Open AccessThe SOFT trial: a Phase III study of the dihydropyrimidine dehydrogenase inhibitory fluoropyrimidine S-1 and oxaliplatin (SOX) plus bevacizumab as first-line chemotherapy for metastatic colorectal cancer
Author(s) -
Masato Nakamura,
Yasuhide Yamada,
Kei Muro,
Keiichi Takahashi,
Hideo Baba,
Yasutsuna Sasaki,
Yoshito Komatsu,
Taroh Satoh,
Hideyuki Mishima,
Masahiko Watanabe,
Yuh Sakata,
Satoshi Morita,
Yasuhiro Shimada,
Kenichi Sugihara
Publication year - 2015
Publication title -
future oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.857
H-Index - 72
eISSN - 1744-8301
pISSN - 1479-6694
DOI - 10.2217/fon.15.59
Subject(s) - oxaliplatin , bevacizumab , medicine , folfox , colorectal cancer , capecitabine , oncology , dihydropyrimidine dehydrogenase , chemotherapy , prodrug , fluorouracil , tegafur , cancer , pharmacology , thymidylate synthase
A combination of oxaliplatin, leucovorin and 5-fluorouracil (FOLFOX) plus bevacizumab has been widely used for the first-line chemotherapy of metastatic colorectal cancer (mCRC). S-1 is an oral fluoropyrimidine preparation that combines tegafur, a prodrug of 5-fluorouracil, with two modulators. Several studies of combination chemotherapy with oxaliplatin plus S-1 (SOX) conducted in Asia have reported promising efficacy and safety in patients with mCRC, suggesting the potential to replace mFOLFOX6. The SOFT trial (JapicCTI-090699) was a randomized Phase III trial designed to evaluate the noninferiority of SOX plus bevacizumab to mFOLFOX6 plus bevacizumab in patients with mCRC. This review summarizes the drug concept of S-1 and the results of clinical trials of S-1 and SOX in CRC and presents an overview of the SOFT trial.