Survival Impact of Immunotherapy in Advanced Head and Neck Squamous Cell Carcinoma: A National Cancer Database Analysis.

Abstract

We evaluated the association between immunotherapy (IO) and overall survival (OS) in advanced head and neck squamous cell carcinoma (HNSCC) and examined outcomes by IO timing. Retrospective cohort study of national NCDB 2004-2022 United States adults with Stages III-IVB HNSCC. Exposure was any IO. The primary outcome was OS from diagnosis; analyses used multivariable Cox models, 24-month landmarking, and propensity methods. Among 221 116 patients (mean age: 62), 10 023 (4.5%) received IO. Median follow-up 37 months. IO was associated with lower mortality (HR: 0.91; 95% CI: 0.89-0.94). Landmark analysis showed benefit 0-24 months (HR: 0.76; 0.74-0.79) that reversed thereafter (HR: 1.09; 1.04-1.14). By intent, median OS was 53.2 months (neoadjuvant), 50.1 months (adjuvant), 16.5 months (later-line), versus 60.7 months without IO. Propensity analyses attenuated effects (HR: ~1.00). In real-world advanced HNSCC, IO confers modest early benefit with varied long-term results; outcomes vary by timing. Prospective biomarker-stratified trials are needed.