Clinical study on combination chemotherapy with irinotecan,fluorouracil,and leucovorin in patients with advanced gastric carcinoma

Key words: 
• irinotecan /
• fluorouracil /
• paclitaxel /
• cisplatin /
• gastric carcinoma /
• chemotherapy

Abstract: Objective :To investigate the efficacy and safety of irinotecan(CPT-11) plus fluorouracil(5-FU) and leucovorin(LV) in patients with advanced gastric carcinoma,in reference to those of paclitaxel(TAX) and cisplatin(DDP) combined with 5-FU and LV. Methods :63 Patients with untreated advanced gastric carcinoma were randomly enrolled into treatment group and control group.The treatment group were treated with CTP-11 200 mg on day 1,LV 200 mg and 5-FU 500 mg on day 1～5 while the control group were given TAX 180 mg on day 1,DDP 60mg on day 3,LV 200 mg and 5-FU 500 mg on day 1～5.Both regimens were repeated every 3 weeks.All the patients received at least two treatments and were evaluable for response rate,survival time,and adverse effect. Results :In 31 evaluable patients in treatment group,CR 0 case,PR 8 cases(25.8 %),SD 12 cases(38.7 %),and PD 11 cases(35.5 %).The response rate was 25.8 %(8/31).In 29 evaluable patients in control group,CR 0 case,PR 8 cases(27.6 %),SD 12 cases(41.4 %),and PD 9 cases(31.0 %).The response rate was 25.8 %(8/31).No significant difference was found in terms of response rate between two groups.The median survival and 1-year survival rates were 7.7 and 8.3 months,and 34.4 % and 41.4 % for both groups,respectively.There was no significant difference between two groups.The most common drug-related adverse effects,mainly grade Ⅰ and Ⅱ,included neutropenia,hepatic toxicity,neurotoxicity,diarrhea,nausea,and vomiting.The incidence rate of diarrhea in treatment group was significantly higher than that in control group.Adverse effects of grade Ⅲ and Ⅳ rested on neutropenia and neurotoxicity,and the incidence rate in treatment group was significantly lower than that in control group.No treatment-related death occurred. Conclusion :Intravenous drip of CPT-11/5-FU/LV seems an active approach for untreated advanced gastric carcinoma with tolerated side effects.Further extensive investigations concerning the dose and course of treatment are demand.