Abstract
PD-1 inhibitor in NSCLC is effective treatment option. PD-L1 expression and tumor mutation burden (TMB) is suggested as predictive biomarker for drug efficacy, but especially in the real-world, predictive factors have not been established. Therefore, we evaluated predictive biomarker for NSCLC treated with PD-1 inhibitor in real world practice. This study evaluated 73 NSCLC patients treated with PD-1 inhibitor at St. Vincent hospital from April 2016 to January 2019. Following baseline data were recorded at the time of PD-1 inhibitor treatment: Age, Sex, ECOG performance status, PD-1 inhibitor type, line of treatment, lymphopenia, NLR (neutrophil-lymphocyte ratio), hyponatremia, presence of brain, liver and bone metastasis, EGFR status, PD-L1 expression. Progression free survival (PFS) and overall survival (OS) was evaluated and Cox survival analysis was used for these analyses. Median age was 66 years old and male was predominant (67.1%). Nivolumab and pembrolizumab was treated in 34 (46.6%) and 39 (53.4%) patients, respectively. Lymphopenia (<1,000/microleter) was 20 (27.4%) and high NLR (≥3) was 41 (56.2%). Hyponatremia (135 mEq/L) was noted in 18 (24.7%) and metastasis of brain, liver and bone were 19 (26%), 12 (16.4%) and 28 (38.4%). Median PFS and OS were 84 days and 180 days, respectively. For PFS, ECOG performance status, presence of brain, liver, bone metastasis, PD-L1 (22C3), presence of EGFR mutation, lymphopenia and NLR was significant predictive factors in univariate analysis. As independent factors, presence of liver (Hazard ratio (HR): 3.32, 95% confidence interval (CI): 1.13-9.75, P-value: 0.029), bone metastasis (HR: 2.90, 95% CI: 1.25-6.75, P-value: 0.013), high PD-L1 expression (≥50%) (HR: 0.32, 95% CI: 0.14-0.72, P-value: 0.006) and high NLR (≥3) (HR: 2.58, 95% CI: 1.16-5.77, P-value: 0.021) were remained in multivariate analysis. Regarding OS, ECOG performance status, presence of bone metastasis, hyponatremia, lymphopenia and NLR were significant predictive factor for PD-1 inhibitor. In multivariate analysis, poor ECOG status (2 or 3 compared to 0 or 1) (HR: 2.95, 95% CI 1.54-5.64, P-value: 0.001) and high NLR (≥3) (HR: 3.29, 95% CI: 1.68-6.47, P-value: 0.001) were significant predictive factors. High NLR is significant predictive biomarker for both PFS and OS in this real world study. Further studies are needed to evaluate these findings.
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