[ImmuCyst intravesical (freeze-dried preparation made from the connaught strain of Bacillus Calmette Guérin) for the treatment of superficial bladder cancer and carcinoma in situ of urinary bladder]

Abstract

BCG has been used as a preventive vaccine of tuberculosis worldwide. However, in 1976, Morales et al. reported the effective use against superficial bladder cancer by intravesical administration. In Japan, in July, 1994, Rhone-Poulenc Rorer Japan Inc, started the cooperative clinical studies with Nippon Kayaku Co. Ltd. as an orphan drug. In the phase I/II studies, BCG preparation at 40.5, 81 and 121.5 mg was given intravesically slowly, keeping it for 2 hrs, in the bladder. This was repeated once weekly for 8 weeks. The CR rates were 60, 68.2 and 75% respectively, but there were no significant differences. The major adverse reactions were polyurea, urination pain, urination difficulty, hematurea and urinary leukocytosis which were frequently observed. Beside these, fever, malaise, loss of appetite and GPT elevation were also observed. In the late phase II study, in which 81 mg were given, CR rates in 39 response evaluable cases, was 61.5% (16/26), response rate (CR + PR) was 85.6% (22/26), and CR rate of CIS was 92.6% (12/13). There were responded cases in the recurred cases and those with previous chemotherapy, and the adverse reactions were polyurea, urination pain, urination difficulty, hematurea, malaise and loss of appetite mainly.

Conclusion: Compared with anticancer drug treatments, BCG prevented the recurrence the disease for a long time. From these studies, freeze-dried BCG preparation (immu-Cyst) seemed to be very useful for the treatment of superficial bladder cancer and carcinoma in situ of urinary bladder.