Collaborative Review – Bladder Cancer

The Role of Bacillus Calmette-Guérin in the Treatment of Non–Muscle-Invasive Bladder Cancer

By: Paolo Gonteroa lowast , Andreas Bohleb, Per-Uno Malmstromc, Michael A. O’Donnelld, Marco Oderdaa, Richard Sylvestere and Fred Witjesf

European Urology, Volume 57 Issue 3, March 2010, Pages 410-429

Published online: 01 March 2010

Keywords: BCG, Intravesical, Bladder cancer, Survival, Progression, Recurrence, Maintenance, Dosing, Toxicity, Tolerability, Side effects, Prognostic factors

Abstract Full Text Full Text PDF (322 KB)



Bacillus Calmette-Guérin (BCG) remains the most effective intravesical treatment for non–muscle-invasive bladder cancer (NMIBC), but the clinical development of BCG has been accompanied by controversy. Recent publications have called into question a number of aspects related to its use.


To review the current clinical role of BCG in NMIBC, focusing on efficacy and tolerability as primary objectives and on strategies to predict response and decrease toxicity as secondary objectives.

Evidence acquisition

We performed a systematic literature search of published articles in PubMed, Embase, and the Cochrane Central Register of Controlled Trials databases for the period from 1976 to November 2008. The following “free text” combination was used in the first instance: “BCG and intravesical and bladder cancer.” Further free text searches were performed by separately adding the following keywords to the combination “BCG and intravesical”: survival, progression, recurrence, maintenance, dosing, toxicity, tolerability, side effects, prognostic factors.

Evidence synthesis

BCG is the most effective intravesical agent for preventing NMIBC recurrence, but its role in disease progression remains controversial. In intermediate-risk NMIBC, the superiority of BCG over chemotherapy is well established for disease recurrence but not for progression and needs to be balanced against higher toxicity. With regard to high-risk NMIBC, there is sufficient evidence to show that BCG is the most effective treatment of carcinoma in situ for ablation, disease-free interval, and progression, but the impact of BCG on the natural history of T1G3 tumors relies on a low level of evidence. Maintenance remains crucial for efficacy. The dose can be safely and effectively reduced to decrease its toxicity, which is slightly greater than chemotherapy.


BCG should still be viewed as the most effective intravesical agent, but its role in the progression of papillary tumors needs to be clarified. BCG remains an alternative to intravesical chemotherapy in intermediate-risk NMIBC, and it is recommended as the standard of care for high-risk NMIBC.

Take Home Message

While bacillus Calmette-Guérin (BCG) reduces the risk of progression in high-risk patients, for whom it is the standard of care, its effect on progression in intermediate-risk patients has not been proven. Further work is needed to better understand the mode of action of BCG, to refine the treatment schedule, and to more accurately identify the patients most likely to benefit.

Keywords: BCG, Intravesical, Bladder cancer, Survival, Progression, Recurrence, Maintenance, Dosing, Toxicity, Tolerability, Side effects, Prognostic factors.


a Department of Urology, University of Turin, Molinette Hospital, Turin, Italy

b Department of Urology, HELIOS Agnes Karll Krankenhaus, Bad Schwartau, Germany

c Department of Surgical Sciences/Urology, Uppsala University Hospital, Uppsala, Sweden

d Department of Urology, University of Iowa, Carver College of Medicine, Iowa City, Iowa, USA

e European Organization for Research and Treatment of Cancer, Headquarters, Brussels, Belgium

f Department of Urology, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

Corresponding author. University of Turin, Urologia 1 Molinette Hospital, Dogliotti 14, Torino, Italy. Tel. +390116335581; Fax: +390116334202.

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