Intravesical Bacillus Calmette-Guerin in Ta and T1 Bladder Cancer
- PMID: 11034738
- PMCID: PMC7017976
- DOI: 10.1002/14651858.CD001986
Intravesical Bacillus Calmette-Guerin in Ta and T1 Bladder Cancer
Abstract
Background: Intravesical therapy with Bacillus Calmette-Guerin (BCG) aims to reduce the incidence of tumour recurrence following transurethral resection (TUR) for patients with superficial bladder cancer.
Objectives: The objective of this review was to compare the incidence of tumour recurrence after the standard therapy of transurethral resection versus transurethral resection plus intravesical Bacillus Calmette-Guerin.
Search strategy: We searched the Cochrane Controlled Trials Register (March 2000), Medline (February, 2000), EMBASE (February, 2000), Cancerlit (February, 2000), Healthstar (February, 2000), Database of Abstracts of Reviews of Effectiveness (February, 2000) and the Bath Information Data Service. The Proceedings of the American Society Clinical Oncology was hand searched (1996 - 1999).
Selection criteria: Randomised or quasi-randomised trials of transurethral resection alone versus transurethral resection plus intravesical Bacillus Calmette-Guerin. Patients with Ta and T1 bladder cancer of medium or high risk of tumour recurrence, were eligible for inclusion.
Data collection and analysis: Four reviewers assessed trial quality and two abstracted the data independently. The Peto odds ratios and log hazard ratios were determined to compare the number of patients with disease recurrence at 12 months and the rate of recurrence, respectively.
Main results: Six randomised trials were included involving 585 eligible patients. There were significantly fewer patients with disease recurrence at 12 months in the BCG plus TUR group compared to those that received TUR alone (odds ratio 0.30, CI 0.21, 0.43). The overall log hazard ratio for recurrence (-0.83, variance 0.02) indicated a significant benefit of BCG treatment in reducing tumour recurrence. Toxicities associated with BCG consisted mainly of cystitis (67%), haematuria (23%), fever (25%) and urinary frequency (71%). No BCG-induced deaths were reported.
Reviewer's conclusions: In patients with medium/high risk Ta or T1 bladder cancer, immunotherapy with intravesical BCG following TUR appears to provide a significant advantage over TUR alone in delaying tumour recurrence.
Conflict of interest statement
None.
Figures
References
References to studies included in this review
Krege 1996 {published data only}
-
- Krege S, Giani R, Meyer R, Otto T, Rubben H, Participating Clinics. A randomized multicenter trial of adjuvant therapy in superficial bladder cancer: transurethral resection only versus transurethral resection plus mitomycin C versus transurethral resection plus bacillus Calmette‐Guérin. Journal of Urology 1996;156:962‐6. - PubMed
Lamm 1985 {published data only}
-
- Lamm DL. Bacillus Calmette‐Guérin immunotherapy for bladder cancer. Journal of Urology 1985;134:40‐7. - PubMed
Melekos 1990 {published data only}
-
- Melekos MD. Intravesical Bacillus Clamette‐Guérin prophylactic treatment for superficial bladder tumors: Results of a controlled prospective study. Urology International 1990;45:137‐41. - PubMed
Pagano 1990 {published data only}
-
- Pagano F, Bassi P, Milani C, Meneghini A, Artibani W, Maruzzi D, Garbeglio A. Low dose BCG therapy in superficial bladder cancer: a clinicopathological prospective study. In: deKernion JB editor(s). Immnunotherapy of Urological Tumours: International Society of Urological Reports. New York: Churchill Livingstone, 1990:69‐81.
Pinsky 1985 {published data only}
-
- Pinsky CM, Camacho FJ, Kerr D, Geller NL, Klein FA, Herr H, Whitmore WF, Oettegen HF. Intravesical administration of bacillus Calmette‐Guérin in patients with recurrent superficial carcinoma of the urinary bladder: Report of a prospective randomized trial. Cancer Treatment Reports 1985;69:47‐53. - PubMed
Yamamoto 1990 {published data only}
-
- Yamamoto T, Hagiwara M, Nakazono M, Yamamoto H. Intravesical bacillus Calmette‐Guérin (BCG) in the treatment of superficial bladder cancer. Japanese Journal of Urology 1990;81(7):99‐1001. - PubMed
References to studies excluded from this review
Badalament 1987 {published data only}
-
- Badalament RA, Herr H, Wong G, Gnecco C, Pinsky C, Whitmore W, Fair W, Oettgen H. A prospective randomised trial of maintenance versus nonmaintenance intravesical BCG therapy for superficial bladder cancer. Journal of Clinical Oncology 1987;5:441‐9. - PubMed
Bassi 1990 {published data only}
-
- Bassi PF, Milani C, Meneghini A, Maruzzi D, Garbeglio A, Aragona F, Tejerizo JC, Pagano F. Low dose BCG regimen in the treatment of superficial bladder cancer [BCG a baja dosis en la terapia de las neoplasias superficiales vesicales]. Arch. Esp. de Urol. 1990;43(5):503‐7. - PubMed
Camacho 1990 {published data only}
-
- Camacho C, Pinsky C, Kerr D, Whitmore W, Oettgen H. Treatment of superficial bladder cancer with intravesical BCG. American Society of Clinical Oncology. 1980:359.
