Superior anti-tumour activity to i.v. 5-FU/LV

Adjuvant setting

Following landmark data from the X-ACT trial, Xeloda^© has been approved by both the EMEA and the FDA as adjuvant treatment for patients with resected stage III colon cancer. Compared with 5-FU/LV, Xeloda^© has been shown to reduce the risk of relapse and death, with:¹

• at least equivalent disease-free survival (DFS) to 5-FU/LV (p<0.001), with a strong trend towards superiority (p=0.05)
• significantly longer relapse-free survival (RFS) (p=0.04) and a 14% reduction in risk of relapse
• a trend towards improved overall survival (OS) (p=0.07)
• a significant effect of Xeloda^© treatment on DFS (p=0.01) and OS (p=0.02) in prospectively planned multivariate analysis.

The efficacy results of the X-ACT trial indicate that Xeloda^© should be the first-choice fluoropyrimidine for adjuvant treatment of stage III colon cancer,1 and should also be considered for use in stage II disease.²

Metastatic setting

Oral Xeloda^© is highly active when administered as first-line monotherapy in patients with metastatic colorectal cancer, showing superior anti-tumour activity to the i.v. Mayo Clinic regimen of 5-fluorouracil/leucovorin (5-FU/LV).^3,4,5 In two international, open-label phase III trials, patients were randomized to treatment with either Xeloda^© (1250 mg/m² twice daily for 14 days, followed by a 7-day rest period) or the Mayo Clinic regimen (LV, 20 mg/m², followed by 5-FU, 425 mg/m², administered as an i.v. bolus on days 1–5 every 28 days).^4,5 An integrated analysis of data from the 1207 patients in these two identically designed studies was performed.³

• Patients treated with Xeloda^© achieved a significantly superior response rate of 26% compared with 17% in the 5-FU/LV group (p<0.0002).