Most frequently observed clinically significant adverse events include neutropenia, leukopenia
THURSDAY, May 14, 2015 (HealthDay News) — For patients with refractory metastatic colorectal cancer, the oral agent TAS-102, that combines trifluridine and tipiracil hydrochloride, is associated with improved overall survival, according to a phase 3 study published in the May 14 issue the New England Journal of Medicine.
Robert J. Mayer, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a double-blind phase 3 trial involving 800 patients with refractory colorectal cancer. Participants were randomized in a 2:1 ratio to receive TAS-102 or placebo.
The researchers found that the median overall survival was 5.3 months with placebo and 7.1 months for TAS-102, and the corresponding hazard ratio for death was 0.68 for the TAS-102 group versus the placebo group (P < 0.001). TAS-102 was associated with clinically significant adverse events, including neutropenia (38 percent), leukopenia (21 percent), and febrile neutropenia (4 percent). One death was reported in relation to TAS-102. The median time to worsening performance status was 5.7 months for TAS-102 versus 4.0 months with placebo (hazard ratio, 0.66; P < 0.001).
“TAS-102 was shown to have clinical activity in a large population of Japanese and Western patients with heavily pretreated metastatic colorectal cancer, including those whose disease was refractory to fluorouracil,” the authors write.
Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Taiho Oncology-Taiho Pharmaceuticals, which funded the study.
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