Chopin 1990 {published data only}
-
- Chopin D, Hoznek A, Colombel M, Surig‐Biscarat M, Antiphon P, Herve JM, Bellot J, Auvert J, Abbou CC. Results of the treatment of superficial bladder tumours by transurethral resection alone or transurethral resection followed by endovesical instillation of Calmette‐Guérin bacillus [Resultat du traitement des tumeurs superficielles de la vessie par resection transurethrale seule et resection transurethrale suivie d'instillation endovesicale de bacille Calmette‐Guérin]. Annales D'Urolgie 1990;24(5):435‐40. - PubMed
Cookson 1997 {published data only}
-
- Cookson M, Herr H, Zhang Z‐F, Soloway S, Sogani PC, Fair WR. The treated natural history of high risk superficial bladder cancer: 15 year outcome. Journal of Urology 1997;158:62‐7. - PubMed
Herr 1983 {published data only}
-
- Herr H, Pinsky C, Willet F Whitmore WF, Oettgen HF, Melamed MR. Effect of intravesical bacillus Calmette‐Guérin (BCG) on carcinoma in situ of the bladder. Cancer 1983;51:1323‐6. - PubMed
Herr 1985 {published data only}
-
- Herr H, Pinsky C, Whitmore W, Sogani PG, Oettgen HF, Melamed MR. Experience with intravesical bacillus Calmette‐Guérin therapy of superficial bladder tumours. Urology 1985;25(2):119‐23. - PubMed
Herr 1986 {published data only}
-
- Herr H, Pinsky CM, Whitmore WF, Sogani PC, Oettgen HF, Melamed MR. Long‐term effect of intravesical bacillus Calmette‐Guérin on flat carcinoma in situ of the bladder. Journal of Urology 1986;135:265‐7. - PubMed
Herr 1988 {published data only}
-
- Herr H, Laudone VP, Badalament RA, Oettgen HF, Sogani PC, Freedmen BD, Melamed MR, Whitmore WF. Bacillus Calmette‐Guérin therapy alters the progression of superficial bladder cancer. Journal of Clinical Oncology 1988;6:1450‐5. - PubMed
Herr 1995 {published data only}
-
- Herr H, Schwalb DM, Zhang Z‐F, Sogani PC, Fair WR, Whitmore WF, Oettgen HF. Intravesical bacillus Calmette‐Guérin therapy prevents tumour progression and death from superficial bladder cancer: ten‐year follow‐up of a prospective randomized trial. Journal of Clinical Oncology 1995;13(6 June):1404‐8. - PubMed
Ibrahiem 1988 {published data only}
-
- Ibrahiem E‐LI, Ghoneim MA, Nigam V, Brailovsky C, Elhilali MM. Prophylactic maltose tetrapalmitate and bacillus Calmette‐Guérin immunotherapy of recurrent superficial bladder tumours: preliminary report. The Journal of Urology 1988;140:498‐500. - PubMed
Lamm 1980 {published data only}
-
- Lamm DL, Thor DE, Harris SC, Reyna JA, Stogdill VD, Radwin HM. Bacillus Calmette‐Guérin immunotherapy of superficial bladder cancer. The Journal of Urology 1980;124:38‐42. - PubMed
Lamm 1981 {published data only}
-
- Lamm DL, Thor DE, Winters WD, Stogdill VD, Radwin HM. BCG immunotherapy of bladder cancer: inhibition of tumour recurrence and associated immune responses. Cancer 1981;48:82‐8. - PubMed
Lamm 1982a {published data only}
-
- Lamm DL, Thor DE, Harris SC, Stogdill VD, Radwin HM. Intravesical and percutaneous BCG immunotherapy of recurrent superficial bladder cancer. In: Terry WD, Rosenberg SA editor(s). Immunotherapy of Human Cancer. New York: Elsevier North Holland, 1982:315‐22.
Lamm 1982b {published data only}
-
- Lamm DL, Thor DE, Stogdill VD, Radwin HM. Bladder cancer immunotherapy. The Journal of Urology 1982;128:931‐5. - PubMed
Pagano 1989 {published data only}
-
- Pagano F, Bassi P, Milani C, Meneghini A, Tuccitto G, Garbeglio A, Guazzieri S. Low‐dose BCG‐Pasteur strain in the treatment of superficial bladder cancer: preliminary results. In: Debruyne FMJ, Denis L, Meijden APM editor(s). EORTC Genitourinary Group Monograph 6: BCG in Superifial Bladder Cancer. New York: Alan R Liss Inc., 1989:253‐61. - PubMed
Pagano 1991 {published data only}
-
- Pagano F, Bassi P, Milani C, Meneghini A, Maruzzi D, Garbeglio A. A low dose bacillus Calmette‐Guérin regimen in superficial bladder cancer therapy: is it effective?. The Journal of Urology 1991;146(July):32‐5. - PubMed
Pinsky 1982 {published data only}
-
- Pinsky CM, Camacho FJ, Kerr D, Braun DW, Whitmore WF, Oettgen HF. Treatment of superficial bladder cancer with intravesical BCG. In: Terry WD, Rosenberg SA editor(s). Immunotherapy of Human Cancer. New York: Elsevier North Holland, 1982:309‐13.
