Control Group and Maintenance Treatment With Bacillus Calmette-Guerin for Carcinoma In Situ and/or High Grade Bladder Tumors (original) (raw)
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European Urology Supplements, 2003
Objectives: Previous publications have suggested that patients developing local and/or systemic side effects to Bacillus Calmette-Guerin (BCG) have a better clinical result, however it is necessary to determine if toxicity is responsible for improved efficacy. Methods: After transurethral resection, intravesical instillations of BCG were given during a 6-week induction course followed by 3-weekly maintenance courses at 3, 6, 12, 18, 24, 30 and 36 months. The prognostic importance of delaying or stopping BCG due to local and/or systemic side effects was assessed in 487 patients. Results: Patients with local BCG side effects had a significantly longer time to first recurrence, suggesting that side effects are related to efficacy. However patients with a better outcome remain on study for a longer period of time and receive more BCG, thus increasing their risk to develop side effects. To prove whether toxicity is responsible for improved efficacy, the prognostic importance of toxicity occurring prior to the 6 month instillations was assessed using the landmark method. Neither local nor systemic BCG toxicity prior to 6 months was related to subsequent recurrence. Conclusions: While a correlation between BCG toxicity and efficacy exists, this study does not confirm that BCG toxicity is actually responsible for an improved outcome. #
Purpose: We examined the efficacy of a 12-week prophylactic course of bacillus Calmette-Guerin (BCG) on superficial bladder cancer. Materials and Methods: From August 1992 until July 1994, 70 evaluable patients 41 to 80 years old (mean age 68.5) with high risk transitional cell carcinoma of the bladder were prospectively randomized to a 12-week prophylactic course of BCG (group 2) versus a traditional 6-week course (group 1). Mean followup was 28 months. Results: A 70% tumor-free rate (21 patients) and mean interval of 12.9 months to recurrence were achieved in group 2 compared to 55% (22 patients) and 12.3 months, respectively, in group 1. Group 2 patients had an overall longer disease-free survival, although no statistical significance was achieved. A subgroup of patients with stage Ta cancer in whom at least 1 tumor was resected 12 months before treatment showed the most benefit from long-term prophylactic treatment in terms of disease-free survival. Side effects were only slightly more prominent in group 2, rendering the longer course fairly acceptable. Conclusions: Our findings suggest a difference for better overall results with the 12-week course of BCG. However, a larger number of patients are needed to demonstrate a statistically significant difference between the 2 groups.
European Urology, 2003
Objectives: Previous publications have suggested that patients developing local and/or systemic side effects to Bacillus Calmette-Guerin (BCG) have a better clinical result, however it is necessary to determine if toxicity is responsible for improved efficacy. Methods: After transurethral resection, intravesical instillations of BCG were given during a 6-week induction course followed by 3-weekly maintenance courses at 3, 6, 12, 18, 24, 30 and 36 months. The prognostic importance of delaying or stopping BCG due to local and/or systemic side effects was assessed in 487 patients. Results: Patients with local BCG side effects had a significantly longer time to first recurrence, suggesting that side effects are related to efficacy. However patients with a better outcome remain on study for a longer period of time and receive more BCG, thus increasing their risk to develop side effects. To prove whether toxicity is responsible for improved efficacy, the prognostic importance of toxicity occurring prior to the 6 month instillations was assessed using the landmark method. Neither local nor systemic BCG toxicity prior to 6 months was related to subsequent recurrence. Conclusions: While a correlation between BCG toxicity and efficacy exists, this study does not confirm that BCG toxicity is actually responsible for an improved outcome. #
Open Journal of Urology, 2015
Objective: The aim of our study was to compare recurrence-free survival between patients who completed treatment with maintenance Bacillus Calmette-Guerin (BCG) and patients who did not complete the planned treatment. Materials and Methods: Data on 115 patients with intermediateand high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) who were treated with BCG were available for analysis. Patients were categorized into 4 groups based on treatment duration: patients who completed three years of maintenance treatment, patients who stopped treatment while on maintenance, patients who were still on-treatment and patients who were treated with induction course only. Results: Of 115 patients, 86 were men and 29 were women with mean age of 67.8 (range 40-93) years. 51% had high-grade tumors and 49% had low-grade tumors. Seventythree patients (63%) had multiple tumors. Thirty patients (26%) were treated with inductiononly, 18 patients (16%) are on-treatment, 14 patients (12%) finished maintenance protocol and 53 patients (46%) discontinued treatment. Reasons for stopping treatment were disease recurrence in 13 patients and toxicity in 40 patients. 5-year recurrence-free survival was 100%, 63%, 60% and 56% in patients who completed maintenance treatment, stopped during maintenance treatment, were on-treatment and those who received induction only therapy, respectively. Conclusions: Patients should be encouraged to adhere to maintenance BCG treatment because of its favorable effect on recurrence-free survival probability.
European Urology, 2003
Objectives: After transurethral resection, the local and systemic side effects of Bacillus Calmette-Guerin (BCG) instillations were assessed during a 6-week induction course followed by 3 weekly maintenance instillations at 3, 6, 12, 18, 24, 30 and 36 months to determine if BCG toxicity increases over time. Methods: 487 patients who received BCG in a multicenter phase III trial were included. Side effects were divided into 5 different treatment periods: the first 6 weeks induction, months 3 and 6, month 12, the second year, and the third year. Results: 99 (20.3%) patients stopped BCG due to side effects. 72 (14.8%) stopped due to local side effects, including 59 for BCG induced cystitis, 33 during the first 6 months. 46 (9.4%) stopped due to systemic side effects: 23 due to fever, 19 within 6 months, and 15 due to general malaise, 12 within 6 months. 68% who stopped due to side effects did so during the first 6 months. The percent stopping after 6 months due to local side effects does not increase and actually decreases for systemic side effects. Conclusions: The majority of local and systemic side effects are seen already during the induction and the first halfyear of maintenance. During further maintenance BCG toxicity does not increase and instillations are generally well tolerated. #
European Urology Supplements, 2003
Objectives: After transurethral resection, the local and systemic side effects of Bacillus Calmette-Guerin (BCG) instillations were assessed during a 6-week induction course followed by 3 weekly maintenance instillations at 3, 6, 12, 18, 24, 30 and 36 months to determine if BCG toxicity increases over time. Methods: 487 patients who received BCG in a multicenter phase III trial were included. Side effects were divided into 5 different treatment periods: the first 6 weeks induction, months 3 and 6, month 12, the second year, and the third year. Results: 99 (20.3%) patients stopped BCG due to side effects. 72 (14.8%) stopped due to local side effects, including 59 for BCG induced cystitis, 33 during the first 6 months. 46 (9.4%) stopped due to systemic side effects: 23 due to fever, 19 within 6 months, and 15 due to general malaise, 12 within 6 months. 68% who stopped due to side effects did so during the first 6 months. The percent stopping after 6 months due to local side effects does not increase and actually decreases for systemic side effects. Conclusions: The majority of local and systemic side effects are seen already during the induction and the first halfyear of maintenance. During further maintenance BCG toxicity does not increase and instillations are generally well tolerated. #