Japanese Journal of Clinical Oncology Advance Access originally published online on June 23, 2005
Japanese Journal of Clinical Oncology 2005 35(7):395-399; doi:10.1093/jjco/hyi111
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© 2005 Foundation for Promotion of Cancer Research
Long-term Outcome of a Low-dose Intravesical Bacillus Calmette–Guerin Therapy for Carcinoma In Situ of the Bladder: Results After Six Successive Instillations of 40 mg BCG
1 Department of Urology, Hamamatsu University School of Medicine and 2 Department of Urology, Seirei Mikatahara General Hospital, Hamamatsu, Shizuoka, Japan
For reprints and all correspondence: Soichi Mugiya, Department of Urology, Hamamatsu University School of Medicine, 1-20-1, Handayama, Hamamatsu, 431-3192 Japan. E-mail: mugiya{at}hama-med.ac.jp
Received March 20, 2005; accepted May 15, 2005
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°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.
Key Words: BCG • CIS • Tokyo 172 strain • low-dose • adverse effect