Tuesday, August 28, 2012 (Last Updated: 08/29/2012)
Takayuki Yoshino, M.D., 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 two or more regimens of standard chemotherapy and were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin. A total of 112 patients (aged 20 or older) 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 (9.0 versus 6.6 months; hazard ratio, 0.56). In the safety population, 50 percent of TAS-102-treated patients had neutropenia of grade 3 or 4, 28 percent had leukopenia, and 17 percent had anemia. None of the placebo-treated patients had grade 3 or worse neutropenia or leukopenia; 5 percent had grade 3 or worse anemia. Serious adverse events occurred in 19 percent of the TAS-102-treated and 9 percent 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.
Several authors disclosed financial ties to pharmaceutical companies, including Taiho Pharmaceuticals, which funded the study and manufactures TAS-102.
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