Intravesical bacillus Calmette‐Guèrin therapy: experience with a reduced dwell‐time in patients with pronounced side‐effects

Andius, Patrik; Fehrling, Marianne; Holmäng, Sten

doi:10.1111/j.1464-410x.2005.05817.x

Cited by 35 publications

(20 citation statements)

References 20 publications

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“…The Tice and Connaught strains have similar side effects (42% vs. 28%, P = 0.09) [25] and no difference in intolerability for the Tokyo and Connaught strains (8.1% vs. 9.8%, P = 0.70) was shown [26]. Andius et al reduced the instillation dwell time to less than 30 min [27]. Decreased fever, chills and dysuria were found while frequency and haematuria were unchanged.…”

Section: Discussionmentioning

confidence: 97%

BCG immunotherapy for non-muscle invasive bladder cancer: is efficacy related to toxicity?

Udovicich

Nankivell²,

Barberi

et al. 2017

Bladder

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OBJECTIVES:To examine the prevalence of local and systemic adverse effects (AEs) associated with Bacillus Calmette-Guerin (BCG) immunotherapy for non-muscle invasive bladder cancer (NMIBC) and to determine if there was any relationship between adverse effects and efficacy of treatment. PATIENTS AND METHODS:Patients receiving induction intravesical BCG immunotherapy for NMIBC from 1995 to 2013 were identified from a group urology practice. Patients completed an AE scoresheet and an AE was recorded if the patient experienced the symptom at any point in the week following instillation. Patients were dichotomised based on recurrence status (treatment efficacy was defined as non-recurrence) and association with AEs was investigated using univariate Cox regression analysis. RESULTS:One hundred and fifty eight patients were examined with a mean age of 70.2 years (range 41-88) and a male predominance (125, 79%). The most prevalent local AEs were frequency (107, 68%), dysuria (98, 62%) and nocturia (95, 60%). Malaise (54, 34%), myalgia (41, 26%) and fever (32, 20%) were the most common systemic AEs. Recurrence status was available for 82 patients, with 43 (52%) diagnosed with recurrence. There was no significant relationship between overall AEs and recurrence [hazard ratio (HR) 0.97, P = 0.57], or for local (HR 0.99, P = 0.90) and systemic (HR 0.88, P = 0.32) AEs. Only frequency was significantly associated with reduced recurrence (HR = 0.42, P = 0.04). CONCLUSIONS:AEs due to BCG immunotherapy are common in the induction period with nearly 70% of patients in our cohort experiencing individual symptoms. Local AEs are considerably more prevalent than systemic. Frequency was the only AE to be significantly associated with non-recurrence. Overall, AEs due to BCG instillation treatment were not related to efficacy for NMIBC.

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Section: Discussionmentioning

confidence: 97%

BCG immunotherapy for non-muscle invasive bladder cancer: is efficacy related to toxicity?

Udovicich

Nankivell²,

Barberi

et al. 2017

Bladder

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“…Reduction of dwell time has been reported as a possibility for improving therapy and as an alternative to dose reduction in patients with severe side effects [16] but no prospective study has compared BCG dwell time as a variable. Our model indicates that increased dwell time might also influence treatment outcome ( Figure 2C ).…”

Section: Discussionmentioning

confidence: 99%

BCG-Mediated Bladder Cancer Immunotherapy: Identifying Determinants of Treatment Response Using a Calibrated Mathematical Model

et al. 2013

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Intravesical Bacillus Calmette Guérin (BCG) immunotherapy is considered the standard of care for treatment of non-muscle invasive bladder cancer; however the treatment parameters were established empirically. In order to evaluate potential optimization of clinical parameters of BCG induction therapy, we constructed and queried a new mathematical model. Specifically, we assessed the impact of (1) duration between resection and the first instillation; (2) BCG dose; (3) indwelling time; and (4) treatment interval of induction therapy – using cure rate as the primary endpoint. Based on available clinical and in vitro experimental data, we constructed and parameterized a stochastic mathematical model describing the interactions between BCG, the immune system, the bladder mucosa and tumor cells. The primary endpoint of the model was the probability of tumor extinction following BCG induction therapy in patients with high risk for tumor recurrence. We theoretically demonstrate that extending the duration between the resection and the first BCG instillation negatively influences treatment outcome. Simulations of higher BCG doses and longer indwelling times both improved the probability of tumor extinction. A remarkable finding was that an inter-instillation interval two times longer than the seven-day interval used in the current standard of care would substantially improve treatment outcome. We provide insight into relevant clinical questions using a novel mathematical model of BCG immunotherapy. Our model predicts an altered regimen that may decrease side effects of treatment while improving response to therapy.

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“…However, the duration can be reduced as an alternative to dose reduction in patients with significant side effects. [19] A standard induction course consists of six weekly instillations. Maintenance is typically given as three weekly instillations at 3 and 6 months and then every 6 months for up to 3 years.…”

Section: Bacillus Calmette Guerinmentioning

confidence: 99%

Intravesical therapy for urothelial carcinoma of the bladder

Manoharan¹

2011

Indian J Urol

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Transurethral resection is an effective therapy for non-muscle-invasive bladder cancer. However, the high rates of recurrence and significant risk of progression in higher grade tumors mandates additional therapy with intravesical agents. In this review we discuss the role of various intravesical agents currently in use including the immunomodualtory agent BCG and chemotherapeutic agents. We discuss the current guidelines and the role of these therapeutic agents in the context of higher grade Ta and T1 tumors.

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Intravesical bacillus Calmette‐Guèrin therapy: experience with a reduced dwell‐time in patients with pronounced side‐effects

Cited by 35 publications

References 20 publications

BCG immunotherapy for non-muscle invasive bladder cancer: is efficacy related to toxicity?

BCG immunotherapy for non-muscle invasive bladder cancer: is efficacy related to toxicity?

BCG-Mediated Bladder Cancer Immunotherapy: Identifying Determinants of Treatment Response Using a Calibrated Mathematical Model

Intravesical therapy for urothelial carcinoma of the bladder

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