尼妥珠单抗在局部晚期食管癌同步放化疗中的疗效观察

Curative effect of nimotuzumab combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal carcinoma

目的 探讨尼妥珠单抗联合同步放化疗治疗局部晚期食管癌患者的临床疗效.方法 选择局部晚期食管癌患者80例为研究对象,按照随机数字表法分为对照组和观察组各40例.对照组给予多西紫杉醇＋顺铂（TP）方案化疗联合放疗,观察组给予尼妥珠单抗联合同步放化疗治疗,21 d为1个疗程,共进行3个疗程.评价并比较两组临床疗效;检测并比较两组治疗前后血清糖类抗原125（CA125）、糖类抗原19-9（CA19-9）、糖类抗原724（CA724）、癌胚抗原（CEA）及鳞状上皮细胞癌抗原（SCC）水平;计算并比较两组治疗期间放射性食管炎、放射性肺炎、血液学毒性及过敏反应等不良反应发生率.结果 观察组有效率为80.00%,明显高于对照组的57.50%,差异有统计学意义（χ2=4.713,P=0.030）.治疗后观察组血清CA125、CA19-9、CA724、CEA、SCC水平分别为（30.18±4.14）U/mL、（32.42±3.67）U/mL、（7.48±1.12）U/mL、（11.68±2.02）μg/L、（0.73±0.17）ng/mL,均明显低于对照组的（44.27±6.42）U/mL、（53.93±5.17）U/mL、（15.03±2.54）U/mL、（25.22±3.27）μg/L、（1.61±0.28）ng/mL,差异均有统计学意义（t=11.665、21.457、17.201、22.280、16.991,均P〈0.05）.两组放射性食管炎、放射性肺炎、血液学毒性及过敏反应发生率（7.50%比10.00%、10.00%比12.50%、2.50%比5.00%、12.50%比15.00%）差异均无统计学意义（χ2=0.157、0.125、0.346、0.105,均P〉00.05）.结论 尼妥珠单抗联合同步放化疗治疗局部晚期食管癌患者的临床疗效显著,安全性较好,能够明显降低血清CA125、CA19-9、CA724、CEA及SCC水平,值得在临床上推广应用.

Objective To study the clinical efficacy of nimotuzumab combined with concurrent chemoradio therapy in the treatment of locally advanced esophageal carcinoma . Methods 80 patients with locally advanced esophageal carcinoma were selected as subjects. They were divided into the control group and the treatment group according to the random number table method, with 40 cases in each group. The control group was treated with docetaxel plus cisplatin（TP） chemotherapy combined with radiotherapy,and the treatment group was treated with nimotuzumab combined with concurrent chemoradiotherapy. 21 days for a period of treatment and the two groups were treated for 3 periods. The clinical efficacy of the two groups after treatment was evaluated and compared. The serum carbohydrate antigen 125 （ CA125 ） , carbohydrate antigen 199 （ CA199 ） , carbohydrate antigen 724 （ CA724 ） , carcinoembryonic antigen（ CEA） and squamous cell carcinoma antigen（ SCC） levels of the two groups before and after treatment were calculated and compared. The incidence rate of adverse reactions, including radioactive esophagitis, radioactive pneumonia,hematology toxicity and allergic reaction were calculated and compared between the two groups during the treatment. Results The effective rate of the treatment group was 80. 00%,which was significantly higher than 57. 50% of the control group（χ2 =4. 713,P=0. 030）. The serum CA125,CA199,CA724,CEA and SCC levels of the treatment group after treatment were （30. 18 ± 4. 14） U/mL,（32. 42 ± 3. 67） U/mL,（7. 48 ± 1. 12） U/mL, （11. 68 ± 2. 02 ）μg/L, （ 0. 73 ± 0. 17 ） ng/mL, which were significantly lower than those of the control group [（44.27 ±6. 42） U/mL,（53. 93 ± 5. 17） U/mL,（15. 03 ± 2. 54） U/mL,（25. 22 ± 3. 27）μg/L,（1. 61 ± 0. 28）ng/mL]（t=11. 665,21. 457,17. 201,22. 280,16. 991,all P〈0. 05）. There were no significant differences in the incidence rates of adverse reactions, including the radioactive esophagitis, radioactive pneumonia, hematology toxicity and allergic reaction （7. 50% vs. 10. 00%,10. 00% vs. 12. 50%,2. 50% vs. 5. 00%,12. 50% vs. 15. 00%） between the two groups（χ2 =0. 157,0. 125,0. 346,0. 105,all P〉00. 05）. Conclusion Nimotuzumab combined with concurrent chemoradiotherapy in the treatment of locally advanced esophageal carcinoma has remarkable clinical efficacy and good safety,which can significantly reduce the serum CA125,CA199,CA724,CEA and SCC levels,and it is worthy of clinical application.