Thursday, September 20, 2012

TS-1 improves Overall survival in patients with resected pancreatic cancer


Taiho Pharmaceutical has announced results from an interim analysis of randomized phase III trial (JASPAC1 01) comparing adjuvant chemotherapy treatments
- gemcitabine and. TS-1 in patients with resected pancreatic cancer. The trial enrolled 385 patients with resected pancreatic cancer.
Based on the interim anlysis done by DSMB, TS-1 has found to be effiective. The DSMB investigation using previously defined statistical conditions, the TS-1 group has been verified to be non-inferior, i.e., the hazard ratio of the TS-1 group relative to the GEM group is 0.79 or below.

The JASPAC Trial Group will release the results of this trial without delay to the institutions that participated in the trial and will present the results at international conferences in 2013 and at conferences held in Japan thereafter.

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 anti-cancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP), which decreases the degradation of 5-FU by the body; 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, Hong Kong, and Malaysia in Asia, Sweden, Denmark, Norway, Finland, U.K., Austria, Bulgaria, Germany in Europe.

About JASPAC 01

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 survival without recurrence and safety. 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, 28-day courses completed over a total of six months. The group treated with TS-1 alone followed a schedule in which TS-1 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 to a totally four courses (six months).
2 Jpn J Clin Oncol 2008;38(3)227–229