#PAGE_PARAMS# #ADS_HEAD_SCRIPTS# #MICRODATA#

Complications of treatment with bacillus calmette-guerin (BCG) in nonmuscle - invasive bladder cancer


Authors: Ondřej Havránek;  Jan Krhut;  David Němec;  Roman Král;  Zdeněk Häring
Authors‘ workplace: Urologické oddělení FN, Ostrava – Poruba
Published in: Ces Urol 2010; 14(2): 92-98
Category: Original article

Práce je věnována našemu kolegovi a kamarádovi MUDr. Petru Vališovi, který zemřel náhle dne 26. února 2009 ve věku nedožitých 33 let.

Overview

Aim:
Patients with non-invasive transitional cell carcinoma (TCC) a high risk of progresion may benefit from intravesical chemotherapy or immunotherapy. Intravesical BCG instillation has better outcomes than Mitomycin instillation in patients with moderate to gross risk of disease progression. However this is accompanied by a higher degree of side effects.

Material and methods:
Together 56 patients were included into the study (42 males and 14 females). All of the patients had histologically proven non-muscle invasive bladder TCC with moderate or high risk of progression. BCG was initiated with six weekly doses followed by maintenance therapy including 3 weekly doses at 3, 6, 9, 12, 15, 21 and 30 months. Median time of instillation was 12,2 months (1,5–30 months).

Results:
In 24 patients (42%) 26 complications were observed. There were 9 not signigicant complications in 7 patients not requiring cessation of BCG therapy. Five patients had 5 moderate side effects and in these patients treatment was interrupted. In this group we restarted with instillations in 12 weeks (4-16 weeks) following diminishing of side effects. Twelve patients suffered 12 severe side effects necessitating treatment to be stopped.

Conclusion:
Intravesical BCG instillation is effective in patients with non-muscle invasive TCC who have moderate or high risk of disease progression. Unfortunately is associated with high degrese of side effects – both local and general. It is possible to decrease the extent of these complications by means of proper indication for treatment, by minimising trauma during catheterisation and by applying sterile technique of catheterisation. Next option is prophylactic use of antibiotics.

Key words:
BCG, cystitis, epididymitis, haematuria, intravesical immunotherapy, transurethral tumour resection.


Sources

1. Heney NM, Ahmed S, Flanagan MJ, et al. Superficial bladder cancer: progression and reccurence: J Urol 1983; 130: 1083–1086.

2. Herr HW, Jakse G, Sheinfeld J. The T1 bladder tumor. Semin Urol 1990; 8: 254–261.

3. Morales A, Eidinger D, Bruce AW. Intracavitary bacillus Callmete-Guerin regimen in superficial bladder cancer therapy: is it effective? J Urol 1976; 116: 180–183.

4. Morales A. Evolution of intravesical immunotherapy for bladder cancer: mycobacterial cell wall preparation as a promisinig agent. Expert Opin Investig Drugs 2008; 17: 1067–1073.

5. Chen F, Zhang G, Cao Y, et al. Bacillus Calmette-Guerine inhibits apoptosis in human urothelial carcinoma cell lines in response to cytotoxic injury: J Urol 2007; 178: 2166–2170.

6. Shintani Y, Sawada Y, Inagaki T, et al. Intravesical instillation therapy with bacillus Calmette-Guerine for superficial bladder cancer: study of the mechanism of bacillus Calmette-Guerine imunotherapy: Int J Urol 2007; 14: 140–146.

7. Böhle A, Bock PR. Intravesical bacille Calmette-Guerine versus mitomycin C in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression: Urology 2004; 63: 682–687.

8. Han RF, Pan JG. Can intravesical bacillus Calmette-Guerine reduce reccurence in patients with superficial bladder cancer? A meta-analysis of randomized trials: Urology 2006; 67: 1216–1223.

9. Shelley MD, Wilt TJ, Court J, et al. Intravesical bacillus Calmette-Guerine 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: 485–490.

10. Lamm DL, Blummenstein BA, Crissman JD, et al. Maintenance bacillus Calmette- Guerine immunotherapy for recurent Ta,T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study: J Urol 2000; 163: 1124–1129.

