A randomized clinical study of capecitabine plus oxaliplatin compared with fluorouracil/leucovorin plus oxaliplatin in the treatment of advanced gastric cancer

Background and purpose: There is still no standard chemotherapy regimen for advanced and metastatic gastric cancer ,and the regimen with high efficacy and safety are scare .Severe toxicities are considered to be limiting factors and influence the quality of life in the patients with advanced gastric cancer. The purpose of this study was to evaluate the efficacy and toxicity of capecitabine plus oxaliplatin regimen (XELOX) versus fluorouracil/leucovorin (LV5FU2) plus oxaliplatin regimen (FOLFOX4) in the treatment of advanced gastric cancer and try to find the regimen more tolerable without the deterioration of treatment response.Methods:48 cases with advanced gastric 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 1 000 mg/(m2·d),po, bid, d 1-14; oxaliplatin 130 mg/(m2·d), ivgtt,d 1。 FOLFOX4 group was treated with oxaliplatin 85 mg/(m2·d),ivgtt, d 1;LV 200 mg/m2 ivgtt 2 hr followed by 5-Fu 400 mg/m2 (bolus) and 5-Fu 600 mg/m2(22 hr-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 56%(CR 1,PR 13)in XELOX group of 25 cases and 47.8%(CR 1,PR 10) 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 5.8 months in XELOX group and 5.7 months in FOLFOX4 group. The median survival time (MST) was 10.0 months in XELOX group and 9.8 months in FOLFOX4 group, The toxicities were well tolerated,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 (P 0.05), 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).Conclusions:Both of the two regimens were feasible, well tolerated and effective in treatment of advanced gastric cancer。XELOX regimen may be safer than FOLFOX4 regimen,especially in elderly patients or patients with ECOG PS of 1 to 2.