Use of Maintenance Intravesical Bacillus Calmette-Guérin (BCG), with or without Intradermal BCG, in Patients with Recurrent Superficial Bladder Cancer

Witjes, J. Alfred; Fransen, M.P.H.; Meijden, A.P.M. van der; Doesburg, W.H.; Debruyne, F. M. J.

doi:10.1159/000282516

Cited by 22 publications

(10 citation statements)

References 16 publications

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“…These trials (1) covered previously tested indications for which clear results had not been obtained; (2) investigated variations in dose, 104 - 107 administration route 108 - 111 and schedule; 111 - 113 and (3) evaluated the safety and efficacy of BCG or BCG components in a few previously untested or scarcely tested settings, including lymphoma, 114 and ovarian cancer 115 - 117 . These clinical studies led to a remarkable refinement in the dosage and schedule of BCG immunotherapy, thus lowering both the incidence and severity of BCG-associated side effects (mainly consisting of fever, hematuria, bladder irritation/infection and a potentially lethal, but very rare, systemic reaction) 118 .…”

Section: Bacillus Calmette-guérinmentioning

confidence: 99%

Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy

Galluzzi²,

et al. 2012

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Toll-like receptors (TLRs) have first been characterized for their capacity to detect conserved microbial components like lipopolysaccharide (LPS) and double-stranded RNA, resulting in the elicitation of potent (innate) immune responses against invading pathogens. More recently, TLRs have also been shown to promote the activation of the cognate immune system against cancer cells. Today, only three TLR agonists are approved by FDA for use in humans: the bacillus Calmette-Guérin (BCG), monophosphoryl lipid A (MPL) and imiquimod. BCG (an attenuated strain of Mycobacterium bovis) is mainly used as a vaccine against tuberculosis, but also for the immunotherapy of in situ bladder carcinoma. MPL (derived from the LPS of Salmonella minnesota) is included in the formulation of Cervarix®, a vaccine against human papillomavirus-16 and -18. Imiquimod (a synthetic imidazoquinoline) is routinely employed for actinic keratosis, superficial basal cell carcinoma, and external genital warts (condylomata acuminata). In this Trial Watch, we will summarize the results of recently completed clinical trials and discuss the progress of ongoing studies that have evaluated/are evaluating FDA-approved TLR agonists as off-label medications for cancer therapy.

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Section: Bacillus Calmette-guérinmentioning

confidence: 99%

Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy

Galluzzi²,

et al. 2012

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“…Several studies and meta-analysis data indicate that the use of thiotepa, MMC, doxorubicin and epirubicin do not significantly change the progression and tumorspecific survival rates [6,[32][33][34]49,100,101]. In contrast, evidence from controlled, randomized trials suggests a significant reduction in tumor progression and tumor-specific mortality rates with BCG administration [6,13,23,52,92,102,103]. The reasons for the apparent advantage of intravesical BCG over chemotherapy in the intermediate-and long-term prevention of tumor recurrence and progression of high-stage and grade disease is unclear.…”

Section: Intravesical Chemoprophylaxis or Bcg Immunoprophylaxismentioning

confidence: 99%

Intravesical Therapy of Superficial Bladder Cancer

Moutzouris

2000

CPD

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Transurethral resection (TUR) of the superficial transitional cell carcinoma (TCC) of the bladder is known to be insufficient in controlling the disease because of the unacceptable rates of recurrence, progression and ultimate cystectomy. Adjuvant intravesical chemo-and/or immunotherapy is administered in an effort to enhance the efficacy of surgery alone. The initial tumor stage and grade, the multifocality of this cancer and the history of previous recurrences remain the determinant factors in survival. It is important to decide exactly which patients are at risk, and, therefore, do need treatment. Knowledge of the natural history of the disease will facilitate this decision making, although the natural history of TCC is largely unpredictable owing to tumor heterogeneity. Several cytotoxic and immune modifying agents have been used intravesically in different treatment schedules. However, despite their effectiveness, no consensus exists about the optimal antineoplastic regimen. The selection of the latter is a subject of continuous investigation. Intravesical treatment with cytotoxic drugs has been demonstrated to achieve an acceptable reduction in short- and intermediate-term recurrence rates, but has no proven ability in preventing disease progression to muscle-invasive cancer or prolonging survival. On the other hand, bacillus Calmette-Guerin (BCG) currently appears to be the most effective agent for intravesical use, especially in patients with high grade and stage neoplasms but the optimum strain, dosage and duration schedule have not been determined. Clinical trials have shown that BCG provides long-term protection from tumor recurrence, while there is evidence that it may favorably alter the progression rate of the disease with prolongation of survival. Toxicity of intravesical chemo- and immunotherapy still remains a major problem and attempts at reducing the dosage, and, thus, toxicity without affecting efficacy are underway. This review endeavors to present updated information on intravesical chemotherapy in treating superficial bladder cancer, the expanding role of intravesical immunotherapy, the recent work comparing various immunotherapeutic regimens with chemotherapeutic intravesical therapies, and the progress made towards achieving optimal treatment regimens.

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“…It has been demonstrated that the use of BCG was associated with a relative risk for UBC recurrence of 0.39 [29,30]. These encouraging results were sustained even in patients with recurrent or aggressive disease, including patients whose prior intravesical chemotherapy had failed [16,31]. …”

Section: Intravesical Bacillus Calmette–guerin Immunotherapymentioning

confidence: 99%

Update on Intravesical Agents for Non-Muscle-Invasive Bladder Cancer

et al. 2010

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Major controversies still exist with regard to the indication, type and regimen of intravesical therapy for non-muscle-invasive bladder cancer. Other areas of controversy are the criteria for response/failure of treatment and for decisions regarding secondary intravesical therapy versus radical cystectomy. In this article, we analyze the different intravesical therapeutic strategies and compare their safety and efficacy. Well-designed clinical trials have found that the addition of bacillus Calmette–Guerin (BCG) to transurethral resection (TUR) decreases the risk for both disease recurrence and progression. These encouraging results are sustained even in patients with recurrent or aggressive disease, including patients whose prior intravesical chemotherapy has failed. Most investigators believe that the efficacy of BCG therapy can be maximized with maintenance therapy. Mitomycin C (MMC), the most commonly used intravesical chemotherapy to date, decreases the risk of disease recurrence but not disease progression when used after TUR compared with TUR alone. The oncologic efficacy of intravesical MMC can be optimized by increasing its concentration in addition to alkalinizing and reducing urine production. For patients at high risk of disease progression, BCG with maintenance therapy should be the preferred primary intravesical therapeutic strategy. However, MMC can be considered as a viable alternative for patients with papillary tumors (no carcinoma in situ) that are at low or intermediate risk of disease progression. Combination intravesical therapy may be more successful than single-agent strategies. Intravesical therapy failures indicate the need to include radical cystectomy as an option in the management decision.

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Use of Maintenance Intravesical Bacillus Calmette-Guérin (BCG), with or without Intradermal BCG, in Patients with Recurrent Superficial Bladder Cancer

Cited by 22 publications

References 16 publications

Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy

Trial watch: FDA-approved Toll-like receptor agonists for cancer therapy

Intravesical Therapy of Superficial Bladder Cancer

Update on Intravesical Agents for Non-Muscle-Invasive Bladder Cancer

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