| Objective : In East Asia,gastrectomy with D2 lymph node dissection is standard method of advanced gastric cancer.For this kind of patients,the NCCN guidelines recommend the use ofoxaliplatin and capecitabine(XELOX),but in the process oral capecitabine will cause hand-foot syndrome.In recent years,S-1 in the adjuvant chemotherapy has also been recognized,especially in Japan and South Korea.A phase II trial in Japan showed the feasibility and safety of oxaliplatin and S-1(SOX)chemotherapy in patients with stage III gastric cancer after radical operation for D2.In view of this,we observed the RFS,OS and adverse reactions of adjuvant treatment of SOX and XELOX in gastric cancer with D2 lymph node dissection.Methods:1.clinical data:All patients with advanced gastric cancer after D2 radical operation in First Affiliated Hospital of Dalian Medical during January 2008 to January2014.The inclusion criteria were R0 surgery with D2 or more extensive lymphadenectomy.For more than 2 cycles of chemotherapy,Sixty-one gastric cancer patients were analyzed.SOX group(n=28): there were 20 males and 8 females;aged 37-75 years old,the median age was 58.5;8 cases of stage II surgery,20 cases of stage III.XELOX group(33),including 24 cases of male,9 cases female;aged 29-71 years,the median age 60years;10 cases of stage II surgery,33 cases in stage III.The end of the follow-up to January 2016.2.Regimen:SOX:oxaliplatin,130mg/m2,ivgtt(over 2 hours),d1;S-1:BS<1.25 ㎡,40 mg,1.25 ㎡<BS<1.5 ㎡,50 mg,BS>1.5 ㎡,60 mg,2 times a day,the 1-14 days administration;every 3 weeks repeated chemotherapy.The average number of cycles was 5.6 ±1.0.XELOX:the same dosage;capecitabine,130mg/m2,2 times a day,the 1-14 days administration;every 3 weeks repeated chemotherapy.The average number of cycles was 5.6 ±1.2.3.observed indicator:The treatment-related adverse reactions were assessed in accordance with CTCAE 4.0 toxicity grading criteria.Compare the RFS,OS and the incidence rate of adverse reaction in the two differert chemotherapy regimens in adjuvant chemotherapy for gastric cancer patients.The completion of the two chemotherapy regimens,drug reduction,recurrence and metastasis were compared.Statistical analyses were carried out using Chi-Square,Kaplan-Meier method,log-rank test.Results:1.The 1-year,2-year and 3-year recurrence free survival are 89.3%,71.4%,57.1% in SOX group and 93.9%,75.8%,60.6% in XELOX group,respectively.Overall survival rates are 92.9%,89.3%,78.6% in SOX group and 97.0%,93.9%,81.8% in XELOX group.The two groups show no statistically significant difference in1-year,2-year and3-year recurrence free survival and overall survival rates.Overall comparison,there are no no statistically significant difference in median RFS and median OS.2.Subgroup analyses:In patients younger than 65 years of age and older than 65 years of age,ⅡA-ⅢB and ⅢC patients,preoperative hemoglobin in normal and low group,preoperative tumor markers in normal and elevated group,there are no statistically significant difference in1-year,2-year and 3-year recurrence free survival and overall survival rates.Overall comparison,there are no no statistically significant difference in RFS and OS.3.The toxic and side effects seen in both groups are mainly hematological toxicity,gastrointestinal reactions,peripheral neuropathy,oral mucositis as well as hand-foot syndrome among which,the incidence of hand-foot syndrome.The toxic and side effects in the two groups are mainly gradeⅠ-Ⅱ,with no grade 4 or higher events.The incidences of hand-foot syndrome in XELOX group is significantly higher than that in SOX group(P=0.020).Subgroup analyses:in patients younger than 65 years of age,the incidences of hand-foot syndrome in XELOX group is significantly higher than that inSOX group(P=0.004).In patients older than 65 years of age,The incidence of neurotoxicity in SOX group is significantly higher than that in XELOX group(P=0.031),the incidence of ALT damage in XELOX group is significantly higher than that in SOX group(P=0.040).4.The two groups were similar in patients with dose reduction of chemotherapy.Reasons for stopping chemotherapy was no significant difference of patients in the SOX group(neutropenia,thrombocytopenia,hemoglobinia,vomiting,peripheral sensory neuropathy,other)and the XELOX group(neutropenia,thrombocytopenia,vomiting,other).5.There were 11 cases of recurrence in SOX group and 13 cases in XELOX group.The recurrence and metastasis were mainly in peritoneal metastasis,lymph node metastasis,anastomotic recurrence,liver metastasis,ovarian metastasis,bone metastasis,and so on.The rate of peritoneal metastasis in the two group are no statistical significance(P=0.171).Conclusion:1.SOX regimen has an efficacy equivalent to XELOX regimen in adjuvant chemotherapy for chemotherapy for advanced gastric cancer after D2 radical operation.2.The incidences of hand-foot syndrome in XELOX group is significantly higher than that in SOX group.There were no differences in the safety and tolerability of the two chemotherapy regimens. |
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