Maintenance Bacillus Calmette-Guerin for Ta T1 Bladder Tumors Is Not Associated with Increased Toxicity: Results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial

Meijden, A.P.M. van der; Sylvester, Richard; Oosterlinck, W; Hoeltl, Wolfgang; Bono, Aldo

doi:10.1016/s0302-2838(03)00357-9

Cited by 242 publications

(123 citation statements)

References 11 publications

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“…16 ). Serious side effects however are described in < 5% of patients 17 . The optimal BCG instillation schedule is unknown.…”

Section: Discussionmentioning

confidence: 99%

Methylation status as a predictor of intravesical Bacillus Calmette-Guérin (BCG) immunotherapy response of high grade non-muscle invasive bladder tumor

Hušek¹,

Pacovský²,

Chmelařová³

et al. 2017

BIOMED PAP

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, Milos Brodak aBackground and Aims. Genetic and epigenetic alterations play an important role in urothelial cancer pathogenesis. Deeper understanding of these processes could help us achieve better diagnosis and management of this life-threatening disease. The aim of this research was to evaluate the methylation status of selected tumor suppressor genes for predicting BCG response in patients with high grade non-muscle-invasive bladder tumor (NMIBC). Materials and Methods. We retrospectively evaluated 82 patients with high grade non-muscle-invasive bladder tumor (stage Ta, T1, CIS) who had undergone BCG instillation therapy. We compared epigenetic methylation status in BCGresponsive and BCG-failure groups. We used the MS-MLPA (Methylation-Specific Multiplex Ligation-Dependent Probe Amplification probe sets ME001 and ME004. The control group was 13 specimens of normal urotel (bladder tissue)). Results. Newly identified methylations in high grade NMIBC were found in MUS81a, NTRK1 and PCCA. The methylation status of CDKN2B (P=0.00312 ** ) and MUS81a (P=0.0191 * ) is associated with clinical outcomes of BCG instillation therapy response. CDKN2B and MUS81a unmethylation was found in BCG failure patients. Conclusion.The results show that the methylation status of selected tumor suppressor genes (TSGs) has the potential for predicting BCG response in patients with NMIBC high grade tumors. Tumor suppressor genes such as CDKN2b, MUS81a, PFM-1, MSH6 and THBS1 are very promising for future research.

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“…16 ). Serious side effects however are described in < 5% of patients 17 . The optimal BCG instillation schedule is unknown.…”

Section: Discussionmentioning

confidence: 99%

Methylation status as a predictor of intravesical Bacillus Calmette-Guérin (BCG) immunotherapy response of high grade non-muscle invasive bladder tumor

Hušek¹,

Pacovský²,

Chmelařová³

et al. 2017

BIOMED PAP

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“…However, the oncologic efficacy was inferior to that of the full dose and three-year maintenance [20,22,23]. Most adverse events occurred within one year after BCG instillation; therefore, the occurrence of systemic adverse events is dependent on the host factors, not on the number of instillations [7,12,19]. Therefore, the host factors are also important to consider in controlling the adverse events of intravesical BCG instillation for NMIBC.…”

Section: Discussionmentioning

confidence: 99%

“…Bacillus Calmette-Guerin (BCG) vaccination is a routine method for TB prevention and is also used to prevent recurrence and progression in high-risk non-muscle invasive bladder cancer (NMIBC) by intravesical instillation [6,7]. Most adverse events with respect to intravesical BCG are local reactions due to immune stimulation required for the eradication of cancer cells [8].…”

Section: Introductionmentioning

confidence: 99%

Symptoms of Bacillus Calmette-Guerin Cystitis in Bladder Cancer Patients according to Tuberculosis Sequelae by Chest Radiography

Seo

Kang

Yoon

et al. 2017

Urogenit Tract Infect

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Purpose: Bacillus Calmette-Guerin (BCG) vaccination has been administered to most infants at birth in Korea; however, tuberculosis (TB) remains extant. TB can leave sequelae on chest radiography according to the immune response of the host. We investigated the symptoms of cystitis after intravesica instillations in bladder cancer, depending on the TB sequelae on chest radiography. Materials and Methods: One hundred forty-two patients with non-muscle invasive bladder cancer (NMIBC) underwent transurethral resection and intravesical BCG therapy for bladder cancer. Patients received a BCG induction course-with or without a maintenance course-and were divided into the two groups: Group A, which included patients with visible sequelae of TB on chest radiography (n=31) and group B, which included patients without visible sequelae of TB (n=111). Cystitis symptoms of BCG intravesical therapy were compared between the two groups. The recurrence and progression rates of bladder cancer were also analyzed. Results: The overall rate of cystitis symptoms was 32.3% (10/31) in group A and 33.3% (37/111) in group B. One patient in group A and three in group B did not complete the treatment course due to severe cystitis symptoms (p=0.876). Pyuria was reported when cystitis symptoms occurred in 80% (8/10) in group A and 56.8% (21/37) in group B. The recurrence and progression rates were not different between the two groups. Conclusions: Our results show that there was no significant difference of cystitis symptoms in accordance with the presence of TB sequelae in chest radiography when BCG instravesical therapy for NMIBC was performed.

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“…Although intravesical BCG has more severe and more frequent side effects compared to intravesical chemotherapy, the number of patients that discontinue BCG instillations during the induction course is significantly different between Europe and North America, at least as reported in the South West Oncology Group (SWOG) trial. In the European Organization for Research and Treatment of Cancer (EORTC) study in which 487 patients received 36 months of BCG, 26 only 20% of patients discontinued BCG due to local and/or systemic side effects. Local toxicity remained constant during maintenance therapy.…”

Section: Defining Bcg Failurementioning

confidence: 99%

The management of BCG failure in non-muscle-invasive bladder cancer: an update

Zlotta

Fleshner

Jewett

2013

CUAJ

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Up to 40% of patients with non-muscle-invasive bladder cancer (NMIBC) will fail intravesical bacillus Calmette-Guérin (BCG) therapy. There is unfortunately no current gold standard for salvage intravesical therapy after appropriate BCG treatment. Indeed, outcomes are at best suboptimal. The vast majority of low-grade NMIBC are prone to recur but very rarely progress. Failure after intravesical BCG in these patients is usually superficial and lowgrade. At the other end of the spectrum, failure to respond to BCG in high-risk T1 bladder cancer and/or carcinoma in situ (CIS or TIS) is more problematic, since those tumours often have the potential to progress to muscle invasion. In these cases, radical cystectomy remains the mainstay after BCG failure. With appropriate selection, certain patients who "fail" BCG (but with favourable risk factors) can be managed with intravesical regimens, including repeated BCG, BCG plus cytokines, intravesical chemotherapy, thermochemotherapy or new immunotherapeutic modalities. In this review, reasons explaining BCG failure, how to define BCG failure, optimal risk stratification and prediction of response and management of BCG failures are discussed.

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Maintenance Bacillus Calmette-Guerin for Ta T1 Bladder Tumors Is Not Associated with Increased Toxicity: Results from a European Organisation for Research and Treatment of Cancer Genito-Urinary Group Phase III Trial

Cited by 242 publications

References 11 publications

Methylation status as a predictor of intravesical Bacillus Calmette-Guérin (BCG) immunotherapy response of high grade non-muscle invasive bladder tumor

Methylation status as a predictor of intravesical Bacillus Calmette-Guérin (BCG) immunotherapy response of high grade non-muscle invasive bladder tumor

Symptoms of Bacillus Calmette-Guerin Cystitis in Bladder Cancer Patients according to Tuberculosis Sequelae by Chest Radiography

The management of BCG failure in non-muscle-invasive bladder cancer: an update

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