[Prevention of postoperative recurrence of human bladder carcinoma by intravesical instillation of immunotoxin, a clinical study].

OBJECTIVE

To observe the effects of intravesical instillation of immunotoxin (IT) on the prevention of recurrence of bladder carcinoma.

METHODS

128 patients with superficial bladder carcinoma or bladder carcinoma of T2 stage underwent operation, and then were randomly divided into 3 groups 2 - 3 weeks after operation to be instilled intravesically with solution of mitomycin (n = 53), Calmette-Guerin vaccine (n = 30), or IT (n = 45) once a week for 8 weeks and then once every month for 8 months respectively. Cystoscopy, blood routine examination, routine urine examination, and liver function test were conducted every 3 months. Immunohistochemistry was used to examine 30 samples of resected carcinoma. The effects and side effects were observed. Recurrence was verified by cystoscopy and/or ultrasonography, CT, and surgery.

RESULTS

Out of the 30 samples of resected bladder carcinoma, 27 were staining positive (+ - + + +) with a positive rate of 90%. The binding activity was significantly different between the G(1) carcinoma of and the G(3) carcinoma (P < 0.05) and not significantly different between the G(1) and G(2) carcinomas and between the G(2) and G(3) carcinomas (both P > 0.05). The higher the grade of carcinoma, the stronger the binding activity of IT (P < 0.05). The recurrence rate in the first year were 11.1%, 10.0%, and 15.1% in the IT, BCG, and MMC groups respectively without significant difference between any 2 groups (all P > 0.05); and the recurrence rate in the 2nd year were 24.4%, 30.0%, and 28.3% in the 3 groups respectively without significant difference between any 2 groups (all P > 0.05). The side effect rate were 17.8% on the IT group, significantly lower than those in the other 2 groups (70.0% and 56.6% respectively, both P < 0.01). However, the side effect rates between the BCG group and MMC group was not significantly different (P > 0.05).

CONCLUSION

IT is more effective on the prevention of recurrence of carcinomas with higher malignancy and has fewer side effects. The short-term effect of IT is similar to those of BCG and MMC. The activity of IT is associated with the grade and not the stage of carcinoma.