Department of Respiratory Medicine, Kobe City Medical Center West Hospital, 2-4, Ichiban-cho, Nagata-ku, Kobe-shi, Hyogo, 653-0013, Japan.
Department of Thoracic Oncology, Osaka International Cancer Institute, 3-1-69 Otemae, Chuo-ku, Osaka, 541-8567, Japan.
BMC Cancer. 2020 Feb 3;20(1):93. doi: 10.1186/s12885-020-6582-4.
Pembrolizumab is effective as first-line therapy against advanced non-small cell lung cancer (NSCLC) in patients with programmed death ligand-1 (PD-L1) expression levels ≥50% [1]. However, it is not effective in all patients, and the factors predicting responses among this population remain unknown.
We retrospectively analyzed patients with NSCLC and a PD-L1 tumor proportion score (TPS) > 50%, who received first-line monotherapy with pembrolizumab from February 1, 2017 to April 30, 2018. The study included 11 hospitals, which participated in the Hanshin Oncology clinical Problem Evaluation group (HOPE). We analyzed the differences between responders and non-responders in terms of age, sex, performance status score, degree of progression, histological type, smoking history, expression of PD-L1, use of steroids prior to treatment, metastasis site, and laboratory data.
A total of 205 patients were included in this study. Of those, 108 patients exhibiting complete or partial response were defined as responders. Those exhibiting progressive disease (N = 52) were defined as non-responders. In the univariate analysis, Eastern Cooperative Oncology Group performance status score ≥ 2 (p = 0.0832), stage IV disease or recurrence (p = 0.0487), PD-L1 TPS 50-89% (p = 0.0657), use of steroids prior to the administration of pembrolizumab (p = 0.0243), malignant pleural effusion (p = 0.0032), and baseline C-reactive protein (CRP) levels > 1.0 mg/dL (p = 0.0390) were significantly associated with non-response to treatment. In the multivariate analysis, use of steroids prior to the administration of pembrolizumab (odds ratio [OR]: 5.86; 95% confidence interval [CI]: 1.32-31.8; p = 0.0200), malignant pleural effusion (OR: 2.68; 95% CI: 1.15-6.35; p = 0.0228), and baseline CRP > 1.0 mg/dL (OR: 2.17; 95% CI: 1.03-4.68; p = 0.0402) were significantly associated with non-response to treatment.
In real-world patients with NSCLC and a PD-L1 TPS ≥50%, use of steroids prior to treatment, malignant pleural effusion, and baseline CRP levels > 1.0 mg/dL reduced the response of first-line monotherapy with pembrolizumab.
对于程序性死亡配体 1（PD-L1）表达水平≥50%的晚期非小细胞肺癌（NSCLC）患者，帕博利珠单抗作为一线治疗是有效的[1]。然而，它并非对所有患者都有效，预测该人群反应的因素仍不清楚。
我们回顾性分析了 2017 年 2 月 1 日至 2018 年 4 月 30 日期间，在 11 家参与汉信肿瘤临床问题评估组（HOPE）的医院中，接受 PD-L1 肿瘤比例评分（TPS）>50%的一线单药帕博利珠单抗治疗的 NSCLC 患者。我们分析了应答者和无应答者在年龄、性别、表现状态评分、进展程度、组织学类型、吸烟史、PD-L1 表达、治疗前使用类固醇、转移部位和实验室数据方面的差异。
本研究共纳入 205 例患者。其中，108 例完全或部分缓解的患者定义为应答者。52 例出现疾病进展的患者定义为无应答者。单因素分析显示，东部肿瘤协作组表现状态评分≥2（p=0.0832）、IV 期疾病或复发（p=0.0487）、PD-L1 TPS 50-89%（p=0.0657）、治疗前使用类固醇（p=0.0243）、恶性胸腔积液（p=0.0032）和基线 C 反应蛋白（CRP）水平>1.0mg/dL（p=0.0390）与治疗无反应显著相关。多因素分析显示，治疗前使用类固醇（比值比[OR]：5.86；95%置信区间[CI]：1.32-31.8；p=0.0200）、恶性胸腔积液（OR：2.68；95%CI：1.15-6.35；p=0.0228）和基线 CRP>1.0mg/dL（OR：2.17；95%CI：1.03-4.68；p=0.0402）与治疗无反应显著相关。
在真实世界中，对于 PD-L1 TPS≥50%的 NSCLC 患者，治疗前使用类固醇、恶性胸腔积液和基线 CRP 水平>1.0mg/dL 降低了一线单药帕博利珠单抗治疗的反应。
