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Infectious complications of intravesical BCG immunotherapy

Michael A O'Donnell, MD, FACS
Section Editors
Derek Raghavan, MD, PhD, FACP, FASCO
Seth P Lerner, MD
Deputy Editor
Elinor L Baron, MD, DTMH


Intravesical administration of Bacillus Calmette-Guérin (BCG), a live attenuated strain of Mycobacterium bovis, has become a mainstay of adjunctive therapy for superficial (non–muscle invasive) bladder cancer.

While generally well tolerated, both local and systemic infectious complications can arise. When disseminated BCG infection occurs, antituberculous therapy with or without glucocorticoids should be administered.

The infectious complications of BCG immunotherapy will be reviewed here. The clinical use of this agent for the treatment of non–muscle invasive bladder cancer and acute noninfectious complications of BCG are discussed separately. Disseminated infection has also been rarely reported in patients receiving BCG vaccination for the prevention of tuberculosis [1]. (See "Treatment of primary non-muscle invasive urothelial bladder cancer" and "BCG vaccination".)


The mechanism by which Bacillus Calmette-Guérin (BCG) leads to the development of infectious complications is not fully understood. Its mechanism of action as an immunotherapeutic agent in cancer is not fully known, but evidence suggests that elaboration of a particular helper T cell cytokine profile known as the "Th1 response" is an integral part of its mechanism [2]. This potentially leads to alteration of suppresser/helper T cell ratios. (See "Treatment of primary non-muscle invasive urothelial bladder cancer", section on 'Mechanism of action of BCG'.)

Considerable debate exists in the literature about whether complications associated with intravesical BCG represent a hypersensitivity reaction or ongoing active infection. The hypersensitivity hypothesis gained early credence based upon the presence of granulomas and the absence of recoverable organisms. In a number of case reports, acid-fast bacilli have not been demonstrated and organisms have not grown despite a high clinical suspicion of BCG infection [3,4]. A response to glucocorticoids, administered along with antituberculous drugs, has also supported the notion of a hypersensitivity response.

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Literature review current through: Nov 2017. | This topic last updated: Sep 21, 2017.
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