[A randomized controlled trial of postoperative adjuvant chemotherapy for colorectal cancer-optimal duration of the treatment].
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.
Hirata
Keiji
K
First Dept. of Surgery, University of Occupational and Environmental Health, Japan.
Nakahara
Shosaku
S
Shimokobe
Tomohisa
T
Imamura
Tetsuo
T
Sakamoto
Yoshitaka
Y
Hirano
Tadashi
T
Abe
Ryuji
R
Kuroki
Nobuyoshi
N
Konomi
Koki
K
Kato
Hidenori
H
Fujiwara
Hiroshi
H
Fukuyama
Norio
N
Hotokezaka
Masayuki
M
Miyazaki
Yasuhiro
Y
Terasaka
Reiji
R
Shiraishi
Masayuki
M
Miyazaki
Ryo
R
Iwashita
Akinori
A
Nakano
Shigeyuki
S
Ito
Hideaki
H
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
D000970:Antineoplastic Agents; D005467:Floxuridine; C025034:doxifluridine