Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 25, Issue 27, Pages 4224-4230Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2006.09.8467
Keywords
-
Categories
Ask authors/readers for more resources
Purpose 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/m(2) bid for 14 days plus oxaliplatin 130 mg/m(2) on day 1 every 3 weeks) or FUOX ( continuous-infusion FU 2,250 mg/m(2) during 48 hours on days 1, 8, 15, 22, 29, and 36 plus oxaliplatin 85 mg/m(2) 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.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available