P3.01-63 Baseline Biomarkers for Outcome of Advanced NSCLC Patients Receiving Anti-PD1/PD-L1 Treatment—Data from a Chinese Population

Abstract

Immune checkpoint inhibitor therapy has shown optimal efficacy in advanced non-small-cell lung cancer (NSCLC). However, the biomarkers of immunotherapy response are not well established. In the present study, we aimed to determine baseline prognostic factors associated with progression-free survival (PFS) in anti-PD1/PD-L1 treatment and to identify a predictive biomarker for immunotherapy response. Data of 54 advanced NSCLC patients receiving anti-PD1/PD-L1 treatment were prospectively collected in Shanghai Chest Hospital from Dec. 2015 to May 2017. Clinical data included baseline routine blood examination and demographic characteristics of patients prior to immunotherapy. Systemic inflammatory biomarkers were obtained from routine blood tests to calculate leukocyte-to-lymphocyte ratio (LLR), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR) and systemic immune-inflammation index (SII, neutrophil × platelet/lymphocyte). Receiver operating characteristic (ROC) and area under the curve (AUC) were used to identify the optimal cut-off value of LLR, NLR, PLR, LMR and SII for survival analysis. Endpoints were PFS and objective response rate (ORR) following anti-PD1/PD-L1 treatment. Univariate survival analysis for PFS was used by Kaplan-Meier method and statistical differences were determined by Log rank test. The Cox proportional hazards model was used for multivariable analysis. A total of 54 cases were analyzed, with 38 treated with Atezolizumab and 16 treated with Nivolumab. Median PFS was 2.8±0.18 and 1.8±1.2 months, respectively (P = 0.988). 44 patients received second-line anti-PD1/PD-L1 treatment and 10 patients underwent three-line or above. The median PFS of the two groups were 2.8±0.88 and 2.8±0.23 months, respectively, (P=0.851). ROC and AUC identified LLR=6.3, NLR=4.5, PLR=124.45, LMR=3.4 and SII=1066 as the best cut-off values. Univariate survival analysis showed that LLR, age, pathological type, neutrophil percentage, hemoglobin, platelet count, albumin, serum lactate dehydrogenase (LDH), NLR and SII were associated with PFS (P<0.05). Cox multivariate analysis showed that LLR (P=0.003；HR 2.99；95%CI：1.45-6.17), albumin (P=0.000；HR 8.11； 95%CI：2.63-25.06) and LDH (P=0.000；HR 4.55；95%CI：2.13-9.73) were independent prognostic factors for PFS. For patients with favorable (1 IN 3 factors), (2 IN 3 factors) and (3 IN 3 factors) biomarker profile median PFS were 0.94, 1.63 and 8.17 months, respectively (P =0.000) . Blood markers predict survival in advanced NSCLC treated with immune checkpoint blockade. Our findings show that baseline LLR≤6.3, normal serum levels of albumin and LDH were independently and advantageously associated with the PFS of patients receiving anti-PD1/PD-L1 treatment, and they may help identify patients with benefit from immune therapy.