Elsevier

European Urology

Volume 65, Issue 2, February 2014, Pages 267-269
European Urology

Platinum Opinion
Myths and Mysteries Surrounding Bacillus Calmette-Guérin Therapy for Bladder Cancer

https://doi.org/10.1016/j.eururo.2013.10.016Get rights and content

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Myth 1: Bacillus Calmette-Guérin only reduces recurrence rates of non–muscle-invasive bladder cancer

False. BCG has been proven to decrease both progression and recurrence based on evidence from high-quality meta-analyses and randomized controlled trials (RCTs) [1], [2], [3]. Specifically, using a meta-analysis of 24 RCTs evaluating BCG in >4000 patients with NMIBC, Sylvester et al. provided the most convincing evidence that intravesical immunotherapy not only reduces recurrence but also provides an overall 27% risk reduction overall in progression to invasive disease (odds ratio: 0.73; p = 

Myth 2: Induction bacillus Calmette-Guérin is sufficient intravesical therapy for non–muscle-invasive bladder cancer

False. Current evidence clearly shows that intravesical BCG should be administered according to the protocol described in SWOG trial 8507 [5]. Induction consists of six weekly intravesical instillations of BCG, followed by maintenance consisting of three weekly treatments at 3 mo and 6 mo and then every 6 mo, for a total of 36 mo. With this regimen, it is possible for approximately 60% of patients who have an initial response to remain tumor free for >5 yr; with maintenance, disease progression

Myth 3: Bacillus Calmette-Guérin is indicated only in high-risk disease

False. The use of adjuvant intravesical therapy after transurethral resection of bladder lesions is recommended based on the likelihood of recurrence and progression. The beneficial effect of BCG is greatest in those with both intermediate- and high-risk disease [1], as only those with low-grade and low-volume Ta tumors (low risk) have a <5% probability of progression. High-risk tumors include those with high-grade histology, T1, and CIS lesions. Intermediate-risk tumors include mainly

Myth 4: Most patients are unable to tolerate the “optimal” bacillus Calmette-Guérin regimen

False. This statement is also said as, “My patients can only tolerate induction, so I will avoid maintenance treatment.” Unfortunately, it reflects a lack of diligence on the part of the treating physician. In the aforementioned EORTC 30962 study comparing full-dose and one-third dose intravesical BCG immunotherapy given with a 1-yr or 3-yr maintenance course, there were no significant differences in side effects based on dose or duration of maintenance schedule given [10]. Of the patients

Myth 5: There is no future in bacillus Calmette-Guérin therapy

This statement deserves more than a one-word response. As highlighted by our discussions, BCG therapy administered diligently and with adequate maintenance therapy in patients with intermediate- and high-risk NMIBC positively affects patient outcomes by decreasing recurrence and progression and improving disease-specific survival, as shown by multiple high-quality, well-performed, multi-institutional clinical trials. It is critical, however, to adhere to the principles outlined earlier because

Conflicts of interest

A.M. Kamat is on the advisory board of Endo Pharmaceuticals, of Bioniche, and of Sanofi-Pasteur.

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