Hematological predictive markers for recurrent or metastatic squamous cell carcinomas of the head and neck treated with nivolumab: A multicenter study of 88 patients
Takashi Matsuki, Isaku Okamoto, Chihiro Fushimi, Michi Sawabe, Daisuke Kawakita, Hiroki Sato, Kiyoaki Tsukahara, Takahito Kondo, Takuro Okada, Yuichiro Tada, Kouki Miura, Go Omura, Taku Yamashita
Abstract
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.