Intravesical Chemotherapy (Mitomycin C) versus Immunotherapy
(Bacillus Calmette-Guérin) in Superficial Bladder Cancer

Rintala, Erkki; Jauhiainen, K.; Alfthan, O; Hansson, E; Juusela, Harri; Kanerva, Kristiina; Korhonen, Heikki; Permi, J; Sotarauta, M; Vaalasti, T.

doi:10.1159/000471653

Cited by 64 publications

(25 citation statements)

References 7 publications

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“…Fourteen articles were excluded as repeat publications, and four further articles comparing mitomycin C with an alternating regimen of BCG and mitomycin C and were also excluded. The remaining reports of seven different randomized trials comparing intravesical BCG with mitomycin C were considered for assessment [18][19][20][21][22][23][24].…”

Section: Resultsmentioning

confidence: 99%

Intravesical bacillus Calmette‐Guérin is superior to mitomycin C in reducing tumour recurrence in high‐risk superficial bladder cancer: a meta‐analysis of randomized trials

et al. 2004

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OBJECTIVETo assess, in a systematic review and meta-analysis, the relative effectiveness of intravesical mitomycin C and bacillus Calmette-Guérin (BCG) for tumour recurrence, disease progression and overall survival in patients with medium-to high-risk Ta and T1 bladder cancer. METHODSThe major medical databases were searched comprehensively up to June 2003, and relevant journals hand-searched for randomized controlled trials, in any language, that compared intravesical mitomycin C with BCG in medium-to high-risk patients with Ta or T1 bladder cancer. RESULTSTwenty-five articles were identified but only seven were considered eligible for the analysis. This represented 1901 evaluable patients in all, 820 randomized to mitomycin C and 1081 to BCG. Six trials had sufficient data for meta-analysis and included 1527 patients, 693 in the mitomycin and 834 in the BCG arm. There was no significant difference between mitomycin C and BCG for tumour recurrence in the six trials, with a weighted mean log hazard ratio, LHR, (variance) of -0.022 (0.005). However, there was significant heterogeneity between trials ( P = 0.001). A subgroup analysis of three trials that included only high-risk Ta and T1 patients indicated no heterogeneity ( P = 0.25) and a LHR for recurrence of -0.371 (0.012). With mitomycin C used as the control in the meta-analysis, a negative ratio is in favour of BCG and, in this case, was highly significant ( P < 0.001). The seventh trial (in abstract form only) used BCG in low doses for two arms of the trial (27 mg and 13.5 mg) compared with a standard dose of mitomycin C (30 mg), and reported a significantly lower recurrence rate with BCG (27 mg) than for mitomycin C ( P = 0.001). Only two trials included sufficient data to analyse disease progression and survival, representing 681 patients (338 randomized to BCG and 343 to mitomycin C). There was no significant difference between mitomycin C and BCG for disease progression, with a LHR of 0.044 (0.04) ( P = 0.16), or survival, at -0.112 (0.03) ( P = 0.50). Adverse events were slightly more frequent with BCG. Local toxicity (dysuria, cystitis, frequency and haematuria) were associated with both mitomycin C (30%) and BCG (44%). SystemicThe first paper in this section is a meta-analysis of randomized trials into the effect of two intravesical agents used to reduce tumour recurrence in high-risk superficial bladder cancer. This is the highest level of evidence-based medicine and the results presented here suggest that intravesical BCG is superior to mitomycin C. There was no difference in the effect of the two agents on disease progression or survival. In a study from Amsterdam and Rome, the authors describe a phase I trial into the toxicity and safety of intravesical gemcitabine, and found that it was well tolerated with no systemic toxicity.In a paper from Taiwan the link between viral infections and tumour foundation is evaluated, in this case specifically infections with the Epstein-Barr virus and its correlation with urothelial cancer. The authors found ...

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Section: Resultsmentioning

confidence: 99%

Intravesical bacillus Calmette‐Guérin is superior to mitomycin C in reducing tumour recurrence in high‐risk superficial bladder cancer: a meta‐analysis of randomized trials

et al. 2004

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“…In total, nine trials were identified, and IPD were obtained from all studies [10][11][12][13][14][15][16][17][18], the main characteristics of which are shown Table 1.…”

Section: Data Sourcesmentioning

confidence: 99%

An Individual Patient Data Meta-Analysis of the Long-Term Outcome of Randomised Studies Comparing Intravesical Mitomycin C versus Bacillus Calmette-Guérin for Non–Muscle-Invasive Bladder Cancer

Malmström

Sylvester

Crawford³

et al. 2009

European Urology

561

337

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Background: Patients with non-muscle-invasive bladder cancer with an intermediate or high risk need adjuvant intravesical therapy after surgery. Based largely on meta-analyses of previously published results, guidelines recommend using either bacillus Calmette-Gué rin (BCG) or mitomycin C (MMC) in these patients. Individual patient data (IPD) meta-analyses, however, are the gold standard. Objective: To compare the efficacy of BCG and MMC based on an IPD meta-analysis of randomised trials. Design, setting, and participants: Trials were searched through Medline and review articles. The relevant trial investigators were contacted to provide IPD. Measurements: The drugs were compared with respect to time to recurrence, progression, and overall and cancer-specific death. Results and limitations: Nine trials that included 2820 patients were identified, and IPD were obtained from all of them. Patient characteristics were 71% primary, 54% Ta, 43% T1, 25% G1, 58% G2, and 16% G3, and 7% had prior intravesical chemotherapy. Based on a median follow-up of 4.4 yr, 43% recurred. Overall, there was no difference in the time to first recurrence ( p = 0.09) between BCG and MMC. In the trials with BCG maintenance, a 32% reduction in risk of recurrence on BCG compared to MMC was found ( p < 0.0001), while there was a 28% risk increase ( p = 0.006) for BCG in the trials without maintenance. BCG with maintenance was more effective than MMC in both patients previously treated and those not previously treated with

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“…The recurrence rate per 100 patient-months was much lower than that in other trials, which used less intensive or short er schedules [17,18].…”

Section: Resultsmentioning

confidence: 55%

Long-Term Follow-Up of Cytostatic Intravesical Instillation in Patients with Superficial Bladder Carcinoma

Schwaibold¹,

Pichlmeier²,

Klingenberger³

et al. 1997

Eur Urol

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Intravesical Chemotherapy (Mitomycin C) versus Immunotherapy (Bacillus Calmette-Guérin) in Superficial Bladder Cancer

Cited by 64 publications

References 7 publications

Intravesical bacillus Calmette‐Guérin is superior to mitomycin C in reducing tumour recurrence in high‐risk superficial bladder cancer: a meta‐analysis of randomized trials

Intravesical bacillus Calmette‐Guérin is superior to mitomycin C in reducing tumour recurrence in high‐risk superficial bladder cancer: a meta‐analysis of randomized trials

An Individual Patient Data Meta-Analysis of the Long-Term Outcome of Randomised Studies Comparing Intravesical Mitomycin C versus Bacillus Calmette-Guérin for Non–Muscle-Invasive Bladder Cancer

Long-Term Follow-Up of Cytostatic Intravesical Instillation in Patients with Superficial Bladder Carcinoma

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