Swiss drug major Roche presented overall survival results from a 14-month follow-up of the Phase III NO16966 study confirming that its oral Xelox - Xeloda (capecitabine) plus oxaliplatin - is comparable to FOLFOX-4 in the first-line treatment of metastatic colorectal cancer at the American Society of Clinical Oncology Gastro-intestinal Cancers Symposium in California, USA.
Study NO16966 was a large, randomized, Phase III trial of 2,034 advanced colorectal cancer patients that initially compared first-line Xelox versus FOLFOX-4 . Patients receiving Xelox lived for a median of 19 months, while patients receiving FOLFOX-4 lived for a median of 18.5 months. The consistency of these results were also further demonstrated in a subset population from the original two-arm part of the study.
The most common adverse events (greater than or equal to 20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome.
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