帕博利珠单抗二线治疗含铂化疗进展的驱动基因阴性NSCLC的临床研究

doi:10.3969/j.issn.1006-6233.2021.12.034

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摘要 目的: 研究免疫检查点抑制剂(immune checkpoint inhibitor,ICI)帕博利珠单抗(pembrolizumab)二线治疗含铂化疗进展后的驱动基因阴性的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的疗效及不良反应,指导临床治疗。方法: 收集从2018年1月到2021年4月我院收治的7838例晚期NSCLC患者的病历资料,按照标准排除后,最终纳入104例患者病理资料,共104例,按治疗方案不同分为研究组(n=51)和对照组(n=53)。研究组给予帕博利珠单抗治疗,对照组53例给予多西他赛(docetaxel)治疗。比较两组的客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、中位无进展生存期(median progression-free survival,mPFS)和不良事件率(adverse events rate)。结果: 与对照组相比,研究组的DCR(90.2%)显著提高,有统计学差异(χ²=4.803,P=0.028)。与TPS 1~49%亚组相比,研究组的中位PFS(5.2月)显著延长,但差异无统计学意义(χ²=3.560,P=0.059)。与对照组相比,研究组TPS≥50%亚组的中位PFS(6.0月)显著延长,有统计学差异(χ²=4.223,P=0.040)。在对TPS≥50%亚组中,与对照组相比,研究组的中位PFS(6.0月)显著延长,有统计学差异(χ²=5.207,P=0.023)。与对照组相比,研究组免疫性肺炎发生率较高,有统计学差异(χ²=4.630,P=0.031)。结论: 帕博利珠单抗对于含铂化疗进展后驱动基因阴性的晚期NSCLC患者可能具有更好的近期及远期疗效,且对于PD-L1 TPS≥50%的患者,使用帕博利珠单抗可能更加受益,但同时需注意可能出现的免疫相关性不良反应。

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关键词 ：非小细胞肺癌, PD-1抑制剂, 帕博利珠单抗, 多西他赛

Abstract：Objective: To study the curative effect and adverse reactions of immune checkpoint inhibitor (ICI) pembrolizumab (pembrolizumab) in the second-line treatment on patients of advanced non-small cell lung cancer (non-small cell lung cancer, NSCLC), and guide its clinical treatment. Methods: The medical records of 7838 patients with advanced NSCLC admitted to our hospital from January 2018 to April 2021 were collected. After standardized screening, the pathological data of 104 patients were finally included, and 104 cases were divided, according to different treatment plans, into study group (n=51) and control group (n=53). The study group was treated with pembrolizumab, and the control group were treated with docetaxel. The objective response rate (ORR), disease control rate (DCR), median progression-free survival (mPFS) and adverse events rate (adverse events rate) of the two groups were compared. Results: Compared with the control group, the DCR (90.2%) of the study group was significantly improved, with statistical difference (χ²=4.803, P=0.028). Compared with the control group, the median PFS (5.2 months) of the study group was significantly longer, but the difference was not statistically significant (χ²=3.560, P=0.059). Compared with the sub group with TPS 1~49%, the median PFS (6.0 months) of the subgroup with TPS≥50% in the study group was significantly longer, with statistical difference (χ²=4.223, P=0.040). In the subgroup for TPS≥50%, the median PFS (6.0 months) of the study group was significantly longer than that of the control group, with statistical difference (χ²=5.207, P=0.023). Compared with the control group, the incidence of immune pneumonia in the study group was higher with statistical difference (χ²=4.630, P=0.031). Conclusion: Pembrolizumab may have better short-term and long-term efficacy in patients with advanced NSCLC who have negative driver genes after the progression of platinum-containing chemotherapy, and for patients with PD-L1 TPS≥50%, pembrolizumab may be more effective, but at the same time attention should be paid to possible immune-related adverse reactions.

Key words： Non-small cell lung cancer PD-1 inhibitors Pembrolizumab Docetaxel

基金资助:江苏省科技计划项目,(编号:H201323)

引用本文:

陈嘉劼, 朱正秋, 单海霞, 孔飞飞. 帕博利珠单抗二线治疗含铂化疗进展的驱动基因阴性NSCLC的临床研究[J]. 河北医学, 2021, 27(12): 2090-2095.
CHEN Jiajie, et al. Efficacy and Safety of Pembrolizumab as Second-Line Treatment for Advanced Non-Small Cell Lung Cancer with Negative Driver Gene After Progression of Platinum-Based Chemotherapy. HeBei Med, 2021, 27(12): 2090-2095.

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http://www.hbyxzzs.cn/CN/10.3969/j.issn.1006-6233.2021.12.034 或 http://www.hbyxzzs.cn/CN/Y2021/V27/I12/2090

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