Roche announces phase III Xelox results

Roche has announced the results of a worldwide phase III trial of Xelox (oral Xeloda plus oxaliplatin) for the treatment of patients with advanced cases of colorectal cancer. The data showed that the treatment achieved its main endpoint of progression survival.

The combination was shown to be as effective as Folfox-4 (infused 5-FU/leucovorin plus oxaliplatin) in slowing the progression of colorectal cancer.

Xeloda (capecitabine), a constituent part of Xelox, is currently licensed in 90 countries worldwide, including the EU, as a monotherapy for the treatment of metastatic colorectal cancer. It is also currently licensed as a combination therapy with Txotere (docetaxel) for women with metastatic breast cancer.

Mace Rothenberg, professor of medicine at Vanderbilt University Medical Centre, said: “Our data complement the findings of the NO16966 study, suggesting that Xeolox is a very reasonable treatment option for patients with recurrent colorectal cancer.”

He added that the data suggested that the treatment can be used instead of IV 5-FU for advanced colorectal cancer patients.

In October, Roche announced that it had submitted an application for marketing authorisation of Herceptin (trastuzumab) to the European Medicines Agency for the treatment of HER2-positive and hormone receptor-positive breast cancer.