BACKGROUND: Although bacillus Calmette-Guérin (BCG) has proven highly effective in non-muscle-invasive bladder cancer (NMIBC), but it can cause severe local and systemic side effects. OBJECTIVES: The objective was to determine whether reducing the dose or duration of BCG was associated with fewer side effects. Efficacy comparisons of one-third dose versus full dose BCG given for 1 yr versus 3 yr have previously been published. DESIGN, SETTING, AND PARTICIPANTS: After transurethral resection, patients with intermediate- and high-risk NMIBC without carcinoma in situ were randomised to one-third dose or full dose BCG and 1 yr or 3 yr of maintenance. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Local and systemic side effects were recorded at every instillation and divided into three time periods: during induction, during the first year after induction, and during the second and third years of maintenance. RESULTS AND LIMITATIONS: Of the 1316 patients who started BCG, 826 (62.8%) reported local side effects, 403 (30.6%) reported systemic side effects, and 914 (69.5%) reported local or systemic side effects. The percentage of patients with at least one side effect was similar in the four treatment arms (p=0.41), both overall and in the different time periods. The most frequent local and systemic side effects were chemical cystitis in 460 (35.0%) patients and general malaise in 204 patients (15.5%); 103 patients (7.8%) stopped treatment because of side effects. No significant difference was seen between treatment groups (p=0.74). In the 653 patients randomised to 3 yr ofBCG, 35 (5.4%) stopped during the first year, and 21 (3.2%) stopped in the second or third year. CONCLUSIONS: No significant differences in side effects were detected according to dose or duration of BCG treatment in the four arms. Side effects requiring stoppage of treatment were seen more frequently in the first year, so not all patients are able to receive the 1-3 yr of treatment recommended in current guidelines. This study was registered at ClinicalTrials.gov with identifier NCT00002990 (http://clinicaltrials.gov/ct2/show/record/NCT00002990).
RCT Entities:
BACKGROUND: Although bacillus Calmette-Guérin (BCG) has proven highly effective in non-muscle-invasive bladder cancer (NMIBC), but it can cause severe local and systemic side effects. OBJECTIVES: The objective was to determine whether reducing the dose or duration of BCG was associated with fewer side effects. Efficacy comparisons of one-third dose versus full dose BCG given for 1 yr versus 3 yr have previously been published. DESIGN, SETTING, AND PARTICIPANTS: After transurethral resection, patients with intermediate- and high-risk NMIBC without carcinoma in situ were randomised to one-third dose or full dose BCG and 1 yr or 3 yr of maintenance. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Local and systemic side effects were recorded at every instillation and divided into three time periods: during induction, during the first year after induction, and during the second and third years of maintenance. RESULTS AND LIMITATIONS: Of the 1316 patients who started BCG, 826 (62.8%) reported local side effects, 403 (30.6%) reported systemic side effects, and 914 (69.5%) reported local or systemic side effects. The percentage of patients with at least one side effect was similar in the four treatment arms (p=0.41), both overall and in the different time periods. The most frequent local and systemic side effects were chemical cystitis in 460 (35.0%) patients and general malaise in 204 patients (15.5%); 103 patients (7.8%) stopped treatment because of side effects. No significant difference was seen between treatment groups (p=0.74). In the 653 patients randomised to 3 yr of BCG, 35 (5.4%) stopped during the first year, and 21 (3.2%) stopped in the second or third year. CONCLUSIONS: No significant differences in side effects were detected according to dose or duration of BCG treatment in the four arms. Side effects requiring stoppage of treatment were seen more frequently in the first year, so not all patients are able to receive the 1-3 yr of treatment recommended in current guidelines. This study was registered at ClinicalTrials.gov with identifier NCT00002990 (http://clinicaltrials.gov/ct2/show/record/NCT00002990).
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: Ashish M Kamat; J Alfred Witjes; Maurizio Brausi; Mark Soloway; Donald Lamm; Raj Persad; Roger Buckley; Andreas Böhle; Marc Colombel; Joan Palou Journal: J Urol Date: 2014-03-25 Impact factor: 7.450
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
Authors: Peter E Clark; Philippe E Spiess; Neeraj Agarwal; Rick Bangs; Stephen A Boorjian; Mark K Buyyounouski; Jason A Efstathiou; Thomas W Flaig; Terence Friedlander; Richard E Greenberg; Khurshid A Guru; Noah Hahn; Harry W Herr; Christopher Hoimes; Brant A Inman; A Karim Kader; Adam S Kibel; Timothy M Kuzel; Subodh M Lele; Joshua J Meeks; Jeff Michalski; Jeffrey S Montgomery; Lance C Pagliaro; Sumanta K Pal; Anthony Patterson; Daniel Petrylak; Elizabeth R Plimack; Kamal S Pohar; Michael P Porter; Wade J Sexton; Arlene O Siefker-Radtke; Guru Sonpavde; Jonathan Tward; Geoffrey Wile; Mary A Dwyer; Courtney Smith Journal: J Natl Compr Canc Netw Date: 2016-10 Impact factor: 11.908
Authors: Wassim Kassouf; Armen Aprikian; Peter Black; Girish Kulkarni; Jonathan Izawa; Libni Eapen; Adrian Fairey; Alan So; Scott North; Ricardo Rendon; Srikala S Sridhar; Tarik Alam; Fadi Brimo; Normand Blais; Chris Booth; Joseph Chin; Peter Chung; Darrel Drachenberg; Yves Fradet; Michael Jewett; Ron Moore; Chris Morash; Bobby Shayegan; Geoffrey Gotto; Neil Fleshner; Fred Saad; D Robert Siemens Journal: Can Urol Assoc J Date: 2016-02-08 Impact factor: 1.862