• Future oncology · Jan 2015

    Randomized Controlled Trial Multicenter Study

    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.

    • 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, and Kenichi Sugihara.
    • Aizawa Hospital, 2-5-1 Honjo, Matsumoto-shi, Nagano 390-8510, Japan.
    • Future Oncol. 2015 Jan 1; 11 (10): 1471-8.

    AbstractA 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.

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