Journal
EUROPEAN UROLOGY
Volume 44, Issue 4, Pages 429-434Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/S0302-2838(03)00357-9
Keywords
bladder neoplasms; transitional cell carcinoma; mycobacterium bovis; adverse effects
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Funding
- NCI NIH HHS [5U10CA11488-27, 5U10 CA11488-23, 5U10 CA11488-26, 5U10 CA11488-29, 5U10 CA11488-24, 5U10 CA11488-32, 2U10 CA11488-25, 5U10 CA11488-33, 2U10 CA11488-28, 2U10 CA11488-31, 2U10 CA11488-22, 5U10 CA11488-30] Funding Source: Medline
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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 half-year of maintenance. During further maintenance BCG toxicity does not increase and instillations are generally well tolerated. (C) 2003 Elsevier B.V. All rights reserved.
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