Intravesical Versus Intravesical Plus Intradermal Bacillus Calmette-Guerin: A Prospective Randomized Study In Patient With Recurrent Superficial Bladder Tumors

No AccessJournal of UrologyClinical Urology: Original Article1 Feb 1996Intravesical Versus Intravesical Plus Intradermal Bacillus Calmette-Guerin: A Prospective Randomized Study In Patient With Recurrent Superficial Bladder Tumors Werner Luftenegger, Daniel K. Ackermann, Andrea Futterlieb, Rainer Kraft, Christoph E. Minder, Peter Nadelhaft, and Urs E. Studer Werner LufteneggerWerner Luftenegger , Daniel K. AckermannDaniel K. Ackermann , Andrea FutterliebAndrea Futterlieb , Rainer KraftRainer Kraft , Christoph E. MinderChristoph E. Minder , Peter NadelhaftPeter Nadelhaft , and Urs E. StuderUrs E. Studer View All Author Informationhttps://doi.org/10.1016/S0022-5347(01)66427-9AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Intravesical instillation of bacillus Calmette-Guerin (BCG) induces various immunological reactions and decreases the recurrence rate of superficial bladder tumors. To determine whether additional immune stimulation with concomitant intradermal BCG applications could further lower the recurrence rate, 154 patients with superficial bladder tumors at high risk for recurrence were randomized to receive either 6 intravesical instillations 120 mg. Pasteur strain BCG alone or combined with intradermal application. Materials and Methods: A total of 76 patients received intravesical and intradermal BCG, while 78 received intravesical BCG only. Median followup was 41 months (range 2 to 89) and 36 months (range 2 to 86), respectively. Both treatment groups were comparable regarding patient age and number of previous transurethral bladder tumor resections, as well as tumor recurrence rate, stage and grade before BCG therapy. Results: A highly significant decrease in the monthly tumor recurrence rate was observed in both arms after BCG compared to the pretreatment recurrence rates (p less than 0.0001). Recurrence rate decreased from 0.73 plus/minus 1.07 (standard deviation) to 0.06 plus/minus 0.13 in the combined treatment group and from 0.71 plus/minus 0.90 to 0.074 plus/minus 0.17 in the intravesical treatment only group. However, we were unable to find any difference between the 2 groups regarding interval to initial recurrence or recurrence rates after BCG treatment. Changes in the purified protein derivative skin test performed before and after BCG therapy were not useful to predict response to treatment because 44 percent of our patients already had a positive test before treatment. Also, interpretation of the skin test was difficult and not always reliable. In the multivariate analysis, however, fever was an important prognostic factor. Patients with increased body temperature greater than 37.5C had a significantly lower recurrence rate than those without fever (37.5C or less) after BCG instillation (p = 0.009). Moreover, fever after BCG instillation was observed significantly more frequently in patients with a positive purified protein derivative skin test before treatment (p = 0.021). Conclusions: The therapeutic benefit from intravesical BCG apparently was not substantially improved by simultaneous intradermal BCG vaccination. Fever following intravesical BCG instillation is an important prognostic factor regarding superficial bladder tumor recurrence. Fever occurs predominantly in patients who were previously sensitized to mycobacterial (by BCG vaccination or infection) as shown by a positive pretreatment purified protein derivative skin test. This finding suggests that previously sensitized patients respond significantly better to a single course of intravesical BCG. References 1 : T-cell subsets required for intravesical BCG immunotherapy for bladder cancer. J. Urol.1993; 150: 1018. Link, Google Scholar 2 : The management of superficial bladder tumors and carcinoma in situ with intravesical bacillus Calmette-Guerin. J. Urol.1985; 133: 598. Link, Google Scholar 3 : Oral or intravesical bacillus Calmette-Guerin immunoprophylaxis in bladder cancer. J. Urol.1991; 145: 498. Google Scholar 4 : Bacillus Calmette-Guerin immunotherapy