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www.fdanews.com/articles/61304-roche-releases-results-of-cancer-treatment-study

ROCHE RELEASES RESULTS OF CANCER TREATMENT STUDY

July 31, 2006

Roche has announced that a Phase III study enrolling 2,035 previously untreated metastatic colorectal cancer patients met both primary endpoints. Results of the study showed that the chemotherapy combination Xeloda plus oxaliplatin, called Xelox, is as effective in terms of progression-free survival, a measure of the time patients live without their disease progressing, as Folfox, or infused 5-FU/LV (5-fluorouracil/leucovorin) plus oxaliplatin.

The study also shows that the addition of Avastin to chemotherapy (Folfox and Xelox) improves progression-free survival compared with chemotherapy alone.

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.