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.

Authors:
Naohiro Tomita
Naohiro Tomita
Hyogo College of Medicine
Japan
Katsuyuki Kunieda
Katsuyuki Kunieda
Gifu University School of Medicine
Atsuyuki Maeda
Atsuyuki Maeda
Anjo-Kosei Hospital
Chikuma Hamada
Chikuma Hamada
Tokyo University of Science
Japan
Takeharu Yamanaka
Takeharu Yamanaka
Kyushu University
Japan
Toshihiko Sato
Toshihiko Sato
Kyoto University
Japan
Kazuhiro Yoshida
Kazuhiro Yoshida
Chiba University
Japan
Narikazu Boku
Narikazu Boku
National Cancer Center Hospital
Japan

Br J Cancer 2019 Apr 5;120(7):689-696. Epub 2019 Mar 5.

Japanese Foundation for Multidisciplinary Treatment of Cancer, Tokyo, Japan.

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/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.

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http://dx.doi.org/10.1038/s41416-019-0410-0DOI Listing
April 2019
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References

(Supplied by CrossRef)
Article in Int. J. Cancer
J Ferlay et al.
Int. J. Cancer 2015
Article in Lancet
RG Gray et al.
Lancet 2000
Article in J. Clin. Oncol.
DG Haller et al.
J. Clin. Oncol. 2005
Article in J. Clin. Oncol.
T André et al.
J. Clin. Oncol. 2003
Article in N. Engl. J. Med
C Twelves et al.
N. Engl. J. Med 2005
Article in J. Clin. Oncol.
BC Lembersky et al.
J. Clin. Oncol. 2006
Article in J. Clin. Oncol.
J Sakamoto et al.
J. Clin. Oncol. 2004
Article in Jpn. J. Clin. Oncol.
C Hamada et al.
Jpn. J. Clin. Oncol. 2011
Article in N. Engl. J. Med.
T André et al.
N. Engl. J. Med. 2004
Article in J. Clin. Oncol.
JP Kuebler et al.
J. Clin. Oncol. 2007
Article in J. Clin. Oncol.
HJ Schmoll et al.
J. Clin. Oncol. 2012

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