keynote 057: Phase II trial of Pembrolizumab (pembro) for patients (pts) with high-risk (HR) nonmuscle invasive bladder cancer (NMIBC) unresponsive to bacillus calmette-guérin (BCG). J Clin Oncol 37:350CrossRef
82.
Zurück zum Zitat Woodcock VK, Purshouse K, Butcher C, Haddon C, Verrall G, Elhussein L et al (2019) A phase I study to assess the safety and tolerability of intravesical pembrolizumab in recurrent non-muscle invasive bladder cancer (NMIBC). J Clin Oncol 37:406CrossRef Woodcock VK, Purshouse K, Butcher C, Haddon C, Verrall G, Elhussein L et al (2019) A phase I study to assess the safety and tolerability of intravesical pembrolizumab in recurrent non-muscle invasive bladder cancer (NMIBC). J Clin Oncol 37:406CrossRef
83.
Zurück zum Zitat Merck Announces Plans to Construct New Facility in the United States to Expand Manufacturing Capacity for TICE® BCG - Merck.com. Merck Announces Plans to Construct New Facility in the United States to Expand Manufacturing Capacity for TICE® BCG - Merck.com.
84.
Zurück zum Zitat Catto JWF, Gordon K, Collinson M, Poad H, Twiddy M, Johnson M et al (2020) Radical cystectomy against intravesical BCG for high-risk high-grade nonmuscle invasive bladder cancer: results from the randomized controlled BRAVO-feasibility study. J Clin Oncol 39:202–214PubMedPubMedCentralCrossRef Catto JWF, Gordon K, Collinson M, Poad H, Twiddy M, Johnson M et al (2020) Radical cystectomy against intravesical BCG for high-risk high-grade nonmuscle invasive bladder cancer: results from the randomized controlled BRAVO-feasibility study. J Clin Oncol 39:202–214PubMedPubMedCentralCrossRef
85.
Zurück zum Zitat Saito R, Smith CC, Utsumi T, Bixby LM, Kardos J, Wobker SE et al (2018) Molecular subtype-specific immunocompetent models of high-grade urothelial carcinoma reveal differential neoantigen expression and response to immunotherapy. Can Res 78:3954–3968CrossRef Saito R, Smith CC, Utsumi T, Bixby LM, Kardos J, Wobker SE et al (2018) Molecular subtype-specific immunocompetent models of high-grade urothelial carcinoma reveal differential neoantigen expression and response to immunotherapy. Can Res 78:3954–3968CrossRef
86.
Zurück zum Zitat Shore ND, Boorjian SA, Canter DJ, Ogan K, Karsh LI, Downs TM et al (2017) Intravesical rAd–IFNα/Syn3 for patients with high-grade, bacillus calmette-guerin–refractory or relapsed non–muscle-invasive bladder cancer: a phase ii randomized study. J Clin Oncol 35:3410–3416PubMedPubMedCentralCrossRef Shore ND, Boorjian SA, Canter DJ, Ogan K, Karsh LI, Downs TM et al (2017) Intravesical rAd–IFNα/Syn3 for patients with high-grade, bacillus calmette-guerin–refractory or relapsed non–muscle-invasive bladder cancer: a phase ii randomized study. J Clin Oncol 35:3410–3416PubMedPubMedCentralCrossRef
87.
Zurück zum Zitat Boorjian SA, Dinney CPN (2020) Safety and efficacy of intravesical nadofaragene firadenovec for patients with high-grade, BCG unresponsive nonmuscle invasive bladder cancer (NMIBC): Results from a phase III trial. J Clin Oncol 38:442CrossRef Boorjian SA, Dinney CPN (2020) Safety and efficacy of intravesical nadofaragene firadenovec for patients with high-grade, BCG unresponsive nonmuscle invasive bladder cancer (NMIBC): Results from a phase III trial. J Clin Oncol 38:442CrossRef
88.
Zurück zum Zitat Mitra AP, Birkhahn M, Cote RJ (2007) p53 and retinoblastoma pathways in bladder cancer. World J Urol 25:563–571PubMedCrossRef Mitra AP, Birkhahn M, Cote RJ (2007) p53 and retinoblastoma pathways in bladder cancer. World J Urol 25:563–571PubMedCrossRef
89.
Zurück zum Zitat Packiam VT, Lamm DL, Barocas DA, Trainer A, Fand B, Davis RL 3rd et al (2018) An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non-muscle-invasive bladder cancer: Interim results. Urol Oncol 36:440–447PubMedCrossRef Packiam VT, Lamm DL, Barocas DA, Trainer A, Fand B, Davis RL 3rd et al (2018) An open label, single-arm, phase II multicenter study of the safety and efficacy of CG0070 oncolytic vector regimen in patients with BCG-unresponsive non-muscle-invasive bladder cancer: Interim results. Urol Oncol 36:440–447PubMedCrossRef
90.
Zurück zum Zitat Bassi PF, Volpe A, D’Agostino D, Palermo G, Renier D, Franchini S et al (2011) Paclitaxel-hyaluronic acid for intravesical therapy of Bacillus Calmette-Guérin refractory carcinoma in situ of the bladder: results of a phase I study. J Urol 185:445–449PubMedCrossRef Bassi PF, Volpe A, D’Agostino D, Palermo G, Renier D, Franchini S et al (2011) Paclitaxel-hyaluronic acid for intravesical therapy of Bacillus Calmette-Guérin refractory carcinoma in situ of the bladder: results of a phase I study. J Urol 185:445–449PubMedCrossRef
91.
Zurück zum Zitat Huang W, Wang F, Wu C, Hu W (2015) Efficacy and safety of pirarubicin combined with hyaluronic acid for non-muscle invasive bladder cancer after transurethral resection: a prospective, randomized study. Int Urol Nephrol 47:631–636PubMedCrossRef Huang W, Wang F, Wu C, Hu W (2015) Efficacy and safety of pirarubicin combined with hyaluronic acid for non-muscle invasive bladder cancer after transurethral resection: a prospective, randomized study. Int Urol Nephrol 47:631–636PubMedCrossRef
92.
Zurück zum Zitat Hedegaard J, Lamy P, Nordentoft I, Algaba F, Høyer S, Ulhøi Benedicte P et al (2016) Comprehensive transcriptional analysis of early-stage urothelial carcinoma. Cancer Cell 30:27–42PubMedCrossRef Hedegaard J, Lamy P, Nordentoft I, Algaba F, Høyer S, Ulhøi Benedicte P et al (2016) Comprehensive transcriptional analysis of early-stage urothelial carcinoma. Cancer Cell 30:27–42PubMedCrossRef
93.
Zurück zum Zitat Pietzak EJ, Bagrodia A, Cha EK, Drill EN, Iyer G, Isharwal S et al (2017) Next-generation sequencing of nonmuscle invasive bladder cancer reveals potential biomarkers and rational therapeutic targets. Eur Urol 72:952–959PubMedPubMedCentralCrossRef Pietzak EJ, Bagrodia A, Cha EK, Drill EN, Iyer G, Isharwal S et al (2017) Next-generation sequencing of nonmuscle invasive bladder cancer reveals potential biomarkers and rational therapeutic targets. Eur Urol 72:952–959PubMedPubMedCentralCrossRef
94.
Zurück zum Zitat Bellmunt J, Kim J, Reardon B, Perera-Bel J, Orsola A, Rodriguez-Vida A et al (2020) Genomic predictors of good outcome, recurrence, or progression in high-grade T1 non–muscle-invasive bladder cancer. Cancer Res 80:4476PubMedCrossRef Bellmunt J, Kim J, Reardon B, Perera-Bel J, Orsola A, Rodriguez-Vida A et al (2020) Genomic predictors of good outcome, recurrence, or progression in high-grade T1 non–muscle-invasive bladder cancer. Cancer Res 80:4476PubMedCrossRef
95.
Zurück zum Zitat Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K et al (2020) Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol 21:1353–1365PubMedCrossRef Marabelle A, Fakih M, Lopez J, Shah M, Shapira-Frommer R, Nakagawa K et al (2020) Association of tumour mutational burden with outcomes in patients with advanced solid tumours treated with pembrolizumab: prospective biomarker analysis of the multicohort, open-label, phase 2 KEYNOTE-158 study. Lancet Oncol 21:1353–1365PubMedCrossRef
Metadaten
Titel
Adjuvant therapies for non-muscle-invasive bladder cancer: advances during BCG shortage
verfasst von
Adithya Balasubramanian
Ashray Gunjur
Andrew Weickhardt
Nathan Papa
Damien Bolton
Nathan Lawrentschuk
Marlon Perera
Publikationsdatum
27.01.2022
Verlag
Springer Berlin Heidelberg
Erschienen in
World Journal of Urology / Ausgabe 5/2022
Print ISSN: 0724-4983
Elektronische ISSN: 1433-8726
DOI
https://doi.org/10.1007/s00345-021-03908-x

