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Efficacy of oral UFT as adjuvant chemotherapy to curative resection of colorectal cancer: multicenter prospective randomized trial.

AbstractBACKGROUND:
The purpose of this study is to evaluate the efficacy of postoperative adjuvant chemotherapy using uracil and tegafur (UFT) for colorectal cancer.
METHODS:
In a multicenter trial among 43 institutions for patients who underwent curative resection of Dukes' B or C colorectal cancer, a surgery alone group (control group) and a treatment group (UFT group) to which UFT was administered at 400 mg/day for 2 years following surgery were compared. A total of 320 patients were registered between March 1991 and April 1994, and 289 of these patients were analyzed as a full-analysis set.
RESULTS:
The 5-year disease-free survival rate was 75.7% in the UFT group and 60.1% in the control group, respectively, and the stratified log-rank test showed the statistical significance ( P=0.0081). This difference was marked in rectal cancer ( P=0.0016) and, in particular, the local recurrence was reduced. No significant difference was observed in the 5-year survival rate. The incidence of adverse reactions on administration of UFT was low, and there was no serious adverse reaction.
CONCLUSION:
It is suggested that the consecutive administration of UFT at 400 mg/day was an effective and highly safe therapeutic method as postoperative adjuvant chemotherapy for rectal cancer.
AuthorsT Kato, Y Ohashi, H Nakazato, A Koike, S Saji, H Suzuki, H Takagi, Y Nimura, A Hasumi, S Baba, T Manabe, M Maruta, K Miura, A Yamaguchi
JournalLangenbeck's archives of surgery (Langenbecks Arch Surg) Vol. 386 Issue 8 Pg. 575-81 (Mar 2002) ISSN: 1435-2443 [Print] Germany
PMID11914933 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents
  • Drug Combinations
  • UFT(R) drug
  • Tegafur
  • Uracil
Topics
  • Adenocarcinoma (drug therapy, pathology, surgery)
  • Administration, Oral
  • Aged
  • Antineoplastic Agents (adverse effects, therapeutic use)
  • Chemotherapy, Adjuvant
  • Colorectal Neoplasms (drug therapy, pathology, surgery)
  • Disease-Free Survival
  • Drug Combinations
  • Female
  • Humans
  • Male
  • Middle Aged
  • Postoperative Period
  • Prospective Studies
  • Recurrence
  • Survival Rate
  • Tegafur (adverse effects, therapeutic use)
  • Treatment Outcome
  • Uracil (adverse effects, therapeutic use)

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