Böhle, A. & Bock, P. R. Intravesical Bacille Calmette-Guerin versus mitomycin C in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression. Urology 63, 682-686

HELIOS Agnes Karll Krankenhaus Bad Schwartau, Bad Schwartau, Schleswig-Holstein, Germany
Urology (Impact Factor: 2.19). 05/2004; 63(4):682-6; discussion 686-7. DOI: 10.1016/j.urology.2003.11.049
Source: PubMed


To compare the therapeutic efficacy of intravesical bacille Calmette-Guérin (BCG) with mitomycin C (MMC) on progression of Stage Ta and T1 bladder carcinoma.
Combined published and unpublished data from comparative studies on BCG versus MMC in superficial bladder carcinoma were analyzed, considering possible confounding factors. Odds ratios (ORs) and 95% confidence intervals (CIs) were used as the primary effect size estimate. Tumor progression was defined as progression to a higher tumor stage or the development of metastatic disease.
In nine eligible clinical trials, 1277 patients were treated with BCG and 1133 with MMC. Within the overall median follow-up of 26 months, 7.67% of the patients in the BCG group and 9.44% of the patients in the MMC group developed tumor progression. In all nine individual studies and in the combined results, no statistically significant difference in the ORs for progression between the BCG and MMC-treated groups was found (combined OR = 0.77; 95% CI 0.57 to 1.03; P = 0.081). In the subgroup with BCG maintenance, the combined result of the five individual studies showed a statistically significant superiority of BCG over MMC (OR = 0.66; 95% CI 0.47 to 0.94; P = 0.02). In the four studies without BCG maintenance, the combined result indicated no statistically significant difference between the two treatments (OR = 1.16; 95% CI 0.65 to 2.07; P = 0.612). Potential confounders, such as tumor risk status, duration of follow-up, BCG strain, BCG and MMC treatment regimen, and year of publication did not significantly influence these results.
The results demonstrated statistically significant superiority for BCG compared with MMC for the prevention of tumor progression only if BCG maintenance therapy was provided.

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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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    • "Firstly, that there is ambiguity with the terminology in use for each research trial for example the term 'worsening disease' to define tumour progression. Secondly, the meta-analyses of Sylvester et al. (2002) and Bohle and Bock (2004) did not include all the studies that were available and used published results rather than individual patient data, which is considered to be the gold standard for meta-analysis (Simmonds et al., 2005). He goes on to say that maintenance treatment does not appear superior to induction treatment alone in preventing or delaying progression and that prolonged use of BCG increases the toxicity of the treatment. "
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    ABSTRACT: Since the turn of the 20th century Bacillus Calmette-Guerin (BCG) treatment for non-muscle invasive bladder cancer (NMIBC) has been in and out of favour. However, only a small proportion of patients, as low as 16%, complete what is seen as a gold standard treatment. To understand why it is the gold standard treatment the epidemiology and aetiology of NMIBC is presented. This article discusses how BCG was first discovered in cows to it being used as a treatment for NMIBC. The issues of side effects which can be from mild to severe and local to systemic, will be discussed. The impact of age in the tolerance of this treatment will be also be looked at. In conclusion, with BCG treatment being the preferred option for NMIBC, it also comes with significant side effects. It is these that should be of concern to the health care professional as they can be potentially life threatening.
    International Journal of Urological Nursing 11/2014; 9(3). DOI:10.1111/ijun.12064 · 0.19 Impact Factor
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    • "They concluded that BCG with maintenance prevents or at least delays progression to muscle invasive disease. Conversely, in a more recent meta-analysis by Malmstrom et al. (2009), who compared BCG and MMC, could not confirm the results of Sylvester et al. (2002) and Bohle and Bock (2004). Since the reporting of these meta-analyses, three randomized studies for intermediate and high risk NMIBC have been undertaken. "
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    ABSTRACT: Bladder cancer is the second most common urological cancer in the UK, with over 10 000 cases diagnosed annually. With 80% of urothelial bladder cancers being non-muscle invasive, it is important to understand the treatments available. This review aims to identify and review the literature regarding bacillus Calmette-Guerin (BCG) treatment. An integrative-based review was conducted to generate a broad overview of the existing knowledge for BCG treatment. An open search of online databases was conducted to identify articles published in English from the earliest date available to September 2013, using key terms related to BCG. A significant number of articles were identified. To narrow the results and identify the most relevant articles, the search terms were cross-referenced. The resulting articles were then reviewed using the critical appraisal skills programme framework. The tools provided by CASP give a systematic, transparent and rigorous approach to the quality assessment of research studies. The research articles were then categorized under the following headings: side effects, including local, systemic and age; quality of life; and attrition. The major conclusion from this literature review is that BCG treatment, when given through an induction and maintenance regime, significantly reduces the risk of progression and recurrence. However, there are potential side effects which the patient and the nurse need to be aware. This review also highlighted that there is a lack of research from the UK and that there is a paucity of research showing why patients withdraw from BCG treatment
    International Journal of Urological Nursing 10/2014; 9(2). DOI:10.1111/ijun.12055 · 0.19 Impact Factor
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