A randomized clinical study of hydroxycamptothecin plus oxaliplatin compared with 5-fluorouracil/leucovorin(LV5FU2) plus oxaliplatin in the treatment of advanced gastric cancer

Objective To evaluate the efficacy and toxicity of hydroxycamptothecin plus oxaliplatin regimen(HCPTOX) versus 5-fluorouracil/leucovorin(LV5FU2) plus oxaliplatin regimen(FOLFOX4) in the treatment of advanced gastric cancer in order to find the regimen more tolerable and without the adverse treatment response.Methods Forty-seven cases of advanced gastric cancer were enrolled into this study,24 patients and 23 patients were randomized into HCPTOX group and FOLFOX4 group respectively.HCPTOX group was treated with hydroxycamptothecin 6 mg/m2 ivgtt,d1-d5,and oxaliplatin 130 mg/(m2·d),ivgtt,d1.FOLFOX4 group was treated with oxaliplatin 85 mg/(m2·d) ivgtt,d1,and LV 200 mg/m2 ivgtt 2 h followed by 5-Fu 400 mg/m2(bolus) and 5-Fu 600 mg/m2(22h-continuous infusion).HCPTOX regimen was repeated every 3 weeks for one cycle,FOLFOX4 regimen was repeated every 2 weeks and 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 47 cases could be evaluated for objective response.The overall response rate was 50.0%(CR 2,PR 10)in HCPTOX group and 47.8%(CR 1,PR 10) in FOLFOX4 group.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 HCPTOX group and 5.7 months in FOLFOX4 group.The median survival time(MST) was 10.0 months in HCPTOX group and 9.8 months in FOLFOX4 group.The toxicity was well tolerated.The incidence of grade-Ⅲ+Ⅳ nausea and vomiting was significantly lower in HCPTOX group than in FOLFOX4 group(P0.05),but hand and foot syndrome was more obvious in HCPTOX group than in FOLFOX4 group(P0.05).Incidence of other side effects in FOLFOX4 group was higher than those in HCPTOX group except for diarrhea,but with no significant difference(P0.05).Conclusion Both of the two regimens were feasible,well tolerated and effective in treatment of advanced gastric cancer.HCPTOX regimen may be safer than FOLFOX4 regimen,especially in elderly patients or patients with ECOG PS of 1 to 2.