The evidence supporting the use of capecitabine in the first-line setting for the treatment of metastatic colorectal cancer comes from the results of 2 large open-label randomised controlled phase III trials.r
Between September 1996 and February 1998, a total of 1207 patients were randomised; 603 patients to oral capecitabine (1250 mg/m2 twice daily for 14 days followed by a 7 day rest period) and 604 patients to the Mayo Clinic 5-FU/FA regimen (5-FU 425 mg/m2 and FA 20 mg/m2 days 1 to 5 every 28 days).
The primary end point of the trial was the overall tumour response rate (complete response and partial response), to establish that oral capecitabine achieves a response rate at least equivalent to the Mayo Clinic regimen in patients with previously untreated metastatic colorectal cancer.
Secondary end points included time to disease progression, overall survival, duration of response and time to first response, as well as safety and quality of life profiles and medical resource utilisation during treatment.
The results from the integrated analysis demonstrated a significantly superior overall response rate with capecitabine compared with the Mayo Clinic regimen (26 vs 17%; p<0.0002). However, there were no statistically significant differences for the number of patients achieving stable disease, time to progression or overall survival between treatment groups.r
|Overall response rate
|Median time to progression
|Median overall survival
NS: non significant
Capecitabine demonstrated a safety profile superior to that of 5-FU/FA (Mayo regimen), with a significantly lower incidence of diarrhoea, stomatitis, nausea, alopecia and grade 3 or 4 neutropenia leading to significantly fewer neutropenic fever/sepsis cases and fewer hospitalizations. The most frequently occurring toxicities in the capecitabine group were hand-foot syndrome and diarrhoea.r
© Annals of Oncology 2002