Hematological predictive markers for recurrent or metastatic squamous cell carcinomas of the head and neck treated with nivolumab: A multicenter study of 88 patients

Background There is increasing evidence that immunotherapy with nivolumab, an anti-programmed death 1 monoclonal antibody, is effective in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). However, the predictive role of hematological inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and the modified Glasgow prognostic score (mGPS) in patients with R/M SCCHN treated with nivolumab remains unclear. Methods We conducted a multi-institutional cohort study to evaluate the impact of pretreatment NLR and mGPS on overall survival (OS) and progression-free survival (PFS) in patients with R/M SCCHN treated with nivolumab in Japan. From 2012 to 2013, 102 patients were eligible, of whom 88 were finally included in the analysis. mGPS was calculated as follows: mGPS of 0, C-reactive protein (CRP) <= 1.0 mg/dL; 1, CRP > 1.0 mg/dL; and 2, CRP > 1.0 mg/dL and albumin < 3.5 mg/dL. Optimal cutoff point of dichotomized NLR was calculated using the area under the receiver operating characteristic curve (AUROC). Hazard ratios (HRs) and 95% confidence intervals (95% CIs) were estimated by Cox proportional hazard models adjusted by potential confounders. Results Higher NLR was significantly associated with worse survival (1-year OS: 45.3% vs 16.3%, log-rank P-value < .001, adjusted HR: 4.40 (95% CIs: 1.78-10.88); one-year PFS: 39.1% vs 9.0%, P-value = .001, adjusted HR: 3.37 (95% CI: 1.64-6.92)). In addition, high mGPS (=2) was significantly associated with worse survival compared to low mGPS (=0) (1-year OS: 37.4% vs 26.1%, P-value = .004, adjusted HR: 4.20 (95% CI:1.54-11.49); 1-year PFS: 41.5% vs 24.8%, P-value = .007, adjusted HR: 2.01 (95% CI: 0.87-4.68)). These associations were consistent with subgroup analyses stratified by potential confounders. Conclusions Pretreatment NLR and mGPS might be predictive markers of survival in patients with R/M SCCHN treated with nivolumab.