Adjuvant Oral Uracil-Tegafur with Leucovorin for Colorectal Cancer Liver Metastases: A Randomized Controlled Trial

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2016 Sep 3

PMID 27588959

Citations 52

Authors

Kiyoshi Hasegawa

Akio Saiura

Tadatoshi Takayama

Shinichi Miyagawa

Junji Yamamoto

Masayoshi Ijichi

Masanori Teruya

Fuyo Yoshimi

Seiji Kawasaki

Hiroto Koyama

Masaru Oba

Michiro Takahashi

Nobuyuki Mizunuma

Yutaka Matsuyama

Toshiaki Watanabe

Masatoshi Makuuchi

Norihiro Kokudo

Affiliations

Soon will be listed here.

Abstract

Background: 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).

Methods: 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).

Results: 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).

Conclusion: Adjuvant therapy with UFT/LV effectively prolongs RFS after hepatic resection for CLM and can be recommended as an alternative choice.

Trial Registration: UMIN Clinical Trials Registry C000000013.

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