Neu im Fachgebiet Urologie

Nierenzellkarzinom: Kein Nachteil durch subkutan appliziertes Nivolumab

Die subkutane Applikation von Nivolumab ist nach Daten einer Phase-3-Studie ähnlich gut wirksam wie die intravenöse: Die Pharmakokinetik ist vergleichbar, die objektive Response war in der Studie sogar leicht besser als in der Gruppe mit Infusionen.

Auf weichem Fahrradsattel ist nicht gut Kinder zeugen

Männer, die sich gern sportlich verausgaben, riskieren möglicherweise, fürs Vaterwerden nicht genug Kräfte übrig zu haben. In einer Studie fanden sich dafür zwar allenfalls schwache Anzeichen. Es gab jedoch eine Ausnahme.

Vorteile für Androgenentzug plus Androgenrezeptorblockade

Für Männer mit metastasiertem hormonsensitivem Prostata-Ca. (mHSPC), die keine Hormonchemotherapie wollen oder vertragen, ist der Androgenentzug plus Darolutamid eine Alternative: Das Progressionsrisiko wird im Vergleich zum alleinigen Androgenentzug fast halbiert.

Bei „Harnwegsinfekt“ mit Fieber an akute Prostatitis denken!

Symptome eines Harnwegsinfekts sind bei geriatrischen Patienten keinesfalls auf die leichte Schulter zu nehmen. Der Urogeriater Prof. Andreas Wiedemann von der Uni Witten/Herdecke warnt vor zwei schweren Krankheitsbildern, die immer noch häufig übersehen werden, und gibt praktische Tipps für die Diagnostik.

Update Urologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.