Two-center phase 2 trial of neoadjuvant sintilimab and chemotherapy followed by transoral surgery for HPV-positive oropharyngeal cancer

A phase 2 trial at two centers in China evaluated neoadjuvant sintilimab plus cisplatin and nab-paclitaxel followed by transoral surgery among patients with resectable HPV-positive oropharyngeal squamous cell carcinoma. Major pathologic response was achieved in 96%, including 68% with pathological complete response. There was one patient with a grade 3 treatment-related adverse events; no patients had grade 4 or 5 TRAEs. Two-year DFS and OS rates were both 96% (95% CI 88.6-100.0). Most patients experienced improved symptoms at 3 months after surgery; remaining stable at 6 and 12 months. The authors conclude that neoadjuvant immunochemotherapy followed by transoral surgery appeared to be a feasible strategy that yielded favorable oncologic and functional outcomes among patients with resectable HPV⁺ OPSCC.