publication date: Jul. 31, 2014

Trifluridine and Tipiracil Hydrochloride Increase OS, PFS in Phase III Colorectal Cancer Trial


A phase III trial of trifluridine and tipiracil hydrochloride significantly improved both overall and progression-free survival in refractory metastatic colorectal cancer that had progressed after standard therapies.

Data from the trial of the oral anticancer combination, also known as TAS-102, were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer in Barcelona, Spain.

The global, randomized, double-blind trial, named RECOURSE, met the primary efficacy endpoint of statistically significant improvement in overall survival versus placebo (HR=0.68, p < 0.0001). TAS-102 reduced the risk of mortality by 32 percent when compared to placebo.

Median overall survival was 7.1 months (95% CI: 6.5-7.8) in the TAS-102 arm and 5.3 months (95% CI: 4.6-6.0) in the placebo arm.

There was also a statistically significant 52 percent decrease in the risk of disease progression between the two arms (HR=0.48, p < 0.0001). In addition, the disease control rate of patients treated with TAS-102 was 44.0 percent compared to 16.3 percent for patients treated with placebo (p < 0.0001). These results were consistent across study regions.

The trial enrolled 800 patients in North America, Japan, Europe and Australia who received at least two prior regimens of standard chemotherapies for mCRC and were refractory to or failed those chemotherapies.

Trifluridine is an antineoplastic nucleoside analog, which is incorporated directly into DNA, thereby interfering with the function of DNA. The blood concentration of trifluridine is maintained via tipiracil hydrochloride. The study findings will form the foundation for regulatory submissions in the U.S. and Europe, according to the drug’s sponsor, Taiho Oncology Inc.


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