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news.Roche has said a phase III study of Xeloda in patients with advanced colorectal cancer met its primary endpoint of progression-free survival, showing it to be as effective as standard medication.
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The primary objective was to answer whether the Xelox (oral Xeloda plus oxaliplatin) regimen is as effective as Folfox-4 (infused 5-FU/leucovorin plus oxaliplatin) in delaying disease progression or death. The secondary outcomes, to be reviewed included overall survival, overall response rates and safety profile.
Study results showed that the chemotherapy combination Xelox is as effective in delaying disease progression as the chemotherapy combination Folfox-4 in previously untreated colorectal cancer patients.
“By demonstrating that Xeloda in combination with oxaliplatin was as effective as Folfox-4, these two studies provide the strongest evidence yet that Xeloda may be used in place of IV 5-FU in the treatment of patients with advanced colorectal cancer,” said Mace Rothenberg, professor of medicine at Vanderbilt University Medical Center.
Xeloda is an oral chemotherapy that can be taken at home and has an important convenience benefit for both patients and doctors compared to intravenous infusions which require multiple hospital visits. Xeloda is already used in previously untreated colorectal cancer patients and last year it received the additional approval for the treatment of early colon cancer.