PMID- 30833647
OWN - NLM
STAT- In-Data-Review
LR  - 20190403
IS  - 1532-1827 (Electronic)
IS  - 0007-0920 (Linking)
VI  - 120
IP  - 7
DP  - 2019 Apr
TI  - Phase III randomised trial comparing 6 vs. 12-month of capecitabine as adjuvant
      chemotherapy for patients with stage III colon cancer: final results of the
      JFMC37-0801 study.
PG  - 689-696
LID - 10.1038/s41416-019-0410-0 [doi]
AB  - BACKGROUND: Up to 6-months oxaliplatin-containing regimen is now widely accepted 
      as a standard adjuvant chemotherapy for stage III colorectal cancer (CRC).
      However, oral fluoropyrimidine monotherapy is used for some part of patients,
      especially in Asian countries including Japan, and its optimal duration is yet to
      be fully investigated. METHODS: A total of 1306 patients with curatively-resected
      stage III CRC were randomly assigned to receive capecitabine (2500 mg/m(2)/day)
      for 14 out of 21 days for 6 (n = 654) or 12 (n = 650) months. The primary
      endpoint was disease-free survival (DFS), and the secondary endpoints were
      relapse-free survival (RFS), overall survival (OS), and adverse events. RESULTS: 
      The 3- and 5-year DFS were 70.0% and 65.3% in the 6M group and 75.3% and 68.7% in
      the 12M group, respectively (p = 0.0549, HR = 0.858, 90% CI: 0.732-1.004). The
      5-year RFS was 69.3% and 74.1% in the 6M and 12M groups, respectively (p =
      0.0143, HR = 0.796, 90% CI: 0.670-0.945). The 5-year OS was 83.2% and 87.6%,
      respectively (p = 0.0124, HR = 0.727, 90% CI: 0.575-0.919). The incidence of
      overall grade 3-4 adverse events was almost comparable in both groups.
      CONCLUSIONS: Although 12-month adjuvant capecitabine did not demonstrate superior
      DFS to that of 6-month, the observed better RFS and OS in the 12-month treatment 
      period could be of value in selected cases.
FAU - Tomita, Naohiro
AU  - Tomita N
AD  - Department of Surgery, Division of Lower Gastrointestinal Surgery, Hyogo College 
      of Medicine, Hyogo, Japan. ntomita@hyo-med.ac.jp.
FAU - Kunieda, Katsuyuki
AU  - Kunieda K
AD  - Department of Surgery, Gifu Prefectural General Medical Center, Gifu, Japan.
FAU - Maeda, Atsuyuki
AU  - Maeda A
AD  - Department of Surgery, Ogaki Municipal Hospital, Gifu, Japan.
FAU - Hamada, Chikuma
AU  - Hamada C
AD  - Graduate School of Engineering, Tokyo University of Science, Tokyo, Japan.
FAU - Yamanaka, Takeharu
AU  - Yamanaka T
AD  - Department of Biostatistics, Yokohama City University School of Medicine,
      Kanagawa, Japan.
FAU - Sato, Toshihiko
AU  - Sato T
AD  - Yamagata Prefectural Central Hospital, Yamagata, Japan.
FAU - Yoshida, Kazuhiro
AU  - Yoshida K
AD  - Department of Surgical Oncology, Gifu University, Graduate School of Medicine,
      Gifu, Japan.
FAU - Boku, Narikazu
AU  - Boku N
AD  - National Cancer Center Hospital, Tokyo, Japan.
FAU - Nezu, Riichiro
AU  - Nezu R
AD  - Nishinomiya Municipal Central Hospital, Hyogo, Japan.
FAU - Yamaguchi, Shigeki
AU  - Yamaguchi S
AD  - Department of Gastroenterological Surgery, Saitama Medical University
      International Medical Center, Saitama, Japan.
FAU - Mishima, Hideyuki
AU  - Mishima H
AD  - Cancer Center, Aichi Medical University, Aichi, Japan.
FAU - Sadahiro, Sotaro
AU  - Sadahiro S
AD  - Department of Surgery, Tokai University School of Medicine, Kanagawa, Japan.
FAU - Muro, Kei
AU  - Muro K
AD  - Aichi Cancer Center, Aichi, Japan.
FAU - Ishiguro, Megumi
AU  - Ishiguro M
AD  - Department of Translational Oncology, Tokyo Medical and Dental University
      Graduate School, Tokyo, Japan.
FAU - Sakamoto, Junichi
AU  - Sakamoto J
AD  - Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
FAU - Saji, Shigetoyo
AU  - Saji S
AD  - Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
FAU - Maehara, Yoshihiko
AU  - Maehara Y
AD  - Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20190305
PL  - England
TA  - Br J Cancer
JT  - British journal of cancer
JID - 0370635
EDAT- 2019/03/06 06:00
MHDA- 2019/03/06 06:00
CRDT- 2019/03/06 06:00
PHST- 2018/08/06 00:00 [received]
PHST- 2019/02/04 00:00 [accepted]
PHST- 2019/01/11 00:00 [revised]
PHST- 2019/03/06 06:00 [pubmed]
PHST- 2019/03/06 06:00 [medline]
PHST- 2019/03/06 06:00 [entrez]
AID - 10.1038/s41416-019-0410-0 [doi]
AID - 10.1038/s41416-019-0410-0 [pii]
PST - ppublish
SO  - Br J Cancer. 2019 Apr;120(7):689-696. doi: 10.1038/s41416-019-0410-0. Epub 2019
      Mar 5.