Roche’s Xeloda (capecitabine) increases the chance that patients with colon cancer will survive five years compared with conventional chemotherapy, according to newly released data from the University of Leeds.
A press release issued Monday reports results from a follow up analysis of the Xeloda in Adjuvant Colon Cancer Therapy (X-ACT) study cohort. X-ACT enrolled 1,987 patients who had undergone surgery for stage III colon cancer (ie. the cancer has spread from the colon to the lymph nodes, but has not metastasised to distant parts of the body). Patients received 24-weeks' treatment with oral capecitabine or the Mayo Clinic regimen: bolus fluorouracil plus leucovorin five days each month for six months.
Initial results in the New England Journal of Medicine(2005;352:2696-704) reported that, based on a non-inferiority analysis, disease-free survival among those receiving capecitabine was at least equivalent to that with the Mayo Clinic regimen. Capecitabine improved relapse-free survival by 14% (hazard ratio 0.86) and was associated with fewer adverse events than fluorouracil plus leucovorin.
According to the statement, patients treated with Xeloda spent 85% less time with their doctor or at the hospital. Furthermore, about 71% of patients given Xeloda were still alive after five years. This compared to 68% of patients treated with the Mayo Clinic regimen.
“Standard chemotherapy can be incredibly disruptive to people’s lives,” said Chris Twelves, professor of clinical cancer pharmacology and oncology at the University of Leeds and lead author of the initial report. “Patients visit hospital five days a week for the injections and then have three weeks off before returning to hospital for the next course – and the side effects can be unpleasant. We now have long-term evidence now that clearly supports Xeloda's superiority over the Mayo Clinic regimen. There is now no reason why we should ask colon cancer patients to endure the burdens associated with that older treatment.”
Xeloda is approved for certain patients with colon, breast and advanced stomach cancer. Xeloda is licensed in more than 90 countries - including the EU, USA, Japan, Australia and Canada - and has treated over 1 million patients. Some analysts expect Xeloda sales to reach 1.7 billion Swiss francs ($1.40 billion) by 2010.