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

• Published in: Japanese journal of clinical oncology 2005-07, Vol.35 (7), p.395-399
• Main Authors: Mugiya, Soichi, Ozono, Seiichiro, Nagata, Masao, Takayama, Tatsuya, Ito, Toshiki, Maruyama, Satoshi, Hadano, Shinsuke, Nagae, Hiroshi
• Format: Article
• Language: English
• Subjects: Administration, Intravesical; adverse effect; Aged; Aged, 80 and over; BCG; BCG Vaccine - administration & dosage; Carcinoma in Situ - drug therapy; CIS; Drug Administration Schedule; Female; Humans; low-dose; Male; Middle Aged; Retrospective Studies; Tokyo 172 strain; Urinary Bladder Neoplasms - drug therapy
• ISSN: 0368-2811; 1465-3621
• DOI: 10.1093/jjco/hyi111

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.