| Objective:1.The one aim of this study was to assess the recent efficacy and tolerability of two drug combinations of S-1 and Oxaliplatin, and tegafur in combination with Oxaliplatin in advanced gastric cancer.2.The other aim of this study was to analy the recent efficacy and tolerability of S-1single-agent therapy for advanced gastric cancer that had been treated by Oxaliplatin.Method:1.From2007-2008, 42patients with advanced gastric cancer were enrolled for study.The eligibility criteria were as follows:advanced gastric cancer with stageⅣ(T4,N3,M1) disease,with histological confirmation of adenocarcinoma or adenosquamous carcinomaetal at least one measurable lesion ,a patients age of 37 to 71years,mean of age was 57.83±8.5,males were 31and female were11,adequate organ functions,a Karnofsky performance status of 60 to 90. 42patients with advanced gastric cancer were divided into trial group and control group in a randomized manner,there were 21 patients in trial group and 21 patients in control group respectively.Details history of two group including age,sex,histology, KPS and other investigational records were documented and analyzed. In the trail group S-1 was administered orally twice daily,at a standard dose of 80 mg/m2 per day from d1 to d14 and intravenous of Oxaliplatin (130mg/m2) was administered on day 1,the treatment schedule was recycled every 28 days. While in the control group,FT(800mg/m2) was administered orally third daily from d1 to d14 and intravenous of Oxaliplatin (130mg/m2) was administered on day 1 ,the treatment schedule was recycled every 28 days. The efficacy and tolerability were estimated after two courses of treatment. 2.5 patients with advanced gastric cancer were eligible for the single-agent group. S-1 was administered orally twice daily,at a standard dose of 80 mg/m2 per day from d1 to d28, the treatment schedule was recycled every 6 weeks. The efficacy and tolerability were estimated after two courses of treatment.Results:1.All of the 21 patients of trial group could be evaluated for clinical response and toxicity,complete response was not observed,partial response was observed in 9 patients(42.9%),no change was observed in 7 patients(33.3%), progressive disease was observed in 5 patients(23.8%).In the control group,there was 1 patient not eligible for study,becouse the patient was discovered also contracted lung cancer,and 20 patients of control group might be evaluated for clinical response and toxicity. complete response was not observed,partial response was observed in 6patients(30.0%),no change was observed in 8 patients(40.0%),progressive disease was observed in 6 patients(30.0%).the total response rate in trial group was 42.9% and the total response rate in control group was 30.0%. There were no difference in clinical response between the two patient groups(X2=0.730,P=0.393).The benefit response rate was 76.2%(16/21)in the trial group and 45.0%( 9/20) in the control group,There were difference in the benefi response between the two patient groups (X2=4.188,P=0.041).The incidence of leucopenia was 47.6% in the trial group and 55.0% in the control group(X2=0.223,P=0.636).The incidence of anemia was 19.0% in the trial group and 30.0% in the control group (X2=0.666,P=0.414) The incidence of thrombocytopenia was 19.0% in the trial group and 35.0% in the control group(X2=1.328,P=0.249), there were no difference in hematologic toxicity between the two patient groups. However there were difference in non hematologic toxicity between the two patient groups, the incidence of nausea/vomiting was 42.9% in the trial group and 75.0% in the control group(X2=4.361,P=0.037).The toxicity of the blood above 3 degrees:the incidence of trial group was 9.5 %in the trial group and 35.0% in the control group,There were difference in the benefit response between the two patient group(sX2=3.881,P=0.049).2.There were 5 patients with advanced gastric cancer in the sigale-agent group.The clinical response rate was 20%(1/5). The benefit response rate was 60%(3/5).The incidence of leucopenia was 60%(3/5),The incidence of anemia was 20%(1/5),The incidence of thrombocytopenia was 20%(1/5).Which were grade 1-2 hematologic toxicity. the incidence of nausea/ vomiting was 60%(3/5),the incidence of mucositis and liver function impairment were 20%(1/5)equally,which were grade 1-2 hematologic toxicity.Conclusion:There were better clinical efficacies and less adverse effe- cts in the treatment of Advanced Gastric Cancer when S-1 combined with Oxaliplatin.S-1 is active,well-tolerate for the advanced gastric cancer patients who relapse after multiple chemtherapy.
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