Background: 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.
Conclusions: The second-line treatment with docetaxel plus PD-1/PD-L1 inhibitor in patients with stage IV NSCLC can improve the DCR and prolong the PFS, and the adverse reactions are tolerable.
【中文题目：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】 【中文摘要：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。 】 【中文关键词：肺肿瘤；多西他赛；PD1/PD-L1抑制剂；安全性；近期疗效】.
Keywords: Docetaxel; Efficacy; Lung neoplasms; PD-1/PD-L1 inhibitor; Safety.