0407) and a trend towards improved disease-free (P=0.0528) and overall survival (P=0.0706). In addition, an improved safety profile was noted in favour of capecitabine (Scheithauer et al, 2003; Twelves et al, 2005). On 31 March CCI-779 2005, capecitabine received approval for the adjuvant treatment of Dukes’ C colon cancer from the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP). Capecitabine was also recently approved as a single agent for the adjuvant treatment of Dukes’ C colon cancer by the US Food and Drug Administration (FDA) in patients ��who have undergone complete resection of the primary tumour, when treatment with fluoropyrimidine therapy alone is preferred’. Patients have long expressed a preference for oral fluoropyrimidine therapy instead of i.v.

treatment (Liu et al, 1997; Borner et al, 2002) and oncologists in Europe and the US are now in a better position to satisfy this preference. Clearly, the results of the X-ACT trial suggest that capecitabine can be used instead of 5-FU/LV in the adjuvant treatment of Dukes’ C colon cancer, and we have seen that oral treatment is preferable from the point of view of most patients. However, with ever-increasing pressures to control medical costs, the decision of whether or not to use a treatment may not be based on clinical effectiveness alone. Medical guidelines and treatment decision-making increasingly give consideration to economic costs associated with achieving the health benefits of a therapy.

The National Institute for Health and Clinical Excellence (NICE), for example, considers ��how well the medicine or treatment works in relation to how much it costs the National Health Service (NHS)’ (NICE, 2005). These comparisons of cost-effectiveness can reveal the balance between costs and savings among alternative treatments and thereby assist healthcare providers in prioritising use of available medical resources to maximise health gain (Siegel et al, 1996; Weinstein et al, 1996). Using data collected prospectively during the X-ACT trial, we undertook this pharmacoeconomic analysis to evaluate the cost-effectiveness of adjuvant capecitabine vs standard adjuvant therapy (bolus 5-FU/LV (Mayo Clinic regimen)) in patients with Dukes’ C colon cancer, Drug_discovery from the UK NHS perspective, as well as from a societal perspective. PATIENTS AND METHODS Medical resource use and cost-effectiveness analyses were conducted as part of a prospective pharmacoeconomic evaluation of the X-ACT study. In brief, the X-ACT study was an open-label, multinational, randomised, phase III trial of adjuvant therapy for resected, histologically confirmed Dukes’ C colon carcinoma (Scheithauer et al, 2003; Twelves et al, 2005).