title: [A randomized controlled trial of postoperative adjuvant chemotherapy for colorectal cancer-optimal duration of the treatment].
abstract: METHODS
  Subjects were 239 patients with colorectal cancer who underwent curative resection surgery from December 1994 to March 1997(Stage I-III b). The patients were given 5'-DFUR for postoperative 10 months as scheduled. They had been allocated into either a 1-year group or a 3-year group by dynamic randomization. 5'-DFUR was administered by an intermittent regimen such as 1,200 mg/body/day for five days followed by two days rest. All patients were followed for five years at least.
  
  
  RESULTS
  239 patients were enrolled in the study. Favorable prognoses in both groups were observed. Although no statistically significant differences in overall survival curves of full analysis set based on the drug administration durations, were detected(log-rank test, p=0.734), a better prognosis was found in the 3-year group(5-year OS: 92.0%; 1- year group, 91.4%; 3-year group). Adverse drug reactions resulted in low rates such as 14.8% in the 1-year group and 19.5% in the 3-year group. Grade 3 was found in either group.
  
  
  CONCLUSIONS
  Due to a result in the present study that 5-year survival rates in both groups were far higher than anticipated, we could not finally clarify the optimal administration duration of 5'-DFUR. However, the results of the present study indicate that 5'-DFUR results in a good prognosis for colorectal cancer patients and is safe over a long / administration period.
authors.affiliation: First Dept. of Surgery, University of Occupational and Environmental Health, Japan.
authors.forename: Keiji
authors.initials: K
authors.lastname: Hirata
authors.forename: Shosaku
authors.initials: S
authors.lastname: Nakahara
authors.forename: Tomohisa
authors.initials: T
authors.lastname: Shimokobe
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Imamura
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Sakamoto
authors.forename: Tadashi
authors.initials: T
authors.lastname: Hirano
authors.forename: Ryuji
authors.initials: R
authors.lastname: Abe
authors.forename: Nobuyoshi
authors.initials: N
authors.lastname: Kuroki
authors.forename: Koki
authors.initials: K
authors.lastname: Konomi
authors.forename: Hidenori
authors.initials: H
authors.lastname: Kato
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Fujiwara
authors.forename: Norio
authors.initials: N
authors.lastname: Fukuyama
authors.forename: Masayuki
authors.initials: M
authors.lastname: Hotokezaka
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyazaki
authors.forename: Reiji
authors.initials: R
authors.lastname: Terasaka
authors.forename: Masayuki
authors.initials: M
authors.lastname: Shiraishi
authors.forename: Ryo
authors.initials: R
authors.lastname: Miyazaki
authors.forename: Akinori
authors.initials: A
authors.lastname: Iwashita
authors.forename: Shigeyuki
authors.initials: S
authors.lastname: Nakano
authors.forename: Hideaki
authors.initials: H
authors.lastname: Ito
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D005467:Floxuridine / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D005467:Floxuridine; C025034:doxifluridine