表在性膀胱腫瘍に対するPirarubicin (THP)の膀胱内注入療法 : Adriamycinとのrandomized study

Abstract

初発症例で乳頭状の表在性膀胱腫瘍に対して抗腫瘍効果を目的としたTHPとADM膀胱内注入療法の多施設参加によるrandomized studyを行った.1) THP (500 μg/ml)の有効率は56.3%(n=32), ADM (500 μg/ml)のそれは26.7%(n=30)であった.2) THPは単発より多発腫瘍に, T1よりTa腫瘍に, G2, 3よりG1腫瘍に有効率が高い傾向がみられたが, いずれも推計学的に有意な変化とはいえなかった.3)副作用として膀胱刺戟症状が主たるものであったが, THP群60.6%, ADM群23.3%の頻度でみられた.4) THPの副作用は注入開始の週より終了の3週目まで毎週ほぼ同数発生した.5)萎縮膀胱はTHP群, ADM群ともに2例ずつ認められた.6) THPはADMの1/2量で, ほぼ同等の抗腫瘍効果がみられたが, 膀胱刺激症状も約2倍であり, 両者は等価の薬剤であると判定された

To determine the antitumor action by intravesical instillation prior to transurethral resection TUR, a randomized study on pirarubicin (THP) versus adriamycin (ADM) was performed for superficial, papillary and initially detected bladder cancers with participation of 21 Urological Clinics in 3 Tokai Prefectures. The instillation dose of 500 micrograms/ml was given 3 times per week for 3 weeks in both THP (n = 33) and ADM (n = 30) groups. The complete and partial response rates were 56.3% in THP group and 26.7% in ADM group. THP instillation was more effective against multiple tumors than a single tumor, stage Ta than T1 and grade G1 than G2 and G3. However, these findings were not statistically significant. Untoward effects were mainly bladder irritability and its frequency was 60.6% in the THP group and 23.3% in the ADM group. Contracted bladder was found in 2 of the 33 patients in the THP group and 2 of the 30 patients in the ADM group. The antitumor effect of a half dose of THP was equivalent to that of one dose of ADM, and the THP group showed a twofold higher frequency of side effects. Therefore, a clinical trial should be made comparing the effect of 500 micrograms/ml of THP and that of 1, 000 micrograms/ml of ADM.