Rubben 1990 {published data only}
-
- Rubben H, Graf‐Dobberstein C, Ostwald R, Stauffenberg A, Jaeger N, Deutz FJ, Steffens L, Giani C. Prospective randomized study of adjuvant therapy after complete resection of superficial bladder cancer; mitomycin C vs BCG Connaught vs TUR alone. In: deKernion JB editor(s). International Society of Urological Reports: Immunotherapy of urological Tumours. 1990:27‐36.
Somogyi 1993 {published data only}
-
- Somogyi L, Szanto A, Polyak L, Baranyay F, Drinoczy M. Adjuvant BCG immunotherapy in the treatment of superficial bladder tumours [BCG immunterapia a felutes holyagtumorok adjuvans kezeleseben]. Orvosi Hetilap 1993;134(34):1851‐1856. - PubMed
Additional references
Bohle 1990
-
- Bohle A, Nowc C, Ulmer AJ, et al. Detection of urinary TNF, IL1, and IL2 after local BCG immunotherapy for bladder carcinoma. Cytokine 1990;2:175‐81. - PubMed
Coptcoat 1998
-
- Coptcoat MJ, Oliver RTD. The role of surgery in the multimodality treatment of bladder cancer. In: Oliver RTD, Coptcoat MJ editor(s). Cancer Surveys: Bladder Cancer. Vol. 31, New York: Cold Spring Harbor Press, 1998:129‐47. - PubMed
Debruyne 1989
-
- Debruyne FM, Meijden AP, Franssen MPH. BCG‐(RIVM) versus mitomycin intravesical therapy in patients with superficial bladder cancer. Therapeutic Progress in Urologic Cancers 1989;Alan R Liss Inc:435‐46. - PubMed
Fellows 1994
-
- Fellows GJ, Parmar MKB, Grigor KM, et al. Marker tumour response to Evans and Pasteur bacille Calmette‐Guérin in multiple recurrent pTa/pT1 bladder tumours: report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). British Journal of Urology 1994;73:639‐644. - PubMed
Hall 1994
Hudson 1987
-
- Hudson M, Ratcliff TL, Gillen DP, et al. Single course versus maintenance Bacillus Calmette‐Guérin therapy for superficial bladder tumours: a prospective, randomized trial. J Urol 1987;138:295‐8. - PubMed
Kurth 1995
-
- Kurth KH, Denis L, Bouffioux Ch, Sylvester R, Debruyne FMJ, Pavone‐Macaluso M, Oosterlinck W. Factors affecting recurrence and progression in superficial bladder tumours. European Journal of Cancer 1995;31A(11):1840‐6. - PubMed
Lamm 1991
-
- Lamm DL, DeHaven JI, Shriver J, et al. Propective randomized comparison of intravesical with percutaneous bacillus Calmette‐Guerin versus intravesical bacillus Calmette‐Guérin in superficial bladder cancer. Journal of Urology 1991;145:738‐40. - PubMed
Lamm 1995
-
- Lamm DL. BCG immunotherapy for carcinoma in situ of the bladder. Oncology 1995;9:947‐56. - PubMed
Morales 1976
-
- Morales A, Eidinger D, Bruce AW. Intracavitary bacillus Calmette Guérin in the treatment of superficial bladder tumours. Journal of Urology 1976;137:180‐3. - PubMed
Parmar 1998
-
- Parmar MKB, Torri V, Stewart L. Extracting summary statistics to perform meta‐analyses of the published literature for survival endpoints. Statistics in Medicine. Vol. 17, John Wiley & Sons Ltd., 1998:2815‐34. - PubMed
Raghavan 1990
-
- Raghavan D, Shipley WU, Garnick MB, Russel PJ, Richie JP. Biology and management of bladder cancer. New England Journal of Medicine 1990;322(16):1129‐38. - PubMed
Smith 1999
-
- Smith JA, Labasky RF, Cockett AT, Fracchia JA, Montie JE, Rowland RG. Bladder cancer clinical guidelines panel summary report on the management of nonmuscle invasive bladder cancer (stages Ta, T1 and TIS). Journal of Urology 1999;162:1697‐1701. - PubMed
van der Meijden APM
-
- Meijden APM. Bacillus Calmette‐Guérin (BCG) for transitional cell carcinoma of the bladder. In: Reginald R Hall editor(s). Clinical Management of Bladder Cancer. London: Arnold, 1999:125‐47.
Wingo 1995
-
- Wingo WJ, Tong T, Bolden S. Cancer Statistics, 1995. CA 1995;45:8‐30. - PubMed
Young 1996
-
- Young RH. Pathology of Bladder Cancer. In: Vogelzang N, Scardino P, Shipley W, Coffey D editor(s). Comprehensive Textbook of Genitourinary Oncology. Baltimore Maryland: Williams & Wilkins, 1996.
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