We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients.
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From New England Journal of Medicine
In patients with refractory colorectal cancer, TAS-102 was associated with a significant improvement in overall survival compared with placebo, a study published in the New England Journal of Medicine has shown.
For the double-blind study, researchers enrolled 800 patients with refractory colorectal cancer and randomly assigned them 2:1 to receive TAS-102 or placebo.
Results showed that the median overall survival was 5.3 months and 7.1 months in the placebo and TAS-102 groups, respectively (HR for death = 0.68; 95% CI: 0.58-0.81; P < 0.001).
In regard to safety, the most common adverse events associated with TAS-102 were neutropenia, leukopenia, and febrile neutropenia. One patient died as a result of TAS-102 treatment. Median time to worsening performance status was also 1.7 months longer in the TAS-102 arm than the placebo arm (HR = 0.66; 95% CI: 0.56-0.78; P < 0.001).
TAS-102 is an oral agent that combines trifluridine and tipiracil hydrochloride. Previous studies conducted mostly in Japan that it was effective in the treatment of patients with refractory colorectal cancer.
We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients.
READ FULL ARTICLE
From New England Journal of Medicine
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