Capecitabine Plus Oxaliplatin Compared With Fluorouracil and Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer

摘要: Purpose This multicenter, randomized trial compared capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil (FU) and folinic acid (FA) as adjuvant therapy for patients stage III colon cancer. Patients Methods who had undergone curative resection were randomly assigned to XELOX (oxaliplatin 130 mg/m 2 on day 1 1,000 twice daily days 14 every 3 weeks 24 weeks) or a standard FU/FA regimen (Mayo Clinic Roswell Park 32 weeks). The primary study end point was disease-free survival (DFS). Results intention-to-treat population comprised 1,886 patients; 944 942 Clinic, n 664; Park, 278). After 57 months of follow-up the analysis, 295 (31.3%) in group relapsed, developed new cancer, died 353 (37.5%) (hazard ratio [HR] DFS, 0.80; 95% CI, 0.69 0.93; P .0045). 3-year DFS rate 70.9% 66.5% FU/FA. HR overall (OS) 0.87 (95% 0.72 1.05; .1486). 5-year OS 77.6% 74.2%, respectively. Follow-up is ongoing. Preplanned multivariate subgroup analyses supported robustness these findings. Conclusion addition improves an additional treatment option patients. J Clin Oncol 29. © 2011 by American Society Clinical Oncology