帕博利珠单抗联合放化疗治疗晚期非小细胞肺癌患者的临床疗效与安全性

Clinical efficacy and safety of pembrolizumab combined with chemoradiotherapy in the treatment of patients with stageⅢ/Ⅳnon-small-cell lung cancer

目的探讨同步放化疗联合PD-1抑制剂帕博利珠单抗治疗晚期非小细胞肺癌的临床效果及安全性。方法将我院于2017年9月至2020年6月收治的73例晚期非小细胞肺癌患者随机分为同步放化疗组和帕博利珠单抗组。其中,同步放化疗组37例,治疗方案为同步放化疗(三维适行放疗+顺铂+吉西他滨);帕博利珠单抗组36例,治疗方案为同步放化疗+帕博利珠单抗。观察两组疗效、总生存率和不良反应。结果两组患者的疾病控制率(DCR)、1年总生存率(OS)和药物相关不良反应发生率比较,差异无统计学意义(P>0.05)。帕博利珠单抗组的总有效率(ORR)高于同步放化疗组(83.33%vs.51.35%,P<0.01)。此外,帕博利珠单抗组的1年无进展生存率(PFS)高于同步放化疗组(83.43%vs.55.47%,P<0.05)。治疗后,两组患者FACT-L各维度评分及总分均较治疗前显著升高(P<0.05),且帕博利珠单抗组的上升幅度高于同步放化疗组。结论对无法手术的晚期非小细胞肺癌患者,采用帕博利珠单抗联合同步放化疗可提高患者的近期疗效、生活质量和1年PFS,表明帕博利珠单抗联合同步放化疗具有良好的安全性和耐受性。

Objective To observe the clinical efficacy and safety of pembrolizumab combined with chemoradiotherapy in the treatment of stageⅢ/Ⅳnon-small-cell lung cancer(NSCLC).Methods Totally 73 patients with stageⅢ/ⅣNSCLC in our hospital from September 2017 to June 2020 were included and randomly assigned into pembrolizumab group(n=36)and chemoradiotherapy group(n=37).Patients in chemoradiotherapy group received routine chemoradiotherapy(3D-CRT+cis-platinum+gemcitabine),and patients in pembrolizumab group were treated with pembrolizumab combined concurrently with chemoradiotherapy.The clinical efficacy,overall survival(OS)and adverse reactions were observed.Results There was no significant difference in the diseased control rate(DCR),1-year OS and the rate of adverse reaction between the two groups(P>0.05).The overall response rate(ORR)of pembrolizumab group was higher than that of chemoradiotherapy group(83.33%vs.51.35%,P<0.01).The 1-year progression-free survival(PFS)rate of pembrolizumab group was higher than that of chemoradiotherapy group(83.43%vs.55.47%,P<0.05).After treatment,the total FACT-L score and the score of each dimension were increased(P<0.05),and the improvement in pembrolizumab group was higher than that in chemoradiotherapy group(P<0.05).Conclusion Pembrolizumab combined with chemoradiotherapy can improve the short-term efficacy,quality of life,and 1-year PFS in the treatment of stageⅢ/ⅣNSCLC,and the therapeutic regimen has good safety and tolerance.