News Release


Phase III Clinical Trial Results of TS-1 on Metastatic Colorectal Cancer Published in Digital Version of The Lancet Oncology (11/11/2013)

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced today that the results of a Phase III clinical trial of TS-1 conducted in Japan on metastatic colorectal cancer (SOFT* Study) were published in the digital version of The Lancet Oncology, a leading medical journal in the field of oncology research.

The SOFT Study enrolled 512 patients with metastatic colorectal cancer to verify that the SOX/Bev regimen (TS-1/oxaliplatin plus bevacizumab) is non-inferior to mFOLFOX6/Bev (modified regimen of 5-FU/l-LV/oxaliplatin plus bevacizumab), which is one of the standard regimens. The primary endpoint was progression-free survival (PFS). Median PFS was 11.5 months in the mFOLFOX6/Bev group and 11.7 months in the SOX/Bev group (hazard ratio 1.04, non-inferiority p value 0.014). Adverse events of Grade 3 or higher (Common Terminology Criteria for Adverse Events) in the SOX/Bev group were sensory neuropathy (10.0%), diarrhea (9.2%), neutropenia (8.8%), hypertension (6.0%), anorexia (5.2%), and anaemia (5.2%), which were tolerable.

The results of the trial were also announced at the 49th Annual Meeting of the American Society of Clinical Oncology® (ASCO®). See the news release of June 6, 2013 for details.

Taiho Pharmaceutical remains dedicated to continuing its efforts to develop new cancer treatments.

*SOFT:A Randomized Phase III Trial of S-1/oxaliplatin (SOX) plus bevacizumab (Bev) versus 5-FU/l-LV/oxaliplatin (FOLFOX) plus Bev in Treating Patients with Metastatic Colorectal Cancer

About TS-1
A member of the fluoropyrimidine class of chemotherapeutic agents, TS-1 is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption, is converted into the anticancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU in the liver; and oteracil potassium (Oxo), which decreases 5-FU phosphorylation in the gastrointestinal tract. Developed as a gastric cancer treatment, TS-1 was first approved in Japan in 1999 and has become a standard of care for the treatment of gastric cancer. TS-1 was subsequently approved in Japan for six additional indications: for the treatment of colorectal, head and neck, non-small cell lung, and inoperable or recurrent breast, pancreatic, and biliary tract cancers. TS-1 is also approved for patients with gastric cancer in 7 countries and regions in Asia, and in 15 European countries.

(As of October 2013)

About The Lancet Oncology
A leading medical journal in the field of oncology with an impact factor of 25.117 (2012).

About the SOFT Study
Title of the Study
A Randomized Phase III Trial of S-1/oxaliplatin (SOX) plus bevacizumab versus 5-FU/l-LV/oxaliplatin (FOLFOX) plus bevacizumab in Treating Patients with Metastatic Colorectal Cancer

From February 2009 to March 2011, patients receiving first-line treatment for metastatic colorectal cancer at 82 participating facilities in Japan were randomly assigned to a mFOLFOX6/Bev regimen group (256 patients) or a SOX/Bev regimen group (256 patients). The mFOLFOX6/Bev group received 5 mg/kg of bevacizumab, followed by 200 mg/m2 of l-leucovorin given simultaneously with 85 mg/m2 of oxaliplatin, followed by a 400 mg/m2 bolus of 5-FU on day 1 and then 2,400 mg/m2 of 5-FU over 46 hours, every 2 weeks. The SOX/Bev group received 7.5 mg/kg of bevacizumab, 130 mg/m2 of oxaliplatin on day 1, and 40 – 60 mg of TS-1 according to body surface area twice daily for 2 weeks, followed by a 1-week rest. The primary endpoint was progression-free survival (PFS) with an allowable non-inferiority margin of 1.33. Secondary endpoints were overall survival, response rate, disease control rate, time to progression, resection rate, and adverse event rate.

This study was a clinical trial registered with the Japan Pharmaceutical Information Center (JapicCTI-090699).

Article title
Leucovorin, fluorouracil, and oxaliplatin plus bevacizumab versus S-1 and oxaliplatin plus bevacizumab in patients with metastatic colorectal cancer (SOFT): an open-label, non-inferiority, randomised phase 3 trial

Yasuhide Yamada, Daisuke Takahari, Hiroshi Matsumoto, Hideo Baba, Masato Nakamura, Kazuhiro Yoshida, Motoki Yoshida, Shigeyoshi Iwamoto, Ken Shimada, Yoshito Komatsu, Yasutsuna Sasaki, Taroh Satoh, Keiichi Takahashi, Hideyuki Mishima, Kei Muro, Masahiko Watanabe, Yuh Sakata, Satoshi Morita, Yasuhiro Shimada, Kenichi Sugihara

The Lancet Oncology, doi: 10.1016/S1470-2045(13)70490-X

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