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

Journal of Urology

Volumn 176, Issue 3, 2006, Pages 935-939

  Colombel, Marc ^a   Saint, Fabien ^c   Chopin, Dominique ^d   Malavaud, Bernard ^f   Nicolas, Ludovic ^b   Rischmann, Pascal ^e  

^a UNIVERSITÉ LYON 1   (France)

^b SANOFI PASTEUR   (France)

^c AMIENS UNIVERSITY HOSPITAL   (France)

^d HENRI MONDOR HOSPITAL   (France)

^e CHU RANGUEIL   (France)

^f NONE

Author keywords

bladder; carcinoma; complications; Mycobacterium bovis; ofloxacin; transitional cell

Indexed keywords

BCG VACCINE; OFLOXACIN;

ADULT; AGE DISTRIBUTION; ALLERGIC REACTION; ARTHRALGIA; ARTHRITIS; ARTICLE; ASTHENIA; BLADDER CARCINOMA; BLOOD CLOTTING DISORDER; CANCER RECURRENCE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYSTITIS; DISEASE CLASSIFICATION; DISEASE SEVERITY; DYSURIA; EPIDIDYMITIS; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; HEMATURIA; HEPATITIS; HUMAN; KIDNEY ABSCESS; KIDNEY PAIN; MAJOR CLINICAL STUDY; MALE; MICTURITION DISORDER; MULTICENTER STUDY; MYALGIA; NOCTURIA; ORCHITIS; PATIENT COMPLIANCE; PELVIS PAIN SYNDROME; POLLAKISURIA; PRIORITY JOURNAL; PROSTATITIS; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY DISTRESS; SEPSIS; SHOCK; SIDE EFFECT; STRESS INCONTINENCE; URETER OBSTRUCTION; URINARY FREQUENCY; URINARY TRACT; URINARY URGENCY; URINE INCONTINENCE; UVEITIS;

ADJUVANTS, IMMUNOLOGIC; AGED; ANTI-BACTERIAL AGENTS; BCG VACCINE; CARCINOMA, TRANSITIONAL CELL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; OFLOXACIN; PILOT PROJECTS; PROSPECTIVE STUDIES; URINARY BLADDER NEOPLASMS;

EID: 33746521368     PISSN: 00225347     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.juro.2006.04.104     Document Type: Article

References (16)

1. Krege S., Giani G., Meyer R., Otto T., and Rubben 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 96 (1996) 962
2. Shelley M.D., Wilt T.J., Court J., Coles B., Kynaston H., and Mason M.D. 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 93 (2004) 485
3. Shelley M.D., Court J.B., Kynaston H., Wilt T.J., Fish R.G., and Mason M. Intravesical bacillus Calmette-Guerin in Ta and T1 bladder cancer. Cochrane Database Syst Rev 4 (2000) CD001986
4. Lamm D.L., Blumenstein B.A., Crissman J.D., Montie J.E., Gottesman J.E., Lowe B.A., 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 163 (2000) 1124
5. Huncharek M., and 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 27 (2004) 522
6. Lamm D.L., van der Meijden P.M., Morales A., Brosman S.A., Catalona W.J., Herr H.W., et al. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol 147 (1992) 596
7. Lamm D.L. Efficacy and safety of bacille Calmette-Guerin immunotherapy in superficial bladder cancer. Clin Infect Dis 31 (2000) S86
8. Saint F., Irani J., Patard J.J., Salomon L., Hoznek A., Zammattio S., et al. Tolerability of bacille Calmette-Guerin maintenance therapy for superficial bladder cancer. Urology 57 (2001) 883
9. Sylvester R.J., van der Meijden A.P., Oosterlinck W., Hoeltl W., and Bono A.V. 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 44 (2003) 423
10. Rischmann P., Desgrandchamps F., Malavaud B., and Chopin D.K. BCG intravesical instillations. recommendations for side-effects management. Eur Urol 37 suppl (2000) 33
11. Martinez-Pineiro J.A., Martinez-Pineiro L., Solsona E., Rodriguez R.H., Gomez J.M., Martin M.G., 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. Club Urologico Espanol de Tratamiento Oncologico (CUETO). J Urol 174 (2005) 1242
12. van der Meijden A.P., Brausi M., Zambon V., Kirkels W., de Balincourt C., and Sylvester R. 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 166 (2001) 476
13. Durek C., Jurczok A., Werner H., Jocham D., and Bohle A. Optimal treatment of systemic bacillus Calmette-Guerin infection. Investigations in animal model. J Urol 168 (2002) 826
14. Durek C., Rusch-Gerdes S., Jocham D., and Bohle A. Sensitivity of BCG to modern antibiotics. Eur Urol 37 suppl (2000) 21
15. Naber C.K., Hammer M., Kinzig-Schippers M., Sauber C., Sorgel F., Bygate E.A., et al. Urinary excretion and bactericidal activities of gemifloxacin and ofloxacin after a single oral dose in healthy volunteers. Antimicrob Agents Chemother 12 (2001) 3524
16. Lamm D.L., Thor D.E., Harris S.C., Reyna J.A., Stogdill V.D., and Radwin H.M. Bacillus Calmette-Guerin immunotherapy of superficial bladder cancer. J Urol 124 (1980) 38