Maintenance Bacillus Calmette-Guérin: The Standard of Care for the Prophylaxis and Management of Intermediate- and High-Risk Non-Muscle-Invasive Bladder Cancer

European Urology, Supplements

Volumn 9, Issue 9, 2010, Pages 715-734

  Lamm, Donald ^a   Persad, Raj ^b   Colombel, Marc ^c   Brausi, Maurizio ^d  

^a UNIVERSITY OF ARIZONA COLLEGE OF MEDICINE   (United States)

^b BRISTOL ROYAL INFIRMARY   (United Kingdom)

^c UNIVERSITÉ LYON 1   (France)

^d AUSL Modena   (Italy)

Author keywords

Bacillus Calmette Gu rin; BCG; Chemotherapy; Immunotherapy; Intravesical therapy; Maintenance therapy; NMIBC; Non muscle invasive bladder cancer

Indexed keywords

BCG VACCINE;

BLADDER CANCER; CANCER GROWTH; CANCER IMMUNIZATION; CANCER MORTALITY; CANCER PREVENTION; CANCER RECURRENCE; CANCER RISK; CLINICAL TRIAL; DRUG UTILIZATION; GOLD STANDARD; HIGH RISK PATIENT; HUMAN; MAINTENANCE THERAPY; NONHUMAN; PATIENT CARE; PATIENT COMPLIANCE; PHYSICIAN ATTITUDE; PRIORITY JOURNAL; REVIEW; STANDARD;

EID: 78049452071     PISSN: 15699056     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eursup.2010.08.005     Document Type: Review

References (69)

