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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

2006; Lippincott Williams & Wilkins; Volume: 176; Issue: 3 Linguagem: Inglês

10.1016/j.juro.2006.04.104

1527-3792

Marc Colombel, Fabien Saint, Dominique Chopin, Bernard Malavaud, Ludovic Nicolas, P. Rischmann,

Urinary Tract Infections Management

No AccessJournal of UrologyAdult urology1 Sep 2006The 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 Studyis accompanied byProtective Effects of Plasma Carotenoids on the Risk of Bladder Cancer Marc Colombel, Fabien Saint, Dominique Chopin, Bernard Malavaud, Ludovic Nicolas, Pascal Rischmann, and ITB01 Study Group Marc ColombelMarc Colombel Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot, Université Claude Bernard, Lyon, France , Fabien SaintFabien Saint Service d'Urologie, Centre Hospitalier Universitaire Sud, Amiens, France , Dominique ChopinDominique Chopin Service d'Urologie, Centre Hospitalier Universitaire Henri Mondor, Toulouse, France , Bernard MalavaudBernard Malavaud , Ludovic NicolasLudovic Nicolas Sanofi Pasteur, Lyon, France , Pascal RischmannPascal Rischmann Créteil and Centre Hospitalier Universitaire Rangueil, Toulouse, France , and ITB01 Study Group View All Author Informationhttps://doi.org/10.1016/j.juro.2006.04.104AboutFull TextPDF Cite Export CitationSelect Citation formatNLMAMAIEEEACMAPAChicagoMLAHarvardTips on citation downloadDownload citationCopy citation ToolsAdd to favoritesTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract 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. 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Link, Google Scholar © 2006 by American Urological AssociationFiguresReferencesRelatedDetailsCited byLamm D (2015) Getting the Most Out of bacillus Calmette-Guérin for Treatment of Bladder CancerJournal of Urology, VOL. 195, NO. 1, (7-8), Online publication date: 1-Jan-2016.Maeda T, Kikuchi E, Matsumoto K, Miyajima A and Oya M (2011) Urinary pH Is Highly Associated With Tumor Recurrence During Intravesical Mitomycin C Therapy for Nonmuscle Invasive Bladder TumorJournal of Urology, VOL. 185, NO. 3, (802-806), Online publication date: 1-Mar-2011.Related articlesJournal of Urology9 Nov 2018Protective Effects of Plasma Carotenoids on the Risk of Bladder Cancer Volume 176Issue 3September 2006Page: 935-939 Advertisement Copyright & Permissions© 2006 by American Urological AssociationKeywordsbladderMycobacterium boviscarcinomatransitional cellofloxacincomplicationsMetrics Author Information Marc Colombel Service d'Urologie et Chirurgie de la Transplantation, Hôpital Edouard Herriot, Université Claude Bernard, Lyon, France Financial interest and/or other relationship with Novartis and Ipsen. More articles by this author Fabien Saint Service d'Urologie, Centre Hospitalier Universitaire Sud, Amiens, France More articles by this author Dominique Chopin Service d'Urologie, Centre Hospitalier Universitaire Henri Mondor, Toulouse, France More articles by this author Bernard Malavaud More articles by this author Ludovic Nicolas Sanofi Pasteur, Lyon, France Financial interest and/or other relationship with Aventis Pasteur. More articles by this author Pascal Rischmann Créteil and Centre Hospitalier Universitaire Rangueil, Toulouse, France More articles by this author ITB01 Study Group More articles by this author Expand All Advertisement PDF downloadLoading ...