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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

2001; Lippincott Williams & Wilkins; Volume: 166; Issue: 2 Linguagem: Inglês

10.1016/s0022-5347(05)65966-6

1527-3792

Adrian P.M. van der Meijden, Maurizio Brausi, Victor Zambon, Wim J. Kirkels, Christine de Balincourt, Richard Sylvester,

Urological Disorders and Treatments

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 Aug 2001INTRAVESICAL 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 ADRIAN P.M. VAN DER MEIJDEN, MAURIZIO BRAUSI, VICTOR ZAMBON, WIM KIRKELS, CHRISTINE DE BALINCOURT, RICHARD SYLVESTER, and MEMBERS OF THE EORTC GENITO-URINARY GROUP* ADRIAN P.M. VAN DER MEIJDENADRIAN P.M. VAN DER MEIJDEN More articles by this author , MAURIZIO BRAUSIMAURIZIO BRAUSI More articles by this author , VICTOR ZAMBONVICTOR ZAMBON More articles by this author , WIM KIRKELSWIM KIRKELS More articles by this author , CHRISTINE DE BALINCOURTCHRISTINE DE BALINCOURT More articles by this author , RICHARD SYLVESTERRICHARD SYLVESTER More articles by this author , and MEMBERS OF THE EORTC GENITO-URINARY GROUP* Participants: A. van der Meijden, s’Hertogenbosch, C. Boeken-Kruger and W. Kirkels, Rotterdam, P. Karthaus and K. Kurth, Amsterdam, P. Vegt, Leiderdorp, J.-V. Zambon, Maastricht, The Netherlands; W. Oosterlinck, Gent, Belgium; J. Carballido, Madrid, Spain; P. Whelan, Leeds, R. Hall, Newcastle-upon-Tyne, D. Hanbury, Stevenage, United Kingdom; S. Ferretti, Carpi, A. Bono, Varese, G. Casetta, Torino, M. Brausi, Modena, Italy; F. Calais da Silva, Lisbon, Portugal; W. Hoeltl, Vienna, D. Mack, Salzburg, Austria; and Z. Kirkali, Izmir, Turkey. More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(05)65966-6AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: After transurethral resection, we compared the efficacy and side effects of weekly intravesical instillations of epirubicin, bacillus Calmette-Guerin (BCG), and BCG plus isoniazid during a 6-week interval followed by 3 weekly maintenance instillations at months 3, 6, 12, 18, 24, 30 and 36 in patients with intermediate and high risk Ta, T1 bladder cancer. Materials and Methods: A total of 957 patients were randomized at 44 institutions in a phase III multicenter trial. Results: The time to first recurrence was significantly longer in patients treated with BCG and BCG plus isoniazid compared to epirubicin (p = 0.0001) but there was no difference between the 2 BCG regimens (p = 0.27). Progression to muscle invasive cancer was rare (5%) and did not differ significantly among the 3 arms (p = 0.12). Drug induced cystitis was observed in 31% of the patients treated with epirubicin, 42% BCG and 45% BCG plus isoniazid. Systemic side effects, such as fever and malaise, were not observed in patients treated with epirubicin, but were noted in 31% BCG and 36% BCG plus isoniazid. Conclusions: Intravesical BCG with or without isoniazid provokes more side effects than epirubicin. Prophylactic isoniazid does not reduce the side effects of BCG, while BCG with or without isoniazid prolongs the time to first recurrence compared to epirubicin. Further followup is required before long-term conclusions can be made for progression-to-muscle invasive disease and survival. References 1 : Prognostic factors in superficial bladder tumors. Prob Urol1992; 6: 471. 