title: The effect of adjuvant 5'-deoxy-5-fluorouridine in early stage breast cancer patients: results from a multicenter randomized controlled trial.
abstract: To assess the efficacy of 5'-DFUR, an intermediate of capecitabine, for adjuvant treatment of early breast cancer, we conducted an open-labeled multi-center randomized controlled trial to compare postoperative 5'-DFUR treatment with surgery alone. We enrolled 1217 primary breast cancer patients and randomly assigned them into two treatment groups; one received six-month postoperative 5'-DFUR treatment by consecutive or intermittent administration, and the other surgery alone. Follow-up surveys were conducted once a year for all subjects simultaneously and examined their outcome/presence or absence of the cancer recurrence. The central study committee reviewed all follow-up data and judged the recurrence data to be used for the analysis. Eight-year follow-up data showed no significant differences in relapse-free and overall survival between the two groups, and 5'-DFUR treatment regimen showed an extremely high tolerance. Possible explanations are discussed for the finding of no significant survival difference between adjuvant 6-month 5'-DFUR monotherapy and surgery alone in early breast cancer.
authors.affiliation: Breast Cancer Center, Toyosu Hospital, Showa University School of Medicine, Tokyo 135-8577, Japan. t-tominaga@hkg.odn.ne.jp
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tominaga
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.forename: Osahiko
authors.initials: O
authors.lastname: Abe
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Ohashi
authors.forename: Junichi
authors.initials: J
authors.lastname: Uchino
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hayasaka
authors.forename: Rikiya
authors.initials: R
authors.lastname: Abe
authors.forename: Masaru
authors.initials: M
authors.lastname: Izuo
authors.forename: Kohji
authors.initials: K
authors.lastname: Enomoto
authors.forename: Hiromu
authors.initials: H
authors.lastname: Watanabe
authors.forename: Minoru
authors.initials: M
authors.lastname: Yoshida
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Taguchi
authors.forename: Hiroki
authors.initials: H
authors.lastname: Koyama
authors.forename: Tsuneaki
authors.initials: T
authors.lastname: Senoo
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Toge
authors.forename: Yasumasa
authors.initials: Y
authors.lastname: Monden
authors.forename: Takao
authors.initials: T
authors.lastname: Hattori
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Nomura
authors.forename: Keizo
authors.initials: K
authors.lastname: Sugimachi
authors.forename: Koichi
authors.initials: K
authors.lastname: Hirata
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Nakazato
authors.forename: Shigeto
authors.initials: S
authors.lastname: Miura
authors.forename: Tadaoki
authors.initials: T
authors.lastname: Morimoto
authors.forename: Kazuaki
authors.initials: K
authors.lastname: Asaishi
authors.forename: Izo
authors.initials: I
authors.lastname: Kimijima
authors.forename: Jun
authors.initials: J
authors.lastname: Ota
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sonoo
authors.forename: Susumu
authors.initials: S
authors.lastname: Yamaguchi
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D005467:Floxuridine / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D005467:Floxuridine; C025034:doxifluridine