Maintenance Therapy with 3-monthly Bacillus Calmette-Guérin for 3 Years is Not Superior to Standard Induction Therapy in High-risk Non–muscle-invasive Urothelial Bladder Carcinoma: Final Results of Randomised CUETO Study 98013

Background: Bacillus Calmette-Guerin (BCG) is the standard of care for adjuvant intravesical instillation therapy for intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) after complete transurethral resection. Increasing evidence suggests that there are marked differences in outcomes according to BCG substrains. BCG-Moreau was recently introduced to the European market to cover the issue of BCG shortage, but there are little data regarding the oncologic efficacy. Methods: We retrospectively analyzed 295 consecutive patients, who received adjuvant intravesical instillation therapy with BCG-Moreau for intermediate- and high-risk NMIBC between October 2007 and April 2013 at a single institution. The end points of this study were time to first recurrence and progression to muscle-invasive disease. Results: Median age was 66 years (interquartile range 59-74, mean 65.9 years). According to the EAU risk group, 76 patients presented with intermediate-risk and 219 patients with high-risk NMIBC. The 5-year recurrence-free survival and progression-free survival rate was 64.8% (95% CI 52.8-74.4) and 81.4% (95% CI 65.2-90.2), respectively. Conclusions: BCG-Moreau is an effective substrain for adjuvant instillation therapies of NMIBC, and outcomes appear to be comparable to series using other substrains. During worldwide shortage of BCG-TICE, Connaught and RIVM, BCG-Moreau may serve as an equally effective alternative.

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“…Similar, the 5-year PFS rate of 81% is in line with recent studies reporting rates between 72 and 84% with other strains [25,26,27,28,29]. …”

Section: Discussionsupporting

confidence: 79%

The Moreau Strain of Bacillus Calmette-Guerin (BCG) for High-Risk Non-Muscle Invasive Bladder Cancer: An Alternative during Worldwide BCG Shortage?

et al. 2015

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“…In this issue of European Urology, Martínez-Piñ eiro et al [7] report the results of a Club Uroló gico Españ ol de Tratamiento Oncoló gico (CUETO) randomized trial in high-risk patients that compared induction BCG alone to induction followed by a single instillation of BCG every 3 mo for 3 yr using the Connaught strain. Patients were randomized to receive 12 maintenance instillations instead of the more classical SWOG/EORTC 21 maintenance instillations following induction.…”

mentioning

confidence: 98%

Maintenance Bacillus Calmette-Guérin Therapy: The Search for the Optimum Treatment Schedule Continues

Sylvester

2015

European Urology

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“…In an RCT of 1355 patients, the EORTC showed that when BCG is given at full dose, 3 yr of maintenance reduces the recurrence rate compared with 1 yr in high-risk but not in intermediate-risk patients [101] (LE: 1b). In an RCT of 397 patients, CUETO suggested that in high-risk tumours, the maintenance schedule with only one instillation every 3 mo for 3 yr may be suboptimal [102] (LE: 1b).…”

mentioning

confidence: 99%

EAU Guidelines on Non–Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016

et al. 2017

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Maintenance Therapy with 3-monthly Bacillus Calmette-Guérin for 3 Years is Not Superior to Standard Induction Therapy in High-risk Non–muscle-invasive Urothelial Bladder Carcinoma: Final Results of Randomised CUETO Study 98013

Cited by 67 publications

References 15 publications

The Moreau Strain of Bacillus Calmette-Guerin (BCG) for High-Risk Non-Muscle Invasive Bladder Cancer: An Alternative during Worldwide BCG Shortage?

The Moreau Strain of Bacillus Calmette-Guerin (BCG) for High-Risk Non-Muscle Invasive Bladder Cancer: An Alternative during Worldwide BCG Shortage?

Maintenance Bacillus Calmette-Guérin Therapy: The Search for the Optimum Treatment Schedule Continues

EAU Guidelines on Non–Muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016

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