Experimental drug adds 2 months of life in metastatic colorectal cancer

Last Updated: 2015-05-13

By Reuters Staff

NEW YORK (Reuters Health) - A phase 3 test of Taiho's experimental cancer drug TAS-102 increased the median overall survival time to 7.1 months from 5.3 months with placebo, according to the RECOURSE trial.

The company financed and helped design the study, which is published in the May 14 New England Journal of Medicine.

The findings, involving 800 patients with refractory disease, were originally reported in June 2014 at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.

The extra 1.8-months reflects a 32% reduction in mortality, said the researchers, who characterized that as a significant improvement (p<0.001).

The team, led by Dr. Robert Mayer of the Dana-Farber Cancer Institute in Boston, also reported that the median time to worsening performance status was 5.7 months with the drug and 4.0 months without (p<0.001).

One death was associated with the drug.

Among the side effects of grade 3 or higher, neutropenia appeared in 38% of all drug patients, leukopenia in 21% and anemia in 18%.

The drug is a combination of the nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil hydrochloride.

The company announced in February that a decision on approval by the U.S Food and Drug Administration should come by mid-December.

The volunteers had failed at least two standard chemotherapy regimens. Two patients got the drug for every one who received placebo. Survival was assessed once 574 had died.

"The 1-year overall survival rates were 27% and 18%, respectively," the researchers wrote. "The overall survival benefit with TAS-102 was observed in essentially all prespecified subgroups, including subgroups defined according to each of the three stratification factors (i.e., KRAS status, time between first diagnosis of metastases and randomization, and geographic region)."

SOURCE: http://bit.ly/1cPUISF

N Engl J Med 2015.