Clinical Observational Study Of SOX Combined With Apatinib As First-line Treatment For Gastric Cancer

Objective: Chemotherapy is the main treatment for advanced gastric cancer.but currently there is no internationally recognized standard chemotherapy regimen.To investigate the clinical efficacy and safety of apatinib combined with SOX regimen in the first-line treatment of advanced gastric cancer,evaluate the efficacy and adverse reactions of this chemotherapy regimen,and provide new options for the treatment of advanced gastric cancer.Methods: According to the standard set,determine the research into the histologic diagnosis of IIIC and early stage IV gastric cancer patients,according to the rules of chemotherapy regimens(SOX): S-1:40-60 mg / ?,1 time in the morning ?and evening,calculated on body surface area(BSA)dose: when BSA < 1.25 dose ?of 40 mg/times,when the BSA is 1.25 ? 1.5 dose of 50 mg/times,when BSA>1.5 ?? 2.0 dose for 60 mg/time,after a meal of oral,1-14 days;Oxaliplatin 130mg/m2,intravenous drip on day 1,every 3 weeks;Apatinib 500mg/qd,21 days for a cycle.At least 2 cycles of chemotherapy should be completed according to the prescribed protocol.If no special conditions are found,the treatment will progress to the disease or there will be intolerant adverse reactions.If the patient has serious adverse reactions during chemotherapy,apatinib can be reduced as appropriate and increased to the treatment dose after the symptoms improve.After 4-6 cycles of chemotherapy,the patient's condition was stable,and the efficacy was evaluated as CR,PR and SD.Apatinib was given 500mg/qd to continue maintenance treatment,and the maintenance treatment lasted for 28 days.The efficacy after chemotherapy was evaluated according to RECIST1.1 standard,and the adverse drug reactions were evaluated according to the fourth edition of the drug adverse reaction evaluation system(ctcae-v4.0)developed by the NCI in the United States.The main observational indicators were progression-free survival time(PFS)and median total survival time(MST).Secondary endpoints were treatment response rate(RR),disease control rate(DCR),and adverse drug reactions.At the same time,the influence of some related factors,such as age,gender,ECOG score,pathological type and pathological stage,on the survival time of patients after using the chemotherapy program was analyzed,and the multivariate Cox regression analysis was used to verify.Results: A total of 24 patients with advanced and locally advanced gastric cancer were collected in this study.8 patients with IIIC stage were evaluated at baseline and 16 patients with IV.There were 11 patients with age ?60 and 13 patients with age <60,with an average age of 58.3±10.4 years(34-72 years).Among the 24 patients,16 were males and 8 were females.Ten(42%)scored zero,eight(33%)scored one,and six(25%)scored two.The efficacy was evaluated in all 24 patients,with an average chemotherapy cycle of 5.0±1.1 times(3-7),and an average maintenance cycle of 3.7±1.7 times(0-7)for apatinib.After combined chemotherapy,1 patient(4.2%)had complete remission(CR),11 patients(45.8%)had partial remission(PR),8 patients(33.3%)had stable condition(SD),4 patients(16.7%)had advanced disease(PD),the total response rate(RR)was 50.0%,and the disease control rate(DCR)was 83.3%.No patients were lost to follow-up,and by the end of follow-up,13 patients had died and 22 of the 24 patients had progressed.Median progression-free survival(m PFS)was 7.7 months(95%ci 7.0-8.4 months)and median overall survival(MST)was 13.0 months(95%ci 10.9-15.1 months).Multivariate Cox regression analysis was used to verify the relevant factors,and the ECOG score(P<0.05)was an independent prognostic factor affecting the survival time of patients.The main adverse reactions during chemotherapy were thrombocytopenia,granulocytopenia,anemia,hypertension,proteinuria,hand-foot syndrome,fatigue,nausea and vomiting.However,most of the 1-2 grade,after symptomatic treatment for the better.Bone marrow suppression,hypertension(4%),proteinuria(4%),and handfoot syndrome(8%)were the major grade 3-4 adverse reactions observed in the study.None of the enrolled patients had a treatment-related death.Conclusion: The first-line treatment of advanced gastric cancer with apatinib combined with SOX regimen is an effective chemotherapy regimen,which can be tried as a new choice for the treatment of advanced gastric cancer.ECOG score is an independent prognostic factor affecting the survival time of patients,and patients with 0-1 score have an advantage in the survival time.The adverse reactions of this protocol are relatively mild and can be tolerated by patients.