Roche announced today that it has submitted an application to the European Medicines Agency (EMEA) to extend the label of Xeloda (capecitabine) for use in combination with oxaliplatin (XELOX) in the adjuvant (post-surgery) treatment of patients with early colon cancer. The filing is based on results from the pivotal NO16968 (XELOXA) study, the largest-ever study of patients with stage III (early) colon cancer, which showed that patients taking XELOX immediately after surgery lived disease-free for longer compared to those treated with commonly used chemotherapy regimen 5-fluorouracil/leucovorin (5-FU/LV). The 3 year disease-free survival (DFS) for patients receiving XELOX was significantly superior to the 5-FU/LV arm (70.9% versus 66.5%, HR 0.80, p=0.0045). The DFS result obtained with XELOX is similar to that shown in trials evaluating the use of FOLFOX (oxaliplatin in combination with infusional 5FU/LV) in patients with stage III colon cancer.
The study also showed that XELOX offered patients significantly superior relapse-free survival (RFS) at 3, 4 and 5 years compared to treatment with 5-FU/LV (HR=0.78, p=0.0024). Overall survival data from the study are currently immature, but show a trend towards superiority for XELOX at 5 years (77.6% versus 74.2%, HR=0.87, p=0.1486). Follow-up is ongoing and results will be reported when available.
Xeloda as monotherapy is already licensed for adjuvant treatment of colon cancer throughout the world including Europe, the US and Japan.
“Xeloda monotherapy is proven to be highly effective in the treatment of colon cancer, and recent studies have shown that the addition of oxaliplatin further improves patient outcomes. When treated promptly, early colon cancer can be considered a curable disease, and the use of XELOX can help more patients live disease-free,” said William M. Burns, CEO of Roche’s Pharmaceuticals Division.
Colorectal cancer is the second most common cause of death from cancer across all tumour types in Europe and is the third most commonly reported cancer in the world.