| Objective: Compare the adverse reactions of perioperative chemotherapy with SOX and XELOX regimens in patients with advanced gastric cancer,to investigate the safety of neoadjuvant chemotherapy and the safety of the two chemotherapy regimens,and to further analyze the influencing factors of chemotherapy tolerance.Methods: A multi-center,prospective,open-label,randomized controlled Phase III clinical trial(NCT01516944)included 749 potentially resectable advanced gastric cancer patients.Subjects eligible for admission to the disease were randomly assigned to A,B,C Three groups,including 290 cases in group A(surgery + SOX regimen adjuvant chemotherapy),223 cases in group B(neoadjuvant chemotherapy in SOX regimen + surgery + SOX regimen adjuvant chemotherapy),236 cases in group C(XELOX regimen neoadjuvant chemotherapy + Surgery + XELOX Adjuvant Chemotherapy).Observe and compare the incidence of adverse reactions between A and B,B and C groups;the incidence of adverse reactions during neoadjuvant and adjuvant chemotherapy in groups B and C,and the completion of 6 cycles of perioperative chemotherapy in groups A,B,and C;Investigate the safety of neoadjuvant chemotherapy and the safety of both chemotherapy regimens,and further analyze the factors that influence the tolerability of chemotherapy.Results:1.The incidence of elevated III-IV creatinine in group B was higher than that in group A(P<0.05).The rate of completion of six cycles of chemotherapy in group B(169/223,75.78%)was higher than that of group A(139/243,57.20%),and the difference was statistically significant(P<0.05).The number of cycles completed in group B was 6.89±2.278,and the number of cycles completed in group A was 6.13±2.712,with a statistically significantdifference(P<0.05).2.The incidence of III-IV neutropenia in group B was higher than that in group C,and The incidence of III-IV nausea and hand-foot syndrome was lower than that in group C(P<0.05).Two cases(2/223,0.90%)in group B had severe granulocytopenia.The proportion of complete chemotherapy in both groups was significantly higher in group B(169/223,75.78%)than in group C(147/236,62.28%).The number of completed cycles in group B was 6.89±2.278 and the number in group C was 6.27±2.906.3.In Group B,Postoperative III-IV neutrophil count decreased,liver enzymes increased,total bilirubin increased,creatinine increased and the incidence of hand-foot syndrome was higher than before surgery,the difference was statistically significant(P<0.05).4.In Group C,the number of III-IV neutrophils decreased,the levels of liver enzymes,total bilirubin and creatinine increased,and the incidence of nausea and hand-foot syndrome were significantly higher than that of preoperative neoadjuvant chemotherapy(P<0.05).5.Logistic regression analysis showed that Older age,III-IV hand-foot syndrome,and nutritional risk were independent risk factors for perioperative chemotherapy tolerance in patients with advanced gastric cancer who had SOX and XELOX regimens.Conclusion:1.SOX and XELOX regimen for advanced gastric cancer,preoperative neoadjuvant chemotherapy has better safety than postoperative adjuvant chemotherapy,and can improve the completion rate of perioperative chemotherapy.2.Both SOX and XELOX chemotherapy have good safety,but perioperative SOX regimen chemotherapy is well tolerated,but the SOX regimen had better perioperative chemotherapy compliance.3.Compared with the SOX regimen,the XELOX regimen is more suitable for advanced gastric cancer patients with poor bone marrow reserve dysfunction,but the XELOX regimen has a higher incidence of hand-footsyndrome and nausea4.Older age,III-IV hand-foot syndrome,and nutritional risk were independent risk factors for perioperative chemotherapy tolerance in patients with advanced gastric cancer who had SOX and XELOX regimens. |
