Article

Intravesical Bacillus Calmette-Guerin Versus Mitomycin C For Superficial Bladder Cancer: A Formal Meta-Analysis of Comparative Studies on Recurrence and Toxicity

Department of Urology, Medical University of Lübeck, Lübeck, Germany.
The Journal of Urology (Impact Factor: 3.75). 01/2003; 169(1):90-5. DOI: 10.1097/01.ju.0000039680.90768.b3
Source: PubMed

ABSTRACT We compare the therapeutic efficacy and toxicity of intravesical bacillus Calmette-Guerin (BCG) with mitomycin C on recurrence of stages Ta and T1 bladder carcinoma.
Combined published and unpublished data from comparative studies on BCG versus mitomycin C for superficial bladder carcinoma considering possible confounding factors were analyzed. Odds ratio (OR) and its 95% CI were used as primary effect size estimate. Toxicity data were evaluated descriptively.
In 11 eligible clinical trials 1,421 patients were treated with BCG and 1,328 were treated with mitomycin C. Within the overall median followup time of 26 months 38.6% of the patients in the BCG group and 46.4% of those in the mitomycin C group had tumor recurrence. In 7 of 11 studies BCG was significantly superior to mitomycin C, in 3 studies no significant difference was found, while in 1 study mitomycin C was significantly superior to BCG. An overall statistically significant superiority of BCG versus mitomycin C efficacy in reducing tumor recurrence was detected (OR 0.56, 95% CI 0.38 to 0.84, p = 0.005). In the subgroup treated with BCG maintenance all 6 individual studies showed a significant superiority of BCG over mitomycin C (OR 0.43, 95% CI 0.35 to 0.53, p <0.001). In 4 of the 5 studies with reported data on toxicity BCG associated cystitis was significantly more frequent than in the mitomycin C group (53.8% versus 39.2%). The combined cystitis OR was 1.81 (95% CI 1.48 to 2.23, p <0.001). The OR for cystitis in the BCG maintenance group did not significantly differ from that in the nonmaintenance therapy group.
The results suggest superiority of BCG over mitomycin C for prevention of tumor recurrences in the combined data and particularly in the BCG maintenance treatment subgroup, irrespective of the actual (intermediate or high) tumor risk status. The toxicity with BCG is higher but does not differ between BCG maintenance and nonmaintenance groups.

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    • "In contrast, patients who were able to tolerate BCG and had an initial response were reported to have a 38.6% recurrence rate after a median follow-up of 26 months [46]. BCG unresponsiveness is defined as persistent high grade tumor at 6 months or a recurrence within 6 months or less after achieving a disease-free state [47] [48]. "
    04/2015; 1(1):15-27. DOI:10.3233/BLC-150014
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    • "En revanche, la fréquence des effets secondaires n'a pas a été augmentée en cas de traitements d'entretien. La méta-analyse de Böhle et al. a montré que la fréquence des syndromes irritatifs vésicaux n'était pas différente selon que les patients reçoivent ou pas un traitement d'entretien [31] (niveau de preuve 1). Dans une étude de phase III comparant deux groupes de 320 et 319 patients traités respectivement sans et avec traitement d'entretien, Van der Meijden et al. ont objectivé que la majorité des EI locorégionaux et généraux survenaient durant le traitement d'induction par BCG et n'étaient pas corrélés au nombre d'instillations réalisées dans le cadre du traitement d'entretien [32] (niveau de preuve 1). "
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    La Presse Médicale 02/2013; 42(7-8). DOI:10.1016/j.lpm.2012.10.017 · 1.17 Impact Factor
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    • "Advances in Urology this therapeutic, which may result in tumour progression [5] [6] [7] [8] [9]. Other important fact related with BCG treatment is that 90% of patients will experience some sort of side effects (local cystitis symptoms such dysuria, frequency alteration, and occasional haematuria) [10] [11] and, for this reason, an elevated number of patients did not complete the treatment schedule [12] [13] although a significant higher withdrawal rate of patients treated with BCG could not be demonstrated [12] [13] [14]. Since the response to BCG is unpredictable, it is important to find a reliable predictive biomarker and/or a marker that could identify elevated risk groups of treatment failure and side effects development. "
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