泌尿器系腫瘍特に膀胱腫瘍に対する術後補助化学療法剤としてのCarmofur(ミフロール)の効果について

Abstract

泌尿器系腫瘍(膀胱腫瘍)の術後再発予防に対する5-FUのmasked compundであるcarmofur(ミフロールー(R))の効果を検討した.1) 134例(男性90例, 女性44例)を対象に術後にcarmofur(ミフロール(R))300～600 mg/日を連日経口投与した.2)解析対象とした121例の再発率は10.7%であった.3)術後2ヵ月以内に投薬が開始された65例についての1年, 2年, 3年累積非再発率はそれぞれ96.0%, 73.0%, 60.8%であった.根治度別では治癒例群>非治癒例群, 術式別ではTUR-Bt例群<部分および全摘除術例群のように累積非再発率が高かった.4) Carmofur(ミフロール(R)) 200 mg経口投与後の血中5-FU濃度は徐々に増加し, 120分後で平均0.65 μg/mlを示した.また尿中5-FU濃度は15～35 μg/mlとミフロール画分濃度より高かった.5)副作用発現率は19.6%で, 熱感(2.2%), 尿意頻数(4.3%), 食欲不振(4.3%), 飲酒によるantabuse様症状(3.8%)など, 他の報告と同様であった

This study was carried out to evaluate the effects of carmofur (Mifurol), a masked compound of 5-fluorouracil (5-FU), in preventing postoperative recurrence of urogenital carcinoma (especially in bladder cancer). Carmofur was given orally at the dose of 300 approximately 600 mg/day to 134 patients (90 males and 44 females) after the resection. Out of 134 patients, 121 patients were evaluable and the rate of their recurrence was 10.7%. The rate of cumulative nonrecurrence for 65 patients it was 96.0, 73.0 and 60.8% in 1, 2 and 3 years, respectively. The group of curative resection demonstrated a higher cumulative nonrecurrence rate than that of noncurative or palliative resection group. In considering the resection methods, transurethral resection of bladder tumor group demonstrated a higher rate than partial or total cystectomy. The average concentration of 5-FU in serum was 0.65 microgram/ml at 120 minutes after oral administration of 200 mg of carmofur. Moreover, the concentration of 5-FU (15 approximately 35 micrograms/ml) in urine was higher than that of carmofur. The rate of side effects that appeared was 19.6%. The side effects were hot feeling (12.2%), pollakisuria (4.3%), anorexia (4.3%), an antabuse-like reaction by drinking (3.8%) and so on. These results were similar to those already reported.