Optimizing biomarkers of immunotherapy response in clinical studies summarizing head and neck cancer natural history

Head and neck squamous cell carcinoma (HNSCC) accounts for 139,000 new cases yearly in Europe. The TNM classification (VIII edition, 2017) is the standard staging system. Early-stage diagnosis offers a high chance of cure, but about two-thirds of patients are diagnosed at advanced stages, with 27-50% relapsing within two years. Long-term survival rates remain low, and current treatments have reached their toxicity limits. Due to the common loco-regional recurrence pattern, achieving objective response and delaying disease progression are unmet clinical needs. Checkpoint inhibitors have revolutionized HNSCC treatment, receiving FDA approval for cisplatin-resistant R/M cases and are expected to move to first-line therapy. However, varying patient responses highlight the importance of considering each tumor's molecular and genetic profile for optimal treatment. This research will evaluate existing biomarkers using materials from prospective clinical trials. Over a 5-year plan, covering all stages of the disease from curative to R/M settings, the study aims to deliver a significant short-term impact on HNSCC management.