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韩春, 叶斯斯, 李娟, 乔迁, 张文胜. 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[J]. 解放军医学院学报, 2021, 42(6): 596-600, 614. DOI: 10.3969/j.issn.2095-5227.2021.06.002
引用本文: 韩春, 叶斯斯, 李娟, 乔迁, 张文胜. 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[J]. 解放军医学院学报, 2021, 42(6): 596-600, 614. DOI: 10.3969/j.issn.2095-5227.2021.06.002
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HAN Chun, YE Sisi, LI Juan, QIAO Qian, ZHANG Wensheng. Clinical outcomes of nimotuzumab combined with gemcitabine as first-line treatment for advanced pancreatic cancer[J]. ACADEMIC JOURNAL OF CHINESE PLA MEDICAL SCHOOL, 2021, 42(6): 596-600, 614. DOI: 10.3969/j.issn.2095-5227.2021.06.002
Citation: HAN Chun, YE Sisi, LI Juan, QIAO Qian, ZHANG Wensheng. Clinical outcomes of nimotuzumab combined with gemcitabine as first-line treatment for advanced pancreatic cancer[J]. ACADEMIC JOURNAL OF CHINESE PLA MEDICAL SCHOOL, 2021, 42(6): 596-600, 614. DOI: 10.3969/j.issn.2095-5227.2021.06.002
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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

    摘要
  • 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。

     

    Abstract:
      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 scale 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.

     

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