Document Detail

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.
MedLine Citation:
PMID:  16890660     Owner:  NLM     Status:  MEDLINE    
PURPOSE: We determined whether prophylaxis with ofloxacin could decrease the toxicity of bacillus Calmette-Guerin for transitional cell carcinoma of the bladder. We also investigated the impact of ofloxacin on bacillus Calmette-Guerin antitumor efficacy. MATERIALS AND METHODS: In this randomized, double-blind, multicenter study 115 patients with primary or recurrent superficial bladder cancer (Ta/T1, CIS, G1-G3) and no prior bacillus Calmette-Guerin treatment were randomized to induction treatment with intravesical bacillus Calmette-Guerin (6 plus 3 instillations) plus 200 mg ofloxacin in group 1 or plus placebo in group 2. Adverse events were assessed using a detailed grid of classification for bacillus Calmette-Guerin related adverse events. Mean patient age +/- SD was 65.6 +/- 10.4 years in the 57 group 1 patients and 65.7 +/- 8.7 years in the 58 in group 2. Median followup was 369 and 374 days in groups 1 and 2, respectively. RESULTS: Ofloxacin significantly decreased by 18.5% the incidence of class II or higher moderate and severe adverse events between instillations 4 and 6. The percent of class III adverse events was significantly decreased by ofloxacin between instillations 1 and 9. Although ofloxacin decreased adverse events involving the lower urinary tract, it did not prevent class I adverse events. Compliance with full bacillus Calmette-Guerin treatment was also improved. Of patients in group 1, 80.7% received 9 instillations compared with 65.5% in group 2 (p = 0.092). At 12 months recurrence and progression rates in group 1 and 2 were 12.7% and 17.2%, and 5.5% and 1.7%, respectively. CONCLUSIONS: Prophylactic ofloxacin decreased the incidence of moderate to severe adverse events associated with bacillus Calmette-Guerin intravesical therapy, particularly class III events, which are primarily associated with patient dropout. Compliance with induction and maintenance therapy may be improved by adjuvant ofloxacin therapy. However, long-term comparative studies with other preventive strategies must be done to confirm these initial findings with compliance and recurrence-free survival as the primary end points.
Marc Colombel; Fabien Saint; Dominique Chopin; Bernard Malavaud; Ludovic Nicolas; Pascal Rischmann
Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  The Journal of urology     Volume:  176     ISSN:  0022-5347     ISO Abbreviation:  J. Urol.     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-08-07     Completed Date:  2006-09-29     Revised Date:  2007-07-02    
Medline Journal Info:
Nlm Unique ID:  0376374     Medline TA:  J Urol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  935-9     Citation Subset:  AIM; IM    
Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot, Université Claude Bernard, 5. Place d'Arsonval, 69437 Lyon Cedex 03, France.
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MeSH Terms
Adjuvants, Immunologic / adverse effects
Anti-Bacterial Agents / pharmacology,  therapeutic use*
BCG Vaccine / adverse effects*
Carcinoma, Transitional Cell / drug therapy*
Double-Blind Method
Ofloxacin / pharmacology,  therapeutic use*
Pilot Projects
Prospective Studies
Urinary Bladder Neoplasms / drug therapy*
Reg. No./Substance:
0/Adjuvants, Immunologic; 0/Anti-Bacterial Agents; 0/BCG Vaccine; 82419-36-1/Ofloxacin
Comment In:
Nat Clin Pract Urol. 2007 Jun;4(6):304-5   [PMID:  17426721 ]

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