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

ABSTRACT 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Combined published and unpublished data from comparative studies on BCG versus MMC in superficial bladder carcinoma were analyzed, considering possible confounding factors.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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    • "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; 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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    • "Several trials in the last two decades have investigated BCG efficacy in reducing the risk of recurrence and progression in intermediate/high risk BCa showing that BCG after TUR is superior to TUR alone or TUR and conventional chemotherapy [14,15]. Two meta-analyses have demonstrated that BCG therapy prevents, or at least delays, the risk of tumour progression [16,17]. "
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    ABSTRACT: Bacillus Calmette-Guérin (BCG) is considered the most effective treatment to reduce recurrence and progression of non-muscle invasive bladder cancer (NMIBC) but can induce local side effects leading to treatment discontinuation or interruption. Aim of this exploratory study is to investigate if the sequential administration of Hyaluronic acid (HA) may reduce local side effects of BCG. 30 consecutive subjects undergoing BCG intravesical administration for high risk NMIBC were randomized to receive BCG only (Group A) or BCG and HA (Group B). A 1 to 10 Visual Analog Scale (VAS) for bladder pain, International Prostate Symptom Score (IPSS) and number of micturitions per day were evaluated in the two groups before and after six weekly BCG instillations. Patients were also evaluated at 3 and 6 months by means of cystostopy and urine cytology. One out of 30 (3,3%) patients in group A dropped out from the protocol, for local side effects. Mean VAS for pain was significantly lower in group B after BCG treatment (4.2 vs. 5.8, p = 0.04). Post vs. pre treatment differences in VAS for pain, IPSS and number of daily micturitions were all significantly lower in group B. Three patients in group A and 4 in group B presented with recurrent pathology at 6 month follow up. These preliminary data suggest a possible role of HA in reducing BCG local side effects and could be used to design larger randomized controlled trials, assessing safety and efficacy of sequential BCG and HA administration. Trial registration NCT02207608 ( 01/08/2014 Policlinico Tor Vergata Ethics Committee, resolution n 69–2011.
    BMC Urology 08/2014; 14(1):64. DOI:10.1186/1471-2490-14-64 · 1.41 Impact Factor
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