卡瑞利珠单抗联合白蛋白结合型紫杉醇三线及以上方案治疗晚期非小细胞肺癌患者的临床疗效及其预后的影响因素研究

Clinical Efficacy of Third-line and Beyond Therapy of Camrelizumab Combined with Albumin Bound Paclitaxel in the Treatment of Patients with Advanced Non-small Cell Lung Cancer and Their Prognostic Factors

背景目前,卡瑞利珠单抗三线及以上方案治疗晚期非小细胞肺癌(NSCLC)患者的临床疗效尚无大型临床试验报道。目的探讨卡瑞利珠单抗联合白蛋白结合型紫杉醇三线及以上方案治疗晚期NSCLC患者的临床疗效及其预后的影响因素,旨在为晚期NSCLC患者的治疗提供参考。方法回顾性选取2019年5月—2020年10月徐州医科大学附属医院收治的晚期NSCLC患者40例,均采用卡瑞利珠单抗联合白蛋白结合型紫杉醇三线及以上方案治疗。所有患者治疗3个周期后评估近期疗效,包括客观有效率(ORR)和疾病控制率(DCR);并同时评估远期疗效〔中位无进展生存期(PFS)〕,并比较不同临床特征的晚期NSCLC患者中位PFS;观察所有患者毒副作用发生情况。结果40例患者ORR、DCR分别为50.0%、72.5%,中位PFS为6.30个月。不同转移类型、表皮生长因子受体(EGFR)突变状态、用药线数、程序性死亡配体1(PD-L1)表达水平的晚期NSCLC患者中位PFS比较,差异有统计学意义(P<0.05)。40例患者中除2例(5.0%)发生3级血液学毒性外,其他均为1~2级毒副作用;所有患者毒副作用可耐受,经对症处理后恢复,未发生治疗相关性死亡。结论卡瑞利珠单抗联合白蛋白结合型紫杉醇三线及以上方案治疗晚期NSCLC患者的近期ORR、DCR分别为50.0%、72.5%,中位PFS为6.30个月;晚期NSCLC患者预后可能与转移类型、EGFR突变状态、用药线数、PD-L1表达水平有关。

Background At present,there is no large clinical trial reported about the clinical efficacy of third-line and beyond therapy of camrelizumab in the treatment of patients with advanced non-small cell lung cancer(NSCLC).Objective To investigate the clinical efficacy of third-line and beyond therapy of camrelizumab combined with albumin bound paclitaxel in the treatment of patients with advanced NSCLC and their prognostic factors,in order to provide reference for the treatment of advanced NSCLC patients.Methods The clinical data of 40 patients suffered from advanced NSCLC in the Affiliated Hospital of Xuzhou Medical University from May 2019 to October 2020 were retrospectively analyzed,and all patients were treated with third-line and beyond therapy of camrelizumab combined with albumin bound paclitaxel.All patients were evaluated for shortterm efficacy after 3 cycles of treatment,including objective response rate(ORR)and disease cintrol rate(DCR);the median progression free survival(PFS)was used as the long-term efficacy index,and the median PFS of was compared in advanced NSCLC patients with different clinical characteristics;and the side effects of all patients were observed.Results The and ORR and DCR of 40 patients were 50.0%and 72.5%,respectively,and the median PFS was 6.30 months.There were significant differences in median PFS among advanced NSCLC patients with different types of metastasis,epidermal growth factor receptor(EGFR)mutation status,the number of medication lines,and the expression level of programmed death ligand 1(PD-L1)(P<0.05).Except for 2 cases(5.0%)with grade 3 hematological toxicity,the other 40 patients had grade 1-2 side effects;the side effects of all patients were tolerable,recovered after symptomatic treatment,and no treatment-related death occurred.Conclusion In the advanced NSCLC patients of this group,the short-term ORR and DCR were 50.0%and 72.5%,respectively,and the median PFS was 6.30 months.The prognosis of patients with advanced NSCLC may be related to the type of metastasis,EGFR mutation status,the number of drug lines and the expression level of PD-L1.