The effect of adjuvant 5'-deoxy-5-fluorouridine in early stage breast cancer patients: results from a multicenter randomized controlled trial.
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.
Tominaga
Takeshi
T
Breast Cancer Center, Toyosu Hospital, Showa University School of Medicine, Tokyo 135-8577, Japan. t-tominaga@hkg.odn.ne.jp
Toi
Masakazu
M
Abe
Osahiko
O
Ohashi
Yasuo
Y
Uchino
Junichi
J
Hayasaka
Hiroshi
H
Abe
Rikiya
R
Izuo
Masaru
M
Enomoto
Kohji
K
Watanabe
Hiromu
H
Yoshida
Minoru
M
Taguchi
Tetsuo
T
Koyama
Hiroki
H
Senoo
Tsuneaki
T
Toge
Tetsuya
T
Monden
Yasumasa
Y
Hattori
Takao
T
Nomura
Yasuo
Y
Sugimachi
Keizo
K
Hirata
Koichi
K
Nakazato
Hiroaki
H
Miura
Shigeto
S
Morimoto
Tadaoki
T
Asaishi
Kazuaki
K
Kimijima
Izo
I
Ota
Jun
J
Sonoo
Hiroshi
H
Yamaguchi
Susumu
S
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
D000964:Antimetabolites, Antineoplastic; D005467:Floxuridine; C025034:doxifluridine