News Releases

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced today that Katsuhiko Uesaka, head of research and Director of the Department of Hepato-Biliary-Pancreatic Surgery at Shizuoka Cancer Center, presented the results of a Randomized phase III trial of adjuvant chemotherapy with gemcitabine (GEM) versus S-1(TS-1) for patients with resected pancreatic cancer (JASPAC-01*1) (Abstract No. 145) at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO GI) held on January 25, 2013.
*1. Japan Adjuvant Study Group of Pancreatic Cancer

The trial was conducted by Pharma Valley Center, part of the Shizuoka Industrial Foundation, which is under contract with Taiho Pharmaceutical. It was a Phase III clinical trial comparing the standard treatment gemcitabine (GEM) monotherapy with TS-1 monotherapy in patients with resected pancreatic cancer. The study verified that the overall survival (OS) of patients who use TS-1 oral anti-cancer monotherapy is superior to GEM monotherapy, the standard adjuvant chemotherapy for patients with resected pancreatic cancer, and demonstrated that TS-1 greatly improved the overall survival rate.

This was the first Phase III clinical trial indicating the effectiveness of TS-1 in patients with resected pancreatic cancer. TS-1 will make a major contribution to both physicians engaged in the treatment of cancer and their patients. Taiho Pharmaceutical maintains its on-going commitment to research in the field of pancreatic cancer.

Refer to the press release (Japanese language only) issued by Pharma Valley Project and Shizuoka Cancer Center.

The Shizuoka Cancer Center press release can be found at: http://www.scchr.jp/
The Pharma Valley Project press release can be found at: http://www.fuji-pvc.jp/

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 anti-cancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU in the liver; and oteracil (Oxo), which decreases 5-FU phosphorylation in the gastrointestinal tract. Developed as a gastric cancer treatment, TS-1 has become a standard of care for the treatment of gastric cancer in Japan since its initial approval there in 1999.
TS-1 was subsequently approved in Japan for six additional indications: for the treatment of colorectal, head and neck, non-small cell lung, unresectable or recurrent breast, pancreatic, and biliary tract cancers. TS-1 is also approved for patients with gastric cancer in South Korea, China, Singapore, Taiwan, Thailand, and Hong Kong in Asia, and in Sweden, Denmark, Norway, Finland, the U.K., Austria, Germany, Bulgaria, and the Netherlands in Europe.

Thirty-three institutions participated in this study. It was begun in April 2007 and was conducted over three years, compiling data from 385 patients with resected pancreatic cancer (UICC stage II and below or stage III patients with additional resection of the celiac artery). The trial compared a group treated only with gemcitabine and a group treated only with the oral anti-tumor agent TS-1. The primary endpoint was overall survival time, and the secondary endpoints were safety, relapse-free survival time and health-related quality of life (HRQOL). The gemcitabine monotherapy group was administered by intravenous drip infusion at 1,000 mg/m2 on days 1, 8, and 15 with day 22 being a day of rest, with a 28-day course completed over a total of six months. The group treated with TS-1 alone followed a schedule in which TS-1 was administered orally at a dose prescribed in accordance with body surface area (80, 100 or 120 mg/day), twice daily for 28 days, followed by a two-week rest period, repeated every six weeks for a total of four courses over six months.
*2. Jpn J Clin Oncol 2008; 38(3) 227–229