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

Author:

Nakamura Masato1,Yamada Yasuhide2,Muro Kei3,Takahashi Keiichi4,Baba Hideo5,Sasaki Yasutsuna6,Komatsu Yoshito7,Satoh Taroh8,Mishima Hideyuki9,Watanabe Masahiko10,Sakata Yuh11,Morita Satoshi12,Shimada Yasuhiro13,Sugihara Kenichi14

Affiliation:

1. Aizawa Hospital, 2-5-1 Honjo, Matsumoto-shi, Nagano 390-8510, Japan

2. National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan

3. Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi 464-8681, Japan

4. Tokyo Metropolitan Cancer & Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo 113-8677, Japan

5. Kumamoto University, 1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto 860-8556, Japan

6. Showa University, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8666, Japan

7. Hokkaido University Hospital, North 14, West 5, Kita-ku, Sapporo-shi, Hokkaido 060-8648, Japan

8. Osaka University, 2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan

9. Aichi Medical University, 1-1, Yazakokarimata, Nagakute-shi, Aichi 480-1195, Japan

10. Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa 252-0375, Japan

11. Misawa City Hospital, 164-65 Horiguchi, Misawa, Misawa-shi, Aomori 033-0022, Japan

12. Kyoto University, 54 Syougoin, Kawara-cho, Sakyo-ku, Kyoto-shi, Kyoto 606-8507, Japan

13. Kochi Health Sciences Center, 2125-1 Ike, Kochi-shi, Kochi 781-8555, Japan

14. Tokyo Medical & Dental University, Graduate School, 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

Abstract

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.

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

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