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Ann Oncol. 2015 Nov;26(11):2274-80. doi: 10.1093/annonc/mdv358. Epub 2015 Sep 7.

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.

Author information

1
Department of Surgery, Tokai University, Isehara sadahiro@is.icc.u-tokai.ac.jp.
2
Department of Surgery, Sendai City Medical Center, Sendai.
3
Department of Surgery, Otaru Ekisaikai Hospital, Otaru.
4
Department of Surgery, National Hospital Organization Nagoya Medical Hospital, Nagoya.
5
Third Department of Surgery, Tokyo Medical University, Tokyo.
6
Department of Surgery, Japanese Red Cross Kanazawa Hospital, Ishikawa.
7
Division of Gastrointestinal Surgery, Department of Surgery, Graduate School of Medicine, Kobe University, Kobe.
8
Department of Gastroenterological Surgery, Kumamoto University, Kumamoto.
9
Department of Surgery, National Hospital Organization Himeji Medical Center, Himeji.
10
Department of Surgery, Teikyo University Chiba Medical Center, Ichihara.
11
Department of Clinical Oncology, Kawasaki Medical School, Kurashiki.
12
Department of Surgery, Aomori Prefectural Central Hospital, Aomori.
13
Department of Palliative Care, Okayama University Hospital, Okayama.
14
Department of Gastroenterological Surgery, Kagawa University, Kagawa.
15
Department of Management Science, Graduate School of Engineering, Tokyo University of Science, Tokyo.
16
Nerima General Hospital, Tokyo, Japan.

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.

KEYWORDS:

UFT/LV; adjuvant chemotherapy; colon cancer; treatment duration

PMID:
26347106
PMCID:
PMC4621030
DOI:
10.1093/annonc/mdv358
[Indexed for MEDLINE]
Free PMC Article

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