A combination of oral uracil-tegafur plus leucovorin (UFT + LV) is a safe regimen for adjuvant chemotherapy after hepatectomy in patients with colorectal cancer: Safety report of the UFT/LV study

Akio Saiura; Junji Yamamoto; Kiyoshi Hasegawa; Masaru Oba; Tadatoshi Takayama; Shinichi Miyagawa; Masayoshi Ijichi; Masanori Teruya; Fuyo Yoshimi; Seiji Kawasaki; Hiroto Koyama; Masatoshi Makuuchi; Norihiro Kokudo

doi:10.5582/ddt.8.48

Original Articles

A combination of oral uracil-tegafur plus leucovorin (UFT + LV) is a safe regimen for adjuvant chemotherapy after hepatectomy in patients with colorectal cancer: Safety report of the UFT/LV study

Akio Saiura, Junji Yamamoto, Kiyoshi Hasegawa, Masaru Oba, Tadatoshi Takayama, Shinichi Miyagawa, Masayoshi Ijichi, Masanori Teruya, Fuyo Yoshimi, Seiji Kawasaki, Hiroto Koyama, Masatoshi Makuuchi, Norihiro Kokudo

Author information

Akio Saiura
Department of Gastrointestinal Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Ariake Hospital
Junji Yamamoto
Department of Surgery, National Defense Medical College
Kiyoshi Hasegawa
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Masaru Oba
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo
Tadatoshi Takayama
Department of Digestive Surgery, Nihon University School of Medicine
Shinichi Miyagawa
First Department of Surgery, Shinshu University School of Medicine
Masayoshi Ijichi
Department of Surgery, Social Insurance Chuo General Hospital
Masanori Teruya
Department of Surgery, Showa General Hospital
Fuyo Yoshimi
Department of Surgery, Ibaraki Prefectural Central Hospital and Cancer Center
Seiji Kawasaki
Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine
Hiroto Koyama
Department of Surgery, Sempos Tokyo Takanawa Hospital
Masatoshi Makuuchi
Hepato-Biliary-Pancreatic Surgery and Transplantation Devision, Japanese Red Cross Medical Center
Norihiro Kokudo
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, The University of Tokyo

Keywords: Adjuvant treatment, colorectal cancer, randomized controlled trial, resection of liver metastases, UFT/LV

JOURNAL FREE ACCESS

2014 Volume 8 Issue 1 Pages 48-56

DOI https://doi.org/10.5582/ddt.8.48

Details

Abstract

The use of adjuvant systemic chemotherapy for resectable liver metastases from colorectal cancer (CRC) is controversial because no trial demonstrated its benefit. We conducted the phase III trial to evaluate UFT/leucovorin (LV) for colorectal liver metastases (CRLM). The primary endpoint has not been available until 2014, we first report the feasibility and safety data of UFT/LV arm. In this multicenter trial, patients who underwent curative resection of liver metastases from colorectal cancer were randomly assigned to receive surgery alone or surgery followed by adjuvant chemotherapy with UFT/LV. The primary endpoint was relapse-free survival. Secondary endpoints included overall survival and safety. A total of 180 patients were enrolled, 90 were randomly assigned to receive UFT/LV therapy. Eighty two of whom were included in safety analyses. In the UFT/LV group, the completion rate of UFT/LV was 54.9%, the relative dose intensity was 70.8% and grade 3 or higher adverse events occurred in 12.2% of the patients. Elevated bilirubin levels, decreased hemoglobin levels, elevated alanine aminotransferase levels, diarrhea, anorexia were common. Most other adverse events were grade 2 or lower and tolerable. In conclusions, UFT/LV is a safe regimen for postoperative adjuvant chemotherapy in patients who have undergone resection of liver metastases from colorectal cancer. Further studies are warranted to improve completion rate, but UFT/LV is found to be a promising treatment in this setting.

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