Real-World Efficacy of First-Line Pembrolizumab in Patients With Advanced or Recurrent Non–Small-Cell Lung Cancer and High PD-L1 Tumor Expression

• Published in: Clinical lung cancer Vol. 21; no. 5; pp. e366 - e379
• Main Authors: Tambo, Yuichi, Sone, Takashi, Shibata, Kazuhiko, Nishi, Kouichi, Shirasaki, Hiroki, Yoneda, Taro, Araya, Tomoyuki, Kase, Kazumasa, Nishikawa, Shingo, Kimura, Hideharu, Kasahara, Kazuo
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2020
• Subjects: First-line pembrolizumab; Immune checkpoint inhibitor; Immune-related adverse events; Real-world data; Tumor proportion score of more than 50; Immune-related adverse events; Immune checkpoint inhibitor; Tumor proportion score of more than 50; First-line pembrolizumab; Real-world data
• ISSN: 1525-7304; 1938-0690
• DOI: 10.1016/j.cllc.2020.02.017

In clinical trials, first-line treatment with pembrolizumab improved overall survival (OS) in patients with advanced non–small-cell lung cancer (NSCLC) with a programmed death ligand 1 (PD-L1) tumor proportion score of ≥ 50%. However, data on the efficacy of this treatment between clinical trials and actual clinical practice are inconsistent. Ninety-five patients with histologically diagnosed advanced or recurrent NSCLC and a PD-L1 tumor proportion score of ≥ 50% who received pembrolizumab as first-line treatment were consecutively enrolled onto this multicenter retrospective study from February 2017 to December 2018. Clinical data were collected from electronic medical records. We assessed the objective response rate, progression-free survival (PFS), OS, and immune-related adverse events (irAE), and determined their associations with clinical characteristics. The objective response rate was 40.0%. The median PFS was 6.1 months, and OS did not reach the median. Multivariate analyses revealed that nonadenocarcinoma histology (hazard ratio, 1.78; 95% confidence interval, 1.05-3.03; P = .015) and ≥ 3 metastatic sites (hazard ratio, 3.97; 95% confidence interval, 1.97-8.01; P < .001) were independently correlated with poor PFS. Patients with irAE and patients without interstitial lung disease had significantly longer PFS (14.0 and 4.9 months, respectively; P = .011) than patients without irAE or patients with interstitial lung disease. The outcome of patients receiving first-line pembrolizumab treatment was worse in those with nonadenocarcinoma and with a large number of metastatic sites. Patients with irAE and without interstitial lung disease had a more favorable outcome. To clarify the real-world efficacy and safety of first-line pembrolizumab, we assessed 95 consecutive patients with programmed death ligand 1 strongly expressed non–small-cell lung cancer in a retrospective multicenter trial. Nonadenocarcinoma and a large number of metastatic sites correlated with poor progression-free survival (PFS). PFS and overall survival (OS) were longer in patients with pembrolizumab-related adverse events; however, PFS and OS were shorter in patients with interstitial lung disease.