Randomized phase III trial of treatment duration for oral uracil and tegafur plus leucovorin as adjuvant chemotherapy for patients with stage IIB/III colon cancer: Final results of JFMC33-0502

Sotaro Sadahiro, T. Tsuchiya, K. Sasaki, K. Kondo, K. Katsumata, G. Nishimura, Y. Kakeji, H. Baba, S. Sato, K. Koda, Y. Yamaguchi, T. Morita, J. Matsuoka, H. Usuki, C. Hamada, S. Kodaira

Research output: Contribution to journalArticlepeer-review

32 Citations (Scopus)

Abstract

Background: While adjuvant chemotherapy is preferable for high-risk colon cancer, treatment duration is controversial. Oral uracil and tegafur (UFT)/leucovorin (LV) is widely used as a standard adjuvant chemotherapy for colon cancer in Japan. We conducted a phase III trial to investigate the optimal duration of adjuvant chemotherapy for stage IIB/III colon cancer. Patients and methods: Patients with curatively resected stage IIB/III colon cancer were eligible for enrollment in this trial. Patients were registered within 6 weeks after surgery and were randomly assigned to receive UFT/LV for 28 of 35 days for 6 months in the control group or for 5 consecutive days per week for 18 months in the study group. The primary end point was the disease-free survival (DFS), and the secondary end points were overall survival (OS) and safety. Result: A total of 1071 patients were registered from 233 centers. A statistically significant difference in DFS was not observed between the study group and the control group; the 5-year DFS was 69% in the study group and 69% in the control group. The 5-year OS was 85% in the study group and 85% in the control group. Conclusion: Eighteen-month treatment with UFT/LV did not improve DFS or OS compared with 6-month UFT/LV treatment in patients with stage IIB/III colon cancer. The important finding from this study is that not 18 months but 6 months of treatment is enough for postoperative UFT/LV for stage IIB/III colon cancer.

Original languageEnglish
Article numbermdv358
Pages (from-to)2274-2280
Number of pages7
JournalAnnals of Oncology
Volume26
Issue number11
DOIs
Publication statusPublished - Nov 2015

Keywords

  • Adjuvant chemotherapy
  • UFT/LV
  • colon cancer
  • treatment durationJFMCJFMC 33-0502

ASJC Scopus subject areas

  • Hematology
  • Oncology

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