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.
RCT Entities:
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 BCGtoxicity 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 BCGtoxicity does not increase and instillations are generally well tolerated.
Authors: Wassim Kassouf; Samer L Traboulsi; Girish S Kulkarni; Rodney H Breau; Alexandre Zlotta; Andrew Fairey; Alan So; Louis Lacombe; Ricardo Rendon; Armen G Aprikian; D Robert Siemens; Jonathan I Izawa; Peter Black Journal: Can Urol Assoc J Date: 2015-10-13 Impact factor: 1.862
Authors: Andrew T Lenis; Nicholas M Donin; Mark S Litwin; Christopher S Saigal; Julie Lai; Jan M Hanley; Badrinath R Konety; Karim Chamie Journal: Clin Genitourin Cancer Date: 2016-06-25 Impact factor: 2.872
Authors: P J Goebell; F Vom Dorp; C Rödel; D Frohneberg; J W Thüroff; D Jocham; C Stief; S Roth; R Knüchel; K W Schmidt; I Kausch; D Zaak; C Wiesner; K Miller; R Sauer; H Rübben Journal: Urologe A Date: 2006-07 Impact factor: 0.639
Authors: Kai Qu; Jian Gu; Yuanqing Ye; Stephen B Williams; Colin P Dinney; Xifeng Wu; Ashish Kamat Journal: Oncoimmunology Date: 2017-01-03 Impact factor: 8.110