- September 11, 2013
- Taiho Pharmaceutical Co., Ltd.
Results of a Clinical Trial (JACCRO GC-05) of Second-line TS-1 Therapy on Patients with Unresectable or Recurrent Gastric Cancer That Is Refractory to Initial Therapy with TS-1
Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Masayuki Kobayashi) announced today that the Japan Clinical Cancer Research Organization (JACCRO), a specified non-profit corporation, has published a summary of the results of the Phase III clinical trial (JACCRO GC-05) of TS-1 on patients with unresectable or recurrent gastric cancer that is refractory to initial TS-1 therapy. JACCRO is the organization that was contracted to conduct the trial.
The objective of this trial was to investigate whether the combination therapy of TS-1+CPT-11 is superior to CPT-11 monotherapy as a second-line therapy (excluding patients whose cancer recurred after postoperative TS-1 adjuvant therapy) for patients with unresectable or recurrent gastric cancer that was refractory to initial TS-1 monotherapy or the combination therapy of TS-1 and another drug (except for combination therapy with CPT-11 [irinotecan]).
This trial was unable to statistically verify the superiority of TS-1+CPT-11 combination therapy over CPT-11 monotherapy in terms of survival. Furthermore, the trial showed that the TS-1+CPT-11 combination therapy had a higher frequency of leucopenia, neutropenia, and febrile neutropenia of Grade 3 or higher as defined in the Common Terminology Criteria for Adverse Events (CTCAE) than did CPT-11 monotherapy. JACCRO plans to further investigate the data and make a detailed announcement of the results at a medical conference in 2014.
Taiho Pharmaceutical maintains its ongoing commitment to develop new cancer treatments.
JACCRO website: http://www.jaccro.com (Japanese only)
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.
About the JACCRO GC-05 Trial
This trial was conducted by JACCRO under contract with Taiho Pharmaceutical. Over 60 medical facilities participated, and data was collected from a total of 304 subjects. The subjects were patients with unresectable or recurrent gastric cancer that was shown to be refractory to TS-1 monotherapy or a combination therapy of TS-1 and another drug (except for combination therapy with CPT-11). They were assigned to either CPT-11 monotherapy group or TS-1+CPT-11 combination therapy group and compared. Overall survival, progression-free survival, antitumor effect, and safety were evaluated. The CPT-11 monotherapy group was administered CPT-11 intravenously once per day in dosages of 150 mg/m2 in repetitive two-week schedules. The TS-1+CPT-11 combination therapy group was administered CPT-11 intravenously once per day in a dosages of 150 mg/m2 and TS-1 orally in dosages determined by each patient's body surface area (80 mg, 100 mg, 120 mg/day) twice per day for 14 consecutive days with seven days of rest in each three-week course. Administration was continued in both groups until the subjects met the established criteria for cessation.
Information in this news release was current as of the original release date.