1. Lamm D.L., Blumenstein B.A., Crissman J.D., et al. Maintenance bacillus Calmette-Guérin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. J Urol 2000, 163:1124-1129.
2. Sylvester R.J., van der Meijden A.P., Lamm D.L. Intravesical bacillus Calmette-Guérin reduces the risk of progression in patients with superficial bladder cancer: a combined analysis of the published results of randomized clinical trials. J Urol 2002, 168:1964-1970.
3. Böhle A., Jocham D., Bock P.R. Intravesical bacillus Calmette-Guérin versus mitomycin C for superficial bladder cancer: a formal meta-analysis of comparative studies on recurrence and toxicity. J Urol 2003, 169:90-95.
4. Böhle A., Bock P.R. Intravesical bacille Calmette-Guérin versus mitomycin C in superficial bladder cancer: formal meta-analysis of comparative studies on tumour progression. Urology 2004, 63:682-686.
5. Sylvester R.J., van der Meijden A.P., Witjes J.A., et al. 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 2005, 174:86-91.
6. Han R.F., Pan J.G. Can intravesical bacillus Calmette-Guérin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials. Urology 2006, 67:1216-1223.
7. Malmström P.-U., Sylvester R.J., Crawford D.E., et al. An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guérin for non-muscle-invasive bladder cancer. Eur Urol 2009, 56:247-256.
8. Sylvester R.J., Brausi M.A., Kirkels W.J., et al. Long-term efficacy results of EORTC Genito-Urinary Group randomized phase 3 study 30911 comparing intravesical instillations of epirubicin, bacillus Calmette-Guérin, and bacillus Calmette-Guérin plus isoniazid in patients with intermediate- and high-risk stage Ta T1 urothelial carcinoma of the bladder. Eur Urol 2010, 57:766-773.
9. Hinotsu S, Akaza H, Naito S, et al. Maintenance therapy with bacillus Calmette-Guérin (BCG) Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumor (TURBT) for non-muscle-invasive transitional cell carcinoma of the bladder. BJU Int. In press.
10. Bladder cancer: guideline for the management of nonmuscle invasive bladder cancer (stages Ta,T1, and Tis): 2007 update. American Urological Association Web site. http://www.auanet.org/content/guidelines-and-quality-care/clinical-guidelines.cfm%3Fsub=bc%26CFID=673377%26CFTOKEN=95927192%26jsessionid=843082c98dcd9c03ed6c6863583e7735217f.
11. Babjuk M, Oosterlinck W, Sylvester R, et al. Guidelines on TaT1 (non-muscle invasive) bladder cancer. European Association of Urology Web site. Updated 2009. http://www.uroweb.org/gls/pdf/TaT1%20(non-muscle%20invasive)%20bladder%20cancer%202010.pdf.
12. Clinical practice guidelines in oncology: bladder cancer including upper tract tumors and urothelial carcinoma of the prostate. National Comprehensive Cancer Network Web site. Updated 2010. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp.
13. Taniguchi K., Koga S., Nishikido M., et al. Systemic immune response after intravesical instillation of bacille Calmette-Guérin (BCG) for superficial bladder cancer. Clin Exp Immunol 1999, 115:131-135.
14. Chen F., Zhang G., Iwamoto Y., See W.A. BCG directly induces cell cycle arrest in human transitional carcinoma cell lines as a consequence of integrin cross-linking. BMC Urol 2005, 5:8.
15. O'Donnell M.A., DeWolf W.C. BCG immunotherapy for superficial bladder cancer. New prospects for an old warhorse. Surg Oncol Clin North Amer 1995, 4:189-202.
16. Prescott S., James K., Hargreave T.B., Chisholm G.D., Smyth J.F. Intravesical Evans strain BCG therapy: quantitative immunohistochemical analysis of the immune response within the bladder wall. J Urol 1992, 147:1636-1642.
17. Böhle A., Brandau S. Immune mechanisms in bacillus Calmette-Guerin immunotherapy for superficial bladder cancer. J Urol 2003, 170:964-969.
18. Ratliff T.L., Gillen D., Catalona W.J. Requirement of a thymus dependent immune response for BCG-mediated antitumor activity. J Urol 1987, 137:155-158.
19. Weir R.E., Gorak-Stolinska P., Floyd S., et al. Persistence of the immune response induced by BCG vaccination. BMC Infect Dis 2008, 8:9.
20. Cookson M.S., Herr H.W., Zhang Z.F., Soloway S., Sogani P.C., Fair W.R. The treated natural history of high risk superficial bladder cancer: 15-year outcome. J Urol 1997, 158:62-67.
21. Reichert D.F., Lamm D.L. Long term protection in bladder cancer following intralesional immunotherapy. J Urol 1984, 132:570-573.
22. Hudson M.A., Ratliff T.L., Gillen D.P., et al. Single course versus maintenance bacillus Calmette-Guerin therapy for superficial bladder tumors: a prospective, randomized trial. J Urol 1987, 138:295-298.
23. Badalament R.A., Herr H.W., Wong G.Y., et al. A prospective randomized trial of maintenance versus nonmaintenance intravesical bacillus Calmette-Guerin therapy of superficial bladder cancer. J Clin Oncol 1987, 5:441-449.
24. Lamm D, Böhle A, Palou J, et al. Re: Per-Uno Malmström, Richard J. Sylvester, David E. Crawford, et al. An individual patient data meta-analysis of the long-term outcome of randomised studies comparing intravesical mitomycin C versus bacillus Calmette-Guérin for non-muscle-invasive bladder cancer. Eur Urol 2010;57:e7-9.
