Albumin-bilirubin grade as a significant prognostic factor in patients with non-small cell lung cancer treated with anti-PD-1-based therapy: A multicenter retrospective study.

Abstract

e21125 Background: Albumin-bilirubin (ALBI) grade is calculated from albumin and bilirubin values as continuous variables, allowing an accurate evaluation of liver function. Some studies showed that ALBI grade was a prognostic and predictive biomarker for the efficacy of chemotherapy in cancer patients. However, no report has examined the association between ALBI grade and outcome in patients with non-small cell lung cancer (NSCLC) treated with anti-programmed cell death-1 (PD-1)-based therapy. Methods: We retrospectively enrolled 452 patients with advanced or recurrent NSCLC treated with anti-PD-1-based therapy (nivolumab or pembrolizumab monotherapy or pembrolizumab combination therapy) between 2016 and 2019 at three medical centers in Japan. With reference to previous reports, ALBI score was calculated using the formula (log10 (total bilirubin [mg/dL] x 17.1) x 0.66) + (albumin [g/dL] x 10 x −0.085), and the score was stratified as grade 1 (≤ −2.60), grade 2 (more than −2.60 to ≤ −1.39), and grade 3 (more than −1.39). We examined the clinical impact of ALBI grade on outcome in patients with NSCLC receiving anti-PD-1-based therapy using Kaplan–Meier survival analysis with the log-rank test and Cox proportional hazards regression analysis. Results: Of the 452 patients, 158 (35.0%) patients were classified as grade 1, 271 (60.0%) as grade 2, and 23 (5.0%) as grade 3. ALBI grade was strongly correlated with performance status (PS), clinical stage, and body mass index, and mutation status ( P < 0.0001, P = 0.0077, P = 0.0050, and P = 0.0302, respectively). The Kaplan–Meier curves showed that ALBI grade was significantly associated with progression-free survival (PFS) and overall survival (OS) ( P < 0.0001 and P < 0.0001, respectively). Multivariate analyses showed that PS ( P = 0.0044), combination therapy of anti-PD-1 and chemotherapy ( P = 0.0004), programmed cell death-ligand 1 (PD-L1) expression status ( P < 0.0001), and ALBI grade ( P < 0.0001) were independent prognostic factors for PFS. Multivariate analyses also showed that PS ( P = 0.0008), combination therapy of anti-PD-1 and chemotherapy ( P = 0.0066), PD-L1 expression status ( P = 0.0006), and ALBI grade ( P < 0.0001) were independent prognostic factors for OS. In the subgroup analysis, ALBI grade effectively stratified PFS and OS regardless of PD-L1 expression status. Conclusions: We report for the first time that ALBI grade was an independent prognostic factor for PFS and OS in patients with advanced or recurrent NSCLC receiving anti-PD-1-based therapy. These findings should be validated prospectively.