title: Treatment of patients with superficial bladder cancer by intravesical instillation of anticancer drugs plus oral chemotherapy following TUR-Bt: a randomized controlled trial.
abstract: We conducted a randomized controlled trial to compare local recurrence rate after transurethral resection of superficial bladder cancer treated by either intravesical instillation of an anticancer drug alone (method A) and the intravesical instillation plus oral chemotherapy (doxifluridine, 5'-DFUR, an intermediate metabolite of capecitabine) (method B). Results between groups showed no difference in recurrence-free survival curves in 196 patients subjected to primary analysis. However, patients subjected to secondary analysis (method B, over 3 months administration of 5'-DFUR) showed a significantly better prognosis than method A (p=0.0244, Wilcoxon). Regarding correlation between thymidine phosphorylase (TP, an enzyme to convert 5'-DFUR to 5-fluorouracil) level and prognosis, method A patients showed poorer prognosis in higher TP level cases than in lower TP levels. However, there was no significant difference in prognosis between those with higher and lower TP levels. In method B patients, there was no difference in prognosis between those with higher and lower TP levels. Method A patients tended to show a slightly better prognosis than those with lower TP levels, while method B patients tended to have a slightly better prognosis with higher TP levels, but no significant difference was observed. These findings suggested 5'-DFUR showed a mild efficacy in patients with higher TP levels and that patients with higher TP levels resulted in poorer prognosis.
authors.affiliation: Department of Urology, Tokyo Metropolitan Police Hospital 10-41, Chiyoda-ku, Tokyo 102-0071, Japan. h-matsu@fides.dti.ne.jp
authors.forename: Hisashi
authors.initials: H
authors.lastname: Matsushima
authors.forename: Kazuki
authors.initials: K
authors.lastname: Kawabe
authors.forename: Makoto
authors.initials: M
authors.lastname: Fujime
authors.forename: Tadaichi
authors.initials: T
authors.lastname: Kitamura
authors.forename: Yukio
authors.initials: Y
authors.lastname: Homma
authors.forename: Hiroichi
authors.initials: H
authors.lastname: Kishi
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kawamura
authors.forename: Takashi
authors.initials: T
authors.lastname: Umeda
authors.forename: Yukihiko
authors.initials: Y
authors.lastname: Ohishi
authors.forename: Masaru
authors.initials: M
authors.lastname: Murai
authors.forename: Tsuneo
authors.initials: T
authors.lastname: Kawai
authors.forename: Hideki
authors.initials: H
authors.lastname: Yoshida
authors.forename: Takashi
authors.initials: T
authors.lastname: Fukuda
mesh_terms: D000283:Administration, Intravesical; D000284:Administration, Oral; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002291:Carcinoma, Papillary / Q000188:drug therapy* / Q000201:enzymology / Q000601:surgery*; D018572:Disease-Free Survival; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005467:Floxuridine / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D011379:Prognosis; D013939:Thymidine Phosphorylase / Q000378:metabolism; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000601:surgery*
chemical_list: D005467:Floxuridine; D013939:Thymidine Phosphorylase; C025034:doxifluridine