重组人血管内皮抑制素联合程序性细胞死亡蛋白1抑制剂治疗晚期非小细胞肺癌的效果及安全性分析

Efficacy and safety analysis of combined therapy with recombinant human endostatin and programmed death-1 inhibitor for advanced non-small cell lung cancer

目的探讨持续静脉泵入重组人血管内皮抑制素联合程序性细胞死亡蛋白1(PD-1)抑制剂治疗晚期非小细胞肺癌(NSCLC)的临床效果及安全性。方法回顾性选取2020年1月至2022年1月于中国人民解放军联勤保障部队第九八〇医院接受治疗的晚期NSCLC患者90例,根据治疗方案不同分为A、B、C组,各30例。A组选用PD-1抑制剂+重组人血管内皮抑制素注射液+含铂两药的治疗方案;B组选用PD-1抑制剂+含铂两药的治疗方案;C组选用重组人血管内皮抑制素注射液+含铂两药的治疗方案。主要研究终点为客观缓解率(ORR)及无进展生存期(PFS),次要研究终点为疾病控制率(DCR)及安全性。结果3组ORR、DCR比较差异均有统计学意义(P=0.039、0.018),其中A组ORR、DCR[50.0%(15/30)、83.3%(25/30)]均最高。A、B、C组中位PFS分别为7.4、5.6、5.7个月,3组PFS比较差异有统计学意义(P<0.001)。多因素Cox回归模型分析结果显示性别、表皮生长因子受体突变及转移器官数量是影响晚期NSCLC患者PFS的危险因素(均P<0.05)。A组发生不良反应总计55例次,其中严重不良反应(3~4级)4例。B组发生不良反应总计54例次,其中严重不良反应(3~4级)4例。C组发生不良反应总计51例次,其中严重不良反应(3~4级)2例。结论重组人血管内皮抑制素联合PD-1抑制剂治疗晚期NSCLC显现出了良好的临床效果,且不良反应相对可控。

Objective To investigate the clinical efficacy and safety of continuous intravenous infusion of recombinant human endostatin in combination with programmed death-1(PD-1)inhibitor for advanced non-small cell lung cancer(NSCLC).Methods Totally 90 patients with advanced NSCLC admitted to 980th Hospital of the Joint Service Support Force of the Chinese People′s Liberation Army were retrospectively selected from January 2020 to January 2022.They were divided into groups A,B and C,30 cases in each group,based on distinct treatment protocols.Group A received PD-1 inhibitor+recombinant human endostatin injection,and platinum-containing two-drug treatment.Group B received PD-1 inhibitor and platinum-containing two-drug.Group C received recombinant human endostatin injection and platinum-containing two-drug.The primary endpoints included the objective remission rate(ORR)and progression-free survival(PFS),with secondary endpoints being the disease control rate(DCR)and safety.Results Statistically significant differences were observed in ORR and DCR among the three groups(P=0.039,0.018),with the highest ORR and DCR[50.0%(15/30),83.3%(25/30)]in group A.The median PFS was 7.4,5.6,and 5.7 months in groups A,B,and C,respectively,and there was statistically significant difference among the three groups(P<0.001).Multivariate Cox regression model analysis revealed that gender,epidermal growth factor receptor mutation,and the number of metastatic organs were risk factors affecting the PFS of advanced NSCLC patients(all P<0.05).In group A,there were 55 cases of adverse reactions,including 4 cases classified as serious adverse reactions(grades 3-4).Group B had 54 cases of adverse reactions,with 4 cases classified as serious adverse reactions(grades 3-4).Group C experienced 51 cases of adverse reactions,including 2 cases classified as serious adverse reactions(grades 3-4).Conclusion The combination of recombinant human endostatin and PD-1 inhibitor exhibited favorable clinical efficacy in treating advanced NSCLC,with relatively manageable adverse reactions.