Safety of capecitabine (X) compared to fluorouracil/leucovorin (5-FU/LV) for the adjuvant treatment of elderly colon cancer patients (pts).

3737 Background: The improved safety profile of the oral fluoropyrimidine X (Xeloda) versus bolus 5-FU/LV has been demonstrated in over 3000 pts in 3 large randomized trials in 1(st) line metastatic and adjuvant colon cancer (Twelves EJC 2002, Scheithauer Ann Oncol 2003). In addition, the safety advantage over 5-FU/LV in the adjuvant setting was maintained in older pts (≥65 years) and also in terms of less early severe toxicity with X. The median age of pts at diagnosis of colon cancer is increasing in developed countries. Therefore we examined whether there is enough evidence to support the safe use of X in an elderly population, i.e. pts 70 years and older. METHODS: We performed retrospective analyses on the safety database of the X-ACT adjuvant colon cancer trial, which compared X (993 pts) to 5-FU/LV Mayo Clinic Regimen (974 pts) in Dukes' C colon cancer pts. Adverse events (AEs) in the two arms were analyzed by age: <40, 41-69 and ≥70 years. P-values are not calculated due to the retrospective nature of analysis. RESULTS: Sufficient patient numbers enable comparisons between X and 5-FU/LV for the 41-69 age group (763 vs 738, not shown) and ≥70 group (186 vs 205, table), whereas there were few pts aged <40 (44 vs 31, not shown). [Figure: see text] Hyperbilirubinemia was minimal in both arms when graded by NCI CTCAE. CONCLUSIONS: The improved safety profile of X vs 5-FU/LV is not only maintained in pts over 65, but also in the elderly over 70 years of age. It would be of interest to compare this dataset to that of the INT 0089 trial (Mayo Clinic regimen vs Roswell Park weekly bolus regimen). Pending the final results of the X-ACT study, capecitabine could provide a convenient and effective new option for an aging population. Study sponsored by F. Hoffmann-La Roche Ltd, Basel, Switzerland. No significant financial relationships to disclose.