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A Randomized Prospective Study Comparing Long-Term Intravesical Instillations of Mitomycin C and Bacillus Calmette-Guerin in Patients with Superficial Bladder Carcinoma

1996; Lippincott Williams & Wilkins; Volume: 156; Issue: 2 Linguagem: Inglês

10.1016/s0022-5347(01)65853-1

1527-3792

CARL LUNDHOLM, Bo Johan Norlén, Peter Ekman, Staffan Jahnson, Mikael Lagerkvist, Torsten Lindeborg, Jan Olov Olsson, Kjell Wijkstrom Tveter, Ronny Westberg, Per‐Uno Malmström,

Urinary Tract Infections Management

No AccessJournal of UrologyClinical Urology: Original Article1 Aug 1996A Randomized Prospective Study Comparing Long-Term Intravesical Instillations of Mitomycin C and Bacillus Calmette-Guerin in Patients with Superficial Bladder Carcinoma Carl Lundholm, Bo Johan Norlen, Peter Ekman, Staffan Jahnson, Mikael Lagerkvist, Torsten Lindeborg, Jan Olov Olsson, Kjell Wijkstrom Tveter, Hans Ronny Westberg, and Per-Uno Malmstrom Carl LundholmCarl Lundholm More articles by this author , Bo Johan NorlenBo Johan Norlen More articles by this author , Peter EkmanPeter Ekman More articles by this author , Staffan JahnsonStaffan Jahnson More articles by this author , Mikael LagerkvistMikael Lagerkvist More articles by this author , Torsten LindeborgTorsten Lindeborg More articles by this author , Jan Olov OlssonJan Olov Olsson More articles by this author , Kjell Wijkstrom TveterKjell Wijkstrom Tveter More articles by this author , Ronny WestbergRonny Westberg More articles by this author , and Per-Uno MalmstromPer-Uno Malmstrom More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)65853-1AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We compared the efficacy and toxicity of long-term mitomycin C versus bacillus Calmette-Guerin (BCG) instillation in patients at high risk for recurrence and progression of superficial bladder carcinoma. Materials and Methods: Our randomized comparison study included 261 patients with primary dysplasia, or stage Tis, stage T1, grade 3 and multiple recurrent stage Ta/T1, grade 1 or 2 disease. Mitomycin C (40 mg.) or Pasteur strain BCG (120 mg.) was instilled weekly for 6 weeks, then monthly for up to 1 year and every 3 months during year 2. Results: After a median followup of 39 months 49 percent of the patients given BCG and 34 percent given mitomycin C were disease-free (p less than 0.03), compared to 48 and 35 percent, respectively, of those with stage Ta or T1 disease, and 54 and 33 percent, respectively, of those with dysplasia or stage Tis tumor. Tumor progressed in 13 percent of patients, with no statistically significant difference observed regarding progression between the mitomycin C and BCG groups. Side effects were more common after BCG instillation, with 5 cases of severe side effects compared to 1 in the mitomycin C group. Treatment was stopped due to toxicity in 10 percent of the patients. Conclusions: The majority of patients tolerated long-term intravesical therapy well. BCG instillation was hampered by more frequent side effects. BCG was superior regarding recurrence prophylaxis, since patients given BCG had fewer recurrences and a significantly longer time to treatment failure compared to those treated with mitomycin C. No statistically significant difference was observed regarding progression. References 1 : The plight of the patient with carcinoma in situ of the bladder. J. Urol.1970; 103: 160. Link, Google Scholar 2 : Intravesical therapy. A critical overview. Urol. Clin. N. Amer.1987; 14: 399. Google Scholar 3 : Adjuvant intravesicular pharmacotherapy for superficial bladder cancer. J. Natl. Cancer Inst.1991; 83: 682. Crossref, Medline, Google Scholar 4 : Intravesical chemotherapy (mitomycin C) versus immunotherapy (bacillus Calmette-Guerin) in superficial bladder cancer. Eur. 