25. Shelley M.D., Mason M.D., Kynaston H. Intravesical therapy for superficial bladder cancer: a systematic review of randomised trials and meta-analyses. Cancer Treat Rev 2010, 36:195-205.
26. Lamm D., Colombel M., Persad R., et al. Clinical practice recommendations for the management of non-muscle invasive bladder cancer. Eur Urol Suppl 2008, 7:651-666.
27. Soloway, MS, editor. International consultation on bladder tumours. Urology 2005;66(Suppl 1):1-125.
28. Martinez-Pineiro J.A., Flores N., Isorna S., et al. Long-term follow-up of a randomized prospective trial comparing a standard 81mg dose of intravesical bacille Calmette-Guérin with a reduced dose of 27mg in superficial bladder cancer. BJU Int 2002, 89:671-680. for CUETO (Club Urologico Espanol de Tratamiento Oncologico).
29. Martinez-Pineiro J.A., Martinez-Pineiro L., Solsona E., et al. Has a 3-fold decreased dose of bacillus Calmette-Guérin 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, 174:1242-1247. for CUETO (Club Urologico Espanol de Tratamiento Oncologico).
30. Sylvester R.J., van der Meijden A.P.M., Oosterlinck W., et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol 2006, 49:466-477.
31. Miladi M., Peyromaure M., Zerbib M., Saïghi D., Debré B. The value of a second transurethral resection in evaluating patients with bladder tumours. Eur Urol 2003, 43:241-245.
32. Langenstroer P., See W. The role of a second transurethral resection for high-grade bladder cancer. Curr Urol Rep 2000, 1:204-207.
33. Huncharek M., Kupelnick B. Impact of intravesical chemotherapy versus BCG immunotherapy on recurrence of superficial transitional cell carcinoma of the bladder: meta-analytic reevaluation. Am J Clin Oncol 2003, 26:402-407.
34. Huncharek M., Kupelnick B. The influence of intravesical therapy on progression of superficial transitional cell carcinoma of the bladder: a meta-analytic comparison of chemotherapy versus bacilli Calmette-Guerin immunotherapy. Am J Clin Oncol 2004, 27:522-528.
35. Epstein J.I., Amin M.B., Reuter V.R., Mostofi F.K. The World Health Organization/International Society of Urological Pathology consensus classification of urothelial (transitional cell) neoplasms of the urinary bladder. Am J Surg Pathol 1998, 22:1435-1448.
36. Sauter G., Algaba F., Amin M., et al. Tumours of the urinary system: non-invasive urothelial neoplasias. WHO classification of tumours of the urinary system and male genital organs 2004, IARC Press, Lyon, France. J.N. Eble, G. Sauter, J.L. Epstein, I. Sesterhenn (Eds.).
37. MacLennan G.T., Kirkali Z., Cheng L. Histologic grading of noninvasive papillary urothelial neoplasms. Eur Urol 2007, 51:889-898.
38. Huang G.J., Hamilton A.S., Lo M., Stein J.P., Penson D.F. Predictors of intravesical therapy for non-muscle invasive bladder cancer: results from the Surveillance. Epidemiology and End Results program 2003 patterns of care project. J Urol 2008, 180:520-524.
39. Lamm D.L., Blumenstein B.A., Crawford E.D., et al. Randomized intergroup comparison of bacillus Calmette-Guerin immunotherapy and mitomycin C chemotherapy prophylaxis in superficial transitional cell carcinoma of the bladder. Urol Oncol 1995, 1:119-126.
40. Krege S., Giani G., Meyer R., Otto T., Rübben H. A randomized multicenter trial of adjuvant therapy in superficial bladder cancer: transurethral resection only versus transurethral resection plus mitomycin C versus transurethral resection plus bacillus Calmette-Guerin. Participating Clinics. J Urol 1996, 156:962-966.
41. Witjes W.P., Witjes J.A., Oosterhof G.O., Debruyne M.J. Update on the Dutch Cooperative Trial: mitomycin versus bacillus Calmette-Guérin-Tice versus bacillus Calmette-Guérin RIVM in the treatment of patients with pTA-pT1 papillary carcinoma and carcinoma in situ of the urinary bladder. Dutch South East Cooperative Urological Group. Semin Urol Oncol 1996, 14(Suppl 1):10-16.
42. Jimenez-Cruz J.F., Vera-Donoso C.D., Witherspoon B., et al. Intravesical immunoprophylaxis in recurrent superficial bladder cancer (stage T1): multicenter trial comparing bacille Calmette-Guerin and interferon-alpha. Urology 1997, 50:529-535.
43. Witjes J.A., Caris C.T., Mungan N.A., et al. Results of a randomized phase III trial of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin versus mitomycin C alone in patients with superficial bladder cancer. J Urol 1998, 160:1668-1671.
44. Ali-El-Dein B., Nabeeh B.A., Ismail E.H., Ghoneim M.A. Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: a randomized prospective study. J Urol 1999, 162:339-342.
45. Van der Meijden A.P., Brausi M., Zambon V., et al. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Research and Treatment of Cancer genito-urinary group randomized phase III trial. J Urol 2001, 166:476-481. members of the EORTC Genito-Urinary Group.
46. De Reijke T.M., Kurth K.H., Sylvester R.J., et al. 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 2005, 173:405-409.
