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

• Published in: Annals of oncology Vol. 26; no. 11; pp. 2274 - 2280
• Main Authors: Sadahiro, S., Tsuchiya, T., Sasaki, K., Kondo, K., Katsumata, K., Nishimura, G., Kakeji, Y., Baba, H., Sato, S., Koda, K., Yamaguchi, Y., Morita, T., Matsuoka, J., Usuki, H., Hamada, C., Kodaira, S.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.11.2015; Oxford University Press
• Subjects: adjuvant chemotherapy; Administration, Oral; Adult; Aged; Aged, 80 and over; Chemotherapy, Adjuvant; colon cancer; Colonic Neoplasms - diagnosis; Colonic Neoplasms - drug therapy; Drug Administration Schedule; Female; Humans; Leucovorin - administration & dosage; Male; Middle Aged; Neoplasm Staging; Original; Tegafur - administration & dosage; Time Factors; treatment duration; UFT/LV; Uracil - administration & dosage; treatment duration; adjuvant chemotherapy; UFT/LV; colon cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdv358

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 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. 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. 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. UMIN-CTR C000000245.