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Urol.1996; 155: 494A. part 2, abstract 734. Google Scholar 10 : Durability of the tumor-free response for intravesical bacillus Calmette-Guerin therapy. J. Urol.1994; 152: 367. Link, Google Scholar Departments of Urology, Vasteras Central Hospital, Vasteras, University Hospital, Uppsala, Karolinska Institute, Huddinge Hospital and Bristol Squibb, Stockholm, Orebro Central Hospital, Orebro, Eskilstuna Hospital, Eskilstuna and Karlstad Central Hospital, Karlstad, Sweden, and Ulleval Hospital, Oslo, Norway.Members of the Swedish-Norwegian Bladder Cancer Study Group: P. Ekman, U. Norming, H. Wijkstrom and M. Lagerkvist, Stockholm; L. Karlberg, Vasteras; J. O. Ohlsson, Karlstad; T. Lindeborg, Eskilstuna; P.-U. Malmstrom, Uppsala; S. Susskind, Hudiksvall; J. Sten, Mora, and S. Jahnson, Orebro, Sweden, and K. J. Tveter, Oslo, Norway.© 1996 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byChou R, Selph S, Buckley D, Fu R, Griffin J, Grusing S and Gore J (2016) Intravesical Therapy for the Treatment of Nonmuscle Invasive Bladder Cancer: A Systematic Review and Meta-AnalysisJournal of Urology, VOL. 197, NO. 5, (1189-1199), Online publication date: 1-May-2017.Hall M, Chang S, Dalbagni G, Pruthi R, Seigne J, Skinner E, Wolf J and Schellhammer P (2018) Guideline for the Management of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 UpdateJournal of Urology, VOL. 178, NO. 6, (2314-2330), Online publication date: 1-Dec-2007.BÖHLE A, JOCHAM D and BOCK P (2018) Intravesical Bacillus Calmette-Guerin Versus Mitomycin C For Superficial Bladder Cancer: A Formal Meta-Analysis of Comparative Studies on Recurrence and ToxicityJournal of Urology, VOL. 169, NO. 1, (90-95), Online publication date: 1-Jan-2003.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.STEINBERG G, BAHNSON R, BROSMAN S, MIDDLETON R, WAJSMAN Z and WEHLE M (2018) EFFICACY AND SAFETY OF VALRUBICIN FOR THE TREATMENT OF BACILLUS CALMETTE-GUERIN REFRACTORY CARCINOMA IN SITU OF THE BLADDERJournal of Urology, VOL. 163, NO. 3, (761-767), Online publication date: 1-Mar-2000.LOSA A, HURLE R and LEMBO A (2018) LOW DOSE BACILLUS CALMETTE-GUERIN FOR CARCINOMA IN SITU OF THE BLADDER: LONG-TERM RESULTSJournal of Urology, VOL. 163, NO. 1, (68-72), Online publication date: 1-Jan-2000.MALMSTROM P, WIJKSTROM H, LUNDHOLM C, WESTER K, BUSCH C and NORLEN B (2018) 5-YEAR FOLLOWUP OF A RANDOMIZED PROSPECTIVE STUDY COMPARING MITOMYCIN C AND BACILLUS CALMETTE-GUERIN IN PATIENTS WITH SUPERFICIAL BLADDER CARCINOMAJournal of Urology, VOL. 161, NO. 4, (1124-1127), Online publication date: 1-Apr-1999.de REIJKE T, de BOER E, KURTH K and SCHAMHART D (2018) URINARY INTERLEUKIN-2 MONITORING DURING PROLONGED BACILLUS CALMETTE-GUERIN TREATMENT: CAN IT PREDICT THE OPTIMAL NUMBER OF INSTILLATIONS?Journal of Urology, VOL. 161, NO. 1, (67-71), Online publication date: 1-Jan-1999.RIEDL C, KNOLL M, PLAS E and PFLUGER H (2018) INTRAVESICAL ELECTROMOTIVE DRUG ADMINISTRATION TECHNIQUE: PRELIMINARY RESULTS AND SIDE EFFECTSJournal of Urology, VOL. 159, NO. 6, (1851-1856), Online publication date: 1-Jun-1998.Keeley F and Bagley D (2018) ADJUVANT MITOMYCIN C FOLLOWING ENDOSCOPIC TREATMENT OF UPPER TRACT TRANSITIONAL CELL CARCINOMAJournal of Urology, VOL. 158, NO. 6, (2074-2077), Online publication date: 1-Dec-1997. (2018) EDITORIAL COMMENTJournal of Urology, VOL. 158, NO. 1, (73-74), Online publication date: 1-Jul-1997. Volume 156 Issue 2 August 1996 Page: 372-376 Advertisement Copyright & Permissions© 1996 by American Urological Association, Inc.Metrics Author Information Carl Lundholm More articles by this author Bo Johan Norlen More articles by this author Peter Ekman More articles by this author Staffan Jahnson More articles by this author Mikael Lagerkvist More articles by this author Torsten Lindeborg More articles by this author Jan Olov Olsson More articles by this author Kjell Wijkstrom Tveter More articles by this author Ronny Westberg More articles by this author Per-Uno Malmstrom More articles by this author Expand All Advertisement PDF downloadLoading ...