![]() Abbreviations: AJCC American Joint Committee on Cancer ATC Anaplastic thyroid carcinoma BICR Blinded Independent Central Radiology CAR Chimeric antigen receptor CPS Combined positive score CR Complete response cSCC Cutaneous squamous cell carcinoma CT Chemotherapy EBV Epstein-Barr virus ECOG Eastern Cooperative Oncology Group EGFR Epidermal growth factor receptor EORTC QLQ-C30 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 module EQ-5D-3 L European Quality of Life–5 Dimensions FDA U.S.Head and neck squamous cell carcinoma (HNSCC).Due to country-specific variances in approvals, availability and regulations regarding the discussed agents, this panel focused solely on FDA-approved drugs for the treatment of patients in the U.S. These consensus guidelines serve as a foundation to assist clinicians’ understanding of the role of immunotherapies in this disease setting, and to standardize utilization across the field for patient benefit. In light of the introduction of these novel therapies for the treatment of patients with head and neck cancer, The Society for Immunotherapy of Cancer (SITC) formed an expert committee tasked with generating consensus recommendations for emerging immunotherapies, including appropriate patient selection, therapy sequence, response monitoring, adverse event management, and biomarker testing. These approvals marked the first new therapies for these patients since 2006, as well as the first immunotherapeutic approvals in this disease. Then in 2019, the FDA granted approval for PD-1 inhibition as first-line treatment for patients with metastatic or unresectable, recurrent HNSCC, approving pembrolizumab in combination with platinum and fluorouracil for all patients with HNSCC and pembrolizumab as a single agent for patients with HNSCC whose tumors express a PD-L1 combined positive score ≥ 1. The European Commission followed in 2017 with approval of nivolumab for treatment of the same patient population, and shortly thereafter with approval of pembrolizumab monotherapy for the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a ≥ 50% tumor proportion score and have progressed on or after platinum-containing chemotherapy. In 2016, the US Food and Drug Administration (FDA) granted the first immunotherapeutic approvals – the anti-PD-1 immune checkpoint inhibitors nivolumab and pembrolizumab – for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (HNSCC) that is refractory to platinum-based regimens. Improvement in outcomes are needed for patients with recurrent and or metastatic squamous cell carcinoma of the head and neck (HNSCC). Head and neck cancers, including those of the lip and oral cavity, nasal cavity, paranasal sinuses, oropharynx, larynx and nasopharynx represent nearly 700,000 new cases and 380,000 deaths worldwide per annum, and account for over 10,000 annual deaths in the United States alone. Publisher’s Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Aff14 The Immunotherapy Foundation San Diego CA.Aff13 0000 0004 0378 8294 grid.62560.37 Brigham and Women’s Hospital and Dana-Farber Cancer Institute Boston MA.Aff10 0000 0004 1936 7486 grid.6572.6 Institute of Head and Neck Studies and Education University of Birmingham Birmingham.Aff9 0000 0001 0807 2568 grid.417893.0 Fondazione IRCCS Istituto Nazionale dei Tumori Milan and University of Milan Milan. ![]() Aff8 0000 0004 0456 9819 UPMC Hillman Cancer Center Pittsburgh PA.Aff7 0000 0001 2171 9952 grid.51462.34 Memorial Sloan Kettering Cancer Center New York NY.Aff4 0000 0001 2291 4776 grid.240145.6 The University of Texas MD Anderson Cancer Center Houston TX.Aff3 0000000419368710 grid.47100.32 Yale School of Medicine and Yale Cancer Center New Haven CT.Franz Cancer Center Providence Cancer Institute Portland OR Chiles Research Institute at the Robert W. Aff1 0000 0001 2107 4242 grid.266100.3 Moores Cancer Center University of California San Diego San Diego CA.
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