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      Managing the adverse events of intravesical bacillus Calmette–Guérin therapy

      review-article
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      Research and Reports in Urology
      Dove Medical Press
      BCG, intravesical therapy, complications

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          Abstract

          This paper provides recommendations on the management of complications arising from intravesical treatment with bacillus Calmette–Guérin (BCG) for nonmuscle-invasive bladder tumors. There is minimal recommendations currently available as randomized trials on the side effects of intravesical BCG are lacking and severe complications are usually described in case reports only. All physicians giving intravesical BCG should be aware of the possible complications that could arise and how to treat these. The incidence of bladder irritation, general malaise, and fever is very high, while severe complications remain rare. Approximately 8% of patients have to stop treatment because of these complications. BCG infections and reactions can occur anywhere in the body, and may happen straight away or even several months or years after BCG treatment, making early diagnosis difficult. Additionally, correct diagnosis is hampered by the uncertain appearance of BCG in tissue and body fluid. An essential step in the management complications arising from BCG is written information for both the family doctor and the patient on the possible adverse events and their management. Recent data demonstrated that none of the earlier advocated methods to prevent BCG toxicity are valid: lowering the dose, tuberculostatic drugs, or oxybutynin. Severe complications are treated with three or four tuberculostatics over 3–12 months, depending on the severity of the situation. Corticosteroids are an essential therapy in BCG septicemia. Nonsteroidal anti-inflammatory drugs and corticosteroids can manage efficiently the immunological complications.

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          Most cited references35

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          The mechanism of action of BCG therapy for bladder cancer--a current perspective.

          Bacillus Calmette-Guérin (BCG) has been used to treat non-muscle-invasive bladder cancer for more than 30 years. It is one of the most successful biotherapies for cancer in use. Despite long clinical experience with BCG, the mechanism of its therapeutic effect is still under investigation. Available evidence suggests that urothelial cells (including bladder cancer cells themselves) and cells of the immune system both have crucial roles in the therapeutic antitumour effect of BCG. The possible involvement of bladder cancer cells includes attachment and internalization of BCG, secretion of cytokines and chemokines, and presentation of BCG and/or cancer cell antigens to cells of the immune system. Immune system cell subsets that have potential roles in BCG therapy include CD4(+) and CD8(+) lymphocytes, natural killer cells, granulocytes, macrophages, and dendritic cells. Bladder cancer cells are killed through direct cytotoxicity by these cells, by secretion of soluble factors such as TRAIL (tumour necrosis factor-related apoptosis-inducing ligand), and, to some degree, by the direct action of BCG. Several gaps still exist in our knowledge that should be addressed in future efforts to understand this biotherapy of cancer.
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            Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer: a meta-analysis of the published results of randomized clinical trials.

            We determine if intravesical bacillus Calmette-Guerin (BCG) reduces the risk of progression after transurethral resection to stage T2 disease or higher in patients with superficial (stage Ta, T1 or carcinoma in situ) bladder cancer. A meta-analysis was performed of the published results of randomized clinical trials comparing transurethral resection plus intravesical BCG to either resection alone or resection plus another treatment other than BCG. We identified 24 trials with progression information on 4,863 patients. Based on a median followup of 2.5 years and a maximum of 15 years, 260 of 2,658 patients on BCG (9.8%) had progression compared to 304 of 2,205 patients in the control groups (13.8%), a reduction of 27% in the odds of progression on BCG (OR 0.73, p = 0.001). The percent of patients with progression was low (6.4% of 2,880 patients with papillary tumors and 13.9% of 403 patients with carcinoma in situ, reflecting the short followup and relatively low risk patients entered in many of the trials. The size of the treatment effect was similar in patients with papillary tumors and in those with carcinoma in situ. However, only patients receiving maintenance BCG benefited. There was no statistically significant difference in treatment effect for either overall survival or death due to bladder cancer. Intravesical BCG significantly reduces the risk of progression after transurethral resection in patients with superficial bladder cancer who receive maintenance treatment. Thus, it is the agent of choice for patients with intermediate and high risk papillary tumors and those with carcinoma in situ.
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              Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer.

              Intravesical therapy with bacillus Calmette-Guerin (BCG) has proved to be more effective in the prophylaxis and treatment of superficial bladder tumors and carcinoma in situ than most chemotherapeutic agents. Compared to intravesical chemotherapy, instillations with BCG provoke more local and systemic reactions. In addition to the commonly induced granulomatous inflammatory changes in the bladder, which produce irritative symptoms, this therapy may cause systemic side effects varying from mild malaise and fever to, in rare instances, life-threatening or fatal sepsis. We report the incidence and varieties of toxicities in 2,602 patients treated with intravesical BCG. Side effects are classified according to local and systemic toxicity. Treatment options vary according to the severity of toxicity from delaying or withholding instillations to treatment with antituberculous drugs for up to 6 months. In general, 95% of the patients have no serious side effects. Recognition of risk factors, particularly traumatic catheterization or concurrent cystitis, that result in systemic BCG absorption, as well as the prompt and appropriate treatment of early side effects should significantly decrease the incidence of severe toxicity.
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                Author and article information

                Journal
                Res Rep Urol
                Res Rep Urol
                Research and Reports in Urology
                Research and Reports in Urology
                Dove Medical Press
                2253-2447
                2015
                23 October 2015
                : 7
                : 157-163
                Affiliations
                Department of Urology, Ghent University Hospital, Ghent, Belgium
                Author notes
                Correspondence: Willem Oosterlinck, Department of Urology, Ghent University Hospital, De Pintelaan 185, 9000 Ghent, Belgium, Tel +32 472 256 120, Fax +32 9 332 3889, Email willem.oosterlinck@ 123456ugent.be
                Article
                rru-7-157
                10.2147/RRU.S63448
                4630183
                26605208
                0ddb7fcf-e085-4a8d-b742-3f8b7f30dd39
                © 2015 Decaestecker and Oosterlinck. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License

                The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

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                Review

                bcg,intravesical therapy,complications
                bcg, intravesical therapy, complications

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