尼妥珠单抗联合吉西他滨一线治疗晚期胰腺癌的疗效观察  

Clinical outcomes of nimotuzumab combined with gemcitabine as first-line treatment for advanced pancreatic cancer

作　　者：韩春[1] 叶斯斯 李娟[1] 乔迁 张文胜 HAN Chun;YE Sisi;LI Juan;QIAO Qian;ZHANG Wensheng(Department of Oncology,the First Medical Center,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军总医院第一医学中心肿瘤内科,北京100853

出　　处：《解放军医学院学报》2021年第6期596-600,614,共6页Academic Journal of Chinese PLA Medical School

基　　金：国家重点研发计划(2016YFC1303602)。

摘　　要：背景尼妥珠单抗是以表皮生长因子受体(epidermal growth factor receptor,EGFR)为靶点的靶向药物,在国外的临床研究中取得良好的效果,但国内大规模的临床试验数据相对较少。目的探讨尼妥珠单抗联合吉西他滨(gemcitabine,GEM)一线治疗晚期胰腺癌的疗效和安全性。方法通过解放军总医院大数据平台,检索2012年1月-2019年6月在解放军总医院第一医学中心治疗的晚期胰腺癌患者的临床资料,根据不同治疗方案,通过倾向性匹配,共纳入122例晚期胰腺癌患者,联合组61例采用尼妥珠单抗+GEM,单药组61例采用GEM单药化疗。比较两组患者的一般资料、不良反应发生率、无进展生存期(progression free survival,PFS)和总生存期(overall survival,OS)。结果联合组PFS优于单药组(4.5个月vs 3.1个月,P<0.001);联合组OS也高于单药组(7.4个月vs 6.4个月,P<0.001)。多因素分析显示,GEM联合尼妥珠单抗一线治疗晚期胰腺癌可延长晚期胰腺癌患者的生存期(P<0.001)。两组间与治疗相关的不良事件发生率无统计学差异(P>0.05)。结论与GEM单药相比,尼妥珠单抗联合GEM一线治疗晚期胰腺癌可增加患者的生存获益,且未增加不良反应,对于晚期胰腺癌患者来说是一个可供选择的一线治疗方案。Background Nimotuzumab is a targeted drug targeting epidermal growth factor receptor(EGFR),which has achieved good outcomes in clinical trials abroad,while domestic clinical data in large scales is relatively small.Objective To investigate the outcomes and safety of nimotuzumab combined with gemcitabine(GEM)as the first-line treatment for advanced pancreatic cancer.Methods Through the big data platform of our hospital,clinical data about patients with advanced pancreatic cancer from January 2012 to June 2019 were searched.According to the inclusion criteria,the cases in line with this study were selected,and divided into combined therapy group(nimotuzumab+GEM monotherapy)and monotherapy group(GEM monotherapy).After matching by sex,age,and differentiation,61 cases were included in each group,and the differences of adverse reactions,progression free survival(PFS)and overall survival(OS)between the two groups were analyzed.Results The combined therapy group had significantly longer PFS(4.5 months vs 3.1 months,P<0.001)and OS(7.4 months vs 6.4 months,P<0.001)compared to the monotherapy group.Further,Cox regression analysis showed that GEM combined with nimotuzumab was associated better prognosis in patients with advanced pancreatic cancer(P<0.001).There was no significant difference in the incidence of treatment-related adverse events between the two groups(P>0.05).Conclusion Compared with GEM monotherapy,nimotuzumab combined with GEM in the first-line treatment of advanced pancreatic cancer can increase the survival benefits without increasing toxic and side effects,which is an alternative first-line treatment for patients with advanced pancreatic cancer.

关 键 词：晚期胰腺癌 尼妥珠单抗 吉西他滨 无病生存期 总生存期 

分 类 号：R735.9[医药卫生—肿瘤]