(HealthDay News) – For patients with previously treated metastatic colorectal cancer who are refractory or intolerant to standard therapies, treatment with a novel oral nucleoside antitumor agent, TAS-102, is tolerable and shows promising efficacy.

Takayuki Yoshino, MD, from the National Cancer Center Hospital East in Chiba, Japan, and colleagues assessed the efficacy and safety of TAS-102 for patients with confirmed colorectal adenocarcinoma who had a treatment history of >2 regimens of standard chemotherapy and were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin. A total of 112 patients (aged ≥20) were randomly assigned to receive TAS-102, and 57 patients were assigned to placebo. Patients were followed for a median of 11.3 months.

The researchers found that the median overall survival was significantly longer in the TAS-102 group compared with the placebo group (9 vs. 6.6 months; hazard ratio, 0.56). In the safety population, 50% of TAS-102-treated patients had neutropenia of Grade 3 or 4, 28% had leukopenia, and 17% had anemia. None of the placebo-treated patients had Grade 3 or worse neutropenia or leukopenia; 5% had Grade 3 or worse anemia. Serious adverse events occurred in 19% of the TAS-102-treated and 9% of placebo-treated patients. There were no treatment-related deaths.

“In conclusion, TAS-102 has promising efficacy with a manageable safety profile in patients with metastatic colorectal cancer who are refractory or intolerant to standard chemotherapy,” the authors write.

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Several authors disclosed financial ties to pharmaceutical companies, including Taiho Pharmaceuticals, which funded the study and manufactures TAS-102.

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