A phase III study (X-act study) of adjuvant capecitabine (Xeloda®) for metastatic colon cancer demonstrated trends toward improve disease-free survival and overall survival supported by statistically superior recurrence-free survival when compared to 5-FU/LV. Coupled with a demonstrated improved safety profile, these results suggest that Xeloda® may be an attractive replacement for 5-FU/LV in the treatment of metastatic colorectal cancer. These results were presented at the 40th annual meeting of the American Society of Clinical Oncology held in New Orleans, Louisiana, June 5-8, 2004.

In this study, a total of 1,987 patients from 164 centers were randomized to receive either Xeloda® or 5FU/LV. The primary endpoint was event-driven, non-inferiority in disease-free survival.

Results showed a non-significant trend for improved disease-free survival and overall survival, with a significant improvement in relapse-free survival (see table 1).   Furthermore, subgroup analysis showed Xeloda® treatment was superior across all groups, including age, nodal status, and gender. The hazard ratio for treatment with Xeloda® was 0.826 (p=0.0141).

Table 1  Xeloda® versus 5FU/LV for the treatment of colon cancer

There was improved safety with Xeloda® compared to 5FU/LV across all types and grades of adverse events, with the exception of hand-foot syndrome (p<0.0001). Xeloda® caused significantly less (p<0.0001) diarrhea, nausea/vomiting, alopecia, and neutropenia and less grade 3-4 neutropenia, stomatitis, and neutropenic fever/sepsis. This safety profile was maintained in older patients.

Reference: Cassidy J, Scheithauer W, McKendrick J, Kroning H, et al. Capecitabine (X) vs bolus 5-FU/leucovorin (LV) as adjuvant therapy for colon cancer (the X-ACT study): Efficacy results of a phase III trial. Proceedings from the 40th annual meeting of the American Society of Clinical Oncology, held in New Orleans LA, June 5-8, 2004; Abstract #3509.