Clinical Observation And Study Of Xiaoaiping Injection Combined With SOX Regimen For Advanced Gastric Carcinoma

Objective:To observe and evaluate the clinical effect and safety of xiaoaiping injection combined with SOX regimen in the treatment of advanced gastric cancer.Methods:A total of 100 cases of inpatients.or outpatients with advanced gastric cancer confirmed by CT,MRI and pathology from Mar.2015 to Oct.2016 in Gastrointestinal or Oncology was collected as the research object.All patients were recurrent or inoperable,age ranges from 31 to 75,KPS from 60 to 100,clinical stage from Ⅲ to Ⅳ according to the TNM staging criteria which was set by American Association of Cancer(AJCC)and International Union Against Cancer in 2010.All cases of patients were divided into observation group and control group randomly.Two groups of subjects were treated with SOX chemotherapy(oxaliplatin 130 mg/m2,intravenous drip on day 1 plus S-1 80mg/m2/d po bid,days 1 to 14,repeat every 3 weeks)for at least two weeks.Observation group was added xiaoaiping injection 60 ml/d,intravenous drip for 14 days combined with SOX chemotherapy.Control group was only treated with SOX chemotherapy.In our study,the treatment was terminated as long as the occurance of time to disease progression(PD),the death of patients or intolerable toxicity.Main outcome was tumor response rate(ORR),the adverse reaction rate,the quality of life(KPS score)before and after chemotherapy and time to progression(TTP).The recent efficacy,the change of KPS score and the adverse reaction rate were evaluated according to RECIST 1.1 criteria and the WHO developed acute and subacute toxicity dividing standards.SPSS20.0 software was employed to analyze the difference between two groups.Results:In all cases,96 patients completed the clinical trials,48 patients in observation group and 48 patients in control group.Four patients were removed from the study because of uncomplaisance,economic factors,non compliant patient or serious adverse reaction,2 in observation group and 2 in control group.There was no statistically significant difference in two groups of baseline data,such as sex,age,KPS score,clinical stages,et al(P=0.670>0.05).1.The ORR in observation group and control group were 66.7%and 62.5%,respectively.There showed no statistically significant difference in those two groups(P>0.05).The DCR in observation group and control group were 95.8%and 89.6%,respectively.And there showed no statistically significant difference in those groups(P=0.432>0.05).2.The improvement rate of KPS in observation group was 62.5%and in control group 37.5%,and there was statistically significant difference in the groups(P=0.022<0.05).3.The incidence of leucopenia and neutrocytopenia in observation group were 22.9%and 45.8%and in control group were 27.1%and 52.1%.The incidence of leucopenia and neutrocytopenia between the two groups has no significant difference(P<0.05).The other adverse drug reactions such like erythropenia,thrombocytopenia,nausea and vomiting,poor appetite,neurotoxicity and oral mucositis,et al,showed no statistically significant difference in those groups(P>0.05).4.The TTP in observation group was 7.0(95%CI:5.913～8.087)months and in control group 6.5(95%CI:5.720～7.280)months.The TTP in those groups showed no statistically significant difference(P=0.746>0.05).Conclusion:1.Xiaoaiping injection combined with SOX chemotherapy had same effects compared to SOX chemotherapy alone in the treatment of advanced gastric cancer,the clinical effective rates were different but there was no statistical significance.2.Xiaoaiping injection combined with SOX chemotherapy could decreased incidence of chemotherapy-induced leucopenia and neutrocytopenia during treatment period of advanced gastric cancer.3.Xiaoaiping injection combined with SOX chemotherapy did not increase the incidence of chemotherapy-induced erythropenia,thrombocytopenia,neusea and vomiting,poor appetite,neurotoxicity and oral mucositis,et al.4.Xiaoaiping injection could improve the patients’ life quality in the treatment of advanced gastric cancer by combined with SOX chemotherapy and was worthy of being widely applied in clinic.