放化疗联合尼妥珠单抗治疗中晚期食管癌的临床研究  

The clinical research nimotuzumab combined with radiotherapy and chemotherapy for advanced esophageal cancer

作　　者：孙长江[1] 陈勇[1] 

机构地区：[1]江苏省苏北人民医院肿瘤科,江苏扬州225000

出　　处：《临床医药文献电子杂志》2014年第17期2346-2348,共3页Electronic Journal of Clinical Medical Literature

摘　　要：目的探讨紫杉醇（TAX）与顺铂（DDP）组成的TP方案联合尼妥珠单抗治疗中晚期食管癌的临床疗效和毒副反应。方法将我院收治并诊断为中晚期食管癌患者42例,随机分为研究组和对照组,每组21例,研究组给予尼妥珠单抗联合TP方案治疗：尼妥珠单抗第1周400 mg,以后每周200 mg,连用6周,TAX140 mg/m2d1＋DDP30 mg/m2d1~d4,静脉滴注。对照组患者仅接受TP方案治疗。两组患者均以28 d为1个周期,共4周期。结果全部病例在放疗结束时（第7周）及完成全部治疗后3周（第16周）进行评价疗效。放疗结束时（第7周）,研究组有效率（71.43%）高于对照组（52.38%）,但差异无统计学意义（P〉0.05）。全组病例全部治疗后3周（第16周）时,研究组的有效率为90.47%,明显高于对照组（61.90%,P〈0.05）,差异有统计学意义。研究组1年、2年、3年生存率分别为：90.47%,38.10%,14.28%,对照组分别为：66.67%,14.28%,4.76%。研究组中位PFS13个月,中位生存期为19个月,对照组中位PFS为9个月,中位生存期为14个月,研究组PFS及OS均明显高于对照组,差异有统计学意义（P〈0.05）。两组患者主要不良反应为恶心、呕吐,白细胞减少,血小板减少,未见Ⅳ级不良反应。结论尼妥珠单抗联合TP方案治疗中晚期食管癌安全有效,值得进一步扩大样本研究。Objective To investigate the efficacy and toxicity of paclitaxel（TAX）and cisplatin（PDD）TP combined with nimotuzumab treatment in advanced esophageal cancer. Methods 42 patients of advanced esophageal cancer were randomly divided into study group and control group,21 cases in each group,study group were given TP combined with nimotuzumab treatment：nimotuzumab 1 week 400 mg after 200 mg per week,for 6 weeks,TAX 140 mg/m2d1 ＋ DDP 30 mg/m2d1~d4,intravenous drip.The control group patients only received the TP treatment. Results All the cases was conducted to evaluate the efficacyat the end of radiotherapy（at seventh weeks from the start of radiotherapy） and 3 weeks after all the treatment completed（at sixteenth weeks from the start of radiotherapy）. At the end of treatment（at seventh weeks from the start of radiotherapy）, the research group＇s efficiency（71.43%） was higher than the control group（52.38%）, but there was no statistical difference（P0.05）.Three weeks after all the treatment（at sixteenth weeks from the start of radiotherapy）, the study group＇s efficiency was 90.47%, which was significantly higher than the control group（61.90%, P0.05）. 1 years, 2 years,3 years survival rates ofthe study group were： 90.47%, 38.10%, 14.28% respectively,whilethe control group were：66.67%, 14.28%, 4.76%. the median PFS and median survival time in study group were 13 months and 19 monthsrespectively,and the control group were 9 months and 14 months respectively. The PFS and OS in study group were significantly higher than those in the control group（P0.05）.the main adverse reactions of the two groups were nausea,vomiting,leukopenia,thrombocytopenia,and no Ⅳ grade adverse reactions. Conclusion TP combined with nimotuzumab for advanced esophageal cancer is security,it is worth further expand the sample study.

关 键 词：食管癌 紫杉醇 顺铂 尼妥珠单抗 

分 类 号：R453.9[医药卫生—治疗学]