Sequential Combination of Mitomycin C Plus Bacillus Calmette-Guérin (BCG) Is More Effective but More Toxic Than BCG Alone in Patients with Non–Muscle-invasive Bladder Cancer in Intermediate- and High-risk Patients: Final Outcome of CUETO 93009, a Randomized Prospective Trial

Solsona, E.; Madero, Rosário; Chantada, Venancio; Fernández, Jesús M.; Zabala, J.A.; Portillo, J.A.; Alonso, José M.; Astobieta, Ander; Unda, Miguel; Martínez‐Piñeiro, Luis; Rabadán, M; Ojea, A; Rodríguez‐Molina, Jesús; Beardo, Pastora; Muntañola, Pedro; Gomez, Matias; Montesinos, M.; Piñeiro, Jose A Martinez

doi:10.1016/j.eururo.2014.09.026

Cited by 60 publications

(66 citation statements)

References 19 publications

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“…A total of 42 studies were excluded for the following reasons: a lack of combination therapy; incomplete outcome data; no definition of the grade of risk; no comparison group; retrospective data; or not in English. The final set of eligible studies included 7 studies 15–21 published from 1999 to 2014. The selection strategy was shown in Figure 1.…”

Section: Resultsmentioning

confidence: 99%

“…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%

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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%

Section: Resultsmentioning

confidence: 99%

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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“…In one RCT, a combination of MMC and BCG reduced recurrences but was more toxic compared with BCG monotherapy [105]. In frequently recurrent NMIBC, another RCT demonstrated a significantly higher efficacy of weekly MMC followed by monthly BCG in reduction of the recurrence rate when compared with BCG and interferon [106].…”

Section: Combination Therapymentioning

confidence: 98%

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

et al. 2017

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“…6 Even though new treatments have been reported, more results and larger studies are needed. 6,12,[14][15][16] Colombo and colleagues found that C-HT is more effective than MMC alone. 17 The 10-year disease-free survival rate for C-HT and MMC alone were 53% and 15%, respectively.…”

Section: Discussionmentioning

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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Sequential Combination of Mitomycin C Plus Bacillus Calmette-Guérin (BCG) Is More Effective but More Toxic Than BCG Alone in Patients with Non–Muscle-invasive Bladder Cancer in Intermediate- and High-risk Patients: Final Outcome of CUETO 93009, a Randomized Prospective Trial

Cited by 60 publications

References 19 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

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

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

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