title: The 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.
abstract: 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.
authors.affiliation: Aizawa Hospital, 2-5-1 Honjo, Matsumoto-shi, Nagano 390-8510, Japan.
authors.forename: Masato
authors.initials: M
authors.lastname: Nakamura
authors.forename: Yasuhide
authors.initials: Y
authors.lastname: Yamada
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
authors.forename: Keiichi
authors.initials: K
authors.lastname: Takahashi
authors.forename: Hideo
authors.initials: H
authors.lastname: Baba
authors.forename: Yasutsuna
authors.initials: Y
authors.lastname: Sasaki
authors.forename: Yoshito
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Taroh
authors.initials: T
authors.lastname: Satoh
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Mishima
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
authors.forename: Yuh
authors.initials: Y
authors.lastname: Sakata
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Shimada
authors.forename: Kenichi
authors.initials: K
authors.lastname: Sugihara
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D004338:Drug Combinations; D006801:Humans; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010094:Oxonic Acid / Q000008:administration & dosage; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; C079198:S 1 (combination); D005641:Tegafur; D000068258:Bevacizumab; D010094:Oxonic Acid
keywords: DPD inhibitory fluoropyrimidine; S-1; SOFT trial; SOX; metastatic colorectal cancer; oxaliplatin