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.

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.

CLINICAL TRIAL NUMBER:

UMIN-CTR C000000245.

• Authors: S 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
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 26 Issue 11 Pg. 2274-80 (Nov 2015) ISSN: 1569-8041 [Electronic] England
• PMID: 26347106 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Chemical References

• Tegafur
• Uracil
• Leucovorin

Topics

• Administration, Oral
• Adult
• Aged
• Aged, 80 and over
• Chemotherapy, Adjuvant
• Colonic Neoplasms (diagnosis, drug therapy)
• Drug Administration Schedule
• Female
• Humans
• Leucovorin (administration & dosage)
• Male
• Middle Aged
• Neoplasm Staging
• Tegafur (administration & dosage)
• Time Factors
• Uracil (administration & dosage)