膀胱腫瘍に対する制癌剤膀注療法およびOK-432(全身投与)の併用療法による再発防止効果の比較検討

Abstract

経尿道的前立腺切除術にて明らかな残存腫瘍を認めない39例の膀胱腫瘍症例を対象に, 制癌剤の膀胱療法兼OK-432全身投与(A群)および制癌剤膀注療法のみ(B群)を行い, 両群間の非再発率を比較検討した.1) A, B両群間の患者背景因子には差を認めなかった.2)非再発率は, 全症例ではA B群間で差を認めなかったが, 初発例・stage T0症例ではB群が, 再発例・stage T1, 2症例ではA群が有効であった.3) OK-432投与によると思われるSU-PS皮内反応の増強が示された.4)膀注療法およびOK-432注射に由来する重篤な副作用は認められなかった

To evaluate the effects of bladder instillation chemotherapy of anticancer agents with OK-432 intradermal injection (group A) in preventing postoperative recurrence of bladder carcinoma, a randomized controlled study with intravesical instillation chemotherapy of anticancer agents (group B) as the reference standard was performed. As the anticancer agents, pepleomycin (PEP) was usually used at a concentration of 30 mg/30 ml physiological saline. OK-432 injection dose was gradually increased from 0.5 KE to 5.0 KE and maintenance dose was decided by local skin reactions. There were no differences in the patient's background factors between group A (22 cases) and group B (17 cases). The no-recurrence rate of bladder carcinoma was similar in the two groups, but the no-recurrence rate for the virgin tumor or the stage T0 cases was higher in group B. On the other hand, the values for the recurrent cases or the stage T1, 2 cases was higher in group A. The SU-PS skin reaction as an immunological response was significantly higher in group A. There were no severe side effects derived from anticancer bladder instillation or OK-432 injection.