表在性膀胱癌再発予防の臨床的研究 --Bleomycin膀注およびBestatin併用比較試験成績の各種統計解析による検討--

Abstract

Objectives and methods of the study: Although superficial bladder carcinoma can be surgically eliminated by TUR, recurrence is common. Various attempts have been made to prevent recurrence, but to date an excellent prophylactic method with few adverse reactions has not been established. We conducted a clinical trial study for prophylaxis of bladder carcinoma recurrence, using intravesical instillation of bleomycin, a drug which cause little local irritation, in combination with bestatin, a recently developed immunomodulator. Bleomycin was selected on the bases of experimental results. That is, in beagle dogs, the 1-hour intravesical instillation of bleomycin gained a drug concentration in the bladder wall of 2.08 micrograms/g, which is approximately 4 times higher than that in the intravenous administration of the same dose. The above bleomycin concentration was thought enough to obtain a good clinical effect. A total of 124 patients were randomly divided into the two treatment groups: An only bleomycin intravesical instillation group (60 mg on each treatment day) (58 patients) and a bleomycin with bestatin (60 mg per every day) group (66 patients). In the 2-year follow-up period the recurrence of bladder carcinoma in the two treatment groups was studied. Analysis of non-recurrence rate by life-table method and Kaplan-Meier method: The non-recurrence rate of the bladder carcinoma every three months was calculated by the life-table and Kaplan-Meier methods. The non-recurrence rate in the bleomycin group was approximately the same as the rates in adriamycin or mitomycin reported in the literature. In the bleomycin + bestatin group, the recurrence rates at 9 months and 12 months were significantly (at P = 0.09 and P = 0.08, respectively) lower, and in addition, even the 2-year overall non-recurrence rate curves showed a nearly significant difference (P = 0.179). Especially in the case of papillary pedunculated tumors, the difference in the non-recurrence rate curves was almost statistically significant (P = 0.104). The stratified analysis on the basis of various tumor factors, were as follows. Pathological grade: Although no differences were found in Grades 1 and 2, the bleomycin + bestatin group had a lower recurrence rate in Grade 3 cases (P = 0.1).(ABSTRACT TRUNCATED AT 400 WORDS)