11. Harding GE, Lawlor DK. Ruptured mycotic abdominal aortic aneurysm secondary to Mycobacterium bovis after intravesical treatment with bacillus Calmette-Guérin: J Vasc Surg 2007; 46: 131–134.

12. Salajka F, Pokorny A, Vomela J, et al. Severe complications following intravesical BCG instillation: Monaldi Arch Chest Dis 2002; 57: 321–324.

13. Dvořák T, Schraml J, Hynek V, et al. Oboustranná granulomatozní orchiepididymiditis jako komplikace BCG léčby povrchového karcinomu močového měchýře: Urologie pro praxi 2007; 8: 180–181.

14. Manzanera Escribano MJ, Morales Ruiz E, Odriozola Grijalba M, et al. Acute renal failure due to interstitial nephritis after intravesical instillation of BCG: Clin Exp Nephrol 2007; 11: 238–240.

15. Fradet V, Gaudreau C, Perrotte P, et al. Management of hepatic granulomatous tuberculosis complicating intravesical BCG for superficial bladder cancer: Can Urol Assoc J 2007; 1: 269–272.

16. Babjuk M, Oosterlinck W, Sylvester R, et al. Guidelines on TaT1 (non-muscle invasive) Bladder Cancer. In: European Association of Urology. Guidelines 2008 ed. Arnhem 2008: 8.

17. van der MeijdenaAP, Sylvester AJ, Oosterlinck W, et al. EORTC Genito-urinary Tract Cancer Group. Maintance bacillus Calmette-Guerine for Ta, T1 bladder tumours 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.

18. Suzuki S, Shinohara N, Harabayashi T, et al. Complications of bacillus Calmette- Guerine therapy in superficial urothelial cancer: clinical analysis and implications: Int J Clin Oncol 2002; 7: 289–293.

19. Colombel M, Saint F, Chopin D, et al. The effect of ofloxacin on bacillus calmette– guerin induced toxicity in pacients with superficial bladder cancer : results of a randomized, prospective, double-blind, placebo controlled, multicenter study: J Urol 2006; 176: 935–939.

20. Colombel M, Picard A. Prevention of Bacillus Calmette-Guérin immunotherapy complications: Prog Urol. 2008; 18(Suppl 5): 105–110.

21. Martinez-Piniero JA, Martinez-Piniero L, Solsona E, et al. Has a 3-fold decreased dose of bacillus Calmette-Guerine the same efficacy against reccurences and progresion of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial: J Urol 2005; 174: 1242–1247.

22. Martinez–Piniero JA, Flores N, Isorna S, et al. Long-term follow-up of randomized prospective trial comparing a standard 81 mg dose of intravesical bacille Calmette- Guerin with a reduce dose of 27 mg in superficial bladder cancer. BJU 2002; 89: 671–680.

23. Ali-El-Dein B, Nabeeh A, Ismail EH, et al. Senquential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerine alone for superficial bladder tumors: a randomized prospective study: J Urol 1999; 162: 339–342.

24. Witjes JA, Caris CT, Mungan NA, 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.

25. Bilen CY, Ozen H, Aki FT, et al. Clinical experience with BCG alone versus BCG plus epirubicin: Int J Urol 2000; 7: 206–209.

26. Paterson DL, Patel A. Bacillus Calmette-Guerine (BCG) imunotherapy for bladder cancer: review of complications and their treatment: Aust N Z J surg 1998; 68: 340–344.

27. Suzuki S, Shinohara N, Harabayashi T, et al. Complications of bacillus Calmette- Guerine therapy in superficial urothelial cancer: clinical analysis and implications: Int J Clin Oncol 200; 27: 289–293.

28. Koya MP, Simon MA, Soloway MS, et al. Complications of intravesical therapy for urothelial Cancer of the bladder: J Urol 2006; 175: 2004–2010.

29. Yossepowitch O, Eggener SE, Bochner BH, et al. Safety and efficacy of intravesical bacillus Calmette-Guerine instillations in steroid treated and immunocompromised patients. J Urol 2006; 176: 482–485.

Labels
Paediatric urologist Nephrology Urology
Login
Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.

Login

Don‘t have an account?  Create new account

#ADS_BOTTOM_SCRIPTS#