多西他赛联合PD-1/PD-L1抑制剂二线治疗晚期非小细胞肺癌的临床分析  

Clinical Analysis of Docetaxel Combined with PD-1/PD-L1 Inhibitor in Second-line Treatment of Advanced Non-small Cell Lung Cancer

作　　者：陈青 李艳[1] 张文杰 杨圣杰 王晨 郭其森[1] 史文娜[3] Qing CHEN;Yan LI;Wenjie ZHANG;Shengjie YANG;Chen WANG;Qisen GUO;Wenna SHI(Department of Oncology,Shandong Cancer Hospital and Institute,Shandong First Medical University and Shandong Academy of Medical Sciences,Jinan 250117,China;Weifang Medical University,Weifang 261000,China;Department of Pharmacy,Shandong Cancer Hospital and Institute,Jinan 250111,China)

机构地区：[1]山东第一医科大学附属山东省肿瘤医院肿瘤内科,山东第一医科大学,济南250117 [2]潍坊医学院,潍坊261000 [3]山东省肿瘤医院药学部,济南250117

出　　处：《中国肺癌杂志》2021年第9期605-612,共8页Chinese Journal of Lung Cancer

基　　金：山东省重点研发计划项目(No.2019GSF108251)资助。

摘　　要：背景与目的程序性死亡受体1(programmed cell death 1, PD-1)/程序性死亡配体1(programmed cell death ligand 1, PD-L1)抑制剂和多西他赛作为晚期非小细胞肺癌(non-small cell lung cancer, NSCLC)患者的标准二线治疗方案,治疗效果有限。多西他赛联合PD-1/PD-L1抑制剂是否能增加疗效并使患者更好地获益少有报道。本研究旨在探索多西他赛联合PD-1/PD-L1抑制剂二线治疗驱动基因阴性的IV期NSCLC的临床疗效和安全性。方法选取2018年10月1日-2020年12月31日在山东省肿瘤医院就诊的IV期NSCLC患者118例,依据治疗方法不同分为观察组(n=69)和对照组(n=49),观察组患者接受多西他赛联合PD-1/PD-L1抑制剂治疗,对照组患者接受PD-1/PD-L1抑制剂治疗,比较两组患者的临床疗效及3级以上不良反应发生情况。结果观察组疾病控制率(disease control rate,DCR)(89.9%)高于对照组(73.5%)(P=0.019),客观缓解率(objective response rate, ORR)(24.6%)与对照组(16.3%)比较差异无统计学意义(P=0.276)。随访至2021年6月22日,观察组中位无进展生存时间(progression-free survival, PFS)(7.17个月)长于对照组(4.43个月)(P=0.027)。观察组1年无进展生存率为15.6%,对照组为7.7%,差异无统计学差异(P=0.205)。治疗期间两组不良反应多为1级-2级,均可耐受,观察组患者骨髓抑制发生率高于对照组(P<0.05),余不良反应与对照组无统计学差异。Cox回归分析结果显示体能状态(performance status, PS)(P=0.020)及年龄(P=0.049)是多西他赛联合PD-1/PD-L1抑制剂治疗效果的独立预后因素。结论驱动基因阴性IV期NSCLC患者应用多西他赛联合PD-1/PD-L1抑制剂二线治疗可提高疾病控制率,延长无进展生存时间,不良反应可耐受。Background and objective Programmed cell death 1 or programmed cell death ligand 1 inhibitor(PD-1/PD-L1 inhibitor) and docetaxel, as the standard second-line treatments of advanced non-small cell lung cancer(NSCLC) patients, have limited effects. There are few studies on whether docetaxel combined with PD-1/PD-L1 inhibitor can increase the efficacy and make patients better benefit. The aim of this study is to evaluate the efficacy and safety of docetaxel combined with PD-1/PD-L1 inhibitor for the second-line treatment of stage IV NSCLC patients. Methods Stage IV NSCLC patients(n=118) who received treatment at Shandong Cancer Hospital between October 1, 2018, and December 31, 2020, were retrospectively analyzed. They were divided into observation group(n=69) and control group(n=49) according to different treatment plan. Observation group was given docetaxel plus PD-1/PD-L1 inhibitor, while control group was given PD-1/PD-L1 inhibitor. The clinical curative effect and the incidence of adverse reactions of grade 3 and above were compared between the two groups. Results The disease control rate(DCR) was higher in the observation group(89.9%) than that in the control group(73.5%)(P=0.019), and the objective response rate(ORR) showed no significant difference between observation group(24.6%) and control group(16.3%)(P=0.276). Till June 22, 2021, the 1-year PFS rate showed no difference between observation group(16.5%) and control group(7.7%)(P=0.205). During the treatment period, the adverse reactions of the two groups were mostly grade 1 to 2, and could be tolerated. The incidence of bone marrow suppression in observation group was higher than that in the control group(P<0.05), and the remaining adverse reactions were not statistically different from control group. Cox regression analysis showed that performance status(PS)(P=0.020) and age(P=0.049) were independent prognostic factors for the effect of docetaxel combined with PD-1/PD-L1 inhibitor. Conclusion The second-line treatment with docetaxel plus PD-1/PD-L1 inhi

关 键 词：肺肿瘤 多西他赛 PD1/PD-L1抑制剂 安全性 近期疗效 

分 类 号：R734.2[医药卫生—肿瘤]