Capecitabine (X) vs bolus 5-FU/leucovorin (LV) as adjuvant therapy for colon cancer (the X-ACT study): positive efficacy results of a phase III trial

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Abstract
3509 Background Treatment with capecitabine (XELODA), a tumor-activated oral fluoropyrimidine, led to significantly superior response rates and improved safety over bolus 5-FU/LV in 1st-line metastatic colorectal cancer patients. MethodsPatients with resected Dukes' C colon cancer were randomized to oral X (1250 mg/m2 twice daily days 1–14, every 3 weeks) or i.v. 5-FU/LV (Mayo Clinic regimen: LV 20 mg/m2+ 5-FU 425 mg/m2 days l-5, every 4 weeks) for 24 weeks' treatment. The primary endpoint was at least equivalence in disease-free survival (DFS). Results A total of 1987 patients from 164 centers were randomized between 11/98 and 11/01. The arms were well balanced for prognostic factors. Median follow-up is 3.8 years. The primary endpoint of the study was met. X was at least equivalent to 5-FU/LV with regard to DFS in the per protocol population (HR 0.89 [95% CI 0.76–1.04]). In the intent to treat (ITT) analysis there was a strong trend towards superior DFS for X vs 5-FU/LV (HR 0.87 [95% CI 0.75–1.00], p = 0.0528), and a trend to superiority for overall survival (OS; ITT: HR 0.84 [95% CI 0.69–1.01], p = 0.0706). Relapse-free survival (RFS) was superior for X vs 5-FU/LV (ITT: HR 0.86 [95% CI 0.74–0.99], p = 0.041). The results seen in the entire population were maintained in patients ≥ 70 years. The favorable safety profile of X compared to 5-FU/LV has been described earlier (Scheithauer, Ann Oncol 2003;14:1735–43). Conclusion The primary endpoint of the study was met. The trend to superiority in DFS and OS, supported by superior RFS and safety mean that X should replace 5-FU/LV in the adjuvant therapy of colon cancer.

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