ROCHE REPORTS XELOX MEETS ENDPOINT IN COLORECTAL CANCER TRIAL

Roche announced 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).

The NO16967 trial randomized 627 patients who had previously received chemotherapy and whose disease had returned or continued to progress. The trial compared XELOX (oral Xeloda plus oxaliplatin) with FOLFOX-4 (intravenous bolus and infusional 5-fluorouracil/leucovorin plus oxaliplatin) as first-line colorectal cancer treatment. The primary objective was to determine whether the XELOX regimen was as effective as FOLFOX-4 in terms of progression-free survival (a measure of time to disease progression or death). The secondary outcomes included overall survival, overall response rates and safety profile. There were no unexpected safety findings in the study.

Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.