表在性膀胱腫瘍に対する1-hexylcarbamoyl-5-fluorouracil (HCFU)および1-(2-tetrahydrofuryl)-5-fluorouracil (Tegafur)剤内服による再発防止効果の比較検討

Abstract

5-FU系の経口制癌剤である1-hexylcarbamoyl-5-fluorouracil (HCFU) (1日600 mg連日投与)の膀胱腫瘍の術後再発予防効果を1-(2-tetrahydrofuryl)-5-fluorouracil (Tegafur) (1日800 mg連日投与)を対照として比較検討した.1)全解析症例103例における累積非再発率はHCFU投与群で1年70.8%, 2年54.1%, Tegafur投与群で1年56.5%, 2年46.2%であり, 術後450～539日の観察期間内においてHCFU投与群に有意の再発抑制が認められた.上記全解析症例中, 投薬が90日以上なされた87例における非再発率はHCFU投与群で1年79.2%, 2年60.4%, Tegafur投与群ではそれぞれ62.5%, 50.0%であり, HCFU群にあきらかな再発率低下が認められた.2) HCFU投与群59例中21例(35.6%), Tegafur投与群60例中31例(51.7%)に副作用が認められ, このうち薬剤投与中止に到った症例はHCFU投与群で12例(20.3%), Tegafur投与群で16例(26.7%)であった.各投与群とも消化器症状がもっとも多く, 皮膚症状, 精神神経症状が数例に認められたが, 両群間に有意差は認められなかった.HCFU投与群でアルコールとの相互作用が5例に認められた

To evaluate the effect of 1-hexylcarbamoyl-5-fluorouracil (HCFU), a derivative of 5-fluorouracil (5-FU), in preventing postoperative recurrence of bladder cancer, a randomized controlled study with 1-(2-tetrahydrofuryl)-5-fluorouracil (Tegafur) as the reference standard was performed. HCFU was given orally 600 mg a day and Tegafur was given orally, 800 mg a day. The following results were obtained: Of 103 patients, 51 were given HCFU and 52 Tegafur, the non-recurrence rate in the group treated with HCFU was 70.8% after 1 year and 54.9% after 2 years of follow up, and that of the group treated with Tegafur was 56.5% and 46.2% respectively. The rate of non-recurrence in the HCFU group was significantly higher (p less than 0.01) than that of the Tegafur group during the period of follow up between 450 and 539 days. Of the 87 patients, who took the drugs for more than 90 days, the rate of non-recurrence in 43 patients receiving HCFU was 79.2% after 1 year and 60.4% after 2 years, compared to 62.5% and 50.0% respectively for 44 patients receiving Tegafur. The non-recurrence rate of the HCFU group was also significantly higher than that of the Tegafur group in the period between 450 and 539 days after operation (p less than 0.05). The incidence of side effects was 35.6% and 51.7% in HCFU and Tegafur patients, respectively. No significant difference of side effects was found between HCFU and Tegafur.