Sequential Intravesical Chemoimmunotherapy with Mitomycin C and Bacillus Calmette-Guérin and with Bacillus Calmette-Guérin Alone in Patients with Carcinoma in Situ of the Urinary Bladder: Results of an EORTC Genito-Urinary Group Randomized Phase 2 Trial (30993)

Oosterlinck, Willem; Kirkali, Ziya; Sylvester, Richard; Silva, Fernando Calais da; Busch, Christer; Algaba, Ferrán; Collette, Sandra; Bono, Aldo

doi:10.1016/j.eururo.2010.11.038

Cited by 47 publications

(33 citation statements)

References 20 publications

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“…Of these patients, 702 patients were treated with combination therapy, and 671 underwent BCG monotherapy. Two studies 17,18 included patients with CIS alone, 5 studies 15–19 compared the efficacy between MMC + BCG and BCG monotherapy, and 2 studies 20,21 compared the efficacy between epirubicin + BCG and BCG monotherapy. In addition, 2 studies 19,20 investigated the efficacy of perioperative chemotherapeutic agent instillation compared with delayed BCG monotherapy, and 5 studies 16,18–21 compared the toxicity between combination therapy and BCG monotherapy.…”

Section: Resultsmentioning

confidence: 99%

“…16,18–21 Table 2 showed the numbers and percentages of the primary side effects. A total of 644 patients were included in this analysis.…”

Section: Resultsmentioning

confidence: 99%

“…Di stasi et al 16 showed the great power of combination therapy, possibly because of the use of electromotive MMC and different instillation therapies: 1 MMC infusion was included after 2 BCG instillations during the induction period, and 2 MMC infusions were included after 1 BCG instillation in the maintenance period. Kaasinen et al 17 and Oosterlinck et al 18 showed different outcomes in patients with CIS alone. The European Organization for Research on Treatment of Cancer genitourinary group suggested that administering BCG instillation every 2 months in the alternating arm was suboptimal for the production of an adequate response.…”

Section: Discussionmentioning

confidence: 99%

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Combination of Intravesical Chemotherapy and Bacillus Calmette–Guerin Versus Bacillus Calmette–Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer

Cui

Chen

et al. 2016

Medicine

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Urothelial carcinoma of the bladder has become a major cause of morbidity, mortality, and health-related costs. There is still no standard instillation therapy against bladder cancer. A meta-analysis was conducted to evaluate the efficacy and toxicity of adding chemotherapy to Bacillus Calmette–Guerin (BCG) in intermediate- and high-risk nonmuscle invasive bladder cancer (NMIBC).All randomized controlled trials (RCTs) that evaluated the efficacy of combination therapy and BCG monotherapy for intermediate- and high-risk NMIBC were comprehensively searched. Relevant databases, including PubMed, Embase, Cochrane Central Register of Controlled trials databases, and American Society of Clinical Oncology (http://www.asco.org/ASCO), the clinical trial registration website (ClinicalTrials.gov), and relevant trials from the references of selected studies were searched from initial state up to June 6, 2015. Random-effects model was used to estimate hazard ratios (HRs) statistics. All statistical analyses were performed by STATA (version 13.0, College Station, TX).Seven studies, including 1373 patients with intermediate- and high-risk NMIBC, were identified. For disease-free survival, the pooled HRs from all studies was 0.69 (95% confidence interval [CI], 0.48–1.00; P = 0.048). The disease-free survival benefit was more apparent among patients with intermediate-risk NMIBC (P = 0.002) or Ta/T1 with/without carcinoma in situ (P < 0.01). In subgroup analysis, a significant reduction in recurrence was found in studies that explored the influence of a perioperative single dose instillation compared with delayed BCG monotherapy (HR = 0.60; 95% CI, 0.38–0.92; P = 0.021). No significant difference was found for progression-free survival (HR = 0.78; 95% CI, 0.43–1.44; P = 0.435).Patients with intermediate- and high-risk NMIBC who underwent combination therapy achieved lower rates of recurrence than those who underwent BCG therapy alone. No difference in progression-free survival was found between the 2 different therapy schedules. Better efficacy for a perioperative single dose instillation compared with delayed BCG monotherapy was found in this meta-analysis.

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Section: Resultsmentioning

confidence: 99%

“…16,18–21 Table 2 showed the numbers and percentages of the primary side effects. A total of 644 patients were included in this analysis.…”

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Combination of Intravesical Chemotherapy and Bacillus Calmette–Guerin Versus Bacillus Calmette–Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer

Cui

Chen

et al. 2016

Medicine

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“…The randomized EORTC30993 trial compared sequential mitomycin C and BCG to BCG alone, but did not demonstrate any benefit of the combi nation treatment in terms of recurrence or progression. 78 Results from an aggregate metaanalysis did not show any difference in response rates or progression between administering chemotherapy and BCG concomitantly or in sequence. 79 However, the combination approach did trend towards reduced recurrence (relative risk 0.75) and progression (relative risk 0.45) for patients with Ta or T1 tumours, while not having much benefit in those with CIS.…”

Section: Options After Bcg Failurementioning

confidence: 92%

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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“…[11][12][13] However, optimum method including regimen and duration are still unknown. 13 In 2010, a randomized trial regarding the recurrence-preventing efficacy of maintenance BCG intravesical therapy for NMI-UCC is reported.…”

Section: Treatment For Non-muscle Invasive Bladder Tumorsmentioning

confidence: 99%

Current and Emerging Strategies for the Management of Bladder Cancer

Sakai¹

2011

Clinical Medicine Reviews in Oncology

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Treatment strategies and outcome of bladder cancer depend on tumor progression. Non-muscle invasive urothelial cell carcinoma (NMI-UCC) is generally treated by transurethral resection (TUR). In addition, intravesical therapy is often followed to prevent the recurrence; however, its effect is not still enough. On the other hand, the prognosis of bladder cancer patients with muscle-invasive and/or metastatic tumors is poor, despite the availability of various therapies. Although radical cystectomy is the "gold standard" for patients with muscle-invasive disease, high frequency of recurrence and decreased quality of life are major disadvantages associated with this procedure. In recent years, various newly developed treatment strategies have progressed to clinical trials for the perioperative treatment of muscle-invasive cancer and for systematic therapy for advanced bladder cancer. Here, we review the current and emerging therapeutic strategies and discuss the recent clinical trials of anti-vascular endothelial growth factor (VEGF) family-and anti-endothelial growth factor receptor (EGFR)-based therapies.

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Sequential Intravesical Chemoimmunotherapy with Mitomycin C and Bacillus Calmette-Guérin and with Bacillus Calmette-Guérin Alone in Patients with Carcinoma in Situ of the Urinary Bladder: Results of an EORTC Genito-Urinary Group Randomized Phase 2 Trial (30993)

Cited by 47 publications

References 20 publications

Combination of Intravesical Chemotherapy and Bacillus Calmette–Guerin Versus Bacillus Calmette–Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer

Combination of Intravesical Chemotherapy and Bacillus Calmette–Guerin Versus Bacillus Calmette–Guerin Monotherapy in Intermediate- and High-risk Nonmuscle Invasive Bladder Cancer

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

Current and Emerging Strategies for the Management of Bladder Cancer

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