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Google Scholar From the Bosch Medicentrum, s’Hertogenbosch, University of Maastricht, Maastricht and Erasmus University Rotterdam, Rotterdam, The Netherlands, University of Modena, Modena, Italy, and European Organization for Research and Treatment of Cancer Data Center, Brussels, Belgium© 2001 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byHendricksen K, Cornel E, de Reijke T, Arentsen H, Chawla S and Witjes J (2018) Phase 2 Study of Adjuvant Intravesical Instillations of Apaziquone for High Risk Nonmuscle Invasive Bladder CancerJournal of Urology, VOL. 187, NO. 4, (1195-1199), Online publication date: 1-Apr-2012.Cai T, Nesi G, Tinacci G, Zini E, Mondaini N, Boddi V, Mazzoli S and Bartoletti R (2018) Can Early Single Dose Instillation of Epirubicin Improve Bacillus Calmette-Guerin Efficacy in Patients With Nonmuscle Invasive High Risk Bladder Cancer? Results From a Prospective, Randomized, Double-Blind Controlled StudyJournal of Urology, VOL. 180, NO. 1, (110-115), Online publication date: 1-Jul-2008.Colombel M, Saint F, Chopin D, Malavaud B, Nicolas L and Rischmann P (2018) 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 StudyJournal of Urology, VOL. 176, NO. 3, (935-939), Online publication date: 1-Sep-2006.ARDELT P, WOOD C, CHEN L, MINTZ P, MOYA C, ARAP M, WRIGHT K, PASQUALINI R and ARAP W (2018) Targeting Urothelium: Ex Vivo Assay Standardization and Selection of Internalizing LigandsJournal of Urology, VOL. 169, NO. 4, (1535-1540), Online publication date: 1-Apr-2003.SYLVESTER R, van der MEIJDEN A and LAMM D (2018) Intravesical Bacillus Calmette-Guerin Reduces the Risk of Progression in Patients with Superficial Bladder Cancer: A Meta-analysis of the Published Results of Randomized Clinical TrialsJournal of Urology, VOL. 168, NO. 5, (1964-1970), Online publication date: 1-Nov-2002.Soloway M, Sofer M and Vaidya A (2018) Contemporary Management Of Stage T1 Transitional Cell Carcinoma Of The BladderJournal of Urology, VOL. 167, NO. 4, (1573-1583), Online publication date: 1-Apr-2002.Durek C, Jurczok A, Werner H, Jocham D and Böhle A (2018) Optimal Treatment of Systemic Bacillus Calmette-Guerin Infection: Investigations in an Animal ModelJournal of Urology, VOL. 168, NO. 2, (826-831), Online publication date: 1-Aug-2002. Volume 166Issue 2August 2001Page: 476-481 Advertisement Copyright & Permissions© 2001 by American Urological Association, Inc.Keywordscarcinomaepirubicinmycobacterium bovisisoniazidbladder neoplasmstransitional cellMetricsAuthor Information ADRIAN P.M. VAN DER MEIJDEN More articles by this author MAURIZIO BRAUSI More articles by this author VICTOR ZAMBON More articles by this author WIM KIRKELS More articles by this author CHRISTINE DE BALINCOURT More articles by this author RICHARD SYLVESTER More articles by this author MEMBERS OF THE EORTC GENITO-URINARY GROUP* Participants: A. van der Meijden, s’Hertogenbosch, C. Boeken-Kruger and W. Kirkels, Rotterdam, P. Karthaus and K. Kurth, Amsterdam, P. Vegt, Leiderdorp, J.-V. Zambon, Maastricht, The Netherlands; W. Oosterlinck, Gent, Belgium; J. Carballido, Madrid, Spain; P. Whelan, Leeds, R. Hall, Newcastle-upon-Tyne, D. Hanbury, Stevenage, United Kingdom; S. Ferretti, Carpi, A. Bono, Varese, G. Casetta, Torino, M. Brausi, Modena, Italy; F. Calais da Silva, Lisbon, Portugal; W. Hoeltl, Vienna, D. Mack, Salzburg, Austria; and Z. Kirkali, Izmir, Turkey. More articles by this author Expand All Advertisement PDF downloadLoading ...