Roche announced today that a large, international Phase III study (NO16967) of 627 previously treated patients with advanced colorectal cancer met its primary endpoint of progression-free survival.
Study results showed that the chemotherapy combination XELOX (oral Xeloda plus oxaliplatin) is as effective in delaying disease progression as the chemotherapy combination FOLFOX-4 (infused 5-FU/leucovorin plus oxaliplatin).
?This data endorses previous findings that oral Xeloda in combination with oxaliplatin may provide a new treatment choice for colorectal cancer patients? said Eduard Holdener, Head of Global Development at Roche. ? These data will be used in the submission to worldwide regulatory authorities to allow patients with colorectal cancer the opportunity to have an effective and more convenient therapy.?
Xeloda is an oral chemotherapy that can be taken at home and as such it has an important convenience benefit for both patients and doctors compared to intravenous infusions which require multiple hospital visits. This targeted cancer medicine is already used in previously untreated colorectal cancer patients and last year Xeloda received the additional approval for the treatment of early (adjuvant) colon cancer.
Results from the NO16967 study will be submitted for presentation at future major medical meetings.
?Our data complement the findings of the NO16966 study, suggesting that XELOX is a very reasonable treatment option for patients with recurrent colorectal cancer,? said Mace Rothenberg, MD, lead investigator and Professor of Medicine at Vanderbilt University Medical Center and Ingram Professor of Cancer Research at Vanderbilt-Ingram Cancer Center. ?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.?
In 2004, colorectal cancer was one of the leading cancers and accounted for 13 percent of all cancers.1 It is estimated that more than 394,000 people die worldwide from colorectal cancer each year.2