Clinical study of capecitabine plus oxaliplatin compared with 5-fluorouracil/ leucovorin (LV5FU2) plus oxaliplatin in the treatment of metastatic colorectal cancer

Objective:To evaluate the efficacy and toxicity of capecitabine plus oxaliplatin regimen (XELOX) versus 5-fluorouracil/leucovorin (LV5FU2) plus oxaliplatin regimen (FOLFOX4) in the treatment of metastatic colorectal cancer.Methods: Total of 48 cases with metastatic colorectal cancer were enrolled into this study,25 patients and 23 patients were randomly divided into XELOX group and FOLFOX4 group respectively.XELOX group was treated with capecitabine 1000mg/m2 d,po,Bid,d1-14;oxaliplatin 130 mg/m2 d,ivgtt,d1.FOLFOX4 group was treated with oxaliplatin 85 mg/m2 d,ivgtt,d1;LV 200 mg/m2 ivgtt 2h followed by 5-FU 400 mg/m2 (bolus) and 5-FU 600 mg/m2(22h-coutinous infusion).XELOX regimen was repeated every 3 weeks for one cycle,FOLFOX4 regimen was repeated every 2 weeks,4 weeks for one cycle.All patients received two cycles of chemotherapy at least.The efficacy and toxicity were evaluated according to WHO standard.Results: All 48 cases were available for objective response.The overall response rate was 48.0%(CR2,PR10)in XELOX group of 25 cases and 47.8%(CR2,PR9) in FOLFOX4 group of 23 cases.The difference in response rate was not statistically significant between the two groups (P0.05).The median time to progression (mTTP)was 7.1 months in XELOX group and 7.3 months in FOLFOX4 group.The median survival time (MST) was 13.8 months in XELOX group and 14.0 months in FOLFOX4 group.The incidence of grade Ⅲ+Ⅳ nausea and vomiting was significantly lower in XELOX group than in FOLFOX4 group (P0.05) but hand and foot syndrome in XELOX group were more obvious than in FOLFOX4 group (P0.05),Incidence of other side effects in FOLFOX4 group was higher than that of those in XELOX group except for diarrhea,but no significance existed (P0.05).Conclusion: Both of the two regimens were feasible,well tolerated and effective in the treatment of metastatic colorectal cancer。XELOX regimen may be safer than FOLFOX4 regimen.