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.
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.


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.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
UMIN-CTR C000000245.
Department of Surgery, Tokai University, Isehara sadahiro@is.icc.u-tokai.ac.jp.
S
S
Sadahiro
Department of Surgery, Sendai City Medical Center, Sendai.
T
T
Tsuchiya
Department of Surgery, Otaru Ekisaikai Hospital, Otaru.
K
K
Sasaki
Department of Surgery, National Hospital Organization Nagoya Medical Hospital, Nagoya.
K
K
Kondo
Third Department of Surgery, Tokyo Medical University, Tokyo.
K
K
Katsumata
Department of Surgery, Japanese Red Cross Kanazawa Hospital, Ishikawa.
G
G
Nishimura
Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe.
Y
Y
Kakeji
Department of Gastroenterological Surgery, Kumamoto University, Kumamoto.
H
H
Baba
Department of Surgery, National Hospital Organization Himeji Medical Center, Himeji.
S
S
Sato
Department of Surgery, Teikyo University Chiba Medical Center, Ichihara.
K
K
Koda
Department of Clinical Oncology, Kawasaki Medical School, Kurashiki.
Y
Y
Yamaguchi
Department of Surgery, Aomori Prefectural Central Hospital, Aomori.
T
T
Morita
Department of Palliative Care, Okayama University Hospital, Okayama.
J
J
Matsuoka
Department of Gastroenterological Surgery, Kagawa University, Kagawa.
H
H
Usuki
Department of Management Science, Graduate School of Engineering, Tokyo University of Science, Tokyo.
C
C
Hamada
Nerima General Hospital, Tokyo, Japan.
S
S
Kodaira
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D017024:Chemotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000175:diagnosis* / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D005641:Tegafur / Q000008:administration & dosage*; D013997:Time Factors; D014498:Uracil / Q000008:administration & dosage*
D005641:Tegafur; D014498:Uracil; D002955:Leucovorin
UFT/LV; adjuvant chemotherapy; colon cancer; treatment duration