化疗联合免疫检查点抑制剂对局部晚期或转移性胃和胃-食管结合部癌患者的疗效及安全性分析

Effectiveness and safety of chemotherapy combined with immune checkpoint inhibitors for patients with advanced gastric cancer or gastric-esophageal junctional cancer

  • 摘要:
      目的  探索晚期胃和胃-食管结合部癌(gastric cancer or gastroesophageal junction cancer,GC/GEJC)患者化疗联合免疫治疗的临床特点及预期生存。
      方法  收集解放军总医院第一医学中心肿瘤内科2015年5月- 2019年5月治疗的晚期GC/GEJC患者。37例化疗患者为化疗组,采用以氟尿嘧啶(5-FU/卡培他滨/替吉奥)联合铂类或紫杉类的双药化疗,34例接受化疗联合免疫检查点(PD-1)抑制剂纳武单抗(Nivolumab)或派姆单抗(Pembrolizumab)的患者为联合组。
      结果  联合组和化疗组中位无进展生存期(progression-free survival,PFS)分别为3.93个月(95%CI:1.56 ~ 6.30)和4.97个月(95%CI:3.36 ~6.58)(P=0.242),中位总生存期(overall survivsal,OS)分别为14.37个月(95%CI:8.17 ~ 20.57)和12.52个月(95%CI:9.82 ~ 15.22)(P=0.101),客观缓解率为23.5%和18.9%(P=0.634),疾病控制率为79.4%和75.7%(P=0.707)。两组药物临床安全性良好,不良反应均以Ⅰ~Ⅱ级为主。
      结论  化疗联合免疫治疗对于晚期GC/GEJC患者有一定的临床获益,需进一步探索治疗策略及筛选免疫治疗的优势人群。

     

    Abstract:
      Objective  To explore the clinical features and survival of patients with advanced gastric cancer or gastroesophageal junctional cancer (GC/GEJC) treated by chemotherapy plus immunotherapy.
      Methods  From May 2015 to May 2019, patients with advanced GC/GEJC who were treated in the department of oncology, the first medical center of Chinese PLA General Hospital were included in our study, with 37 patients treated with chemotherapy (fluorouracil/capecitabine/tegafur combined with platinum- or taxane-based drugs) as chemotherapy group, and another 34 patients treated with chemotherapy combined with immune checkpoint inhibitors (PD-1, Nivolumab or Pembrolizumab) as combination group. Clinical outcomes were observed and compared between the two groups.
      Results  The progression-free survival (PFS) was 3.93 months (95% CI: 1.56-6.30) in the combination group and 4.97 months (95% CI: 3.36-6.58) in the chemotherapy group (P=0.242); and the overall survival (OS) was 14.37 months (95% CI: 8.17-20.57) and 12.52 months (95% CI: 9.82-15.22) (P=0.101); ORR was 23.5% and 18.9% (P=0.634), DCR was 79.4% and 75.7% (P=0.707). Mild (GradeⅠ-Ⅱ) adverse reactions were found in the two groups.
      Conclusion  Chemotherapy combined with immunotherapy has certain clinical benefits for patients with advanced GC / GEJC, and further exploration of treatment strategies and screening of target population for immunotherapy are still needed.

     

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