Single Course Versus Maintenance Bacillus Calmette-Guerin Therapy for Superficial Bladder Tumors: A Prospective, Randomized Trial

Hudson, M’Liss A.; Ratliff, Timothy L.; Gillen, Daniel; Haaff, Eric O.; Dresner, Steven M.; Catàlona, William J.

doi:10.1016/s0022-5347(17)43125-9

Cited by 137 publications

(62 citation statements)

References 9 publications

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“…Initial controlled trials of BCG maintenance were inconclusive, possibly as a result of the small sample size and short follow-up [37, 38]. The subsequent SWOG study, involving 384 patients followed-up over 10 years, used a superior 3-week maintenance schedule and clearly demonstrated the superiority of maintenance BCG.…”

Section: Maintenance Bcg Immunotherapymentioning

confidence: 99%

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Preventing Progression and Improving Survival with BCG Maintenance

Lamm¹

2000

Eur Urol

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Section: Maintenance Bcg Immunotherapymentioning

confidence: 99%

“…This may relate to the mechanism of action of BCG. Optimal response in animal studies has occurred with juxtaposition of BCG and tumour cells [38]. With CIS, which is rarely removed with biopsy and fulguration, juxtaposition occurs with the initial course of BCG instillations.…”

Section: Maintenance Bcg Immunotherapymentioning

confidence: 99%

Preventing Progression and Improving Survival with BCG Maintenance

Lamm¹

2000

Eur Urol

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“…Differences in the results are possibly due to the maintenance schedules. The maintenance schedules varied considerably and it appears that a weekly, monthly, quarterly or 6-monthly schedule for 1-2 years may be immunologically suboptimal (4,10,11,13). The aim of this study was to confirm the recurrence-and progression-preventing efficacy and safety of 12 times monthly BCG maintenance therapy for NMIBC.…”

Section: Introductionmentioning

confidence: 99%

“…Meta-analyses reported that BCG maintenance significantly reduces recurrence or progression in patients with NMIBC (8,9). Several studies, however, revealed no benefit of maintenance therapy in controlling tumor recurrence or progression (10)(11)(12). Differences in the results are possibly due to the maintenance schedules.…”

Section: Introductionmentioning

confidence: 99%

Monthly intravesical bacillus Calmette-Guérin maintenance therapy for non-muscle-invasive bladder cancer: 10-year experience in a single institute

Yoo

Lim

Chang

2011

Experimental and Therapeutic Medicine

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Abstract. Intravesical bacillus Calmette-Guérin (BCG) therapy is the standard prophylaxis for recurrence of non-muscle-invasive bladder cancer (NMIBC). The aim of this study was to confirm the recurrence-and progressionpreventing efficacy and safety of 12 times monthly BCG maintenance therapy for NMIBC. This study included 126 patients diagnosed with Ta, T1 and carcinoma in situ bladder cancer between January 2000 and December 2009. Thirty-four patients in the no maintenance group received a single 6-week course of intravesical immunotherapy after transurethral resection of the bladder tumor (TUR-BT). Ninety-two patients in the maintenance group received a 12-month course after a single 6-week course of intravesical immunotherapy. Recurrence, progression and side effects were assessed. End-points were recurrence-free survival (RFS), progression-free survival (PFS) and disease-specific survival (DSS). The estimated median RFS was 87 months (95% CI 53.0-120.9) in the maintenance group and 48 months (95% CI 0-96.8) in the no maintenance group (log-rank test; P=0.002). The 2-year cumulative RFS rates were 77.3% in the maintenance group and 52.6% in the no maintenance group. Median PFS and DSS were not estimable in both groups. The 2-year cumulative PFS rates were 91.1% in the maintenance group and 80.5% in the no maintenance group (log-rank test; P=0.178). The 2-year cumulative DSS rates were 97.7% in the maintenance group and 91.4% in the no maintenance group (log-rank test; P= 0.111). The overall side effects were 40.2% in the maintenance group and 44.1% in the no maintenance group. Monthly maintenance immunotherapy appears to increase RFS rates in high-risk NMIBC. Further study is required to evaluate the efficacy of BCG monthly maintenence for increasing the PFS rate.

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“…13 Five RCTs com pared non3week maintenance schedules to BCG induction only (Table 1). [14][15][16][17][18] None of these alternative maintenance schedules showed a statistically significant reduction in recurrence (range -4% to 22%, average 7%). By contrast, two studies that compared 3week mainten ance to induction treatment alone showed a statistically significant 28% reduction in tumour recur rence (Table 2).…”

Section: Optimal Schedule and Duration Of Therapymentioning

confidence: 95%

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

et al. 2015

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| Multiple clinical trials have demonstrated that intravesical Bacillus Calmette-Guérin (BCG) treatment reduces recurrences and progression in patients with non-muscle-invasive bladder cancer (NMIBC). However, although BCG has been in use for almost 40 years, this agent is often underutilized and practice patterns of administration vary. This neglect is most likely caused by uncertainties about the optimal use of BCG, including unawareness of optimal treatment schedules and about patient populations that most benefit from BCG treatment. To address this deficit, a focus group of specialized urologic oncologists (urologists, medical oncologists and radiation oncologists) reviewed the current guidelines and clinical evidence, discussed their experiences and formed a consensus regarding the optimal use of BCG in the management of patients with NIMBC. The experts concluded that continuing therapy with 3-week BCG maintenance is superior to induction treatment only and is the single most important factor in improving outcomes in patients with NMIBC. They also concluded that a reliable alternative to radical cystectomy in truly BCG-refractory disease remains the subject of clinical trials. In addition, definitions for common terms of BCG failure, such as BCG-refractory and BCG-intolerant, have been formulated.

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Single Course Versus Maintenance Bacillus Calmette-Guerin Therapy for Superficial Bladder Tumors: A Prospective, Randomized Trial

Cited by 137 publications

References 9 publications

Preventing Progression and Improving Survival with BCG Maintenance

Preventing Progression and Improving Survival with BCG Maintenance

Monthly intravesical bacillus Calmette-Guérin maintenance therapy for non-muscle-invasive bladder cancer: 10-year experience in a single institute

Consensus statement on best practice management regarding the use of intravesical immunotherapy with BCG for bladder cancer

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