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: 4.47). 01/2003; 169(1):90-5. DOI: 10.1097/01.ju.0000039680.90768.b3
Source: PubMed


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Combined published and unpublished data from comparative studies on BCG versus mitomycin C for superficial bladder carcinoma considering possible confounding factors were analyzed.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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    • "for intermediate and high-risk tumors [2]. Intravesical BCG with maintenance has been shown to decrease rates of both recurrence [3] [4] and progression [5] [6]. Despite BCG therapy, treatment failure occurs in approximately 40% of patients followed for 2 years [7]. "
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    ABSTRACT: Background: Bacillus Calmette-Guerin (BCG) is the most effective intravesical therapy for non-muscle invasive bladder cancer (NMIBC), but patients can fail or supply shortages can develop. For BCG failures, radical cystectomy is recommended. However, in patients who desire bladder preservation or are poor surgical candidates, alternative salvage intravesical therapies should be explored. Objective: To determine whether dual sequential intravesical gemcitabine and docetaxel is effective in treating NMIBC. Methods: We evaluated our initial experience with 45 patients treated with intravesical gemcitabine and docetaxel between June 2009 and May 2014. Patients were treated with 6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline). Treatment success was defined as no bladder cancer recurrence and no cystectomy. Intention-to-treat analysis was performed using the Kaplan Meier method. Results: Forty-five patients received treatment with a median overall follow-up of 15 months. Median follow up for treatment success was 6 months in all patients and 13 months for responders. Five patients were unable to tolerate a full induction course. Treatment success was 66% at first surveillance, 54% at 1 year, and 34% at 2 years after initiating induction. Ten patients received cystectomy (median of 5.6 months from starting induction) with no positive margins or lymph nodes on final pathology. Conclusions: Sequential dual intravesical gemcitabine and docetaxel can salvage some patients in a challenging NMIBC cohort
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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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    • "Intravesical bacillus Calmette-Guerin (BCG) is currently regarded as the standard treatment after transurethral resection for patients with NMIBC. Several randomized-controlled trials have shown the superiority of adjuvant BCG over TUR-BT alone or combined with non-BCG adjuvant intravesical therapy [1]-[3]. As BCG induces immune response, researchers developed maintenance protocols that include long-term admission of intravesical BCG beyond the induction period. "

    Open Journal of Urology 01/2015; 05(06):77-83. DOI:10.4236/oju.2015.56012
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