Phase III study of capecitabine plus oxaliplatin compared with continuous-infusion fluorouracil plus oxaliplatin as J Gastrointest Canc (2013) 44:79–88 87 first-line therapy in metastatic colorectal cancer: final report of the Spanish Cooperative Group fo

The aim of this phase III trial was to compare the efficacy and safety of capecitabine plus oxaliplatin (XELOX) versus Spanish-based continuous-infusion high-dose fluorouracil (FU) plus oxaliplatin (FUOX) regimens as first-line therapy for metastatic colorectal cancer (MCRC). Patients and Methods A total of 348 patients were randomly assigned to receive XELOX (oral capecitabine 1,000 mg/m2 bid for 14 days plus oxaliplatin 130 mg/m2 on day 1 every 3 weeks) or FUOX (continuous-infusion FU 2,250 mg/m2 during 48 hours on days 1, 8, 15, 22, 29, and 36 plus oxaliplatin 85 mg/m2 on days 1, 15, and 29 every 6 weeks). Results There were no significant differences in efficacy between XELOX and FUOX arms, which showed, respectively, median time to tumor progression (TTP; 8.9 v 9.5 months; P .153); median overall survival (18.1 v 20.8 months; P .145); and confirmed response rate (RR; 37 % v 46%; P .539). The safety profile of the two regimens was similar, although there were lower rates of grade 3/4 diarrhea (14 % v 24%) and grade 1/2 stomatitis (28 % v 43%), and higher rates of grade 1/2 hyperbilirubinemia (37 % v 21%) and grade 1/2 hand-foot syndrome (14 % v 5%) with XELOX versus FUOX, respectively. Conclusion This randomized study shows a similar TTP of XELOX compared with FUOX in the first-line treatment of MCRC, although there was a trend for slightly lower RR and survival. XELOX can be considered as an alternative to FUOX. J Clin Oncol 25:4224-4230. © 2007 by American Society of Clinical Oncolog