Kanazawa University Hospital

Use of pembrolizumab as first-line treatment in patients with non-small cell lung cancer (NSCLC) with PD-L1 tumor proportion score (TPS) ≥ 50 % was approved in Japan 5 years ago.We investigated the long-term efficacy and safety of this treatment in a real-world setting.This multicenter observational study enrolled 95 consecutive cases of histol. diagnosed advanced or recurrent NSCLC with a PD-L1 TPS score ≥ 50 %, who received pembrolizumab as first-line treatment between Feb. 2017 and Dec. 2018.Clin. data were collected from electronic medical records.PD-L1 TPS scores were assessed immunohistochem., using the 22C3 antibody.The median follow-up period was 71.1 mo.The median progression-free survival (PFS) was 6.9 mo (95 % confidence interval [CI]; 4.7-9.1 mo), and the 2-, 3-, and 5-yr PFS rates were 24.9 %, 19.3 %, and 14.2 %, resp.The median overall survival (OS) was 19.1 mo (95 %CI; 13.3-24.9 mo).The 2-, 3-, and 5-yr OS rates were 42.7 %, 33.9 %, and 24.8 %, resp.On multivariate anal., histol. (squamous vs. non-squamous cell carcinoma; hazard ratio [HR] 2.23, 95 %CI 1.40-3.89, p = 0.001) and number of metastatic sites (< 3 vs. ≥ 3; HR 4.65 95 %CI 2.51-8.62, p < 0.001) independently affected long-term survival.Immune-related adverse events occurred in 43 cases (45.3 %; 20 [21.0 %] Grade ≥ 3).The real-world 5-yr survival rate of NSCLC cases with PD-L1 ≥ 50 % treated with first-line pembrolizumab was comparable to that in a clin. trial.Histol. type and number of metastatic sites influenced long-term and 5-yr survival.