Final Results of an EORTC-GU Cancers Group Randomized Study of Maintenance Bacillus Calmette-Guérin in Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Urinary Bladder: One-third Dose Versus Full Dose and 1 Year Versus 3 Years of Maintenance

Oddens, Jorg R.; Brausi, Maurizio; Sylvester, Richard; Bono, Aldo; Beek, C. van de; Andel, George van; Gontero, Paolo; Hoeltl, Wolfgang; Türkeri, Levent; Marréaud, Sandrine; Collette, Sandra; Oosterlinck, Willem

doi:10.1016/j.eururo.2012.10.039

Cited by 418 publications

(361 citation statements)

References 18 publications

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“…3,4 Although BCG has demonstrated superiority than chemotherapy, it needs to be balanced with side effects. 5 Due to side effects and failure of BCG, new chemotherapy agents and device-assisted instillation have been tested in high-risk patients. 6 Intravesical mitomycin-C (MMC) for NMIBC has been widely studied.…”

Section: Introductionmentioning

confidence: 99%

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Ekin¹,

Akarken

Zorlu³

et al. 2015

CUAJ

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Introduction: Patients with high-risk non-muscle invasive bladder cancer (NMIBC) need adjuvant intravesical treatment after surgery. Although bacillus Calmette-Guérin (BCG) is highly effective, new adjuvant treatments to decrease recurrences and toxicity have been studies. We performed a retrospective propensity score-matched study to compare the efficacy of BCG and chemohyperthermia (C-HT). Methods: We included 1937 patients diagnosed with bladder cancer between January 2004 and January 2014. The primary efficacy endpoint was recurrence-free interval. Patients treated with C-HT were matched with patients treated with BCG using propensity score-matched analysis. Cox-regression models were used to estimate the association between intravesical treatments and the presence of recurrence and progression. Results: Of the 710 patients treated with intravesical treatments, 40 and 142 were eligible for inclusion in C-HT and BCG groups, respectively. Following case matching, there were no differences in patient or tumour characteristics between treatment groups. The 2-year recurrence-free interval in C-HT and BCG groups were 76.2% and 93.9%, respectively (p = 0.020). C-HT treatment (hazard ratio [HR] 5.42; 95% confidence interval [CI] 1.11-26.43; p = 0.036) and high-grade tumour (HR 4.60; 95% CI 1.01-20.88; p = 0.048) are associated with an elevated odds of tumour recurrence. In multivariate Cox-regression analysis, there was no significant difference between C-HT and BCG in the odds of recurrence (p = 0.054). There were no differences in progression between C-HT and BCG. Conclusion: C-HT is not as effective treatment as BCG in high-risk NMIBC patients who are BCG-naive. Although, there were no significant difference in the odds of recurrence, recurrence-free interval is significantly improved by the administration of BCG.

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Section: Introductionmentioning

confidence: 99%

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Ekin¹,

Akarken

Zorlu³

et al. 2015

CUAJ

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“…22,35 Symptom management, such as use of singledose, shortterm quinolones 6 h after BCG instillation and/or use of anticholinergics, has been shown to decrease moderate to severe adverse events in some published reports, 36,37 and enables the majority (90%) of patients to tolerate fulldose BCG without discontinuation of therapy. 38 …”

Section: Practical Issues Of Bcg Administrationmentioning

confidence: 99%

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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“…If there is persistent Ta or CIS disease, an additional 6-week induction course can be used to provide a response in up to 50% of patients [O'Donnell and Boehle, 2006;Babjuk et al 2013]. Three-week maintenance courses for 1-3 years following induction have been shown to reduce cancer recurrence and progression in multiple studies, although the optimal duration of maintenance BCG remains unclear [Hinotsu et al 2011;Oddens et al 2013]. With regard to dosing, fulldose BCG has been shown to decrease recurrence rates compared with 1/3 and 1/6 dose BCG [Ojea et al 2007;Oddens et al 2013].…”

Section: Bcgmentioning

confidence: 99%

The role of mycobacterial cell wall nucleic acid complex in the treatment of bacillus Calmette–Guérin failures for non-muscle-invasive bladder cancer

Packiam

Pearce

Steinberg

2015

Therapeutic Advances in Urology

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Introduction:The treatment of high-risk non-muscle-invasive bladder cancer (NMIBC) utilizes transurethral resection followed by adjuvant intravesical immunotherapy or chemotherapy. Intravesical bacillus Calmette-Guérin (BCG) is the mainstay of adjuvant immunotherapy, but there are limited nonsurgical options for patients that fail this treatment. Mycobacterial cell wall nucleic acid complex (MCNA) is an immunotherapeutic agent utilized primarily after failure of intravesical BCG. The purpose of this paper is to provide a comprehensive review of the published literature regarding MCNA. Methods: A literature review was performed and identified studies indexed in MEDLINE ® related to utilization of MCNA for patients with NMIBC. Results: Two trials assessed the efficacy of MCNA in patients with NMIBC, comprising a total of 184 patients. Most patients had carcinoma in situ (CIS) with (26%) or without (52%) concomitant papillary tumors. A minority of patients had only papillary tumors (22%). Most patients (95%) previously received BCG or other intravesical therapy prior to receiving MCNA. In the largest available trial, 25% and 19% of patients had no evidence of residual cancer in 1 and 2 years following initiation of MCNA. A total of 2.3% of patients had adverse events (AEs) leading to delay or discontinuation of therapy and 66% of patients had mild drug-related AEs. Conclusion: Based on analysis of available published data, MCNA offers a durable response for a small proportion of patients that have failed prior intravesical therapy. There still exists a large unmet need for nonsurgical treatment options for patients with NMIBC who have failed adjuvant intravesical therapies.

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Final Results of an EORTC-GU Cancers Group Randomized Study of Maintenance Bacillus Calmette-Guérin in Intermediate- and High-risk Ta, T1 Papillary Carcinoma of the Urinary Bladder: One-third Dose Versus Full Dose and 1 Year Versus 3 Years of Maintenance

Cited by 418 publications

References 18 publications

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

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

The role of mycobacterial cell wall nucleic acid complex in the treatment of bacillus Calmette–Guérin failures for non-muscle-invasive bladder cancer

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