Abstract
Programmed death‐ligand 1 (PD‐L1) expression status is inadequate for indicating nivolumab in patients with non–small cell lung cancer (NSCLC). Because the baseline advanced lung cancer inflammation index (ALI) is reportedly associated with patient outcomes, we investigated whether the pretreatment ALI is prognostic in NSCLC patients treated with nivolumab. We retrospectively reviewed the medical records of all patients treated with nivolumab for advanced NSCLC between December 2015 and May 2016 at three Japanese institutes. Multivariate logistic regression and Cox proportional hazards models were used to assess the impact of the pretreatment ALI (and other inflammation‐related parameters) on progression‐free survival (PFS) and early progression (i.e., within 8 weeks after starting nivolumab). A total of 201 patients were analyzed; their median age was 68 years (range, 27–87 years), 67% were men, and 24% had an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher. An ECOG performance status ≥2, serum albumin <3.7 g/dL, neutrophil‐to‐lymphocyte ratio ≥4, and ALI <18 were significantly associated with poor PFS and early progression on univariate analysis. Multivariate analyses revealed that pretreatment ALI <18 was independently associated with inferior PFS (median, 1.4 vs. 3.7 months, P < 0.001) and a higher likelihood of early progression (odds ratio, 2.76; 95% confidence interval 1.44–5.34; P = 0.002). The pretreatment ALI was found to be a significant independent predictor of early progression in patients with advanced NSCLC receiving nivolumab, and may help identify patients likely to benefit from continued nivolumab treatment in routine clinical practice.
Highlights
Immunotherapy represents a major breakthrough in cancer treatment
We found that the pretreatment advanced lung cancer inflammation index (ALI) was found to be a strong independent predictor of progression-free survival (PFS) and early progression in patients with previously treated non–small cell lung cancer (NSCLC) who received nivolumab
Eastern Cooperative Oncology Group (ECOG) PS, serum a lbumin (ALB), neutrophil- to-lymphocyte ratio (NLR), and ALI were associated with PFS and early progression
Summary
Immunotherapy represents a major breakthrough in cancer treatment. Nivolumab is a fully humanized immunoglobulin G4 antibody that inhibits programmed death-1 (PD-1), a T-cell checkpoint receptor protein. Nivolumab disrupts the interaction of PD-1 with its ligands PD-L1 and PD- L2. In two recent phase III studies [1, 2], nivolumab showed a survival benefit over docetaxel in patients who were previously treated for advanced non–small cell lung cancer (NSCLC). While PD-L1 expression does correlate with treatment outcomes, whether its expression status is the optimal biomarker for indicating nivolumab in lung cancer patients remains unclear [3, 4]. Additional novel biomarkers predictive of nivolumab efficacy that can complement PD-L1 expression status are required to identify
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