Capecitabine As First-line Treatment in Colorectal Cancer. Pooled Data from Two Large, Phase III Trials

The oral, tumour-selective fluoropyrimidine capecitabine represents a major new strategy for the treatment of colorectal cancer. Pooled results from two large, multicentre, open-label, phase III studies comparing oral capecitabine (1250 mg/m2 twice daily for 14 days every 3 weeks) with the Mayo Clinic regimen (5-fluorouracil [5-FU] 425 mg/m2 plus leucovorin 20 mg/m2 days 1-5, every 4 weeks) provide information on over 1200 patients receiving first-line chemotherapy for metastatic colorectal cancer. Analysis of all randomised patients demonstrated a significantly superior overall response rate as assessed by the investigator for capecitabine compared with 5-FU/leucovorin (25.7% versus 16.7%, P<0.0002), reinforcing the individual trial results. Median time to disease progression, overall survival and duration of response were equivalent in the two treatment groups. Furthermore, capecitabine showed a superior safety profile compared with 5-FU/leucovorin, with a significantly lower incidence (P<0.001) of diarrhoea, stomatitis, nausea and alopecia, together with a reduced treatment-related hospitalisation rate. In addition, the incidence of neutropenic fever/sepsis was significantly lower in patients receiving capecitabine.