2024-03-29T13:10:13Z
https://soar-ir.repo.nii.ac.jp/oai
oai:soar-ir.repo.nii.ac.jp:00020243
2022-12-14T03:56:02Z
461:462
Adjuvant Oral Uracil-Tegafur with Leucovorin for Colorectal Cancer Liver Metastases: A Randomized Controlled Trial
Hasegawa, Kiyoshi
Saiura, Akio
Takayama, Tadatoshi
Miyagawa, Shinichi
Yamamoto, Junji
Ijichi, Masayoshi
Teruya, Masanori
Yoshimi, Fuyo
Kawasaki, Seiji
Koyama, Hiroto
Oba, Masaru
Takahashi, Michiro
Mizunuma, Nobuyuki
Matsuyama, Yutaka
Watanabe, Toshiaki
Makuuchi, Masatoshi
Kokudo, Norihiro
© 2016 Hasegawa et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Background<br/>The high recurrence rate after surgery for colorectal cancer liver metastasis (CLM) remains a crucial problem. The aim of this trial was to evaluate the efficacy of adjuvant therapy with uracil-tegafur and leucovorin (UFT/LV).<br/>Methods<br/>In the multicenter, open-label, phase III trial, patients undergoing curative resection of CLM were randomly assigned in a 1:1 ratio to either the UFT/LV group or surgery alone group. The UFT/LV group orally received 5 cycles of adjuvant UFT/LV (UFT 300mg/m2 and LV 75mg/day for 28 days followed by a 7-day rest per cycle). The primary endpoint was recurrence-free survival (RFS). Secondary endpoints included overall survival (OS).<br/>Results<br/>Between February 2004 and December 2010, 180 patients (90 in each group) were enrolled into the study. Of these, 3 patients (2 in the UFT/LV group and 1 in the surgery alone group) were excluded from the efficacy analysis. Median follow-up was 4.76 (range, 0.15–9.84) years. The RFS rate at 3 years was higher in the UFT/LV group (38.6%, n = 88) than in the surgery alone group (32.3%, n = 89). The median RFS in the UFT/LV and surgery alone groups were 1.45 years and 0.70 years, respectively. UFT/LV significantly prolonged the RFS compared with surgery alone with the hazard ratio of 0.56 (95% confidence interval, 0.38–0.83; P = 0.003). The hazard ratio for death of the UFT/LV group against the surgery alone group was not significant (0.80; 95% confidence interval, 0.48–1.35; P = 0.409).<br/>Conclusion<br/>Adjuvant therapy with UFT/LV effectively prolongs RFS after hepatic resection for CLM and can be recommended as an alternative choice.
Article
PLOS ONE.11(9):e0162400(2016)
PUBLIC LIBRARY SCIENCE
2016-09-02
eng
journal article
VoR
http://hdl.handle.net/10091/00021001
https://soar-ir.repo.nii.ac.jp/records/20243
https://www.ncbi.nlm.nih.gov/pubmed/27588959
27588959
https://doi.org/10.1371/journal.pone.0162400
10.1371/journal.pone.0162400
1932-6203
PLOS ONE
11
9
e0162400
https://soar-ir.repo.nii.ac.jp/record/20243/files/journal.pone.0162400.PDF
application/pdf
3.0 MB
2018-10-31