卡培他滨联合奥沙利铂治疗胃癌的临床研究OA

Objective To observe the clinical efficacy and safety of capecitabine tablets combined with oxaliplatin for injection(XELOX)in the treatment of gastric cancer.Methods Patients with stage Ⅱ gastric cancer who underwent D2 radical surgery in the hospital were divided into control group and treatment group by the random number table method.Starting at 4 weeks postoperatively,the control group was administered tegifur capsules with dosage adjusted based on body surface area of 40 or 60 mg,taken twice daily for 14 consecutive days,followed by a 1-week break,with each 21-day cycle repeated for 8 consecutive cycles.The treatment group received 130 mg·m-2 of intravenous oxaliplatin on the first postoperative day,followed by capecitabine tablets at 1 000 mg·m-2 per dose,twice daily from days 1 to 14,followed by a 1-week break,with each 21-day cycle repeated for 8 consecutive cycles.The carcinoembryonic antigen(CEA),carbohydrate antigen 72-4(CA72-4),carbohydrate antigen 19-9(CA19-9),microRNA-34a(miR-34a),disease-free survival(DFS)and overall survival(OS)were compared between the two groups,and the safety evaluation was performed.Results A total of 150 patients were screened,and 130 cases were enrolled in the trial,including 65 cases in control group(with 5 dropouts)and 65 cases in treatment group(with 5 dropouts).Ultimately,60 patients from each group were included in the statistical analysis.After 8 cycles of treatment,CEA levels in treatment group and control group were(4.83±1.22)and(6.33±1.14)ng·mL-1,CA19-9 levels were(24.33±3.58)and(28.86±4.18)U·mL-1,CA72-4 levels were(5.48±1.22)and(7.27±1.55)μg·L-1,the relative expression levels of miR-34a were 2.57±0.45 and 2.13±0.42,respectively.Compared with control group,the aforementioned indicators in treatment group showed statistically significant differences(all P＜0.05).The median DFS values in treatment group and control group were 56 and 48 months,respectively,and the difference in DFS survival curve between the two groups was statistically significant(P＜0.05);the median OS values were 62 and 60 months,respectively,and there was no statistically significant difference between the two groups(P＞0.05).Adverse drug reactions in treatment group included leukopenia,thrombocytopenia and peripheral neurotoxicity,while those in control group included leukopenia and thrombocytopenia.The incidence rates of peripheral neurotoxicity in treatment group and control group were 6.67％(4 cases/60 cases)and 0％(0 cases/60 cases),the incidence rates of hand-foot syndrome were 21.67％(13 cases/60 cases)and 0％(0 cases/60 cases),the incidence rates of grade≥ Ⅲ leukopenia were 16.67％(10 cases/60 cases)and 5.00％(3 cases/60 cases),the incidence rates of grade≥ Ⅲ thrombocytopenia were 8.33％(5 cases/60 cases)and 0％(0 cases/60 cases),respectively.The incidence rates of the aforementioned adverse drug reactions in treatment group were statistically significantly different from those in control group(all P＜0.05).Conclusion The application of XELOX regimen as postoperative adjuvant chemotherapy for stage Ⅱ gastric cancer can effectively improve the levels of tumor markers and prolong the DFS,and has more obvious advantages compared to tegafur capsule gimeracil oteracil potassium single-drug regimen,but the adverse drug reactions are also more obvious.