47. Colombel M., Saint F., Chopin D., Nicolas L., Rischmann P. The effect of ofloxacin on bacillus Calmette-Guérin induced toxicity in patients with superficial bladder cancer: results of a randomized, prospective, double-blind, placebo controlled, multicenter study. J Urol 2006, 176:935-939.
48. Di Stasi S.M., Giannantoni A., Giurioli A., et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Lancet Oncol 2006, 7:43-51.
49. Witjes J.A., Palou J., Soloway M., et al. Clinical practice recommendations for the prevention and management of intravesical therapy-associated adverse events. Eur Urol Suppl 2008, 7:667-674.
50. Böhle A., Balck F., von Wietersheim J., Jocham D. The quality of life during intravesical bacillus Calmette-Guérin therapy. J Urol 1996, 155:1221-1226.
51. Lundholm C., Norlén B.J., Ekman P., et al. A randomized prospective study comparing long-term intravesical instillations of mitomycin C and bacillus Calmette-Guérin in patients with superficial bladder carcinoma. J Urol 1996, 156:372-376.
52. Lamm D.L. Complications of bacillus Calmette-Guérin immunotherapy. Urol Clin North Am 1992, 19:565-572.
53. Falkensammer C., Gozzi C., Hager M., et al. Late occurrence of bilateral tuberculous-like epididymo-orchitis after intravesical bacille Calmette-Guerin therapy for superficial bladder carcinoma. Urology 2005, 65:175.
54. Steg A., Leleu C., Debre B., Boccon-Gibod L., Sicard D. Systemic bacillus Calmette-Guérin infection: 'BCGitis' in patients treated by intravesical bacillus Calmette-Guérin therapy for bladder cancer. Eur Urol 1989, 16:161-164.
55. Rischmann P. Improving compliance of BCG immunotherapy: practical approaches to managing side-effects. Eur Urol Suppl 2006, 5:660-662.
56. Picard A, Champetier D, Perrin P, Martin X, Devonenc M, Colombel M. Discontinuance of BCG instillation for non-muscle invasive bladder cancer: prognostic impact on recurrence. Poster presented at: European Association of Urology 25th Annual Congress; April 16-20, 2010; Barcelona, Spain.
57. Van der Meijden A.P.M., Sylvester R.J., Oosterlinck W., Hoeltl W., Bono A.V. Maintenance bacillus Calmette-Guérin 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, 44:429-434. for the EORTC Genito-Urinary Tract Cancer Group.
58. Adherence to long-term therapies: evidence for action. World Health Organization Web site. Accessed June 27, 2010. http://www.who.int/chp/knowledge/publications/adherence_introduction.pdf.
59. Sylvester R.J., van der Meijden A.P.M., Oosterlinck W., et al. The side-effects of bacillus Calmette-Guerin in the treatment of Ta T1 bladder cancer do not predict its efficacy: results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group phase III trial. Eur Urol 2003, 44:423-428. for the EORTC Genito-Urinary Tract Cancer Group.
60. Saint F., Irani J., Patard J.J., et al. Tolerability of bacille Calmette-Guérin maintenance therapy for superficial bladder cancer. Urology 2001, 57:883-888.
61. Andius P., Holmäng S. Bacillus Calmette-Guérin therapy in stage Ta/T1 bladder cancer: prognostic factors for time to recurrence and progression. BJU Int 2004, 93:980-984.
62. Takeda T., Kikuchi E., Yuge K., et al. Discontinuance of bacille Calmette-Guérin instillation therapy for non-muscle-invasive bladder cancer has negative effect on tumor recurrence. Urology 2009, 73:1318-1322.
63. Decobert M., LaRue H., Harel F., et al. Maintenance bacillus Calmette-Guerin in high-risk non-muscle invasive bladder cancer: how much is enough?. Cancer 2008, 113:710-716.
64. Ojea A., Nogueira J.L., Solsona E., et al. A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27mg) versus very low-dose bacillus Calmette-Guérin (13.5mg) versus mitomycin C. Eur Urol 2007, 52:1398-1406. CUETO Group (Club Urológico Español De Tratamiento Oncológico).
65. Buckley R, Rischmann P, Colombel M, et al. Prophylactic ofloxacin to improve tolerance of BCG instillations: two-year results of a prospective double-blind placebo-controlled study in patients with bladder cancer [Abstract PD-11.12]. Poster presented at: Société Internationale d'Urologie (SIU) 28th Congress; November 12-16, 2006; Cape Town, South Africa.
66. Rischmann P., Desgrandchamps F., Malavaud B., Chopin D.K. BCG intravesical instillations: recommendations for side-effects management. Eur Urol Suppl 2000, 37:33-36.
67. Vegt P.D., van der Meijden A.P., Sylvester R., et al. Does isoniazid reduce side-effects of intravesical bacillus Calmette-Guérin therapy in superficial bladder cancer? Interim results of Cancer protocol 30911. J Urol 1997, 157:1246-1249. EORTC Genito-Urinary Group.
68. Nieder A.M., Sved P.D., Stein J.P., Skinner D.G., Soloway M.S. Cystoprostatectomy and orthotopic ileal neobladder reconstruction for management of bacille Calmette Guérin-induced bladder contractures. Urology 2005, 65:909-912.
69. British Association of Urological Surgeons (BAUS) Section of Oncology and British Uro-oncology Group (BUG). MDT (multi-disciplinary team) guidance for managing bladder cancer. Peterborough and Stamford Hospitals NHS Foundation Trust Web site. Accessed July 12, 2010. http://www.echurology.co.uk/bausca/MDT%20Guidance%20for%20Bladder%20Cancer.pdf.