BACKGROUND: In Japan, bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation is generally performed at a dose of 80 mg once weekly for eight consecutive weeks; however, many adverse effects including severe ones have been reported. We employed a dose of 40 mg once a week for six consecutive weeks in principle for carcinoma in situ (CIS) of the bladder, and retrospectively evaluated its effectiveness and safety. METHODS: A total of 43 patients with CIS of the bladder were treated by this method and followed-up for a subsequent 12-79 months (median, 54 months). The patients consisted of 35 males and eight females aged 45-87 years (mean, 67.5 years). Intravesical BCG instillation at a dose of 40 mg was conducted once a week for six consecutive weeks. RESULTS: A complete response (CR) was achieved in 84% of the patients, in whom the recurrence-free rate was 72.4% after 3 years and 61.9% after 5 years. The median CR duration was 37.5 months. Two patients underwent total cystectomy, but none died of bladder cancer. As adverse effects, bladder irritation symptoms were observed in 48.8%, pyuria in 46.5%, macroscopic hematuria in 18.6% and fever (>37.5 degrees C) in 9.3%. There were no severe adverse effects requiring discontinuation of drug administration. CONCLUSION: Our present study corroborated both the effectiveness and safety of low-dose BCG therapy for CIS of the bladder. This therapy warrants further study by prospective randomized trials in the future.
BACKGROUND: In Japan, bacillus Calmette-Guerin (BCG: Tokyo 172 strain) instillation is generally performed at a dose of 80 mg once weekly for eight consecutive weeks; however, many adverse effects including severe ones have been reported. We employed a dose of 40 mg once a week for six consecutive weeks in principle for carcinoma in situ (CIS) of the bladder, and retrospectively evaluated its effectiveness and safety. METHODS: A total of 43 patients with CIS of the bladder were treated by this method and followed-up for a subsequent 12-79 months (median, 54 months). The patients consisted of 35 males and eight females aged 45-87 years (mean, 67.5 years). Intravesical BCG instillation at a dose of 40 mg was conducted once a week for six consecutive weeks. RESULTS: A complete response (CR) was achieved in 84% of the patients, in whom the recurrence-free rate was 72.4% after 3 years and 61.9% after 5 years. The median CR duration was 37.5 months. Two patients underwent total cystectomy, but none died of bladder cancer. As adverse effects, bladder irritation symptoms were observed in 48.8%, pyuria in 46.5%, macroscopic hematuria in 18.6% and fever (>37.5 degrees C) in 9.3%. There were no severe adverse effects requiring discontinuation of drug administration. CONCLUSION: Our present study corroborated both the effectiveness and safety of low-dose BCG therapy for CIS of the bladder. This therapy warrants further study by prospective randomized trials in the future.
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