表在性膀胱癌に対する5'-DFURの再発予防効果の検討

Abstract

表在性膀胱癌に対するTUR-Bt後の5'-DFUR再発予防効果についてprospective randomized trialにて検討を行った.5'-DFUR群(n=31)においてはTUR-Bt後2～3週目より600mg/dayを2年間投与し, 対照群(n=31)ではTUR-Bt後無治療とした.1)両群の累積非再発率は全体では有意差を認めなかったが, 5'-DFUR群の方が概して良好であった(P=0.256).又, 腫瘍要因別の検討では, 異型度別の分析でG2症例において5'-DFUR群にて再発率が低くなる傾向が認められた(P=0.070).2)5'-DFURによる副作用発現率は40.0%(12/30)であったが, いずれもその程度は軽微であった.3)以上の結果より5'-DFURは表在性膀胱癌に対する再発予防治療薬の一つの選択肢となりうる可能性を示唆するが, 今後更なる検討が必要である

5'-Deoxy-5-fluorouridine (5'-DFUR), an oral fluorinated pyrimidine carbamate, is widely used in patients with gastrointestinal and breast cancers because of its effectiveness. However, in bladder cancer, response rates have only been reported in Phase II clinical trials. Therefore, we conducted a prospective randomized trial to investigate chemoprophylactic effect of 5'-DFUR against recurrence of superficial bladder cancer after transurethral bladder tumor resection (TUR-Bt). The subjects were grouped as follows: 1) 5'-DFUR group (n = 31), received 600 mg/day of 5'-DFUR starting 2-3 weeks after TUR-Bt for 2 years; and 2) control group (n = 31) received no 5'-DFUR. Although there was no significant difference between groups, the cumulative recurrence rates was more favorable in the 5'-DFUR group (p = 0.256) than in the controls. Results according to cancer factors showed that, in patients with G2 based on grading, those in the 5'-DFUR group tended to have a lower recurrence rate than the control group (p = 0.070). There was a 40% incidence of adverse drug reactions (12/30 patients), primarily slight gastrointestinal symptoms which disappeared or improved with drug discontinuation. The results of the present study suggest that 5'-DFUR might be the choice of treatment to prevent recurrence of superficial bladder cancer.