for bladder cancer. J. Urol.1985; 134: 40. Link, Google Scholar 5 : Multicenter study of superficial bladder cancer treated with intravesical bacillus Calmette-Guerin or adriamycin. Urology1990; 35: 101. Google Scholar 6 : Long-term effect of intravesical bacillus Calmette-Guerin on flat carcinoma in situ of the bladder. J. Urol.1986; 135: 265. Link, Google Scholar 7 : Prospective randomized comparison of intravesical with percutaneous bacillus Calmette-Guerin versus intravesical bacillus Calmette-Guerin in superficial bladder cancer. J. Urol.1991; 145: 738. Link, Google Scholar 8 : Prognostic value of purified protein derivative skin test and granuloma formation in patients treated with intravesical bacillus Calmette-Guerin. J. Urol.1986; 135: 268. Link, Google Scholar 9 : Prognostic factors in patients treated with intravesical bacillus Calmette-Guerin for superficial bladder cancer. J. Urol.1988; 139: 941. Link, Google Scholar 10 : Immunotherapy of superficial bladder cancer with BCG. World J. Urol.1986; 3: 209. Google Scholar 11 Harrison's Principles of Internal Medicine. In: . Edited by . New York: McGraw-Hill Book Co.1987. Google Scholar 12 : Mycobacterium tuberculosis. In: Principles and Practice of Infectious Diseases. Edited by . New York: Churchill Livingstone1995: 2219. chapt. 230. Google Scholar 13 : Analysis of early failures after intravesical instillation therapy with bacille Calmette-Guerin for carcinoma in situ of the bladder. Brit. J. Urol.1995; 75: 180. Google Scholar 14 : Maintenance BCG immunotherapy of superficial bladder cancer: a randomized prospective Southwest Oncology Group study. J. Urol., part 21992; 147: 274A. abstract 242. Google Scholar 15 : Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J. Urol.1992; 147: 596. Link, Google Scholar Departments of Urology, Pathology and Social and Preventive Medicine, University of Berne, Berne, Switzerland.© 1996 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byBİLEN C, İNCİ K, ERKAN İ and ÖZEN H (2018) The Predictive Value Of Purified Protein Derivative Results On Complications And Prognosis In Patients With Bladder Cancer Treated With Bacillus Calmette-GuerinJournal of Urology, VOL. 169, NO. 5, (1702-1705), Online publication date: 1-May-2003.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.KUMAR A, DUBEY D, BANSAL P, MANDHANI A and NAIK S (2018) Urinary Interleukin-8 Predicts the Response of Standard and Low Dose Intravesical Bacillus Calmette-Guerin (Modified Danish 1331 Strain) for Superficial Bladder CancerJournal of Urology, VOL. 168, NO. 5, (2232-2235), Online publication date: 1-Nov-2002.LAMM D, BLUMENSTEIN B, CRISSMAN J, MONTIE J, GOTTESMAN J, LOWE B, SAROSDY M, BOHL R, GROSSMAN H, BECK T, LEIMERT J and CRAWFORD E (2018) MAINTENANCE BACILLUS CALMETTE-GUERIN IMMUNOTHERAPY FOR RECURRENT TA, T1 AND CARCINOMA IN SITU TRANSITIONAL CELL CARCINOMA OF THE BLADDER: A RANDOMIZED SOUTHWEST ONCOLOGY GROUP STUDYJournal of Urology, VOL. 163, NO. 4, (1124-1129), Online publication date: 1-Apr-2000.ZLOTTA A, DROWART A, VAN VOOREN J, SHEKARSARAI H, DE COCK M, PIRSON M, PALFLIET K, JURION F, SIMON J, SCHULMAN C and HUYGEN K (2018) SUPERFICIAL BLADDER TUMORS AND INCREASED REACTIVITY AGAINST MYCOBACTERIAL ANTIGENS BEFORE BACILLUS CALMETTE-GUERIN THERAPYJournal of Urology, VOL. 159, NO. 6, (1885-1891), Online publication date: 1-Jun-1998.Thalmann G, Dewald B, Baggiolini M and Studer U (2018) INTERLEUKIN-8 EXPRESSION IN THE URINE AFTER BACILLUS CALMETTE-GUERIN THERAPY: A POTENTIAL PROGNOSTIC FACTOR OF TUMOR RECURRENCE AND PROGRESSIONJournal of Urology, VOL. 158, NO. 4, (1340-1344), Online publication date: 1-Oct-1997. Volume 155Issue 2February 1996Page: 483-487 Advertisement Copyright & Permissions© 1996 by American Urological Association, Inc.MetricsAuthor Information Werner Luftenegger More articles by this author Daniel K. Ackermann More articles by this author Andrea Futterlieb More articles by this author Rainer Kraft More articles by this author Christoph E. Minder More articles by this author Peter Nadelhaft More articles by this author Urs E. Studer More articles by this author Expand All Advertisement PDF downloadLoading ...