| Objective:This study was designed to investigate the efficacy and toxicity betweenS-1combined L-OHP and5-Fu combined L-OHP, leucovorin in treatment ofadvanced gastric cancer, and to evaluate the change of immunity afterchemotherapy. Then seeking the effective and security regimen for theadvanced gastric cancer.Methods:62case of advanced gastric cancer patients diagnosed by histopathologyor cytology were randomized into the two group from September2010toNovember2011. The eligibility criteria were as follows:advanced gastriccancer with stage IV (T4, N3, M1) disease, patients age of28to70years,males were41and female were21, adequate organ functions, a Karnofskyperformance status of70to90. All patients are adequate bone marrowfunctions, hepatic function and renal function. It is estimated life expectancyof at least3month and no other malignancies. All patients, with normal bonemarrow storage and liver and renal function, showed no contraindications tochemotherapy. Patients in the two groups are comparable in gender, age,height, weight, body surface area (BSA), initial treatment and retreatment,pathological type and metastasis. In the trial group, S-1was administered oralltwice daily at a standard dose of60~80mg/m2per day for14consecutive daysand intravenous of oxaliplatin (130mg/m2)was administered on day1every3weeks. While in the control group, the patients was treated with FOLFOX6ormodified FOLFOX6(includes leucovorin400mg/m2intravenous (IV) on day1,5-FU400mg/m2IV on day1followed by2,400~3000mg/m2IV over46hours, and oxaliplatin80~100mg/m2IV on day1). All patients receivedroutine blood tests every week and biochemistry blood examination, ECG and ultrasonic twice weekly. Computer tomography(CT) and nuclear magneticresonance imaging(MRI) were also performed before treatment and after twocycles. All patients underwent a physial examination before and after everycycle treatment. After two cycles of treatment, efficacy was evaluated byRECIST standard. It is compared the beneficial response by evaluating pain,weight and KPS. It is evaluated side effects by WHO criteria for acute andsubacute toxic reactions of antineoplastic agents. Compared the change oflymphocyte phenotype to evaluate the immunity. Statistical process was usedby SPSS17.0of statistical software, all the datas were indicated bymean±standard deviation (x±s). P<0.05was considered statistically differentbetween of them.Results:A total of31cases of trial group and31cases of control group advancedgastric cancer patients have been treated, there was one patient quitted duringthe first cycle, no evaluation was taken in the trial group. One of the controlgroup patient quitted (because of IV myelosuppression), and there was onlyevaluation for toxicity. Finally the number of patients can be evaluated for30cases of the trial group, and30cases of the control group.①Efficacy:Amongthe trial2patients reached complete response(CR),12partial response(PR),14stabilility of disease(SD),2progress of disease, the overall response ratewas46.7%. In the control group1patients reached complete response(CR),12partial response(PR),14stabilility of disease(SD),3progress of disease(PD),the overall response rate was43.3%, the difference has no statistics to learnmeaning (P>0.05).②T he beneficial response:It is evaluated of the beneficialbetween after two chemotherapy cycles. The beneficial response was20patients and non-beneficial response was10in trial group. In control group11patients was beneficial response and19patients was non-beneficial. Thetrial group is higher than the control group in the rate of beneficial response(66.7%:36.7%), and the difference was significant between the group (P <0.05).③T oxicity:The main toxicity was bone marrow suppression, gastrointestinalreaction, neurological toxicity and liver function impairment. Most of toxicity is grade I~II, while only a little patients occurred grade III~IV toxicity. Therewas no patient who had been dead by the serious toxicity. The marrowsuppression contented leukopenia, anemia and thrombocytopenia. There wereno difference in leukopenia toxicity between the two patient groups (P>0.05).The incidence of thrombocytopenia between the two groups has no statisticalsignificance (P>0.05). The incidence of anemia in the two groups have nostatistical significance (P>0.05). Non-hematologic toxicity, the mainGastrointestinal reaction is nausea and vomiting and diarrhea. Compared thetwo groups of nause and vomiting it has statistical significance (P<0.05). Theincidence of neurotoxicity, mucositis and liver function impairment were notstatistical significance between the two group.④Immunity: CD4+andCD4+/CD8+increased after chemotherapy in two group (P<0.05), while CD3+,CD8+, and CD19+renmained unchanged (P>0.05), and chemotherapy does notinduces lymphocytopenia, and respecially in trial group (P<0.05).Conclusions:There were better clinical efficacies and less adverse effects in thetreatment of advanced gastric cancer when S-1combined with Oxaliplatin,and patients with them do not debased in immunity, but also the cellularimmune function is improving followed the tumor regression. S-1is activewell tolerate for the advanced gastric cancer patients. It is worth furtherclinical application. |
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