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Postoperative chemoradiation with cisplatin is the standard of care for locally advanced head and neck squamous cell carcinoma (HNSCC) in patients with high risk for recurrence (e.g., pathologic findings of positive margins, extranodal extension of tumor). Whether patients with intermediate-risk disease would benefit from concurrent systemic therapy with postoperative radiation is unclear.
This multicenter, open-label, randomized phase 3 trial evaluated the efficacy of adding cetuximab to postoperative radiotherapy (RT) in patients with resected intermediate-risk HNSCC (close [<5 mm] resection margins, pathologic stage T3 or T4a tumors, pathologic N2 disease, lymphovascular or perineural invasion, or T2 oral cavity cancer with >5mm depth of …