谢建连, 李瑾昱, 刘哲峰. PD-1/PD-L1免疫检查点抑制剂对KRAS突变晚期NSCLC的疗效及安全性分析[J]. 解放军医学院学报, 2020, 41(6): 588-592. DOI: 10.3969/j.issn.2095-5227.2020.06.010
引用本文: 谢建连, 李瑾昱, 刘哲峰. PD-1/PD-L1免疫检查点抑制剂对KRAS突变晚期NSCLC的疗效及安全性分析[J]. 解放军医学院学报, 2020, 41(6): 588-592. DOI: 10.3969/j.issn.2095-5227.2020.06.010
XIE Jianlian, LI Jinyu, LIU Zhefeng. Efficacy and safety of PD-1/PD-L1 immune checkpoint inhibitors in KRAS-mutant advanced non-small cell lung cancer[J]. ACADEMIC JOURNAL OF CHINESE PLA MEDICAL SCHOOL, 2020, 41(6): 588-592. DOI: 10.3969/j.issn.2095-5227.2020.06.010
Citation: XIE Jianlian, LI Jinyu, LIU Zhefeng. Efficacy and safety of PD-1/PD-L1 immune checkpoint inhibitors in KRAS-mutant advanced non-small cell lung cancer[J]. ACADEMIC JOURNAL OF CHINESE PLA MEDICAL SCHOOL, 2020, 41(6): 588-592. DOI: 10.3969/j.issn.2095-5227.2020.06.010

PD-1/PD-L1免疫检查点抑制剂对KRAS突变晚期NSCLC的疗效及安全性分析

Efficacy and safety of PD-1/PD-L1 immune checkpoint inhibitors in KRAS-mutant advanced non-small cell lung cancer

  • 摘要:
      目的  比较PD-1/PD-L1免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)对于KRAS突变型及野生型晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的抗肿瘤活性及安全性。
      方法  回顾性分析2015年10月- 2019年10月于解放军总医院第一医学中心就诊且接受PD-1/PD-L1单药免疫治疗的晚期NSCLC患者的临床病例资料。本研究共纳入KRAS突变型NSCLC患者28例(男性21例,女性7例,中位年龄63岁),KRAS野生型NSCLC患者30例(男性22例,女性8例,中位年龄67岁)。入组患者接受纳武利尤单抗(3 mg/kg,每2周1次静脉输注,每4周为1个治疗周期)或帕博利珠单抗(2 mg/kg,每3周1次静脉输注,每3周为1个治疗周期)治疗,每2个周期复查评估疗效和安全性。
      结果  KRAS突变组和野生组患者近期疗效客观缓解率(25% vs 20%,P=0.648)、疾病控制率(64.3% vs 63.3%,P=0.940)的差异无统计学意义。随访截至2020年1月,KRAS突变组患者中位无进展生存期(PFS)为5.85个月(95% CI:0.00 ~ 12.26),中位总生存期(OS)为17.68个月(95% CI:13.44 ~ 21.91),KRAS野生组患者的中位PFS为6.74个月(95% CI:3.79 ~ 9.68),中位OS为15.70个月(95% CI:2.66 ~ 28.75),两组远期生存数据无统计学差异(P>0.05)。KRAS突变组和野生组的不良反应谱相似,任意级别不良事件的发生率为60.7%和56.7%(P=0.754)。
      结论  PD-1/PD-L1免疫检查点抑制剂是晚期NSCLC患者的有效且安全的治疗选择,临床结局不受KRAS突变状态的影响。

     

    Abstract:
      Objective  To compare the anti-tumor efficacy and safety of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) for advanced non-small cell lung cancer (NSCLC) presenting with or without KRAS mutation.
      Methods  From October 2015 to October 2019, clinical data about patients with advanced NSCLC who had been administrated with PD-1/PD-L1 ICIs monotherapy in the first medical center of Chinese PLA General Hospital were retrospectively analyzed. A total of 28 KRAS-positive patients (21 males and 7 females with median age of 63 years) and 30 KRAS-negative patients (22 males and 8 females with median age of 67 years) were included. The patients were administrated with Nivolumab (3 mg/kg, intravenous infusion once per two weeks, four weeks as a treatment cycle) or Pembrolizumab (2 mg/kg, intravenous infusion once per three weeks, three weeks as a treatment cycle). Clinical outcomes and adverse events were evaluated among KRAS-mutant and KRAS wild-type patients every 2 treatment cycles.
      Results  No significant difference was observed in objective response rate (ORR, 25% vs 20%, P=0.648) and disease control rate (DCR, 64.3% vs 63.3%, P=0.940) between the KRAS-mutant group and wild-type group. The follow-up lasted to January 2020. The median PFS was 5.85 months (95% CI: 0.00 to 12.26) in KRAS-mutant group compared with 6.74 months (95% CI: 3.79 to 9.68) in wild-type group, and the median OS was 17.68 months (95% CI: 13.44 to 21.91) in KRAS-mutant group, while 15.70 months (95% CI: 2.66 to 28.75) in the KRAS wild-type group, without significant difference (P > 0.05). The adverse events profile was similar in the two subgroups, with adverse events rate of 60.7% in the KRAS-mutant group versus 56.7% in the wild-type group (P=0.754).
      Conclusion  PD-1/PD-L1 ICIs are potential and safe therapeutic options for advanced NSCLC patients, regardless of KRAS mutation status.

     

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